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Archive for the ‘Neuropathy’ Category

Tri-State Neuropathy Centers continues to expand its peripheral neuropathy treatment practice in the tri-state area to continue its mission to help…

Tuesday, August 17th, 2021

Originally known as Neuropathy Treatment Centers of PGH, Tri-State Neuropathy Centers was established in 2013 by Dr. Shawn Richey and served patients only from their Wexford office until 2015 when expansions began. There are now five locations with three of those located in Pennsylvania (Monroeville, Washington, and Wexford), one in Poland, Ohio, and one in Weirton, West Virginia.

Approximately 30 million Americans suffer from peripheral neuropathy and its debilitating symptoms of painful cramping, burning and tingling, numbness in the feet, legs and/or hands, difficulty walking and even interruption of sleep. Tri-State Neuropathys program has had a phenomenal satisfaction rate and has seen thousands of patients suffering with peripheral neuropathy who have tried everything including potentially harmful medications and other painful testing and treatments. This can leave patients still struggling and wandering down the long road of endless disappointment.

With Tri-State Neuropathy Centers innovative treatments, patients now have hope and can have the pain associated with peripheral neuropathy addressed. We have treated over 8,000 patients with a 90% satisfaction rate, and we are confident that we can help improve most anyones life who has been affected by this devastating disease, said Dr. Shawn Richey, CEO, Tri-State Neuropathy Centers.

Tri-State Neuropathy Centers are 100% focused on helping people obtain relief from neuropathy, said Dr. Richey. Our proven treatment protocol is a PAINLESS, NON-INVASIVE AND DRUG-FREE therapy that utilizes advanced technology to reverse the horrible symptoms of peripheral neuropathy. It was once thought that there was no hope for neuropathy sufferers, and now there is.

Paula Connelly sought help in 2020 when her foot became numb after surgery. I was getting very depressed as my foot was numb on the side of the incision and it was affecting my life.I decided to meet with Tri State Neuropathy Centers for a free consultation. I have completed the program I am pain free and 90 percent better. I am 68 and a Grammy of 6 grandchildren.The treatment has helped me walk without a cane and be more active with my active family as my balance has improved tremendously.

Janine Caddys pain was progressing to the point where she couldnt walk. It seems like it became noticeable about 20 years ago. At first my feet would ache from time to time, then my feet would ache so bad that I had to limit my time standing or walking. I could no longer go hiking with my husband or just take a walk. I knew it was just a matter of time before I would need a wheelchair. I heard about Tri-State Neuropathy Centers and went for my free consultation to see if I was a candidate. To date, I see a significant improvement. I can take short walks, cook and I have even been gardening. It feels like a miracle.

Frank Smitts foot condition preventing him from enjoying his usual activities. Ten years ago I hurt my foot and it continued to get worse over the years. It got to the point that my feet were so sore and cold all the time. Outdoor activities are very important to me and I was losing the ability to do them. I felt there was no hope. A friend of mine learned of Tri StateNeuropathy Centers and I made an appointment. The results have been unbelievable. I have no more pain and my feet are no longer cold. My range of motion is so much better, and my balance is back. I am now enjoying all the outdoor activities I use to and am nearly 100% better.

If you are suffering with peripheral neuropathy, you may want to consult Tri-State Neuropathy Centers for a free evaluation. We offer the first initial consultation, examination and first treatment for FREE. We qualify patients to make sure they are candidates for our treatments, and of the over 8,000 patients we have qualified, we have an outstanding success rate, said Dr. Richey.

Patients can call 724-940-9000 to schedule an initial, no-cost consultation to determine if they qualify for the Tri-State Neuropathy Centers treatment program. Additionally, a free confidential online survey is available for patients on the Tri-State Neuropathy website ( Each survey is reviewed by a doctor.

Sponsored content brought to you byTri-State Neuropathy Centers.

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Tri-State Neuropathy Centers continues to expand its peripheral neuropathy treatment practice in the tri-state area to continue its mission to help...


Out of Every Ten Diabetic Patient, At least Seven are Identified with Diabetic Neuropathy – BioSpace

Tuesday, August 17th, 2021

Expanding at 5.9% CAGR, Peripheral Neuropathy to Cement Dominance in Diabetic Neuropathy Treatment Market

The diabetic neuropathy market study by Fact.MR offers compelling insights into key growth drivers and restraints impacting the market through 2031. The survey offers diabetic neuropathy demand outlook and studies opportunities existing in key segments, including type and end user. It also highlights key strategies adopted by market players to increase diabetic neuropathy sales.

Fact.MR A Market Research and Competitive Intelligence Provider: As per the insights by Fact.MR, the global market for diabetic neuropathy is anticipated to rise at a CAGR of 5.6% over the forecast period 2021-2031.

Increasing prevalence of diabetes as a result of changing lifestyles and imbalanced diets is a primary factor, supporting the growth of the diabetic neuropathy market. In 2019, it was found that over 1/10th of the worlds population suffered from diabetes.

Considering this, leading manufacturers are increasingly focusing on incorporating anti-diabetic formulations within their diversified portfolio. For instance, Janssen Global Services LLC, a leading pharmaceutical company offers a wide range of drugs including NUCYNTA, NUCYNTA ER, Duragesic and INVOKANA.

These drugs include tapentadol and canagliflozin, which help in regulating the blood sugar levels. Several other leading pharmaceutical companies are expected to join the bandwagon, while expanding their portfolio. These factors will contribute towards the growth of the diabetic neuropathy market.

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Among various types of disorders, peripheral neuropathy segment is gaining traction and exhibiting a higher sales of diabetic neuropathy formulations. As per the Fact.MR, demand outlook for peripheral neuropathy remains optimistic and it is set to expand at a CAGR of 5.9% over the upcoming years.

Besides these, hospitals have emerged as dominant end users owing to the availability of advanced infrastructure and healthcare expertise. Also higher footfall patients will continue supporting growth in demand across hospitals.

According to the study, North America is dominating the market for diabetic neuropathy, accounting for nearly 2/5 of the market revenue across the globe. Owing to factors such as increasing number of patients for getting treatment along with rising investment in research for the development of new drugs, the market in the region is expected to expand considerably over the forecast period 2021-2031.

Increasing emphasis on research and development pursuits along with innovations in drug combinations for fulfilling the dual purpose of providing symptomatic pain relief and preventing the progression of neuropathic processes will bolster future growth prospects, says a Fact.MR analyst.

Key Takeaways from Diabetic Neuropathy Market Survey

Key Drivers

Key Restraints

To learn more about Diabetic Neuropathy Market, you can get in touch with our Analyst at:

Competitive Landscape

Diabetic neuropathy manufacturers are focusing on receiving certifications from international organizations for their new product launches.

In 2017, Pfizer announced that the U.S. Food and Drug Administration (FDA) approves STEGLATRO(ertugliflozin) tablets, an oral sodium-glucose cotransporter 2 (SGLT2)inhibitor, and the fixed-dose combination STEGLUJAN (ertugliflozin and sitagliptin) tablets

For instance, in 2020, Lupin Pharmaceuticals Inc, received tentative approval from U.S. health regulator to market type 2 diabetes drugs namely Empagliflozin and Linagliptin tablets.

Some of the leading players operating in the diabetic neuropathy market profiled by Fact.MR are:

More Valuable Insights on Diabetic Neuropathy Market

Fact.MR, in its new report, offers an unbiased analysis of the global diabetic neuropathy market, analysing forecast statistics through 2021 and beyond. The survey reveals growth projections on diabetic neuropathy market with detailed segmentation:

Key Questions Covered in the Diabetic Neuropathy Market Report

Explore Fact.MRs Coverage on the Healthcare Domain

Diabetes Diagnostics Market- The demand for diabetes diagnostics is predicted to increase as a result of the COVID-19 outbreak, which has resulted in an increase in hospitalizations. Diabetes test strips are in high demand as a result of studies that show diabetics are at a higher risk of becoming seriously ill if infected with the virus. Government investment for hospitals will help to expand the market overall by making healthcare more accessible in remote areas. The diabetes diagnostics industry will see further growth as the prevalence of obesity rises. Through 2030, the global diabetes diagnostics market will be dominated by players from North America, Asia Pacific, and Europe.

Diabetes Management Software Market- The rising prevalence of type 1 and type 2 diabetes is one of the factors driving the growth of the diabetes management software industry. Diabetes patients are growing as a result of unhealthy lifestyles, poor diets, and rising stress and tensions. As a result, in recent years, the adoption of diabetes management software has increased, resulting in a favourable impact on the diabetes management software market. Another factor driving the growth of the diabetes management software market is technological advancements. One of the most important elements driving the remarkable development in the use of diabetes management software is the increasing number of younger diabetics.

OTC Analgesics Market- Over the last few years, there has been an increase in the use of off-label medications, which are inexpensive and unapproved but effective in treating ailments. Off-label medications such as tricyclic antidepressants, antihistamines, anticonvulsants, selective serotonin reuptake inhibitors, anti-anxiety medicines, and steroids are increasingly being used to treat pain sensations. Because of the widespread availability of over-the-counter analgesics, which are administered with approved medications as maintenance therapy, symptom management linked with pain has become convenient and straightforward. The market for over-the-counter analgesics has shown to have a lot of potential all over the world.

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Out of Every Ten Diabetic Patient, At least Seven are Identified with Diabetic Neuropathy - BioSpace


CCM can identify nerve damage in patients with long COVID, new study finds – Mobihealth News

Tuesday, August 17th, 2021

New research, released by a team based in Turkey, Qatar, and the United Kingdom, has indicated that a specialised eye exam can be used to identify long COVID.

Published in the British Journal of Ophthalmology, the research found that corneal confocal microscopy (CCM) a non-invasive eye test that conducts real-time imaging of corneal nerve fibres can also potentially be used to confirm suspected cases of long COVID by identifying specific nerve damage.

CCM is also used to identify other conditions, such as diabetic neuropathy, Parkinsons disease, multiple sclerosis, and dementia.


Penned by researchers from Turkeys Necmettin Erbakan University, Weill Cornell Medicine-Qatar (WCM-Q), and the UKs University of Manchester, the study stated that CCM identifies corneal small nerve fibre loss and increased DCs [dendritic cells] in patients with long COVID, especially those with neurological symptoms.

As a result, CCM could be used to objectively identify patients with long COVID.

The paper added: Long COVID is characterised by a range of potentially debilitating symptoms which develop in at least 10% of people who have recovered from acute SARS-CoV-2 infection.

Symptoms of long COVID include headache, tingling and/or numbness, neuropathic pain, a loss or change in the senses of taste and smell, and so called brain fog.


According to a statement by WCM-Q, nerve damage observed in the corneas using CCM can be reliably used as an indicator of nerve damage in other parts of the body.

CCMs value as a diagnostic tool is increased by a number of important factors: the test takes only a few minutes, is completely non-invasive, causes almost no discomfort for patients, utilises existing and widely available ophthalmic equipment, and can be done in the clinic.


The predominance of neurologic symptoms in people with long COVID prompted us to investigate whether CCM could be used to objectively identify nerve damage in patients with the disease, said Rayaz Malik, professor of medicine and assistant dean for clinical investigations at WCM-Q. We are the first group in the world to report a very strong association between nerve damage observed using CCM and long COVID.

Although the majority of people had mild COVID, patients with more severe disease had evidence of greater corneal nerve damage, suggesting that the severity of nerve damage may be related to the severity of disease at presentation.

We believe CCM has the potential to serve as an extremely valuable tool to be used by physicians to help diagnose and assess the evolution of long COVID and to determine the severity in individual cases. The identification of underlying nerve damage also allows us to think about this condition as a neurodegenerative disease, which may be amenable to treatment.

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CCM can identify nerve damage in patients with long COVID, new study finds - Mobihealth News


Spotlight on ultrasonography in the diagnosis of PND | IJGM – Dove Medical Press

Tuesday, August 17th, 2021


Entrapment mononeuropathies are common and contribute to considerable morbidity in the community. The most common entrapment is carpal tunnel syndrome, with an estimated incidence of 197 per 100,000 women,1,2 and much higher rates among employees in certain industries (eg, up to 42% prevalence in poultry workers).3,4 Early diagnosis is essential in entrapment mononeuropathy, to limit nerve injury and associated morbidity. Unfortunately, electrodiagnostic studies (EDX) are frequently non-localising in entrapment neuropathy, and this is the most frequent indication for nerve ultrasound in clinical practice.5 In addition, a significant proportion of EDX are non-diagnostic, between 10% and 25% in CTS for instance, depending on the severity of presentation and EDX protocol used.6,7

Separately, peripheral neuropathy (PN) represents a major cause of morbidity globally,8 and its prevalence is increasing. This has been attributed to the ageing population, an increased prevalence of diabetes and use of neurotoxic drugs such as chemotherapeutics and antiretrovirals.914 The assessment of PN has traditionally relied on neurological assessment, close review of comorbidities and EDX testing. EDX enables neuropathy to be diagnosed, providing information on the pattern of involvement, severity, distinction between axonal and demyelinating pathologies, as well as allowing prognostication and monitoring.15 The clinical and EDX assessment has several limitations however, including a lack of precise anatomical information,15 difficulty diagnosing proximal demyelinating PN,16 and difficulty in distinguishing hereditary from acquired demyelinating PN.17,18 Consequently, there is a need for newer techniques to better diagnose and monitor patients with PN.

Ultrasound using modern, high-frequency probes and image processing provides excellent visualisation of the peripheral nerve, with good spatial resolution and the ability to assess vascularisation with power Doppler. Ultrasound has the further advantage of being able to assess the entire nerve course in real time, whilst being quick, painless, non-invasive, free of radiation and relatively cheap. Ultrasound therefore provides the ideal tool for assessing PN, entrapment mononeuropathy and complements the clinical and EDX assessment. Given the rapid uptake of ultrasound by clinicians, the present review is designed as a practical resource to promote an understanding of the basics of peripheral nerve ultrasound as well as current and emerging applications of ultrasound in the diagnosis of neurological disease.

An ultrasound system uses a transducer to convert electrical current into ultrasound waves via the piezoelectric effect. These waves travel through tissue and are either reflected, refracted, scattered, or absorbed. The amount of resistance an ultrasound beam experiences as it travels through a tissue is referred to as acoustic impedance and is dependent on tissue density. The degree of ultrasound reflection is dependent on the relative differences in tissue densities at a tissue interface, as well as the angle of insonation. Reflected waves are recorded by the transducer and converted into electrical energy which is used to generate our image. The brightness of this image is labelled echointensity (EI) and is proportional to the amount of reflection. This signal is amplified (gain), which can be adjusted. Anisotropy is the loss of echogenicity when an ultrasound beam is not perpendicular to the structure imaged and can be exploited to distinguish peripheral nerves (low anisotropy) from adjacent structures such as tendons (high anisotropy).

The ultrasound image resolution is determined largely by the frequency of the waves, recorded in megahertz (MHz). Higher frequencies allow for greater image resolution, and frequencies greater than 12 MHz are typically utilised for peripheral nerve imaging. In contrast, higher frequencies undergo greater attenuation at increasing depths, and therefore lower frequency ultrasound with better penetration is preferable when imaging deeper structures such as muscle. Consequently, ultrasound imaging is a trade-off between resolution and penetrance, which is achieved in neuromuscular ultrasound by using a transducer with a range of frequencies, for example, 186 MHz. Linear array transducers are typically used in neuromuscular diagnosis, providing a narrower field of view but better resolution at the edges of an image than curvilinear transducers. A smaller footprint probe is sometimes desirable when imaging structures where only limited contact between a probe and the body surface is possible, for instance the hands and feet.

The appearance of peripheral nerves on ultrasound correlates with the microscopic and macroscopic anatomy.19 When viewed longitudinally nerves appear as linear hypoechoic fascicles surrounded by hyperechoic perineurial connective tissue, both enclosed by the bright epineurial connective tissue layer (Figure 1). In cross section, nerves take on a honeycomb appearance of rounded hypoechoic fascicles surrounded by hyperechoic connective tissue (Figure 1). The size and fascicular pattern of healthy nerves can vary depending on location. More proximal nerve segments are typically larger in cross-sectional area (CSA) with fewer or no fascicles, meaning they appear more hypoechoic. This is the result of densely packed fascicles with less connective tissue.20 This process also occurs at fibro-osseous boundaries, for instance the ulnar nerve at the level of the medial epicondyle also appears relatively more hypoechoic even in normal limbs21 (Figure 2D).

Figure 1 Ultrasound appearance of normal nerves. Ulnar nerve imaged in axial/cross-sectional view with honeycomb pattern (A) and longitudinal view with tram track pattern (B).

Figure 2 Normal ulnar nerve and ulnar artery (artery denoted *) in cross section at the wrist (A) in Guyons canal. Ulnar nerve in cross section in the forearm (B), cubital tunnel between two heads of flexor carpi ulnaris (FCU) muscle (C) and between the medial epicondyle (**) and olecranon at the elbow (D).

When differentiating nerves from other structures the following key features can be utilised. Firstly, nerves are surrounded by a hyperechoic rim due to epineurial connective tissue. Secondly, they are more anisotropic than muscle and tendons, meaning tilting the transducer will markedly change the echointensity of these other structures when compared to nerves. Thirdly, unlike blood vessels they are non-compressible, with no pulsatile movement or Doppler flow.

