StemCell Therapy

Tissue engineering combines the field of cell biology with material science in order to generate tissues and organs that may be used for regeneration, replacement or reconstruction of human bodies. In the past 10 years, there has been an exponential growth in these therapies, with great optimism and excitement about the potential effects or implications.

Since the end of the 20th century, cultured urethral mucosa cells have been used for repair of hypospadias, a congenital malformation of the urinary tract. In a survey published in 2019, tissue-engineered grafts showed even better results when used in children for primary hypospadias repair than in adults for urethral stricture repair.

Recently, a breakthrough in the surgical treatment of male urethral stricture was reported when a total of 65 patients with urethral strictures successfully were treated with MukoCell, a tissue-engineered oral mucosa transplant. With a mean follow-up of 12.1 months, recurrence was observed in only 12 patients. This corresponds to a success rate of 81.5%.About 1% of the male population suffers from strictures of the urethra.

Patients are chronically ill, with severely diminished quality of life, suffering from low urinary flow, pain, chronic urinary infections, urinary stones, urinary reflux, and damage to and failure of the urinary system. If left untreated, life-threatening urinary retention can occur.

The gold standard for urethral reconstruction is represented by the use of oral mucosa graft, with success rates reported in literature of around 80%. However, due to the complication rate at the mucosa harvest site, only a minority of operative urologists carry out this procedure.

It requires the excision of large segments of mucosa from the mouth of the patients. This severe damage to healthy tissue frequently is accompanied by multiple injuries with a significant impact on patients quality of life intraoral pain, bleeding, swelling, sensory loss and oral numbness which in many cases are persistent.

Other long term consequences include compromised oral health, scarring, chronic ulcers due to repeated bites on scar bulges, impaired lip mobility, permanent salivation, oral stenosis, facial deformities, diminished facial expressions, impaired mouth opening and impaired drinking, eating and speaking, periodontal disease; and loss of teeth and implants. One of the late consequences resulting from chronic irritation and inflammation is the increased risk of oral cancer.

Because of these risks and complications, many doctors and patients refuse this operation. Moreover, in certain situations this operation cannot be performed, such as where the patient only has a small oral cavity or limited mouth opening capacity, meaning access to the oral cavity is limited and excision of larger pieces of oral mucosa is not possible.

A significant proportion of patients are not willing to undergo the excision of oral grafts, including patients with tendency to increased scar formation, where the excision of oral mucosa is associated with risks of parafunctional bites, chronic irritation and inflammation; or patients with dentures, where the excision may lead to poorly fitting dentures or loss of dental implants. This counts even more if there is pre-existing oral mucosal damage, for example after previous removal of oral mucosa.

For other patients, the oral complications cannot be tolerated because impairment of physiognomy, oral anatomy or gustatory sensation impacts their job or social function; such as teachers, singers, politicians, actors, speakers, salespeople, cooks and musicians who play wind or brass instruments.

Tissue-engineered transplants represent the group of advanced tissue-engineered therapies (ATMPs). These are subject to EU regulation; in order to obtain market access, they must receive authorisation from the European Medicines Agency (EMA).

In order to obtain this approval, high standards must be met regarding proof of the quality, safety and efficacy of these products. Although tissue-engineered products may have a high impact on patients health, only a few of them will be approved. Tissue engineering techniques are complex and require a high standard of specialised laboratories.

Regarding quality and safety, MukoCell has already received a certificate from the EMA. MukoCell is manufactured in a state of the art cell culture factory, which has been specifically designed for engineering of tissue especially for medical use and complies with GMP guidelines for the production of pharmaceuticals. The manufacturing process starts with a tiny biopsy from the oral mucosa of the patient.

Oral mucosa is easily accessible in any patient; and biopsy under simple local anaesthesia is easy, non-invasive and painless for patients. The tissue is sent to the tissue factory where the biopsy is explanted in cell culture media. Cells are grown out and undergo a standardised aseptic manufacturing process, at the end of which, before the products are used therapeutically, strict quality and safety tests are conducted. Only if the specified quality criteria are met are the products then released for therapeutic application.