There are several characteristic sonographic features in peripheral nerve injury, including changes in nerve size, echointensity, fascicle dimensions, epineurial boundaries and Doppler signal. Peripheral nerve size increases focally with entrapment and more diffusely in some patients with PN. The cross-sectional area (CSA), measured by tracing inside the hyperechoic epineurium, has a high inter and intraobserver reliability and is highly reproducible.22 The CSA has been widely used to quantify PN, by reference to established normal values for several key peripheral nerves and the brachial plexus.2326 It is important to adjust CSA for normal variability seen across age, sex, height, and BMI.23,24

Echointensity is typically reduced in nerve injury and is usually assessed qualitatively and is usually associated with loss of the normal fascicular architecture described above. Nerve echogenicity can be measured quantitatively using mean gray-scale analysis.21,27,28 Quantitative measures are specific to the individual ultrasound machine used to establish the normative data, limiting their broader application, unless values are normalized using standardized phantoms.

Improvements in ultrasound technology has facilitated measurement of individual nerve fascicles,29 for instance ultra-high frequency ultrasound can identify increased fascicular diameter in immune-mediated PN.30 Fascicular architecture varies from person to person, nerve to nerve and from one anatomical location to another, and there is more work needed to characterise this metric in health and disease.

The Doppler effect is a change in ultrasound frequency reflected from an object, such as a red blood cell, moving toward or away from the transducer. This can be used to demonstrate changes in vascularity of peripheral nerves and surrounding structures. Normal nerve does not have any detectable blood flow. Hence, the presence of Doppler flow is abnormal in peripheral nerves and indicates hypervascularity, which has been described in compressive and inflammatory and some axonal neuropathies.3133

Elastography is a technique used to determine the elasticity of tissue. This is in the form of either strain elastography, in which tissue displacement from extrinsic compression or ambient tissue oscillations is used, or shear wave elastography (SWE), produced by acoustic radiation force impulses generated by the ultrasound probe. Peripheral nerve injury involves the destruction of myelin, which is more compliant, and a proliferation of stiff connective tissue.34 This results in increased stiffness on elastography. There are now several studies supporting the role of both strain and shear wave elastography in diagnosing carpal tunnel syndrome, ulnar neuropathy at the elbow, diabetic PN and even optic neuropathy.35 Further research is ongoing to assess the ability of elastography to diagnose nerve injury in preclinical neuropathy, and to evaluate elastography as a monitoring tool for longitudinal assessment.

Peripheral nerve compression results in nerve enlargement proximal /or distal to the entrapment site on cross-sectional imaging and can appear as an hourglass configuration on longitudinal views (Figure 3).5,36,37 The entrapped nerve may also appear flattened, hypoechoic, immobile and hypervascular.3739 Importantly, up to 42% of mononeuropathy cases studied with ultrasound detect a pathology that alters diagnosis or management, for instance nerve strictures, ganglion cysts or other intraneural or extraneural lesions.40

Figure 3 Normal median nerve and flexor tendons (*) in cross section (A) and longitudinal view (B). Normal median nerve in the forearm (C) superficial to flexor digitorum profundus (FDP) and deep to flexor digitorum superficialis (FDS) muscles. Abnormal median nerve at the wrist (D) with hourglass constriction (white arrows) with swelling proximally at the carpal tunnel entrance (**).

Interestingly, a Sonographic Tinel sign may be present, with clinical symptoms elicited by mechanical pressure from the ultrasound probe at a compression site. Of further interest, chronic nerve compression may result in neurogenic changes to the muscle supplied, such as hyperechogenic and eventually atrophied muscle with fasciculations. The sonographic findings for specific mononeuropathies are summarised below and in Table 1.

Table 1 Diagnostic Sonographic Findings in Compressive Mononeuropathies

The median nerve is optimally studied with the patient seated or lying with the palm facing upward. Imaging can begin at the distal wrist crease, with a cross-sectional view of the median nerve at the entry to the carpal tunnel. The nerve can then be traced proximally as it dives between the flexor digitorum superficialis and profundus in the forearm, and then between the two heads of the pronator teres (another potential site of entrapment).41,42 At the elbow, it runs with the brachial artery, and it can be traced with the artery up to the axilla.

Carpal tunnel syndrome (CTS) results in increased median nerve CSA at the wrist (Figure 3). The ratio of CSA between the wrist and forearm (12 cm proximal to the distal wrist crease), known as wrist to forearm ratio (WFR) will also be increased (Table 1). The median nerve may also be swollen distally at the carpal tunnel outlet, and scanning this region increases the diagnostic sensitivity by 15%20%.43,44 The presence of an immobile, hypoechoic or hypervascular median nerve at the wrist also aids in diagnosis.39 There are several clinical and EDX mimics for CTS, such as benign tumours (neuroma, schwannoma, hamartomas), ganglion cysts, thrombosed vessels or tenosynovitis.45 These are easily diagnosed with ultrasound.45,46 A bifid median nerve can also be identified, which is more prevalent in patients with CTS.47 Ultrasound is useful to assess persistent symptoms post-surgical carpal tunnel release, where it can detect a compressive post-operative scar, a residual anatomical constriction point suggesting incomplete release or an alternative cause for neuropathy.48

In addition, ultrasound can localise a proximal median nerve injury and may help establish a cause, such as entrapment by the ligament of Struthers,49 pronator teres muscle,50 or an accessory palmaris longus muscle,51 as well as vascular pathology52 and iatrogenic injury.53

The ulnar nerve is ideally studied with the elbow flexed at 90 degrees, palm facing upwards and the patient either seated or supine. The Ulnar nerve can be easily located at the elbow in the groove between the olecranon and the medial epicondyle of the humerus (Figure 2C). The nerve can be traced proximally as it runs between the biceps brachii and medial head of triceps brachii en route to join the axillary artery. The nerve can then be traced from the elbow distally as it travels between the two heads of the flexor carpi ulnaris muscle (forming the cubital tunnel) (Figure 2C), before travelling between the flexor digitorum profundus and superficialis as it approaches the ulnar artery (Figure 2B). The ulnar nerve together with the ulnar artery enter the hand superficially via the guyons canal (Figure 2A).

Approximately 76% of ulnar neuropathies are localised to the olecranon groove54 and are typically caused by extrinsic compression or stretch of the nerve resulting in focal demyelination. Focal increase in the ulnar nerve CSA at or above the olecranon is diagnostic.55 The next most common site for injury is at the cubital tunnel due to ulnar nerve entrapment, referred to as cubital tunnel syndrome. Ultrasound demonstrating focal nerve constriction at the entry to the tunnel with proximal swelling is diagnostic. Longitudinal views can aid in localising compression. Both the degree of swelling and hypervascularity are markers of severity56 and axonal loss.57,58 It is important to differentiate cubital tunnel entrapment from compression in the olecranon groove because the former is amenable to surgical release.59 Less common aetiology of ulnar nerve injury can also be identified with ultrasound, including Struthers arcade compression in the upper arm,60 ganglion at the elbow, benign tumours, abscess or anomalous muscles (anconeus epitrochlearis).55 Dynamic ultrasound can also detect a subluxing ulnar nerve, which refers to the migration of the ulnar nerve to the medial epicondyle tip with elbow flexion. Studies assessing the causative role of this abnormality in ulnar neuropathy are conflicting.6163 An elegant study by Omejec et al demonstrated higher rates of ulnar nerve subluxation in patients without a clinical neuropathy, especially those with subclinical ulnar nerve changes on EDX.64

A common dilemma when assessing ulnar neuropathy electrodiagnostically is the inability to localise the dysfunction, and between 14% and 25% of EDX studies are non-localising.65,66 Importantly, the majority of these electrodiagnostically non-localising ulnar neuropathies can be localised with ultrasound.65,66 In addition, ultrasound can readily diagnose ulnar nerve injury at Guyons canal for example due to cycling-related wrist compression,67 intraneural ganglion cyst68 or ulnar artery thrombosis.69

The radial nerve is best imaged with the elbow flexed and the dorsal upper arm directed toward the examiner, so that the posterior course of the nerve above the elbow can be easily traced. The nerve is readily identified in the lateral antecubital fossa, lying above the brachialis and beneath the brachioradialis muscles (Figure 4A). At this location, the nerve starts to divide into the superficial and deep branches. The radial nerve can be traced proximally as it wraps behind the humerus. The radial nerve is then followed up to the spiral groove, between the medial and lateral heads of the triceps brachii muscle (Figure 4B). The nerve can be traced from the antecubital fossa distally as it divides. The superficial branch travels laterally, beneath the brachioradialis and next to the radial artery, before perforating the extensor facia in the distal forearm to reach the anatomical snuff box and provides sensation to the dorsolateral hand and dorsal aspect of digits 13. The deep branch travels medially and dives through the arcade of Frohse (a fibrous arch extending from supinator muscle to lateral epicondyle) as it pierces the supinator muscle (Figure 4C). The nerve then becomes the posterior interosseus nerve travelling over the interosseus membrane and supplying the extensor compartment of the forearm.

Figure 4 Posterior interosseus nerve (PIN) and Superficial radial nerve (SRN) branches of the radial nerve in the cubital fossa (A). Radial nerve branches deep to brachioradialis and superficial to brachialis muscles. Cross section of normal radial nerve in the spiral groove between the triceps muscle and humerus bone (B). Posterior interosseus nerve travelling between the two heads of supinator muscle (*) overlying the proximal radius bone (C). Cross section of abnormal enlarged radial nerve in spiral groove with CSA measuring 35 mm2 (D).

The commonest cause of radial neuropathy is compression at the spiral groove due to extrinsic pressure, known as the Saturday night palsy because it may be associated with sleeping awkwardly when sedated. Ultrasound will show focally increased radial nerve CSA in the spiral groove (Figure 4D). This can be based on absolute increase in CSA or side-to-side comparison (Table 1). Swelling in the radial groove also has prognostic value and predicts a worse clinical outcome at 3 months then radial palsy with normal nerve calibre.70 Another common cause for proximal radial neuropathy is a humeral shaft fracture. Nerve injury secondary to fracture is readily diagnosed with ultrasound.71 The deep motor branch, the posterior interosseus nerve, can be injured at the arcade of Frohse. Causes of this Posterior Interosseus Syndrome may be diagnosed with ultrasound including iatrogenic injury,72 ganglion cysts,73,74 vascular abnormalities,75 tumours76 and entrapment from other structures.77 The superficial radial sensory nerve is susceptible to injury from extrinsic compression, trauma, or mass lesions7880 which may be seen on ultrasound.

The fibular nerve can be identified on ultrasound by first imaging the sciatic nerve in the proximal popliteal fossa (Figure 5A) and tracing it distally as it bifurcates into the fibular (lateral) and tibial (medial) nerves (Figure 5B). The common fibular nerve can then be traced around the head of the fibular bone (Figure 5C). An enlarged and hypoechoic nerve at the fibular head support a diagnosis of compression,24,8183 although care must be taken to not image the nerve obliquely at this location. The deep and superficial fibular nerve branches are more difficult to visualise distally due to their small size and depth, although the deep fibular nerve is readily identified in the anterior ankle. The most common cause for fibular nerve injury at the fibular head is stretch or contusion,84 often associated with significant weight loss, sustained immobility and excessive leg crossing.85,86 However, in one series, as many as 18% of patients presenting with foot drop, have an intraneural ganglion of the fibular nerve identifiable with ultrasound.87 Entrapment of the fibular nerve in the fibular tunnel is a rare cause of fibular neuropathy,88 but this can be seen on ultrasound as a focal stricture of the nerve just prior to the fibular (Figure 5). It is critical to image patients with fibular neuropathy to exclude entrapment and intraneural ganglion, as these patients require surgical decompression whereas non-operative management is indicated for other causes.

Figure 5 Cross-sectional view of the normal sciatic nerve in the distal thigh (A), fibular and tibial nerves in the popliteal fossa (B), fibular nerve at the fibular head (C) and tibial nerve just above the ankle, * denote the ulnar artery (D).

The tibial nerve can also be identified in the popliteal fossa (Figure 5B) before it dives between the heads of the gastrocnemius muscle. The patient is usually examined in the prone position. The tibial is more difficult to identify when running deep in the calf due to the overlying gastrocnemius and soleus muscles but the nerve can be imaged distally as it travels behind the medial epicondyle of the ankle, beneath the flexor reticulum (also known as the tarsal tunnel), in the company of the posterior tibial vessels, tibialis posterior, flexor digitorum longus and flexor hallucis longus tendons. The tibial nerve then branches into the medial and lateral plantar nerves to innervate the sole of the foot.

Ultrasound can identify a cause for distal tibial neuropathy in up to 94% of presentations.89 In one series of 81 ultrasound cases the most prevalent causes were varicose plantar veins, static foot disorders, epineurial ganglion cysts, neuropathies, and iatrogenic injuries. Tarsal tunnel syndrome is a rare compressive mononeuropathy which may be diagnosed on ultrasound by demonstrating an enlarged tibial nerve CSA within the tunnel (Table 1). Ultrasound may also detect a cause in proximal tibial neuropathies, such as bakers cyst90 or soleus arcade/sling.91,92

After significant nerve trauma we may see axonotmesis with interruption of axons but intact connective tissue which acts to guide axonal regrowth. If severe axonotmesis occurs, axonal regrowth occurs proximal to distal at a rate of 1 mm per day. Alternatively, nerve trauma may result in neurotmesis with interruption of both axon and connective tissue. In this circumstance, axonal regeneration is precluded by scar tissue.93 There are several limitations to clinical and EDX evaluation of traumatic peripheral nerve injury. EDX in the acute setting cannot differentiate between a nerve with damaged axons but intact connective tissue and a complete nerve transection.94 This is crucial, however, because complete transection can improve with time-critical surgical intervention. In addition, without imaging one cannot identify other specific anatomical lesions that may require surgery, for instance a painful chronic neuroma,95 or ongoing nerve injury from bone spurs, haematoma, or surgical hardware.96

Importantly, ultrasound can assist in diagnosing and localising a traumatic peripheral nerve injury.95,96 This is visualised by focal swelling and reduced echogenicity, altered fascicular architecture, discontinuity97 or neuroma formation.95 In addition, ultrasound allows the detection of muscle hyperintensity and atrophy secondary to nerve trauma, which often precedes other sonographic and EDX changes.98 In addition, ultrasound can be used to assess whether surgical intervention is required in the setting of nerve discontinuity,96 neuromas99 or bony entrapment.100,101 It is worth noting that ultrasound will not differentiate between severe axonal injury with and without intact epineurium.

Ultrasound also plays a role in surgical planning, by identifying the exact location and length of nerve injury as well as associated structures.20,96,102 Intraoperative high-resolution nerve ultrasound monitoring can also be used103 as it matches closely with intraoperative neurophysiological and neuropathological findings. Following surgical peripheral nerve repair104 ultrasound has a role in identification of partial discontinuity, neuroma formation and compression by overlying scars that may require surgical re-exploration. In a retrospective series of 143 consecutively imaged traumatic peripheral nerve injuries96 ultrasound was 90% sensitive for any nerve injury. The most common abnormalities seen were nerve swelling, followed by neuroma, scar tissue, and discontinuity. Complete nerve transections were infrequent, but readily identified by swollen nerve stumps proximally and distally. The degree of nerve swelling did not correlate with severity of motor dysfunction on EDX.

Thus, ultrasound is an important tool in diagnosing and localising nerve trauma, grading injury, determining the need for surgery and provides useful information in the intra and post-operative setting. In concert with improvements in ultrasound, MRI techniques to visualize the peripheral nervous system such as Diffusion tensor imaging (DTI) have undergone rapid development. DTI with tractography uses water diffusion anisotropy along longitudinal fibre tracts to image nerve pathways.105 DTI has the capability to image nerve injury not identified using EDX or standard imaging techniques.93 In addition, DTI can identify axonal regeneration following traumatic nerve injury with the potential to guide the need for surgical intervention.106

Generalised peripheral neuropathy may be associated with changes on nerve ultrasound. The most prominent changes are identified in demyelinating neuropathies where nerve enlargement is characteristic. Axonal neuropathies are perhaps surprisingly only infrequently associated with reduction of nerve size. The role for ultrasound in diagnosing PN is increasing, and it has the potential to streamline diagnostic algorithms, reduce the need for expensive or invasive investigations and even rationalise costly immunomodulatory and genetic therapies. The following section explores the current ultrasound findings in hereditary, immune mediated and axonal PN.

CIDP is an immune-mediated process typified by multifocal demyelinating nerve pathology in proximal and distal limbs, leading to weakness, sensory loss and reduced deep tendon reflexes. The presentation of CIDP is variable and includes atypical forms such as pure motor or pure sensory CIDP, multifocal acquired demyelinating sensory motor neuropathy (MADSAM) and distal acquired demyelinating sensory (DADS) neuropathy. Abnormal nerve morphology is identified on ultrasound in 6487% of patients.107109Typical sonographic findings are increased nerve CSA in a multifocal pattern, affecting proximal and distal segments and non-entrapment sites110 (Figure 6). Like clinical features, ultrasound findings are similarly variable, with some patients even demonstrating normal nerve size on ultrasound.107

Figure 6 Abnormal median nerve in the forearm in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), demonstrating multifocal nerve enlargement in longitudinal views (A). Heterogeneous hypo and hyperechoic fascicular enlargement seen of the same nerve in cross section (B) with CSA measuring 68 mm2. Cross sectional view of enlarged median nerve in the forearm with uniform fascicular enlargement seen in Charcot Marie Tooth Type 1A (C) with CSA measuring 62 mm2.

MADSAM is an asymmetric CIDP variant with a more asymmetrical, multifocal pattern of nerve enlargement on ultrasound.111,112 Enlarged hypoechoic fascicles are typically seen in segments with past or present conduction block112,113 and seem to reduce in response to treatment.114

Several distinct ultrasound patterns in CIDP have been identified which correlate with disease duration. Three ultrasound classes were described by Padua et al108 based on CSA and echogenicity. Large hypoechoic nerves (class 1) were associated with the shortest disease duration (04 years) when compared to normal size nerve with hyperechoic changes (class 3) (711 years duration). Large nerves with heterogeneous hypo- and hyperechoic fascicles (class 2) were also heterogenous regards disease duration (0.516 years).

Ultrasound can increase diagnostic accuracy in CIDP, especially when proximal segments and the brachial plexus are imaged.115 This is important because misdiagnosis is common in CIDP, especially in the atypical variants.116 One prospective study assessed 100 suspected chronic immune mediated polyneuropathy referrals with EDX and ultrasound.115 Enlargement in the proximal median nerve or C5 root (referred to as the Short Ultrasound Protocol) was diagnostic with a sensitivity of 84.696.4% and specificity of 44.972.8% depending on the reference standard. Importantly, 25% (11/44) of the those ultimately diagnosed as CIDP/MMN had normal EDX but abnormal ultrasound and were responsive to immunotherapy.

Ultrasound has also been researched as a tool to differentiate between hereditary demyelinating neuropathies, CIDP and other immune mediated PN (Table 2). Various schema has been proposed to quantify these differences. CMT1A is typically associated with the largest nerves, which are homogeneously/diffusely enlarged.107,117 The pattern of enlargement is more variable and to a lesser degree in CIDP. Normal nerve calibre, focal and diffuse enlargement resembling CMT have all been described in CIDP.23,107,109,118 Mild, regional, asymmetrical or heterogenous enlargement all point towards atypical CIDP, MMN, or GBS.23,107 Various imaging protocols and scoring systems have been proposed eg, the homogeneity score and the regional nerve enlargement index.119 The more focal pattern of nerve enlargement seen in inflammatory neuropathies can also be quantified using the intranerve variability (maximum CSA/minimum CSA for a given nerve) and the internerve variability (maximum intranerve variability/minimum intranerve variability for a given patient).120 However, these patterns and scores are predominantly based on relatively small retrospective cohorts, and larger prospective studies are required to define the optimal ultrasound protocols to differentiate these disorders.119

Table 2 Diagnostic Sonographic Findings in Peripheral Neuropathies

Ultrasound provides surrogate markers for disease severity in CIDP, such as hypervascularity, number of nerves involved and cervical nerve root CSA.121,122 Larger nerve CSA has been correlated with slower conduction velocities on EDX testing in many123,124 but not all studies.125 Nerve enlargement has also been associated with clinical weakness and disability.124,125 Additionally, ultrasound provides prognostic information in CIDP, with both decreasing intra-nerve CSA variability and normal or decreasing nerve calibre predicting treatment responsiveness.126

Furthermore, ultrasound has potential as an outcome measure in CIDP. A study of 23 consecutive patients with CIDP followed with serial ultrasound measurements over 3-years, noted CSA increased in 51% of nerve segments, and was associated with increased functional disability and decreased motor nerve amplitudes on EDX.124

GBS is an acute immune mediated generalised polyneuropathy, characterised by ascending sensory disturbance and areflexic weakness, with both demyelinating (acute inflammatory demyelinating polyneuropathy AIDP) and axonal forms (acute motor/sensory axonal neuropathy AMAN/AMSAN). The nadir is typically reached by 6 weeks, and diagnosis is clinical, supported by EDX and cerebrospinal fluid studies.

Proximal nerve and nerve root enlargement has been reported on ultrasound, although the degree and frequency are less then CMT1A and CIDP.23,107 For example, mild enlargement was reported in 8/17 upper limb nerves in one cohort,23 and 5/6 patients in another cohort, although this involved only 9% of the studied nerve segments.127 Importantly, nerve enlargement can be seen as early as day 13 of symptoms,23,128 before EDX changes are apparent.23 The presence of enlarged cervical nerve roots and vagus nerves, together with normal nerve calibre elsewhere can differentiate GBS from CIDP with a positive predictive value > 85%.117 Vagal nerve enlargement on ultrasound has also been correlated with autonomic dysfunction in AIDP.128,129

Some studies have suggested ultrasound can be used to distinguish demyelinating and axonal variants of GBS,130 while other studies have found no difference.131 Mori et al demonstrated enlarged cervical and proximal nerve segments in 6 patients with AIDP, contrasting to enlarged distal nerve segments (forearm, wrist and ankle) in 9 patients with AMAN/AMSAN.130

Miller Fisher Syndrome (MFS) is a rare GBS variant characterised by the triad of ophthalmalgia, ataxia and areflexia, and is often associated with bilateral facial weakness. Hsueh et al132 reported significantly enlarged facial but normal limb nerves in MFS.

Ultrasound has been proposed as an outcome measure for treatment in GBS.129,131 Grimm and colleagues assessed 27 patients with GBS and 31 controls with ultrasound at baseline and 6 months follow up.129 Cervical spinal, medial and vagus nerves were significantly larger in GBS at baseline, but returned to normal at 6 months, except for the vagus nerve which remained enlarged in those patients with significant autonomic dysfunction.

MMN is a rare upper limb predominant demyelinating polyneuropathy characterised by slowly progressive weakness and response to treatment with intravenous immunoglobulin.133135 In practice, MMN can be difficult to distinguish from certain ALS variants.136 Sonographically mild multifocal nerve enlargement, typically in proximal sites and the brachial plexus, is seen in up to 90% MMN patients.137 Ultrasound enlargement can also occur in clinically and electrophysiologically unaffected nerve segments.137

Importantly, nerve and nerve root enlargement on ultrasound can differentiate MMN from ALS. Grimm and colleagues demonstrated that 4 enlarged nerves/nerve roots had a 87.5% sensitivity and 94.1% specificity for distinguishing MMN from ALS in their cohort.138 Others have found that ultrasound is better at distinguishing MMN from ALS then standard EDX assessments.139,140 Ultrasound can occasionally aid in the distinction of MMN from CIDP by the presence of milder, asymmetric nerve enlargement with greater side-to-side intranerve variability, although considerable overlap exists.141

Multiple studies have demonstrated a variable association between ultrasound findings and clinical weakness, disability and EDX abnormalities.139,141,142 Rattay et al demonstrated that the nerve enlargement reduced in parallel with disability after 612 months of treatment in MMN, although baseline nerve enlargement did not correlate with clinical or EDX markers of severity.143 Thus, nerve ultrasound can not only improve diagnosis but also disease monitoring in MMN.

Anti-MAG is an immune mediated demyelinating neuropathy with distally predominant symmetrical sensorimotor impairment and prolonged distal motor latencies on EDX. Despite this the ultrasound abnormalities tend to be proximal144 and there are no reports of distal nerve enlargement. Segmental nerve enlargement has been described in cervical nerve roots, brachial plexus, and proximal nerve segments145 with considerable inter-nerve variability.146 Nerve ultrasound has been used to distinguish anti-MAG neuropathy from similar pathologies. Specifically, nerve size is greater in MAG positive than MAG-negative paraproteinaemic neuropathy.146 Some cohorts found nerve calibre in MAG to be smaller than CIDP.146

POEMS is a rare paraneoplastic multisystem plasma cell disorder causing a mixed axonal and demyelinating polyneuropathy that can mimic CIDP. Pathogenesis is attributed to increased vascular endothelial growth factor leading to neovascularisation and peripheral nerve oedema.147 It is somewhat surprising then, that peripheral nerve ultrasound studies have demonstrated nerve enlargement at entrapment sites only.148 Indeed, the lack of diffuse/multifocal enlargement has been offered as a means of distinguishing POEMS from CIDP.148 However, the published cases describe nerve ultrasound in the subacute setting, after significant secondary axonal degeneration has occurred, and thus the ultrasound findings in early disease remain to be defined.

Brachial neuritis is an idiopathic monophasic inflammatory condition affecting the branches of the brachial plexus. The typical presentation is with severe pain followed by unilateral upper limb weakness. Imaging with ultrasound and other modalities, combined with surgical exploration, have led to greater pathological understanding of this condition. It is now hypothesized that a sequence of nerve enlargement, fascicular adhesion and constriction contributes to ongoing nerve injury.149 Rotational movements of the upper limb are then thought to cause the adhered nerve to tort, with fascicular entwinement and further constriction which has been associated with poor recovery.149 The most common finding on ultrasound, seen in 74% of cases, is unilateral focal nerve enlargement, often affecting the median, radial, anterior, or posterior interosseus nerves.150,151 Other findings include partial nerve constriction, fascicular entwinement or complete nerve constriction with an hourglass morphology, described in up to 50% of cases.152 Early imaging with ultrasound can potentially identify those cases with partial or complete constriction who may benefit from surgical intervention.149,151 Diaphragmatic ultrasound can be used to diagnose phrenic nerve involvement in this condition.

Mononeuritis multiplex is the characteristic pattern of peripheral nerve vasculitis both in isolated nerve and systemic vasculitic disorders. This is reflected on nerve ultrasound by focal, asymmetrically enlarged nerves, in proximal segments without extension to the brachial plexus.153155 Enlargement is described in most EDX affected nerve segments, and prominently in the tibial and fibular nerves.154,156,157 Importantly, nerve enlargement is seen in almost half of all clinically and EDX unaffected nerves.155 Hypervascularity can support a diagnosis of vasculitis PN and is reported in 19% of cases.155 The presence of an axonal neuropathy, with multifocal nerve enlargement proximal to compression sites without plexus involvement is argued to be 94% sensitive and 88% specific for vasculitis.155 Nerve enlargement might reduce with treatment, although this is based on a single case study only.153 Nerve ultrasound has also been suggested as a tool to guide nerve biopsy. Hence, ultrasound can improve diagnosis in PN vasculitis and has the potential to guide biopsy sites and support treatment monitoring.

Hereditary neuropathies are among the most studied conditions in the field of neuromuscular ultrasound. The disorders discussed below are just some of the hereditary conditions that have been studied. There are many others where no data exists.

CMT1A is the most common form of CMT, caused by an autosomal dominant duplication of the peripheral myelin protein 22 gene, resulting in a demyelinating PN. Ultrasound in CMT1A demonstrates diffuse symmetrical nerve CSA increase in 89100% of patients158160 (Figure 6C). This occurs from the brachial plexus and proximal nerve segments to the small sensory nerves such as the sural and auricular nerves.158 Nerve enlargement is detectable from as young as 19 months of age,161 and as such ultrasound is an ideal non-invasive diagnostic aid in young children. Larger CSA has been associated with more severe disease, measured with the CMT neuropathy score.158,162 In addition, a number of studies have demonstrated a correlation between the degree of nerve enlargement and neurophysiological dysfunction,158,162 although this has not been a universal finding.159

CMT1B is another demyelinating form of CMT, due to Myelin Protein Zero mutations. Ultrasound in CMT1B demonstrates nerve enlargement proximally,163,164 but reduced CSA in the lower limbs, helping to distinguish it from CMT1A.164 CMT1X is an X linked mutation of the gap junction associated protein and demonstrates symmetrically enlarged CSA in proximal segments and lower limbs on ultrasound.165 Finally, CMT2 is a heterogenous collection of variably inherited axonal polyneuropathies, with similarly variable findings on ultrasound.100,166

Research into nerve ultrasound as a longitudinal biomarker in CMT has been limited to date. A small study of 15 adults with CMT1A over 5 years failed to demonstrate a change in nerve calibre when assessing the sural and median nerves.167

Although outside the scope of this review, muscle ultrasound in a cohort with CMT has demonstrated reduced thickness and increased echointensity of the first dorsal interossei and tibialis anterior muscles.168 This was more pronounced in CMT1A compared to CMTX1 and CMT2A patients, and correlate with degree of muscle weakness. Consequently, nerve and possibly muscle ultrasound can improve diagnosis and assessments of severity in CMT.

HNPP is caused by an autosomal recessive deletion of the PMP22 gene, leading to multiple painless entrapment mononeuropathies. The classical ultrasound finding in HNPP is multiple areas of nerve enlargement at entrapment sites,169,170 but enlargement at non entrapment sites have also been described.171 Sonographic findings such as CSA do not correlate with neurophysiological parameters, such as the distal motor latency.172

Variant or hereditary transthyretin amyloidosis is an autosomal dominant disorder, where point mutations in the transthyretin gene results in an axonal sensorimotor and autonomic neuropathy. The recent development of disease modifying therapy has prompted great interest in diagnostic and treatment biomarkers. Ultrasound studies in vATTR Amyloidosis have reported increased nerve CSA at entrapment sites, proximal nerve segments and the brachial plexus when compared to healthy controls.100,173 CSA is also greater in symptomatic vATTR then asymptomatic carriers100 and in those with abnormal motor conduction studies.174 While carpal tunnel syndrome is common in vATTR, the median nerve CSA at the wrist is smaller than in idiopathic CTS and is discordant with EDX severity.175 This has been suggested as an early clinical clue for vATTR in patients presenting with CTS.

CANVAS is an adult-onset disorder caused by mutation in the RFC1 gene. A sensory neuronopathy is universally seen in patients with CANVAS,176 and can be detected on ultrasound as a reduction in CSA of the median, ulnar, tibial, and sural nerves.177 A reduced median and ulnar nerve CSA < 5 mm2 in the mid-forearm or mid-humerus demonstrate a sensitivity of 7993%, specificity 100% and area under the curve (AUC) of 0.970.99178 for distinguishing CANVAS from healthy controls.

SCA 2 is an autosomal dominant CAG triplet repeat mutation in the Ataxin 2 gene, resulting in cerebellar ataxia, sensory motor neuropathy, pyramidal and extrapyramidal dysfunction.179 Reduced nerve CSA on ultrasound is seen in the majority (74%) of patients and correlates with the presence of a sensory neuronopathy.177

Friedrich Ataxia is an autosomal dominant GAA triplet repeat disorder affecting the Frataxin gene, leading to cerebellar ataxia, cardiomyopathy and sensory neuropathy/neuronopathy. Interestingly, upper limb nerve CSA is enlarged in Friedrich ataxia, attributed to dysmyelintation and perineurial connective tissue proliferation,180 while lower limb nerve CSA is normal.

The utility of ultrasound in axonal PN is less well characterised. It was hypothesized initially that nerve calibre would be reduced in axonal neuropathies. However, ultrasound has revealed that nerves are typically either normal or slightly enlarged.23,119 The potential application of nerve ultrasound to many forms of axonal neuropathy, eg, toxic, metabolic, inflammatory aetiology remains to be defined by future research.

DPN is characterised sonographically by mild hypoechoic nerve enlargement, notably at compression sites. Several studies have reported enlarged CSA for the median and tibial nerves of Type 1 and Type 2 Diabetics with PN when compared to healthy controls.181184 Nerve enlargement can also predate clinical neuropathy,185 and increases further once DPN develops.186 In addition, the degree of enlargement and vascularity are biomarkers of severity, and correlate with clinical and EDX parameters.182,184,185 Further, in type 2 diabetics nerve ultrasound can demonstrate enlarged fascicles and marked hypoechogenicity when compared to controls, and this to correlates with EDX abnormalities.184,185 Type 2 diabetics with metabolic syndrome also demonstrate larger nerves and more severe neuropathy then diabetics without metabolic syndrome.187 Furthermore, increased tibial nerve stiffness on shear wave elastography is 90% sensitive and 85% specific for diabetes and increases with the development of DPN.188

Chemotherapy-associated PN demonstrates mild, often asymptomatic nerve enlargement at compression sites in 69% of patients and may point to nerve vulnerability to mechanical stress.188 In contrast, Lycan et al studied 20 patients with breast cancer exposed to taxane-based chemotherapy and reported reduced sural nerve calibre on ultrasound.190 Nerve size was further correlated with older age, longer time since exposure and intraepidermal nerve fibre density on skin biopsy.