The efficacy of MukoCell has been shown in an open non-interventional study. However, to achieve market authorisation, the EMA requests that efficacy be further confirmed in a pivotal clinical study in direct comparison with native oral mucosa. This study will begin shortly and will involve a total of 200 patients, divided into two therapy groups of 100 patients each. Initial results of the study are expected by the beginning of 2023.

One goal of this clinical study is to show equivalence of the tissue-engineered product with native oral mucosa in urethral stricture treatment; the other goal is to clearly demonstrate the superiority of MukoCell over native oral mucosa as a graft, in terms of the aforementioned frequent and severe intraoral complications and impact on quality of life for patients.

The demonstration of MukoCells superiority is not only important regarding market authorisation, but also with respect to reimbursement by health insurances. The transplantation of native oral mucosa is a procedure developed by hospital surgeons. A critical examination of its safety and effectiveness has never been carried out, and complications are accepted if there is no alternative treatment.

Moreover, besides the surgical procedure which is paid for by the health insurance companies there are no additional costs associated with using native oral mucosa. In contrast, to justify additional costs arising from the use of a cultivated transplant, the efficacy, safety and superiority to native oral mucosa need to be proven.

Therefore, in the clinical trial, it is particularly important that the complications arising from excision of the transplant are recorded and documented as objectively as possible. Since the goal of surgery is to reconstruct the urethra, urologists pay little attention to intraoral complications and commonly play down their severity and importance.

Although the production of MukoCell is very complex and absolute sterility must be maintained during the three-week cultivation period, the costs are acceptable at several thousand euros. What pushes the costs even higher is the need to fulfil the requirements of the EMA in order to obtain marketing authorisation for the product: the planned clinical trial alone will cost around 10m. These costs must also be considered when pricing MukoCell.

The requirements of the regulatory authorities and health insurance companies not only influence the price of the products but also their availability. MukoCell has been on the market since 2013, but its approval is limited to Germany and only applies in a few individual cases due to the issue of reimbursement.

In a 2019 review the opinion was expressed that, due to the specificity of tissue-engineered products and the health benefits they offer, it would be advantageous to reconsider their regulatory requirements. The simplification of these requirements would allow the acceleration of these products into the market, faster availability for the patients and a decrease in the associated costs, making reimbursement less challenging for public health insurances in different countries.

Further, it was stated that the use of MukoCell represents a real, safe and efficient opportunity for patients with urethral stricture diseases. However, at present, regulatory, legal and financial issues represent important factors that restrict and slow down the wider use of MukoCell.

Soeren Liebig, CEOMukoCell GmbHBioMedizinzentrumDortmund+49 (0)23197426370s.liebig@mukocell.comwww.mukocell.com

Please note, this article will appear in issue 12 of Health Europa Quarterly, which will be available to read in February 2020.

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The Alliance for Regenerative Medicine Outlines Recommendations on Enabling Cross-border and Regional Access to Advanced Therapy Medicinal Products (ATMPs) in Europe

BRUSSELS, BELGIUM 27 January, 2020

The Alliance for Regenerative Medicine (ARM), the international advocacy organization representing the cell and gene therapy and broader advanced therapies sector, today published a positioning paper outlining recommendations for the timely and effective access to cross-border healthcare for patients.

Todays new position paper focuses, and further elaborates, on the recommendations of ARMs July 2019 report on ensuring timely access to ATMPs in Europe (see the report here). It represents the views of the ARM members and aims to stimulate debate and reach consensus among key stakeholders, including marketing authorisation holders, payers and treatment centres, on solutions to ensure all European patients can secure access to ATMPs, irrespective of their country or region of origin.

Challenges to expanded ATMP access in Europe

ARMs key recommendations

In order to ensure that patients across Europe can access ATMPs, ARM recommends the following:

Additional recommended measures to facilitate industry engagement in existing initiatives could include: improved opportunities for cross-country collaboration, removing duplicative processes at national level, and adopting policy principles to enhance cross-country collaboration.