Leprosy secondary to infection with Mycobacterium leprae is a prevalent cause for PN outside the western world191 and has been well studied with peripheral nerve ultrasound. Leprosy is characterised by both axonal and segmentally demyelinating PN with palpably thickened nerves and skin changes. Leprosy typically manifests with recurrent immune reactions referred to as active leprosy. Ultrasound studies have reported multiple asymmetric nerve enlargement with epineurial thickening.32,192195 Active leprosy is associated with nerve hypervascularisation in 5571% of patients and decreases to 2.75.9% with treatment.193,195 Thus, peripheral nerve ultrasound has potential as both a diagnostic and monitoring tool in Leprosy.193

EDX in children is challenging. EDX testing is potentially painful, with pain more frequently experienced when EMG is performed, when greater than one muscle and proximal muscles are tested.196 It is unsurprising therefore that younger age, especially under 3 years, is associated with inadequate and incomplete EDX in paediatric cohorts.196 Furthermore, EMG relies on active muscle recruitment and patient participation which is limited in the very young.197 Nerve imaging with MRI in children is also challenging due to the need to lie still for prolonged periods which may necessitate sedation. Nerve ultrasound on the other hand is painless, quick, adaptable, cost effective and well tolerated in paediatric patients.198 It seems natural therefore to see a recent growth in paediatric neuromuscular ultrasound research.107,199

Peripheral nerves increase in size as we age, meaning children with enlarged nerves may be incorrectly interpreted as normal if adult references values are applied. Therefore, the accurate interpretation of abnormal nerve CSA is reliant on the ongoing expansion age-specific normative ultrasound data.200,201 Zaidman et al23 examined 40 healthy children aged 217, among a larger cohort of 90 adults and children, and reported a range of normal CSA values. Of interest, an association between height and nerve CSA was seen, and was stronger in children (r =0.9, P < 0.001) than adults (r = 0.5, P < 0.001). Cartwright et al202 recorded peripheral nerve CSA in a further 43 children aged 3 months to 16 years as well 160 adults. Age was the strongest predictor of nerve CSA, although height and BMI were also predictive. Druzhinin et al201 systematically collected ultrasound CSA measurements in an children and young adults, scanning 72 healthy subjects aged 230 years. Their data suggest that nerve CSA is independently associated with age and weight but not height, differing from previous studies by Zaidman23 and Cartwright.201 Zaidman and Cartwright analysed for associations using pooled CSA values from all nerve measurements while Druzhinin analysed each nerve measurement individually, and this may explain their different findings. All three studies found nerve size plateaued at 1214 years leading the authors to conclude that paediatric specific normative values are essential to interpret imaging in subjects below this cut off. The intra and inter-nerve variability was measured in Zaidman and Druzhinins populations and interestingly did not differ significantly with age.23,201 This may be a potential age-independent measure to use where normative data is limited.

Entrapment mononeuropathies are uncommon in children, and when they do occur ultrasound can detect unusual causes such as mucopolysaccharidosis.203,204 Research in adult populations has been used to argue for supplementation or even replacement of standard EDX assessments with neuromuscular ultrasound in certain focal mononeuropathies such as carpal tunnel syndrome.46,205,206 A similar argument could be made for children with mononeuropathies but will require further studies to evaluate.

Polyneuropathies on the other hand are common in children and sonographic nerve changes are detectable in certain hereditary neuropathies such as CMT from a very young age.107,161 Further, nerve CSA in children with CMT1A correlates with disease severity, as well as age, height and weight.161 Furthermore, ultrasound can aid in the distinction between hereditary and acquired inflammatory polyneuropathies in this age group.107,119 Zaidman et al performed nerve ultrasound in 128 adults and children with a range of hereditary and acquired peripheral neuropathies. Thirty-five CMT1 patients age 271 years were examined and 8 out of 9 children with CMT demonstrated diffuse sonographic nerve enlargement.

Ultrasound has also been used to assess neonatal brachial plexopathy, which occurs in up to 3 in 1000 live births.207 The current standard is a 3-month period of observation for spontaneous recovery followed by surgical exploration where recovery is poor.208 In 2015, Somashekar et all compared preoperative US to surgical exploration in the detection of traction neuromas in 33 children.209 Of their cohort, 31 of the 33 surgically identified neuromas were detectable on US. Furthermore, muscle atrophy was identified in 11 children and guided spinal accessory and supra scapular nerve transfers in 8 of those patients.

Another advantage of ultrasound is its potential to limit the amount of EDX testing required to achieve a diagnosis. Rardin et al210 compared retrospective data from 21 children who were assessed by ultrasound prior to EDX with 84 aged-matched control subjects who had EDX assessment alone. Those subjects investigated with ultrasound first required less EDX tests, with fewer nerve stimulations and fewer muscles sampled by EMG. This led the authors to conclude an ultrasound first approach should be considered in paediatric patients to limit EDX testing.

Therefore, ultrasound has a number of distinct advantages in paediatric neuromuscular assessment and its role is likely to grow in this population. Further studies are needed to better define normal nerve size, as well as more detailed structural assessment such as fascicle measurements, echotexture and elastography.

Disorders of the motor neuron include Amyotrophic Lateral Sclerosis (ALS), Spinal Muscular Atrophy (SMA) and Spinal Bulbar Muscular Atrophy (SBMA or Kennedys disease) and Poliomyelitis. Diagnostic delay is a significant issue in these disorders, for instance in ALS the median time to diagnosis is 11.5 months after onset of symptoms.210 In SMA, the emergence of disease modifying therapy has generated the need for accessible, accurate, responsive, and reliable outcome measures. Hence, ultrasound has clear potential to improve the diagnosis and monitoring of motor neuron disease, and there is a growing body of literature supporting its use in ALS and SMA.

ALS is a fatal neurodegenerative disorder affecting the motor neuron, with a median survival of 35 years,212214 characterised by dysfunction of both upper and lower motor neurons (UMN and LMN) as well as cognition.213 Clinical heterogeneity exists, and there is an absence of pathognomonic investigations, leading to significant diagnostic delay.215 To better define the investigations of ALS and to promote recruitment of patients to clinical trials, the El Escorial and revised El Escorial (rEEC) were developed incorporating the presence of upper (UMN) and lower motor neuron (LMN) signs.216218 It was argued that the rEEC, although specific, was lacking in sensitivity, particularly in the early stages of disease, and consequently the Awaji criteria and more recently the Gold Coast criteria were developed.220224 These included the identification of fasciculations on EMG as an LMN sign and have contributed to the increased sensitivity in diagnosing ALS.216,224226 Neuromuscular ultrasound offers greater sensitivity then EMG in the detection of fasciculations especially in bulbar structures and thus has the potential to further improve the diagnostic sensitivity of the criteria.228 Further, muscle ultrasound in ALS can improve diagnosis through the detection of reduced muscle thickness and increased muscle echointensity98,227229 (Figure 7). Furthermore, quantitative measures of muscle echotexture have been used as diagnostic biomarkers and responsive outcome measures in ALS.230,231

Figure 7 Cross-sectional image of a normal tibialis anterior muscle (A) and quadriceps muscles (C) in a healthy individual. Cross-sectional image of abnormal tibialis anterior muscle (B) and vastus intermedius muscle and to a lesser extent rectus femoris muscle (D) in a person with amyotrophic lateral sclerosis. Note in the abnormal muscles there is atrophy with increased brightness or echointensity with a loss of the underlying bone reflection (*).

A reduction in motor nerve and cervical nerve root calibre with a sparing of sensory nerves has been consistently described in ALS232235 and is likely to reflect motor axon loss. This occurs in both clinically affected and unaffected regions.233 Nerve ultrasound can distinguish ALS from mimic disorders such as MMN and peripheral nerve hyperexcitability syndromes.236 Specifically an increased distal:proximal CSA ratio of the median nerve can distinguish ALS and reflects the relative density of motor fibres in the proximal portion of the nerve.236 Additionally, nerve ultrasound is abnormal in preclinical ALS where axonal degeneration is compensated and thus muscle wasting/weakness not yet apparent.233,237 Detecting the submillimetre nerve CSA changes in this preclinical state will likely improve as higher frequency ultrasound probes are developed and in wider use.237,238 One current limitation of nerve ultrasound is its insensitivity as a tool to monitor disease progression.238 Furthermore, nerve ultrasound measurements are not consistently correlated with disease severity on clinical and EDX measures, in part due to the confounding effect of UMN dysfunction.235

Bulbar motor neuron dysfunction, associated with dysphagia, is common in ALS, and can be measured by ultrasound in several ways. Video ultrasonography, a technique to dynamically assess tongue position and morphotexture during attempted swallow, is an early and sensitive measure of dysphagia in ALS.239 Further, ultrasound measures of tongue thickness are reduced in ALS, and this is most marked in those patients with bulbar onset disease and lower BMI.240 Furthermore, tongue thickness decreases with disease progression and may be used to monitor dysphagia and potentially guide timing of nutritional interventions such as parenteral feeding which are associated with improved survival in ALS.241,242 Lastly, minimal change in tongue thickness during swallowing, measured as a reduced thickness ratio is a specific marker of UMN bulbar dysfunction.243 Thus, dynamic tongue ultrasound has potential as a diagnostic and prognostic biomarker of bulbar dysfunction in ALS.

Respiratory dysfunction is universal in ALS as the disease progresses.244 Monitoring respiratory dysfunction, traditionally with spirometry, is essential to guide institution of non-invasive ventilation which can improve survival and quality of life.244246 A major limitation of spirometry in ALS is its poor reliability in the setting of bulbar and facial weakness as well as cognitive impairment. Dynamic diaphragmatic ultrasound thickness, measured as inspiration:expiration thickness or thickening ratio, offers an alternative measure in such patients. Ultrasound diaphragm thickness and thickening ratio are reliable in ALS,247 and correlate with vital capacity, hypercapnia, hypoventilation and motor disability more broadly.247 Thus, diaphragmatic ultrasound represents an important diagnostic biomarker for respiratory dysfunction in ALS,248 although at this stage it remains experimental and is not a substitute for standard measurements.

SMA is an autosomal recessive disorder of spinal lower motor neurons, caused by the mutation in the survival motor neuron (SMN1) gene. This ranges in severity from the severe type 1 SMA with onset before 6 months of age to Type 4 SMA with adult onset. There is considerable interest in biomarkers for diagnosis and disease progression in SMA due to the emergence of disease modifying therapy in the form of antisense oligonucleotides (Nusinersen and Risdiplan) and the gene replacement therapy (onasemnogene abeparvovec-xioi). Nerve ultrasound can distinguish adult onset SMA from mimicking disorders such as CIDP and MMNCB, based on reduced proximal nerve and nerve root CSA in SMA.249

In addition, high-frequency nerve ultrasound may provide prognostic information. This was suggested in a pilot study of 3 SMA patients using ultra high-frequency median nerve imaging.250 A reduced median nerve CSA and fascicle number was seen in the most severely affected subject (SMA I) relative to controls. Further, quantitative muscle ultrasound echo intensity, expressed as a Luminosity ratio, was increased in a cohort of SMA II and III subjects compared to healthy controls.251 Luminosity ratio was higher in more severe disease (SMA II) and correlated with dynamometry measures of strength. This suggests the diagnostic and monitoring potential for muscle ultrasound in SMA. Further research is needed to assess the role of nerve and muscle ultrasound in SMA.

The use of ultrasound to assess peripheral nerves in routine clinical practice is increasing due to its safety, accessibility, and dynamic quality. Current ultrasound technology provides excellent resolution of peripheral nerves and the flexibility of point of care machines allow easy integration into neuromuscular and electrodiagnostic clinics. Ultrasound adds critical structural information to compliment clinical and EDX assessments, contributing to improved diagnosis and pathophysiological understanding of peripheral nerve disorders. While nerve ultrasound is most frequently used to diagnose focal compressive mononeuropathy, its application has grown to include traumatic nerve injury, generalised peripheral neuropathy, motor neuron diseases and a range of other neuromuscular conditions in both adult and paediatric populations. Despite the operator-dependant nature of ultrasound, further development of quantitative measures, standardised protocols and consensus scoring frameworks will allow wider application and lead to improved diagnosis of peripheral nerve disease.

Funding support from the National Health and Medical Research Council of Australia is gratefully acknowledged.

Professor Matthew C Kiernan reports grants from NHMRC, is the Editor-in-Chief of Journal of Neurology, Neurosurgery & Psychiatry, during the conduct of the study. The authors report no conflicts of interest in this work. There are no financial interests or other conflicts of interest to declare.

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9. Simmons Z, Feldman EL. Update on diabetic neuropathy. Curr Opin Neurol. 2002;15(5):595603. doi:10.1097/00019052-200210000-00010

10. Kandula T, Farrar MA, Cohn RJ, et al. Chemotherapy-induced peripheral neuropathy in long-term survivors of childhood cancer: clinical, neurophysiological, functional, and patient-reported outcomes. JAMA Neurol. 2018;75(8):980988. doi:10.1001/jamaneurol.2018.0963

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Spotlight on ultrasonography in the diagnosis of PND | IJGM - Dove Medical Press


Eye scan could determine whether COVID patients will be long haulers – WGNO New Orleans

Tuesday, August 17th, 2021

( Long COVID continues to confound doctors as patients still struggle with debilitating symptoms months after first being infected. A new study now suggests that COVID patients who could be long-haulers could be diagnosed by taking a close look at their eyes. Nerve fiber loss and an increase in key immune cells on the surface of the eye may be a way of identifying the long term impact of the virus, say scientists.

The changes are particularly evident among those with neurological symptoms, such asloss of taste and smell,headache, dizziness, numbness, and neuropathic pain. Doctors at Weill Cornell Medicine-Qatar say long COVID ischaracterized by a range of symptomswhich continue for more than four weeks after the acute phase of the infection has passed, and which arent explained by an alternative diagnosis.

CCM has been used to identify nerve damage and inflammatory changes attributable to diabetic neuropathy,multiple sclerosis, and fibromyalgia..

Forty people who had recovered from confirmed COVID-19 infection between one and six months earlier completed a National Institute of Health and Clinical Excellence (NICE) questionnaire. Data was used to find out if they had long Covid, with a total score ranging from zero to 28. Neurological symptoms were present at four and 12 weeks in 22 out of 40 patients (55 percent) and 13 out of 29 (45 percent), respectively, according to the findings published in theBritish Journal of Ophthalmology.

The participants corneas were then scanned using CCM to look for small nerve fiber damage and the density of dendritic cells. These have a key role in the primaryimmune system responseby capturing and presenting antigens from invading organisms.

The corneal scans were compared with those of 30 healthy people who hadnt been infected by COVID.

Results show that 55 percent of theCOVID patientshad no clinical signs of pneumonia. Twenty-eight percent had clinical signs of pneumonia not requiring oxygen therapy. Ten percent had been admitted to hospital with pneumonia and received oxygen therapy, and 8 percentt with pneumonia had been admitted to the intensive care.

The corneal scans revealed that patients with neurological symptoms for four weeks after they had recovered from acute COVID-19 had greater corneal nerve fiber damage and loss, with higher numbers of dendritic cells, than those who hadnt been infected by the virus. Those without neurological symptoms had comparable numbers of corneal nerve fibers as those who hadnt been infected with COVID, but higher numbers of dendritic cells.

The questionnaire responses indicative oflong COVID symptomscorrelated strongly with corneal nerve fiber loss, says study author Professor Rayaz Malik in astatement.

He notes that it was an observational study, and as such, cant establish cause, and only a small number of participants were involved.

To the best of our knowledge, this is the first study reporting corneal nerve loss and an increase in [dendritic cell] densityin patients who have recoveredfrom COVID-19, especially in subjects with persisting symptoms consistent with long COVID, he adds. We show that patients with long COVID have evidence of small nerve fiber damage which relates to the severity of long COVID and neuropathic as well as musculoskeletal symptoms. Corneal confocal microscopy may have clinical utility as a rapid objective ophthalmic test to evaluate patients with long COVID.

South West News Service writer Stephen Beech contributed to this report.

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Eye scan could determine whether COVID patients will be long haulers - WGNO New Orleans


Diabetic Neuropathy Treatment Market Trends and Forecast to 2027 Players are Abbott, Roche, Eli Lilly – The Manomet Current

Tuesday, August 17th, 2021

The Diabetic Neuropathy Treatment Market is expected to account for a robust CAGR of 5.6% during the forecast period of 2021-27. The market held a CAGR of xx % in 2021 and xx USD billion in terms of revenue.

Once the immediate and direct impact of COVID-19 has passed in a given geographic area, the consequences of delaying care will almost certainly generate new issues for individuals and the healthcare system, potentially raising annual expenses globally. The pandemic has created an everlasting impact on the market and the healthcare industry.

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Top key players: Abbott, Roche, Eli Lilly, Johnson and Johnson, GlaxoSmithKline, Lupin, Glenmark, Depomed, Astellas, and Pfizer

Segmentation of Diabetic Neuropathy Treatment Market:

Product Type Coverage

Peripheral Neuropathy

Autonomic Neuropathy

Proximal Neuropathy

Focal Neuropathy

Application Coverage




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Key questions answered in the report include:What will the market size and the growth rate be in 2027?What are the key factors driving the Diabetic Neuropathy Treatment Market?What are the key market trends impacting the growth of the Diabetic Neuropathy Treatment Market?What are the challenges to market growth?Who are the key vendors in the Diabetic Neuropathy Treatment Market?What are the market opportunities and threats faced by the vendors in the Diabetic Neuropathy Treatment Market?Trending factors influencing the market shares of the Americas, APAC, Europe, and MEA.

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The report includes six parts, dealing with:1.) Basic information;2.) The Asia Diabetic Neuropathy Treatment Market;3.) The North American Diabetic Neuropathy Treatment Market;4.) The European Diabetic Neuropathy Treatment Market;5.) Market entry and investment feasibility;6.) The report conclusion.

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Diabetic Neuropathy Treatment Market Trends and Forecast to 2027 Players are Abbott, Roche, Eli Lilly - The Manomet Current


The Feather and the Knife: Navigating Life With Chronic Pain – POZ

Tuesday, August 17th, 2021

For Jess Guilln, pain is a feather touch and a constant companion. To illustrate, Guilln, who has been living with HIV since 1985, moves one elegant hand, bending at the wrist to mimic running a feather gently along skin.

I just start doing this over and over and over, he says. I tell people, This is a feather. But what do you feel if I keep doing this for 30 minutes, or for an hour?

Usually, folks push him away, irritated at the sensation. Thats one of the ways Guilln describes the chronic pain that sometimes keeps him in bed until noon and can make every step hurt. But thats not the only way he describes it. Theres the feeling of a nail or a thorn from a rose pressed nonstop against skin. And then, theres the pain that wakes him up in the middle of the night and consumes his thoughts, like a knife stabbing him over and over again. For Guilln, chronic pain is a lack of sensation, then, all at once, too much sensationand a sensation he cant escape.

It never stops. [People with chronic pain] dont get used to it, but we manage somehow, he says. We still want to experience life in some way.

Guilln is far from alone. Studies have found that between 25% and 85% of people living with HIV experience chronic pain, compared with estimates of 11% to 20% of the general population. Often, this is neuropathic painpain that starts in the brain but is usually experienced as numbness, tingling, burning or stabbing in the limbs, hands and feet.

Despite the high rates of pain, some research suggests that people living with HIV are less likely to be prescribed opioid pain treatment than their HIV-negative peers. The additional challenge of coexisting substance use disorders can render even that form of pain relief elusive for some people with HIV. But the opioid epidemic has led to new research on pain and how to address it at its core, including specifically for people living with HIV.

What We Know About Pain and HIV

Jessica Robinson-Papp, MD, had just come off a general medicine internship at St. Vincents hospital in New York City, where she fell in love with working with HIV-positive people, when she began training in neurology. Luckily for her, she was able to combine her passions. Today, shes a clinical neurologist at New York Citys Mount Sinai Hospital, serving people with HIV who have a variety of pain syndromes.

The more people with HIV she saw, the more Robinson-Papp realized that peripheral neuropathy was usually just one of a litany of pain complaints her patients had.

Youll start talking about neuropathic pain, she says. And then theyll say, Oh, but then, theres back pain, and Theres pain radiating down, and Theres pain over here, and Then, there are headaches.

What shes learned, and what the science of pain in general has revealed, is that there is no one cause of pain, or, if there is, science hasnt discovered it yet. Its not even clear whether people living with HIV really experience more pain than people without HIV, Robinson-Papp says.

We dont even really know that, she says. Understanding the [source] of pain is very much in its infancy.

We manage somehow. We still want to experience life.

What researchers do know is that pain is more likely a syndromea constellation of symptomsthan one disease with a single cause that can be cured. In fact, each kind of pain could have a different cause.

For instance, neuropathy is often a side effect of older HIV medications or chemotherapy for AIDS-defining illnesses. It could also be due to accelerated aging in people with HIV. Then theres degenerative joint diseasethat is, joint pain due to osteoarthritis or avascular necrosis, which often necessitate joint replacements. For people who menstruate, menopause can come with its own kinds of pain. HIV-associated chronic inflammation is another likely contributor to pain, Robinson-Papp says.

Whats more, people with one pain syndrome, such as HIV-associated peripheral neuropathy, are more likely to have another, like migraines or joint pain from osteoarthritisor even multiple other pain syndromes. Scientists dont know why that is either, says Robinson-Papp.

Plus, some factors may amplify ones perception of pain. For instance, its possible that some HIV viral proteins themselves may enhance pain. Pain is also associated with other health conditions, such as depression, anxiety or posttraumatic stress disorder, most of which can be part of whats known as AIDS Survivor Syndrome, a cluster of symptoms resulting from trauma endured during the early years of the epidemic.

Then there are factors that can make it easier to focus on pain, like the social isolation that can accompany aging. Moreover, certain behaviors, such as lack of exercise, can increase pain, and conditions such as insomnia or drug misuse or addiction (which can be an attempt to self-medicate) can complicate how individuals cope with pain.

All of this can impact the ability to take HIV meds as prescribed, which can deprive people with uncontrolled pain of the health benefits of having an undetectable viral load.

So when Robinson-Papp talks to patients about options to alleviate pain, the first step is to see if theres a physical reason for it, like diabetes, autoimmune diseases, infections such as hepatitis B or C or malnutrition associated with alcoholism.

But once Robinson-Papp has helped patients address those problems, there are only a few proven solutions she can offer people to help manage their pain or at least cope with it. These include physical therapy, massage, acupuncture, mindfulness-based stress reduction, cognitive behavioral therapy, exercise, non-opioid pain relievers and cortisone injections (for joint pain). Some data show that cannabis and capsaicin (derived from chili peppers) alleviated some pain in people with HIV, according to a systematic review published in a recent special issue of the journal AIDS Care on the topic of HIV and chronic pain that Robinson-Papp coedited. But the quality of the data were low, and more work is needed to confirm their effectiveness, researchers wrote.

That leaves one last option. Sometimes people are on opioids, she says. Thats a fact of life.

Guilln knows this all too well. Its taken years to find the right mix of meds, one that keeps the pain to a manageable level but doesnt wallop him with brain fog or fatigue. He rattles off the list of meds hes tried for pain: Cymbalta, morphine, medicines for depression, even schizophrenia drugs.

For five years, hes been on a regimen that works for him: a base of 20 milligrams of OxyContin (oxycodone hydrochloride) twice a day, with Norco (a combination of hydrocodone and acetaminophen) as needed but no more than one pill every four hours. He augments these with over-the-counter pain patches, hot and cold compresses, a device to deliver nerve stimulation to muscles and massagers.

Temperature, movement, vibrationthese are all different elements that affect whatever youre feeling, he says. But this is not a formula or a recipe. It is a lot of work, sadly, to find whatever works for you.

Opioid Epidemic Leads to Innovations

Sciences understanding of HIV and pain may be about to change, however. In the HIV and chronic pain issue of AIDS Care, a global task force of HIV experts began to lay out a research agenda for studying pain in people with HIV. (Their preference: Start with what causes it.) The issue includes new data showing that many HIV-positive people cant separate their chronic pain from their experience of having the virus.

The HIV Global Pain Task Force, of which Robinson-Papp is a member, is now soliciting recommendations for the HIV pain research agenda from people living with HIV.

Another effort is more wide-ranging. The National Institutes of Health (NIH) launched the Helping to End Addiction Long-term (HEAL) Initiative in 2018 and has so far funded it with $1.5 billion to back experimental research and the development of medical devices that might treat opioid use disorder or address or prevent pain.

The funding also supports the Pain Management Effectiveness Research Network, which is testing existing non-opioid drugs against pain, and the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing as well as new research paths for interventions that could treat pain without requiring opioids.

Thats where Marco Loggia, PhD, associate director of Massachusetts General Hospitals Center for Integrative Pain NeuroImaging, comes in.

Loggia isnt an HIV researcher. But he has dedicated his career to studying what pain of all sorts looks like in the brain using PET and MRI scans.

Neuroinflammation is what brought him to HIV. Chronic HIV infection can lead to persistent immune activation and inflammation even among people on effective antiretroviral treatment who have an undetectable viral load.

Loggias lab was the first to show that in people with chronic pain a protein in the brain called translocator protein (TSPO) is present in unusually high numbers in the thalamus, the part of the brain that perceives pain and other stimuli. If his theory is correct and the presence of TSPO in people with chronic pain isnt just a coincidence but actually an objective marker of how much pain people are in, lowering TSPO might also reduce how much pain a person feels, without the need for opioids. Drugmakers could then develop medications that target and reduce TSPO and therefore reduce the pain itself.

HIV is a perfect storm of neuroinflammation, he says. We wanted to knowabove and beyond the inflammation associated with the viruswhy some people with HIV have pain and some dont.

In short, if all people with HIV have neuroinflammation, why dont they all also have pain? And does neuroinflammation look different in the brains of HIV-positive and HIV-negative people with chronic pain?

Loggias current study is recruiting participants in the Boston area to be part of an imaging study to look at just this. It divides participants into three categories: 30 people living with HIV without chronic pain, 30 people with HIV and chronic pain who engaged in opioid pain management and 30 people with HIV with chronic pain not taking opioids. Thats because of another complication of opioid use: Scientists think ongoing opioid use could actually increase inflammation, and maybe TSPO, in the brain.

The HEAL Initiative gives Robinson-Papp hope for the future of pain treatment for people living with HIV.

The HEAL Initiative has really brought together the addiction world and the pain world, which I think is extraordinarily beneficial, particularly for the pain world, because there are ways addiction medicine conceptualizes care that would be really lovely for us as well, she says, noting addiction cares focus on harm reduction. You have to think about the whole personwhere they live, what the context of their pain is.

Jess GuillnAngela DeCenzo

Reclaiming Joy

One of Guillns early memories as a child was dancing with his aunts. One aunt would take him by the hand, and another aunt would grab his sister. They would teach the kids salsa and other dances. When Guilln remembers it, he beams with adoration for his aunts, one of whom recently died.

In the years since, his experience in his body is, like pain, never just one thing. The breathtaking rush of a first kiss and first touch with another man linger with memories of the burning under his skin that came with his HIV diagnosis. The horror of the feel of bald patches on his scalp from the stress of being closeted and living with HIV in 1985 coexist with the youthful energy of nights spent at discos, dancing until dawn. Theres the mix of adrenaline and the great vibration in his chest from standing in front of a crowd and singing. Now, at 60, in chronic pain and with a hip replacement, Guilln is proud of the fact that these days, when he does dance, he can still break it down all the way to the ground.

Sometimes, when every step on the sidewalk feels like stabbing, he imagines hes walking on a bed of Jell-O. It takes him out of his current body, this painful body that nevertheless he loves.

He can still access the joy he felt dancing as a child. It will cost him in energy and recovery later, but for five or 10 minutes, his feet move in that familiar way, in concert with his shoulders, hips leading, weight shifting from balls of feet to heels, shoulders shifting to compensate. For those minutes, he is that child again, dancing in the kitchen with his aunt.

Some days, thats just a fantasy. But he can escape into that memory and know what its been like to be a whole person in a currently painful body.

Even if were sitting down, we can have those wonderful memories of movement, he says, as his hands come up in front of his chest and his shoulders shimmy. And even with just the hands, or the hands right here, we are in our brains really doing the twist. And it might help.

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The Feather and the Knife: Navigating Life With Chronic Pain - POZ


Taysha Gene Therapies Secures up to $100 Million Non-Dilutive Term Loan Financing – Yahoo Finance

Tuesday, August 17th, 2021

Financing strengthens balance sheet, furthers financial and operational flexibility and lowers overall cost of capital

No financial covenants and no warrants issued in connection with non-dilutive financing

Full drawdown expected to extend cash runway to support key value-creating milestones including availability of Phase 1/2 GAN data from the highest dose cohort as well as regulatory guidance on registration pathway for GAN, data readouts in GM2 gangliosidosis, Rett syndrome, CLN1 disease, and SURF1-associated Leigh syndrome and, importantly, a potential regulatory approval for TSHA-120 in GAN without the need for additional financing

DALLAS, August 16, 2021--(BUSINESS WIRE)--Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a patient-centric gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system in both rare and large patient populations, today announced that it has entered into a loan and security agreement with Silicon Valley Bank (SVB) that provides Taysha with up to $100 million of borrowing capacity.

"Access to this non-dilutive financing at an attractive cost of capital, along with the current cash on hand, will provide Taysha with operational and financial flexibility to achieve numerous value-generating milestones including a potential regulatory approval for TSHA-120 in giant axonal neuropathy, or GAN," said RA Session II, Chief Executive Officer of Taysha. "Additional milestones include the release of Phase 1/2 data in the highest dose cohort in GAN, and Phase 1/2 data in GM2 gangliosidosis, Rett syndrome, CLN1 disease and SURF1-associated Leigh syndrome. We are pleased to partner with SVB as we continue to execute on our ambitious business plan."

This non-dilutive financing provides Taysha with up to $100 million, with $40 million available at closing of which Taysha has drawn $30.0 million. The Company has the option to draw down the remaining tranches, subject to certain conditions. The interest rate is the greater of 7.0% or the WSJ Prime Rate plus 3.75%. There are no financial covenants and no warrants associated with the term loan.

Story continues

"Our financial commitment to Taysha speaks to our confidence in its core strategies and is consistent with our support of innovative life sciences businesses," said Michael White, Head of Business Development, Life Science & Healthcare, Silicon Valley Bank. "We are delighted to provide additional capital for the Company to further advance its robust development pipeline and achieve key value-generating milestones in the years to come."

"In the last 12 months, we have quickly made the transition from a private to public company and from preclinical to clinical to pivotal-stage," said Kamran Alam, Chief Financial Officer of Taysha. "Building upon this momentum, we expect this non-dilutive financing to enable us to be well positioned to maximize long-term stockholder value."

About Taysha Gene Therapies

Taysha Gene Therapies (Nasdaq: TSHA) is on a mission to eradicate monogenic CNS disease. With a singular focus on developing curative medicines, we aim to rapidly translate our treatments from bench to bedside. We have combined our teams proven experience in gene therapy drug development and commercialization with the world-class UT Southwestern Gene Therapy Program to build an extensive, AAV gene therapy pipeline focused on both rare and large-market indications. Together, we leverage our fully integrated platforman engine for potential new cureswith a goal of dramatically improving patients lives. More information is available at

About Silicon Valley Bank

For nearly 40 years, Silicon Valley Bank (SVB) has helped innovative companies and their investors move bold ideas forward, fast. SVB provides targeted financial services and expertise through its offices in innovation centers around the world. With commercial, international and private banking services, SVB helps address the unique needs of innovators. Learn more at

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning or implying the potential of our product candidates to positively impact quality of life and alter the course of disease in the patients we seek to treat, our research, development and regulatory plans for our product candidates, the anticipated use of proceeds from borrowings under the loan and security agreement, our ability to access the full $100 million potentially available under the loan and security agreement and our ability to fund operations into the second half of 2023. Forward-looking statements are based on managements current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission ("SEC") filings, including in our Annual Report on Form 10-K for the year ended December 31, 2020 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, both of which are available on the SECs website at Additional information will be made available in other filings that we make from time to time with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

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Company Contact: Kimberly Lee, D.O.SVP, Corporate Communications and Investor RelationsTaysha Gene

Media Contact: Carolyn HawleyCanale

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Taysha Gene Therapies Secures up to $100 Million Non-Dilutive Term Loan Financing - Yahoo Finance


Sonnet BioTherapeutics Provides Fiscal Year 2021 Third Quarter Business and Earnings Update – Yahoo Finance

Tuesday, August 17th, 2021

Sonnet BioTherapeutics Provides Fiscal Year 2021 Third Quarter Business and Earnings Update

Expanded F H AB Intellectual Property Portfolio

Completed $15.9 million At-The-Market Financing

SON-1010 and SON-080 on track for IND submissions by calendar year end

PRINCETON, NJ / ACCESSWIRE / August 16, 2021 / Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, announced today its financial results for the three months ended June 30th , 2021 and provided a business update.

"Throughout the quarter, we've continued to make several advancements towards the clinic with our proprietary Fully Human Albumin Binding (F H AB) pipeline assets, and our partnered product" commented Pankaj Mohan, Ph.D., Founder and CEO. "We are progressing our SON-1010 (F H AB-IL12) and SON-080 (Low-dose IL-6) programs, with IND applications on track to be filed with the FDA for both before the end of 2021, with an additional IND for SON-1210 (IL12-F H AB-IL15) during the first half of 2022. We remain confident that the ability to deliver a therapeutic payload in a more targeted manner than traditional, wild-type cytokines has the potential to result in greater efficacy with an improved toxicity profile."

"We are pleased with our ongoing financing strategy, which is designed to provide the company with the funding necessary to advance our R&D activities and to grow the company beyond 2021," commented Jay Cross, CFO.

FY 2021 Third Quarter and Recent Corporate Updates

Sonnet provided the following corporate updates:

In May 2021, Sonnet entered into a license agreement with New Life Therapeutics, granting exclusive licenses to develop and commercialize SON-080 for the prevention, treatment, or palliation of diabetic peripheral neuropathy in certain territories in Asia.

In June 2021, the United States Patent and Trademark Office issued U.S. Patent No. 11,028,166 entitled "Albumin Domain Fusion Proteins" that covers Sonnet's F H AB technology. The patent also includes therapeutic fusion proteins that utilize F H AB for tumor targeting and retention, thereby providing extended pharmacokinetics.

Story continues

In June 2021, Sonnet executed its final issuance of shares of its common stock under the At-the-Market Sales Agreement, pursuant to which the Company executed issuances of an aggregate of 7,454,238 Shares for aggregate gross proceeds of $15,874,999.

FY 2021 Third Quarter Ended June 30, 2021 Financial Results

As of June 30, 2021, Sonnet had $6.0 million cash on hand.

Research and development expenses were $3.9 million for the three months ended June 30, 2021, compared to $2.5 million for the three months ended June 30, 2020. The increase of $1.4 million was primarily due to increased expenditures for the development of the cell line for IL12-FHAB and IL12-FHAB-IL15 and increased costs for research and development activities due to the acquisition of Relief and an increase in payroll and share-based compensation expense as operations are expanded.

General and administrative expenses were $2.4 million for the three months ended June 30, 2021, compared to $2.5 million for the three months ended June 30, 2020. The decrease of $0.1 million was primarily due to a $0.9 million decrease in professional fees and transaction-related fees associated with the closing of the merger, offset by an increase in payroll and share-based compensation expense of $0.7 million to support expanded operations.

About Sonnet BioTherapeutics Holdings, Inc.

Sonnet BioTherapeutics is an oncology-focused biotechnology company with a proprietary platform for innovating biologic drugs of single or bispecific action. Known as F H AB (Fully Human Albumin Binding), the technology utilizes a fully human single chain antibody fragment (scFv) that binds to and "hitch-hikes" on human serum albumin (HSA) for transport to target tissues. F H AB is the foundation of a modular, plug-and-play construct for potentiating a range of large molecule therapeutic classes, including cytokines, peptides, antibodies and vaccines.

Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which the Company operates and management's current beliefs and assumptions.

These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential, "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or the Company's financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Sonnet Biotherapeutics Investor Contact

Michael V. Morabito, Ph.D.Solebury

Sonnet BioTherapeutics Holdings, Inc.Consolidated Balance Sheets(unaudited)

June 30,

September 30,




Current assets:






Prepaid expenses and other current assets



Total current assets



Property and equipment, net



Operating lease right-of-use asset



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Total assets





Liabilities and stockholders' equity

Current liabilities:

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Stockholders' equity:

Preferred stock; $0.0001 par value: 5,000,000 shares authorized. No shares issued or outstanding



Common stock; $0.0001 par value: 125,000,000 shares authorized; 24,757,847 and 14,724,105 issued and outstanding at June 30, 2021 and September 30, 2020, respectively



Additional paid-in capital



Accumulated deficit



Excerpt from:
Sonnet BioTherapeutics Provides Fiscal Year 2021 Third Quarter Business and Earnings Update - Yahoo Finance


Ugly Side Effects of Too Many Vitamins – Eat This Not That – Eat This, Not That

Tuesday, August 17th, 2021

Most of us learn pretty earlywhether it's via an ice cream headache or pizza-party hangoverthat it is indeed possible to get too much of a good thing. Unfortunately, as health-conscious adults, many of us are slow to realize the same lesson still applies. When it comes to vitamins and supplements, more doesn't mean better. Taking too many vitamins can have unpleasant or serious side effects, and some vitamins shouldn't be taken in supplement form at all. Read on to find out moreand to ensure your health and the health of others, don't miss these Sure Signs You Have "Long" COVID and May Not Even Know It.

The first sign that you've taken too many vitamins or supplements is usually gastrointestinal. You might experience nausea, vomiting or diarrhea. It might mean you've taken a vitamin on an empty stomach that you'd better tolerate with foodor that you're taking more supplements than your body should handle. To be safe, it's always a good idea to talk with your doctor before beginning a new vitamin or supplement regimen.

This is one of the side effects associated with taking too much vitamin A, which is a fat-soluble vitamin. Unlike water-soluble vitaminsof which the body eliminates any excess in the urinefat-soluble vitamins are stored in body fat. If you take too many, that can result in toxicity. The other fat-soluble vitamins are D, E and K, and you should take care not to exceed the recommended daily dosage of each.

RELATED: What Taking a Vitamin Every Day Does to Your Body

Yikes. But indeed, that's what research has indicated about taking supplements of beta-carotene or vitamin E, or excessive amounts of biotin. Last spring, the United States Preventive Services Task Force (USPSTF) officially recommended against taking vitamin E or beta-carotene supplements, saying they may increase the risk of cancer or poor outcomes from heart disease. Another study found that men had an increased risk of lung cancer after taking megadoses of biotin (5 mg to 10 mg daily).

RELATED: The #1 Best Supplement to Take For Immunity

Taking too much of certain vitamins, such as vitamin B6, can result in nerve issues, such as neuropathy (numbness) or tingling. To avoid this, never take more than the recommended daily allowance.

RELATED: Signs You're Getting One of the "Most Deadly" Cancers

Another potentially dangerous vitamin or multivitamin ingredient is vitamin E. "Unless you have a reason to take vitamin E, you shouldn't be taking it as a random supplement," says Kathryn Boling, MD, a family medicine doctor with Mercy Medical Center in Baltimore. "We used to think it was good to take because it's an antioxidant, but it turns out the risk is higher than the benefit." That risk: Vitamin E thins the blood, which could turn minor injuries into serious bleeding episodes.And to get through this pandemic at your healthiest, don't miss these 35 Places You're Most Likely to Catch COVID.

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Ugly Side Effects of Too Many Vitamins - Eat This Not That - Eat This, Not That


Chemotherapy Induced Peripheral Neuropathy Pipeline Analysis Shows Tremendous Growth Opportunities for the Coming Years in the Domain – Digital…

Friday, May 14th, 2021

The Chemotherapy Induced Peripheral Neuropathy Pipeline Insight report from DelveInsight offers a detailed overview of the pipeline therapies in various clinical and preclinical stages of growth, their introduction, and how the Chemotherapy Induced Peripheral Neuropathy market is expected to change as a result.

The Chemotherapy Induced Peripheral Neuropathy Pipeline Insight report from DelveInsight offers a detailed overview of the pipeline therapies in various clinical and preclinical stages of growth, their introduction, and how the Chemotherapy Induced Peripheral Neuropathy market is expected to change as a result.

The Chemotherapy Induced Peripheral Neuropathy Pipeline Analysis report gives you a complete picture of the Chemotherapy Induced Peripheral Neuropathy therapeutic landscape, including development stage, product type, route of administration, molecule type, and MOA.

The report addresses a wide range of topics, including market opportunities, challenges, future alliances, strong competitors, and growth strategies.

Some of the Key Highlights from the Chemotherapy Induced Peripheral Neuropathy Market Report

There are more than 30+ Chemotherapy Induced Peripheral Neuropathy pipeline therapies in different stages of development, and their expected adoption in the Chemotherapy Induced Peripheral Neuropathy market will significantly increase market revenue.

Out of the emerging therapies, Tetrodotoxin and PledOx are in Phase III of clinical development, whereas MP-101 and Ibudilast are in Phase II development phase for Chemotherapy Induced Peripheral Neuropathy.

Chemotherapy Induced Peripheral Neuropathy pipeline therapies in the early stage of development include Ricolinostat and APX 3330 in Phase I of clinical trials.

Some Chemotherapy Induced Peripheral Neuropathy pipeline therapy which is still in the pre-clinical stage of development include AM 1710.

For more information request sample @ Chemotherapy Induced Peripheral Neuropathy Pipeline Analysis

Chemotherapy Induced Peripheral Neuropathy: Disease Overview

Taxanes, platinum-based drugs, vinca alkaloids, thalidomide, bortezomib, and interferon all cause Chemotherapy-Induced Peripheral Neuropathy (CIPN), which is a normal, dose-dependent side effect of many commonly prescribed chemotherapy and biotherapy drugs. CIPN causes a wide range of symptoms, including physical and emotional discomfort from neuropathic pain, as well as degeneration.

Chemotherapy Induced Peripheral Neuropathy: Symptoms

Exaggerated sensation (neuropathic pain), loss of sensation (numbness, muscle weakness, loss of balance), or both are symptoms of CIPN. Symptoms are normally bilateral and develop in a distal to proximal pattern, starting at the tips of the fingers and toes and progressing to the upper and/or lower extremities.

Chemotherapy Induced Peripheral Neuropathy: Treatment

However, there are no licenced medications to prevent or treat CIPN at this time. Some chemotherapy medications have a higher risk of causing neuropathy. Platinum medications like oxaliplatin, taxanes like docetaxel, vinca alkaloids like vincristine, and myeloma therapies like bortezomib are among them. Neuropathy can also be caused by other chemotherapy medications.

Learn more about CIPN @ CIPN Market Trends

Chemotherapy Induced Peripheral Neuropathy Pipeline Analysis: Drug Profile

Pledox (Calmangafodipir): Egetis Therapeutics

PledOx (also known as calmangafodipir, SP-04) is a first-in-class drug candidate being developed by Pledpharma for the prevention of nerve damage caused by chemotherapy in colorectal cancer patients. Calmangafodipir is currently in Phase III clinical trials for the prevention of chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN) caused by the drug Oxaliplatin in patients with cancer.

Chemotherapy Induced Peripheral Neuropathy Pipeline Therapies and Major Companies

Tetrodotoxin: WEX Pharmaceuticals

PledOx: Egetis Therapeutics

MP-101: Metys Pharmaceuticals AG

Ibudilast: MediciNova

Ricolinostat: Regenacy pharmaceuticals

APX 3330: Apexian Pharmaceuticals

AM 1710: MakScientific

Chemotherapy Induced Peripheral Neuropathy Therapeutics Assessment

Scope of the Report

Coverage: Global

Key CIPN Players: WEX Pharmaceuticals, Egetis Therapeutics, Metys Pharmaceuticals AG, MediciNova, Regenacy pharmaceuticals, Apexian Pharmaceuticals, MakScientific, among others.

Key CIPN Pipeline Therapies: Tetrodotoxin, PledOx, MP-101, Ibudilast, Ricolinostat, APX 3330, AM 1710, others.

Table of Contents




Executive Summary


Chemotherapy Induced Peripheral Neuropathy: Overview


Chemotherapy Induced Peripheral Neuropathy- Analytical Perspective In-depth Commercial Assessment


Chemotherapy Induced Peripheral Neuropathy Pipeline Therapeutics


CIPN Late Stage Products (Phase III)


CIPN Mid Stage Products (Phase II)


CIPN Early Stage Products (Phase I)


CIPN Preclinical Stage Products


CIPN Therapeutic Assessment


CIPN Inactive Products


Company-University Collaborations (Licensing/Partnering) Analysis


Chemotherapy Induced Peripheral Neuropathy Key Companies


Chemotherapy Induced Peripheral Neuropathy Key Products


Chemotherapy Induced Peripheral Neuropathy- Unmet Needs


Chemotherapy Induced Peripheral Neuropathy- Market Drivers and Barriers


Chemotherapy Induced Peripheral Neuropathy- Future Perspectives and Conclusion


CIPN Analyst Views




About DelveInsight

Get in touch with our Business executive @ Chemotherapy Induced Peripheral Neuropathy Pipeline Insightsto know more

Key Questions Answered in the Chemotherapy Induced Peripheral Neuropathy Report

What treatment options are available for Chemotherapy-Induced Peripheral Neuropathy?

How many companies are working on treatments for Chemotherapy-Induced Peripheral Neuropathy (CIPN)?

What are the main therapies that these companies in the industry have developed?

How many therapies are being developed for the treatment of Chemotherapy Induced Peripheral Neuropathy by each company?

How many Chemotherapy Induced Peripheral Neuropathy emerging therapies are in progress for the treatment of Chemotherapy Induced Peripheral Neuropathy at the early, mid, and late stages?

How many therapies are offered as monotherapies and in conjunction with other therapies out of the total pipeline products?

What are the main industry-industry and industry-academia partnerships, mergers and acquisitions, and major licencing activities that will have an effect on Chemotherapy Induced Peripheral Neuropathy?

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Osmol Therapeutics Initiates IND Enabling Studies to Develop First Therapy for Prevention of Chemotherapy-Induced Peripheral Neuropathy – BioSpace

Friday, May 14th, 2021

-- Founded by Barbara Ehrlich, Ph.D. at Yale University

-- Bob Linke appointed Chief Executive Officer

NEW HAVEN, Conn.--(BUSINESS WIRE)-- Osmol Therapeutics today announced that it has initiated Investigational New Drug (IND) enabling studies to develop a therapy to prevent chemotherapy-induced peripheral neuropathy (CIPN). A phase 1 clinical study is projected to begin in 2022. There are currently no Food and Drug Administration (FDA) approved therapies for the prevention or treatment of CIPN, a debilitating condition resulting from the off-target toxicity of many chemotherapy treatments.

Osmol was founded by Dr. Barbara Ehrlich, Professor of Pharmacology and of Cellular and Molecular Physiology, Yale School of Medicine. Her research on neuronal calcium sensor-1 (NCS1), a critical calcium binding protein that regulates intracellular calcium levels, forms the basis of Osmols CIPN treatment, OSM-0205 and future potential NCS1 therapeutics. OSM-0205s mechanism addresses the off-target toxicity of microtubule-based chemotherapy agents that results in a calcium surge leading to CIPN. OSM-0205 modulates NCS1 to prevent the calcium surge and maintain neuronal integrity.

The companys initial focus is CIPN in breast cancer patients resulting from taxane-based chemotherapy treatment. Taxanes are the most widely used chemotherapy treatment for breast cancer and can lead to CIPN in up to 80% of patients. Independent market research conducted with breast cancer oncologists at leading US cancer centers confirmed that CIPN is the most significant toxicity issue facing clinicians and patients when treating breast cancer.

Chemotherapy-induced peripheral neuropathy is a devastating adverse event that can leave patients and their treating physicians with a very difficult choice reduce taxane therapy with the possibility of negatively impacting patient outcomes or continue therapy at the recommended dose with the potential of causing increased and possibly permanent, disabling CIPN, said Dr. Ehrlich. OSM-0205 is being developed with the goal of preventing CIPN before it occurs. By blocking the calcium surge that causes neuropathy, optimal treatment with taxanes can continue. This is particularly important in the treatment of breast cancer where taxanes remain the foundation of most therapeutic regimens.

There are currently no FDA-approved therapies to avoid or reduce CIPN, creating an urgent need for patients being treated with chemotherapy, said Robert Berman, M.D., Executive Chairman of Osmol Therapeutics and co-founder and former Chief Medical Officer at Biohaven Pharmaceuticals. Over 225,000 patients in the U.S. and the European Union with early stage or metastatic breast cancer are treated with taxanes each year. We have recruited an experienced and capable executive team, led by Bob Linke, Osmols Chief Executive Officer, to advance OSM-0205 to address this need as well as explore the potential use of neuronal calcium sensor-1 (NCS1) in other indications. We are excited by the potential of OSM-0205 and expect to begin clinical development as early as next year.

Bob Linke, MBA, is an experienced biopharma entrepreneur, who is also Executive Chairman of Embera NeuroTherapeutics and IonSense. He has an established track record developing strategies, building and leading emerging companies through all phases of growth from research, product development and clinical studies to successful commercialization, partnership and acquisitions. Bob brings an open management style to create cohesive, high-functioning teams. He has raised over $70 million in private equity and non-dilutive financing to fund these companies development and commercialization efforts. His early career was spent at Baxter, developing and commercializing pharmaceuticals and drug delivery systems.

About OSM-0205 and CIPN

Osmols lead drug, OSM-0205, is based on Dr. Barbara Ehrlichs research in neuronal calcium sensor-1 (NCS1) at Yale University and is designed to prevent the off-target calcium surge caused by taxanes and potentially other chemotherapy treatments associated with peripheral nerve damage. Data from preclinical studies conducted by Osmol show that pre-treatment with OSM-0205 prevents neuronal damage from taxanes in mice by preventing the off-target intracellular calcium surge caused by these chemotherapy agents. It is hypothesized that OSM-0205 modulates NCS1 in patients to protect neurons from damage leading to a reduction of CIPN. CIPN affects hundreds of thousands of cancer patients every year and can compromise optimum chemotherapy dosing. There are no effective treatments for CIPN, a condition which can diminish quality of life and lead to lifelong disability.

About Osmol Therapeutics

Osmol Therapeutics is a privately held biopharma company focused on developing a treatment to prevent chemotherapy-induced peripheral neuropathy (CIPN) based on the ground-breaking work of Dr. Barbara Ehrlich on the role of NCS1 in calcium signaling and regulation in preventing nerve damage associated with chemotherapy. The companys lead indication will be for the prevention of CIPN in breast cancer patients treated with taxane-based therapy, a treatment regimen in which up to 80% of patients experience CIPN. For more information, please go to .

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Osmol Therapeutics Initiates IND Enabling Studies to Develop First Therapy for Prevention of Chemotherapy-Induced Peripheral Neuropathy - BioSpace


Global Chronic Pain associated with Painful Diabetic Neuropathy Market to 2025 – Insight, Competitive Landscape and Forecasts –…

Friday, May 14th, 2021

DUBLIN--(BUSINESS WIRE)--The "Chronic Pain associated with Painful Diabetic Neuropathy - Market Insight, Competitive Landscape and Market Forecast, 2026" report has been added to's offering.

This report delivers an in-depth understanding of Chronic Pain associated with Painful Diabetic Neuropathy and the historical and forecasted Chronic Pain associated with Painful Diabetic Neuropathy market trends in the US, EU5 (Germany, Spain, Italy, France and United Kingdom) and Japan.

The Chronic Pain associated with Painful Diabetic Neuropathy market report provides an overview of Chronic Pain associated with Painful Diabetic Neuropathy, its cause, signs and symptoms, pathophysiology, diagnosis and currently available therapies. Additionally, this report covers the overview, various treatment practices, and Chronic Pain associated with Painful Diabetic Neuropathy forecasted epidemiology from 2018 to 2026, segmented by the seven major markets. The report also covers the market drivers, market barriers and unmet medical needs to curate best of the opportunities and assesses underlying potential of the market.

Chronic Pain associated with Painful Diabetic Neuropathy: Market Drivers and Barriers

The report provides insights into the market driving factors and the barriers shaping the Chronic Pain associated with Painful Diabetic Neuropathy market.

Market Drivers:

Market Barriers:

KOL- Views

To keep up with the market trends, we take KOLs and SME's opinion working in Chronic Pain associated with Painful Diabetic Neuropathy domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or Chronic Pain associated with Painful Diabetic Neuropathy market trend. This will support the clients in making informed business decisions by identifying the overall scenario of the market and the unmet needs.

Scope of the Report

Report Highlights

Companies Mentioned

For more information about this report visit

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Global Chronic Pain associated with Painful Diabetic Neuropathy Market to 2025 - Insight, Competitive Landscape and Forecasts -


Leber’s Hereditary Optic Neuropathy (LHON) (Leber Optic Atrophy) Market Will Accelerate at a CAGR Through 2021-2027 | Rising Technological Innovations…

Friday, May 14th, 2021

Global Lebers Hereditary Optic Neuropathy (LHON) (Leber Optic Atrophy) Market Growing Demand and Growth Opportunity 2027


The report is a comprehensive analysis of the Lebers Hereditary Optic Neuropathy (LHON) (Leber Optic Atrophy) market and covers facts and growth drivers for the market profile. Manufacturing technologies and applications that form a part of this Lebers Hereditary Optic Neuropathy (LHON) (Leber Optic Atrophy) market success are also included in the report. Based on such information, the market has been segmented into various categories and portrays the maximum market share for the forecast period. The study is a result of various analysis techniques used to derive the relevant information. These analysis techniques include SWOT methodologies and Porters Five Force Model. Further, the report has an acute focus on global players, products with the highest demand, and the various product categories, which are causative of the Lebers Hereditary Optic Neuropathy (LHON) (Leber Optic Atrophy) market growth. Micro and macroeconomic indicators, government stipulations that could affect the market, and advice from industry leaders is also included in the report compilation. The study of the market has been taken place during 2019, the base year and the forecast period stretches till 2027.

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Top Key Players Profiled in this report: Alkeus Pharmaceuticals, Amgen, Biovista, Editas Medicine, GenSight Biologics, Ixchel Pharma, Khondrion, Mitotech, ProQR Therapeutics, Sanofi, Spark Therapeutics, Stealth BioTherapeutics, and Usher Syndrome

Segmental Analysis

The market study contains the division of the overall market into different regional segments according to the key geographic regions. The whole of the Lebers Hereditary Optic Neuropathy (LHON) (Leber Optic Atrophy) market has been covered with regards to the key countries and regions. Using the results from the regional analysis, the report also presents a forecast for the local markets. The market presence of manufacturers and key players have also been studied.

All the major regions in the market have been covered with broad segments including North America, South America, Asia-Pacific, the Middle East, Europe, and Africa. The other major segmentations on the market cover the product types and end-user applications.

North America held dominant position in the global Lebers Hereditary Optic Neuropathy (LHON) (Leber Optic Atrophy) market in 2021, accounting for XX% share in terms of value, followed by Europe and Asia Pacific, respectively.

Research objectives

To study and forecast the market size of Lebers Hereditary Optic Neuropathy (LHON) (Leber Optic Atrophy) in global market.

To analyze the global key players, SWOT analysis, value and global market share for top players.

To define, describe and forecast the market by type, end use and region.

To analyze and compare the market status and forecast among global major regions.

To analyze the global key regions market potential and advantage, opportunity and challenge, restraints and risks.

To identify significant trends and factors driving or inhibiting the market growth.

To analyze the opportunities in the market for stakeholders by identifying the high growth segments.

To strategically analyze each submarket with respect to individual growth trend and their contribution to the market

To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market.

To strategically profile the key players and comprehensively analyze their growth strategies.

Market Segment by Regions, regional analysis covers

North America (United States, Canada and Mexico)

Europe (Germany, France, UK, Russia and Italy)

Asia-Pacific (China, Japan, Korea, India and Southeast Asia)

South America (Brazil, Argentina, Colombia etc.)

Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa).

Lebers Hereditary Optic Neuropathy (LHON) (Leber Optic Atrophy) Report mainly covers the following:

1) World Wide Lebers Hereditary Optic Neuropathy (LHON) (Leber Optic Atrophy) Industry Overview

2) Country and Regional Lebers Hereditary Optic Neuropathy (LHON) (Leber Optic Atrophy) Market Diagnosis

3) Lebers Hereditary Optic Neuropathy (LHON) (Leber Optic Atrophy) Data predicated on technician varies and Process Analysis

4) Key success factors and Lebers Hereditary Optic Neuropathy (LHON) (Leber Optic Atrophy) Economy Share Summary

For Customization of the Report on Global Lebers Hereditary Optic Neuropathy (LHON) (Leber Optic Atrophy) market 2021 Click on the Links, We Will do Our Best

Some Major TOC Points:

Chapter 1: Overview of Lebers Hereditary Optic Neuropathy (LHON) (Leber Optic Atrophy) Market

Chapter 2: Global Market Status and Forecast by Regions

Chapter 3: Global Market Status and Forecast by Types

Chapter 4: Global Market Status and Forecast by Downstream Industry

Chapter 5: Market Driving Factor Analysis

Chapter 6: Market Competition Status by Major Manufacturers

Chapter 7: Major Manufacturers Introduction and Market Data

Chapter 8: Upstream and Downstream Market Analysis

Chapter 9: Cost and Gross Margin Analysis

Chapter 10: Marketing Status Analysis

Chapter 11: Market Report Conclusion

Chapter 12: Research Methodology and Reference

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Reports and Markets is not just another company in this domain but is a part of a veteran group called Algoro Research Consultants Pvt. Ltd. It offers premium progressive statistical surveying, market research reports, analysis & forecast data for a wide range of sectors both for the government and private agencies all across the world. The database of the company is updated on a daily basis. Our database contains a variety of industry verticals that include: Food Beverage, Automotive, Chemicals and Energy, IT & Telecom, Consumer, Healthcare, and many more. Each and every report goes through the appropriate research methodology, Checked from the professionals and analysts.

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Leber's Hereditary Optic Neuropathy (LHON) (Leber Optic Atrophy) Market Will Accelerate at a CAGR Through 2021-2027 | Rising Technological Innovations...


Chemotherapy induced peripheral neuropathy Pipeline Insight to See Strong Expansion Through 2027 Covid-19 Analysis The Courier – The Courier

Friday, May 14th, 2021

Chemotherapy induced peripheral neuropathy Pipeline Insight Market Report defines the business objective to help business owners to avoid contradictory expectations. It provides you customer data along with their demands hence you can accordingly plan for the launching of the product in the market. It presents all the data about whole market scenario. With the help of prominent data provided in the Chemotherapy induced peripheral neuropathy Pipeline Insight Market Report, organizations come to know about customers completely and can achieve their goal of selling products in huge quantity and getting huge profits too. Clearly setting the business goal at the beginning will surely help to avoid getting difficulties and set the business easily.

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Chemotherapy induced peripheral neuropathy (CIPN): Therapeutic Assessment

This segment of the report provides insights about the different Chemotherapy induced peripheral neuropathy (CIPN) drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Chemotherapy induced peripheral neuropathy (CIPN)

There are approx. 15+ key companies which are developing the therapies for Chemotherapy induced peripheral neuropathy (CIPN). The companies which have their Chemotherapy induced peripheral neuropathy (CIPN) drug candidates in the most advanced stage, i.e. phase II include, MediciNova.


DelveInsight s report covers around 15+ products under different phases of clinical development like

Late stage products (Phase III)

Mid-stage products (Phase II)

Early-stage product (Phase I) along with the details of

Pre-clinical and Discovery stage candidates

Discontinued & Inactive candidates

Route of Administration

Chemotherapy induced peripheral neuropathy (CIPN) pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as






Molecule Type

Products have been categorized under various Molecule types such as

Monoclonal Antibody



Small molecule

Gene therapy

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Chemotherapy induced peripheral neuropathy (CIPN): Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Chemotherapy induced peripheral neuropathy (CIPN) therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Chemotherapy induced peripheral neuropathy (CIPN) drugs.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Chemotherapy induced peripheral neuropathy (CIPN) R&D. The therapies under development are focused on novel approaches to treat/improve Chemotherapy induced peripheral neuropathy (CIPN).

In December 2019, Solasia Pharma entered into an exclusive license agreement with Maruho for commercialization of Solasia s product SP-04 (PledOx , hereinafter product ), a therapeutic agent for chemotherapy induced peripheral neuropathy (currently undergoing Phase III clinical trials) in Japan.

Chemotherapy induced peripheral neuropathy (CIPN) Report Insights

Chemotherapy induced peripheral neuropathy (CIPN) Pipeline Analysis

Therapeutic Assessment

Unmet Needs

Impact of Drugs

Chemotherapy induced peripheral neuropathy (CIPN) Report Assessment

Pipeline Product Profiles

Therapeutic Assessment

Pipeline Assessment

Inactive drugs assessment

Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

How many companies are developing Chemotherapy induced peripheral neuropathy (CIPN) drugs

How many Chemotherapy induced peripheral neuropathy (CIPN) drugs are developed by each company

How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Chemotherapy induced peripheral neuropathy (CIPN)

What are the key collaborations (Industry Industry, Industry Academia), Mergers and acquisitions, licensing activities related to the Chemotherapy induced peripheral neuropathy (CIPN) therapeutics

What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies

What are the clinical studies going on for Chemotherapy induced peripheral neuropathy (CIPN) and their status

What are the key designations that have been granted to the emerging drugs

Key Players

NeuroBo Pharmaceuticals


Midatech Pharma


Sonnet BioTherapeutics

Toray Industries

EA Pharma


Asahi Kasei Pharma


Key Products




MN-166 (ibudilast)






Thrombomodulin alfa


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Key Features of the Report:

Complete report is available at

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Research Foretell is an information service company that provides market research, custom, and consulting services. Decision-making is complicated and we help you to solve your biggest puzzle, by identifying, analyzing, and monitoring the recent developing technologies and markets. Research Foretell is always forefront on classifying new opportunity in the market; with us you always have the first mover advantage.

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Chemotherapy induced peripheral neuropathy Pipeline Insight to See Strong Expansion Through 2027 Covid-19 Analysis The Courier - The Courier


Diabetic Retinopathy Market Size Growth Expects Significant Thrust at a CAGR of 3% During the Study Period, 2018-30 in the 7MM | DelveInsight -…

Friday, May 14th, 2021

LAS VEGAS, May 12, 2021 /PRNewswire/ -- DelveInsight's Diabetic Retinopathy MarketInsightsreport offers detailed information on current treatment practices, emerging drugs, Diabetic Retinopathy market share of the individual therapies, current and forecasted Diabetic Retinopathy market size from 2018 to 2030 segmented into 7MM (the USA, EU5 (the UK, Italy, Spain, France, and Germany), and Japan).

Some of the key takeaways from the Diabetic Retinopathy MarketInsights:

Download report to know which drug is going to capture the maximum market share @ Diabetic Retinopathy Market Analysis and Forecast

Diabetic Retinopathy: Disease Overview

Diabetic Retinopathy is a significant complication of diabetes mellitus, which is a leading cause of visual loss in working-age populations. With an increasing prevalence of diabetes, it appears that the prevalence of Diabetic Retinopathy is also on the rise. Type 2 diabetes, which is becoming more common, leads to over 60% of patients diagnosing with Diabetic Retinopathy within the first 20 years of onset.

Furthermore, Age is a noteworthy risk factor for Diabetic Retinopathy prevalence as the chances increase with the age.

Diabetic Retinopathy Epidemiology Segmentation

Diabetic RetinopathyMarket and Epidemiology Report offers historical as well as forecasted epidemiological analysis during the study period 2018-30 in the 7MM segmented into:

The report proffers a holistic view of the present Diabetic Retinopathy treatment practice/algorithm, market drivers, market barriers, and unmet medical needs that help clients curate the best of the opportunities and assess the market's hidden potential, and plans strategically to handle market risks.

For a comprehensive analysis, visit Diabetic Retinopathy Epidemiological Analysis and Changing Trends

Diabetic Retinopathy Therapy Market

The present scenario in the Diabetic Retinopathy therapeutic landscape appears quite confined, limited to laser treatment, eye injections, and anti-VEGF drugs, which are the preferred first line of therapy. The treatments for DR relies heavily on the presence of macular edema.

Available anti-VEGF drugs include aflibercept (Eylea from Regeneron and Bayer), ranibizumab (Lucentis from Genentech and Novartis), and bevacizumab (Avastin from Genentech) that are presently enjoying the monopoly in the Diabetic Retinopathy market.

However, there exist several gaps in the Diabetic Retinopathy therapeutic market in the form of an absence of biomarkers, a lack of technologies that are potential enough to predict the disease course in patients, and novel pathways to offer novel treatments.

Reach out to us @ Diabetic Retinopathy Marketed Therapiesfor more information on available treatment regimens

Diabetic Retinopathy Market

The Diabetic Retinopathy market encompasses several novel pipeline therapies with better efficiency and tolerability than conventional and available therapies. Key companies such as Novartis, Roche, Kodiak Sciences, Adverum Biotechnologies, Kubota Vision, Allegro Ophthalmics, and several others are developing new drugs that project a promising picture of the Diabetic Retinopathy market landscape in the coming decade.

The market has limited options to offer, and a lack of gene therapy, personalized treatment approaches offer pharma companies a latitude to explore and penetrate with novel gene therapies, biosimilars into the market.

This does not only promise one-time treatment but also facilitates the usage of lower doses ascribed to favorable anatomy of the eye owing to its size. Moreover, an increasing patient pool also gives pharma companies room for making cost-effective drugs without compromising with gains. Different possible pathways have been extensively studied, which could be responsible for the disease. Therefore, a better understanding has been obtained through years of thorough research and development. The emergence of personalized medications is expected to further drive the growth of the DR market share.

Diabetic Retinopathy Pipeline Therapies and Key Companies

Brolucizumabt: Novartis PharmaceuticalsFaricimab: RocheADVM-022: Adverum BiotechnologiesEmixustat Hydrochloride: Kubota VisionKVD001: KalVista Pharmaceuticals

Get a detailed analysis of Diabetic Retinopathy Emerging Drug Pipeline and Key Companies

Scope of the Report

Coverage: 7MM (the US, EU5, and Japan)Study Period: 2018-30Key Companies: Novartis, Roche, Adverum Biotechnologies, Kubota Vision, Kodiak Sciences andAllegro Ophthalmics.Key Diabetic Retinopathy Pipeline Therapies:Brolucizumab, Faricimab, ADVM-022, Emixustat Hydrochloride, KVD001, KSI-301 and Risuteganib.Diabetic Retinopathy Market Segmentation:By Geography, By Diabetic Retinopathy TherapiesAnalysis: Comparative and conjoint analysis of Diabetic Retinopathy emerging therapiesTools used: SWOT analysis, Conjoint Analysis, Porter's Five Forces, PESTLE analysis, BCG Matrix analysis methods.Case StudiesKOL's ViewsAnalyst's Views

Drop by to learn more about the future market trends@ Diabetic Retinopathy Market Landscape and Forecast

Table of Contents


Key Insights


Diabetic Retinopathy Market Report Introduction


Diabetic Retinopathy Market Overview at a Glance


Executive Summary of Diabetic Retinopathy


Disease Background and Overview


Organizations in the Diabetic Retinopathy Market


Diabetic Retinopathy Epidemiology and Patient Population


Diabetic Retinopathy Treatment


Diabetic Retinopathy Marketed Therapies


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Diabetic Retinopathy Market Size Growth Expects Significant Thrust at a CAGR of 3% During the Study Period, 2018-30 in the 7MM | DelveInsight -...


GenSight Biologics Provides 2021 Operations Update in the Context of COVID-19 – Business Wire

Friday, May 14th, 2021

PARIS--(BUSINESS WIRE)--Regulatory News:

GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today provides an update on the impact of COVID-19 on its operations in 2021.

It has been slightly over a year since we had to adjust our operations to the COVID-19 situation and provided you with an update on our activities. Although conditions have improved in many regions, the burden of the COVID-19 crisis continues to impact the medical and regulatory ecosystems. GenSight is preparing for the commercialization of LUMEVOQ first in Europe in 2022, then in North America a year later, despite the US Defense Production Act introducing a slight delay in manufacturing our validation batches, said Bernard Gilly, Co-founder and Chief Executive Officer of GenSight Biologics. Our team will be ready in due time to deliver LUMEVOQ to patients affected with this highly debilitating disease and continue to work tirelessly to develop alternative strategies to minimize the impact of COVID-19 on our operations.

LUMEVOQ Commercial Launch in Europe Still Expected in H1 2022

The REVERSE and RESCUE Phase III trials of LUMEVOQ (GS010) for the treatment of Leber Hereditary Optic Neuropathy (LHON) are completed, and patients have been transferred to long-term follow-up, the RESTORE study, for an additional three-year period. The sustained efficacy of LUMEVOQ three years after injection was previously reported. Patients are now followed-up annually, and given the follow-up nature of these visits and the stability of patients with no safety concern, delaying some of these visits has been an acceptable precautionary measure, which should have no impact on the conduct of the trial, and will be properly documented and reported to regulators.

The strategic manufacturing partner (CDMO) for LUMEVOQ, ThermoFischer Scientific (TFS) in Boston, USA, is maintaining its operations and is due to manufacture three validation batches to support the MAA filing with the European Medicines Agency (EMA) in Europe. TFS informed the Company that, as a consequence of the US Defense Production Act (DPA), American suppliers have had to redirect certain consumables towards the manufacture of COVID vaccines in the US. It is our understanding that this is an Industry issue impacting many manufacturers, biotech and pharmaceutical companies in particular. This has resulted in extended timelines for the availability of some items required for manufacturing LUMEVOQ. Accordingly, the Company anticipated delays in providing data from the planned validation batches to the EMA and, after discussions with the European Agency, agreed upon an extended clock-stop period. Responses to the Agency D120 questions are therefore now due by January 2022 instead of the previously anticipated August 2021. Based on this new timeline the Company now expects EMA approval for LUMEVOQ to shift from Q4 2021 to H1 2022. The revised timeline will be confirmed as soon as there is greater clarity from TFS on material availability. The timing for commercialization remains unchanged and the Company will continue to build the European commercial platform during 2021 to prepare the commercial launch of LUMEVOQ in Europe, still expected in H1 2022.

LUMEVOQ Regulatory Pathway in the US: REFLECT Phase III read-out in June 2021; BLA Submission Now Expected Q2 2022

The REFLECT Phase III trial of LUMEVOQ is fully recruited with a primary endpoint at 78 weeks. Although some on-site visits had to be postponed due to COVID-19 travel restrictions, the Company closely partnered with clinical sites and properly documented and reported delays to regulators, as well as pre-specified them in the Statistical Analysis Plan (SAP), in agreement with biostatisticians, before database lock. Consequently, GenSight Biologics was able to collect data from 95 out of 98 patients with no consequence on the primary endpoint, other than a delay in the 78-week read out from Q1 initially to June 2021. The Company expects to meet with the U.S. Food and Drug Administration (FDA) for a pre-BLA meeting in Q3 2021. Due to the impact of the US DPA on the manufacturing of LUMEVOQs validation batches, the regulatory submission target in the US is now Q2 2022.

PIONEER Phase I/II Clinical Trial of GS030 in Retinitis Pigmentosa (RP)

In order to protect patients, the Company and investigators together decided to delay recruiting new patients into the 3rd cohort of the PIONEER Phase I/II clinical trial of GS030 until the COVID-19 situation had improved, as RP is a chronic disease and does not require urgent treatment. The use of corticosteroids pre- and post-gene therapy injection, performed as part of the protocol to minimize inflammatory response, was deemed by GenSight and investigators to expose patients to a higher risk of COVID-19 infection. In the interim, the six patients in the first two cohorts were remotely monitored for safety aspects by investigators. Consequently, recruitment took longer than originally planned.

PIONEER, combining gene therapy and optogenetics for the treatment of RP, has now fully completed recruitment of the 3rd cohort. The Data Safety Monitoring Board (DSMB) is expected to make a recommendation on the optimal dose to use in the extension cohort in the coming weeks. GenSight Biologics expects to complete the recruitment of the extension cohort by the end of 2021. In the meantime, the Company expects to report early findings shortly in Q2 2021 and more preliminary results later in the second half of the year.

LUMEVOQ Temporary Authorization for Use, Compassionate Use and Early Access Programs

Additional patients were treated with LUMEVOQ in France in Q1 2021 under a nominative Temporary Authorization for Use (ATU) granted by the French National Drug Safety Agency (Agence Nationale de Scurit du Mdicament or ANSM). Additional ATUs have been requested by the CHNO of the Quinze-Vingts in Paris.

GenSight is committed to providing the drug, subject to available stock. For now, the Company does not foresee any shortage due to the impact of the DPA on TFS in the US and is closely monitoring the situation. Bilateral injections are priced at 700,000 per patient and are expected to generate revenues prior to regulatory approval and official reimbursement in France. In addition, the Company has submitted to the French ANSM an application for a cohort ATU to further facilitate access to LUMEVOQ for patients in France. The application is under review and patients can benefit from nominative ATUs in the meantime.

Compassionate use in Italy was granted with some patients already treated in Q1 2021. A compassionate use program in Germany is under review by competent authorities. Patients have also been treated in the United States under an Expanded Access Program granted by the FDA. For all these programs, LUMEVOQ is provided free of charge to requesting physicians.

GenSight continues to implement measures to protect its staff against COVID-19 by putting in place telecommuting for all employees. These measures have not affected activities carried out at its Paris headquarters.

The Company is financed until at least the end of Q2 2023 and is able to face any evolution of the COVID-19 situation with as much flexibility and foresight as required.

About GenSight Biologics

GenSight Biologics S.A. is a clinical-stage biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. Using its gene therapy-based approach, GenSight Biologics product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery. Developed as a treatment for Leber Hereditary Optic Neuropathy (LHON), GenSight Biologics lead product candidate, LUMEVOQ (GS010; lenadogene nolparvovec), is currently in the review phase of its registration process in Europe, and in Phase III to move forward to a BLA filing in the U.S.

GenSight Biologics Provides 2021 Operations Update in the Context of COVID-19 - Business Wire


Cohort study protocol to characterize the incidence and severity of neuropathic pain in patients with severe acute respiratory syndrome coronavirus 2…

Friday, May 14th, 2021

This article was originally published here

Pain Rep. 2021 Apr 20;6(1):e925. doi: 10.1097/PR9.0000000000000925. eCollection 2021.


INTRODUCTION AND OBJECTIVES: The coronavirus disease 2019 (COVID-19) pandemic has resulted in patients experiencing symptoms that include neurological dysfunction. As many viral infections are associated with neuropathy, the aim of the study is to characterize the incidence and severity of neuropathic pain in patients with COVID-19.

METHODS: A cohort study will be conducted in adult (18 years) patients who were tested for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Washington University/Barnes-Jewish Hospital. Participants who are deceased, with incomplete test results, or who cannot be contacted will be excluded. Approximately 1320 participants will be recruited in a 1:2 ratio of those with a positive-to-negative SARS-CoV-2 test result. Each participant will be invited to complete a survey to assess their symptoms related to neuropathy, 30 to 90 days after their initial SARS-CoV-2 test. Survey responses, demographics, and clinical data from the electronic health record will be used for analysis. The primary outcome is the incidence of new symptoms of neuropathic pain. The self-reported DN4 and Neuropathic Pain Symptom Inventory questionnaires (Appendix 1, will be used for neuropathic pain screening and severity assessment, respectively. Exploratory analyses will be performed to investigate other potential clinical endpoints and trends.

RESULTS/CONCLUSION: Similar to previous coronavirus infections, an increased incidence of new-onset neuropathic pain after COVID-19 disease is expected, along with an increase in the severity experienced by patients with COVID-19 with pre-existing chronic pain. Comprehensive understanding of how COVID-19 affects the nervous system can provide a better framework for managing pain in this disease.

PMID:33981939 | PMC:PMC8108598 | DOI:10.1097/PR9.0000000000000925

Continued here:
Cohort study protocol to characterize the incidence and severity of neuropathic pain in patients with severe acute respiratory syndrome coronavirus 2...


Phenotypic Stratification of Patients With Painful Neuropathy May Predict Response to Therapy – Clinical Pain Advisor

Sunday, May 2nd, 2021

A transetiologic, phenotype-based approach was associated with response to treatment and may improve the management of neuropathic pain. These findings were published in the journal Pain.

Patients (n=628) with probable or definite neuropathic pain were recruited from the Pain Center at Ambroise Par Hospital in France. All patients were assessed by a standard clinical neurologic examination. They then rated their pain during the past 24 hours on an 11-point numerical scale and completed the Neuropathic Pain Symptom Inventory (NPSI).

A clustering approach was used to stratify patients by pain phenotypes. Researchers used data from a previous study of patients (n=97) with neuropathic pain who were randomly assigned to receive botulinum toxin A (BTX-A) or placebo to assess whether patient clusters would be more or less responsive to BTX-A treatment.

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The internal and BTX-A cohorts comprised patients who had a mean age of 56.4 (15.2) and 52.3 (16.1) years, 51.9% and 50.5% were women, their duration of pain was 64.8 (74.7) and 63 (67) months, and their pain intensity was 6.4 (1.7) and 6.4 (1.6) points, respectively.

Among the internal cohort, 3 major clusters were identified. Patients in cluster 1 (31.4%) had pinpointed pain with above-average paresthesia or dysesthesia and below-average evoked pain. Patients in cluster 2 (30.4%) had evoked pain with above-average pain that was provoked by brushing, cold, pressure, or electric shocks, and below-average deep pain and paresthesia or dysesthesia. Patients in cluster 3 (38.2%) comprised patients who had deep pain that felt like squeezing and above-average pressure with below-average paresthesia or dysesthesia.

Patients in the BTX-A cohort were stratified into 3 patient clusters. Patients in group 2 had a significant group (F, 6.71; P =.013) and group by time interaction (F, 2.24; P =.009). Similarly, patients in cluster 3 had both a significant group (F, 4.41; P =.042) and group by time interaction (F, 2.01; P =.021). BTX-A therapy did not have a significant effect compared with placebo among patients in cluster 1 (F, 0.35; P =.56).

This study was based on post hoc analyses and requires validation in a prospective cohort.

These findings suggest that a transetiologic, phenotype-based approach may have the potential to improve treatment selection for patients with painful neuropathy.

Bouhassira D, Branders S, Attal N, et al. Stratification of patients based on the Neuropathic Pain Symptom Inventory: development and validation of a new algorithm. Pain. 2021;162(4):1038-1046. doi:10.1097/j.pain.0000000000002130

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Phenotypic Stratification of Patients With Painful Neuropathy May Predict Response to Therapy - Clinical Pain Advisor


Peripheral Neuropathy Treatment Market: Development, Growth, Trends, Demand, Analysis and Forecast 2026 KSU | The Sentinel Newspaper – KSU | The…

Sunday, May 2nd, 2021

Coherentmarketinsights.Com Presents Global Peripheral Neuropathy Treatment Market Research Report 2019 New Research To Its Studies Database

The global Peripheral Neuropathy Treatment Market research report highlights the need for up-to-date market data for the business management that will offer development and profitability of the global Peripheral Neuropathy Treatment market. The research report presents all the essential facts and figures on drifts & growths. It emphasizes technologies & capacities, materials & markets, and the unpredictable structure of the Peripheral Neuropathy Treatment market. In addition, it also highlights the dominating players in the market joined with their market share. The well-established players in the market are Abbott, Bristol Myers Squibb, Cipla Limited, Eli Lilly and Company, GlaxoSmithKline plc., Lupin Limited, Merck and Co. Inc., Novartis AG, Pfizer Inc., Dr. Reddys Laboratories, Mylan NV, Johnson & Johnson Services Inc., and Teva Pharmaceutical Industries Ltd. among others.

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The global Peripheral Neuropathy Treatment Market report portrays the best approaches to assess the global Peripheral Neuropathy Treatment market. It offers reliable facts and extensive analysis of the global Peripheral Neuropathy Treatment Market. The report presents a summary of the global Peripheral Neuropathy Treatment industry, embracing categorizations, applications, and industry chain structure. The study also represents a thorough analysis including significant insights, industry-legalized figures, and facts of the global Peripheral Neuropathy Treatment market.

Furthermore, the study also assesses the principal aspects of the market that entails revenue, demand, gross value, growth rate, cost, capability, market share, import, gross margin, expenditure, export, manufacture, supply, and so on. A number of methodological tools are used in the global Peripheral Neuropathy Treatment market analysis. It offers a complete analysis of the market statistics and the estimation of the global Peripheral Neuropathy Treatment industry players along with their market scope.

Global Peripheral Neuropathy Treatment market size expected to reach xx Million USD by 2027, from xx Million USD in 2019, at a CAGR of xx% during the forecast period (2019-2027). In this study report, 2019 has been considered as the base year, 2019 as the Estimated Year, (2013-2017) as the History Year and 2019 to 2027 as the forecast period to estimate the market size for Peripheral Neuropathy Treatment.

GlobalPeripheral Neuropathy Treatment Market Segmentations

The segmentation chapter allows the reader to understand aspects of the globalPeripheral Neuropathy Treatment market such as products/services, available technologies, and applications. This chapter is written in a way that describes the years of development and the process that will take place in the years to come. Research reports also provide insightful information on emerging trends that can define the progress of these segments over the next few years.

Peripheral Neuropathy Treatment Consumption Breakdown Data by Region

The Report Offers The Following Study Objectives:

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The Peripheral Neuropathy Treatment Market report emphasizes various procedures and approaches endorsed by the key players to make crucial business decisions.

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It identifies the growth of nature having a forecast period of 7 years.

The report influences advantageous prospects to convert into Peripheral Neuropathy Treatment business acquisitions.

It reveals product overview, business overview, Peripheral Neuropathy Treatment market share, demand and supply ratio, supply chain analysis, and import/export details.

Peripheral Neuropathy Treatment Market is a comprehensive collection of information and figures in the form of graphs, pie charts, and tables. Data is specifically acquired from secondary sources including the internet, journals, magazines, and press releases. All the retrieved data is validated using primary interviews and questionnaires.

Report Covers Impacts of COVID-19 to the market

The on-going pandemic has overhauled various facets of the market. This research report provides financial impacts and market disturbancein thePeripheral Neuropathy Treatment market. It also includes an analysis of the potentially lucrative opportunities and challenges in the foreseeable future. Coherent Market Insights has interviewed various delegates of the industry and got involved in the primary and secondary research to confer the clients with information and strategies to fight against the market challenges amidst and after the COVID-19 pandemic.

Table of Contents :

Global Peripheral Neuropathy Treatment Sales Market Report 2018 Mainly Covers Following Chapters:

1. Peripheral Neuropathy Treatment Overview(Product Overview, Scope and Classification of Peripheral Neuropathy Treatment), Type and Application of Peripheral Neuropathy Treatment, Peripheral Neuropathy Treatment Market by Regions;2. Global Peripheral Neuropathy Treatment Competition by Manufacturers, Type, and Application with (Sales and Market Share, Revenue and Share, Volume and Value) by Manufacturers, by Type, by Regions and by Application;3. United States Peripheral Neuropathy Treatment (Volume, Value and Sales Price, Revenue and Growth Rate) by Manufacturers, Type, Application (2011-2018);4. China Peripheral Neuropathy Treatment (Volume, Value and Sales Price, Revenue and Growth Rate) by Manufacturers, Type, Application (2011-2018);5. Europe Peripheral Neuropathy Treatment (Volume, Value and Sales Price, Revenue and Growth Rate) by Manufacturers, Type, Application (2011-2018);6. Japan Peripheral Neuropathy Treatment (Volume, Value and Sales Price, Revenue and Growth Rate) by Manufacturers, Type, Application (2011-2018);7. Global Peripheral Neuropathy Treatment Manufacturers Analysis(Company Basic Information, Manufacturing Base and Competitors, Product Type, Application and Specification), Peripheral Neuropathy Treatment Sales, Revenue, Price and Gross Margin (2011-2018), Main Business/Business Overview;8. Peripheral Neuropathy Treatment Manufacturing Cost Analysis, Key Raw Materials Analysis(Key Raw Materials, Price Trend of Key Raw Materials, Key Suppliers of Raw Materials, Market Concentration Rate of Raw Materials), Proportion of Manufacturing Cost Structure(Labour Cost, Raw Materials, Manufacturing Process Analysis of Peripheral Neuropathy Treatment);9. Industrial Chain Analysis, Upstream Raw Materials Sourcing, Sourcing Strategy and Downstream Buyers;10. Marketing Strategy Analysis, Distributors/Traders with Marketing Channel(Direct Marketing, Indirect Marketing, Marketing Channel Development Trend), Market Positioning(Pricing Strategy, Brand Strategy, Target Client), Distributors/Traders List;11. Market Effect Factors Analysis (Technology Progress/Risk, Substitutes Threat, Technology Progress in Related Industry), Consumer Needs/Customer Preference Change, Economic/Political Environmental Change;12. Global Peripheral Neuropathy Treatment Market Sales, Revenue Forecast (2018-2021) by Regions, by Type, by Application;13. Appendix, Disclosure Section, Research Methodology, Data Source, Disclaimer.

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In conclusion, the Global Peripheral Neuropathy Treatment Market report presents the complete analysis of the modern market depend on leading players, present, past and upcoming period information which will provide as a valuable guide for all the Peripheral Neuropathy Treatment business associate.

Thanks for reading this Report; you can also get specific chapter-wise, section wise or region-wise reports.

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Coherent Market Insights is a prominent market research and consulting firm offering action-ready syndicated research reports, custom market analysis, consulting services, and competitive analysis through various recommendations related to emerging market trends, technologies, and potential absolute dollar opportunity.

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Peripheral Neuropathy Treatment Market: Development, Growth, Trends, Demand, Analysis and Forecast 2026 KSU | The Sentinel Newspaper - KSU | The...


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