Janet Lambert, CEO of ARM, commented: Europe has always been a leader in ATMP innovation, both in R&D and getting products to market, however, to ensure that patients have access to these transformative treatments, there are several challenges that need to be overcome at EU, national and regional levels. This paper builds on the EU Market Access Report published in 2019 and the subsequent European stakeholder meeting in Brussels, and outlines the challenges and the recommendations that we, alongside our members, believe will most effectively get these therapies to patients in a sustainable manner.

To read the report in full, please follow this link.

Press inquiriesFor more information about the report or media requests, please contact Consilium Strategic Communications at arm@consilium-comms.com.

About the Alliance for Regenerative Medicine

The Alliance for Regenerative Medicine (ARM) is an international multi-stakeholder advocacy organization that promotes legislative, regulatory, and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine worldwide. Founded in 2009, ARM works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its 350+ member organizations worldwide. ARM represents the interests of therapeutic developers, academic research institutions, major medical centers, investors, and patient groups that comprise the broader regenerative medicine community and is the prominent international advocacy organization in this field.

ARM has 70+ members across 15 countries in Europe. ARM aims to work closely with European stakeholders, leveraging its membership to create a supportive commercial and regulatory environment to create better conditions for the development and commercialization of ATMPs in Europe; develop strong stakeholder support around proposed solutions to improve patient access to ATMPs; promote clear, predictable and efficient regulatory framework across Europe; and promote international convergence of key regulations and guidance. For more information, visit alliancerm.org.

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The Alliance for Regenerative Medicine Outlines Recommendations on Enabling Cross-border and Regional Access to Advanced Therapy Medicinal Products...

The approach builds on technology developed for regenerative medicine. I work in a lab that investigates ways to engineer tissue for the replacement or repair of human organs. We use some of these methods to grow meat.

The first step involves what I call a high-tech cotton-candy machine. The machine takes in a solution of water and gelatin, spins it at a high rate, and sends out nano- and microfibers that get woven together into a slab. The texture of the slab mimics that of an animals muscular tissuethe part that gives meat its texture. We then immerse the slab into a solution containing stem cells from a cow or a rabbit, where it acts as a scaffolding for the cells to cling to and grow. We use myoblastsstem cells that are already committed to turning into muscle cells. Once the solution has permeated the scaffolding, we turn the stem cells into muscle cells by tweaking the nutrients in the solution. Et voil, we have long, thin threads of muscle, like in real meat.

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Q&A: Growing Steaks in the Lab - Physics

The idea of scientists trying to grow brain tissue in a dish conjures up all sorts of scary mental pictures (cue the horror-movie music). But the reality of the research is quite far from that sci-fi visionand always will be, say researchers in the field. In fact, a leader in this area of research, Arnold Kriegstein of the University of California, San Francisco, says the reality does not measure up to what some scientists make it out to be.

In a paper published on January 29 in Nature, Kriegstein and his colleagues identified which genes were active in 235,000 cells extracted from 37 different organoids and compared them with 189,000 cells from normally developing brains. The organoidsat times called mini brains, to the chagrin of some scientistsare not a fully accurate representation of normal developmental processes, according to the study.

Brain organoids are made from stem cells that are transformed from one cell type to the another until they end up as neurons or other mature cells. But according to the Nature paper, they do not always fully complete this developmental process. Instead the organoids tend to end up with cells that have not fully transformed into new cell typesand they do not re-create the normal brains organizational structure. Psychiatric and neurodevelopmental conditionsincluding schizophrenia and autism, respectivelyand neurodegenerative diseases such as Alzheimers are generally specific to particular cell types and circuits.

Many of the organoid cells showed signs of metabolic stress, the study demonstrated. When the team transplanted organoid cells into mice, their identity became crisper, and they acted more like normal cells, Kriegstein says. This result suggests that the culture conditions under which such cells are grown does not match those of a normally developing brain, he adds. Cellular stress is reversible, Kriegstein says. If we can reverse it, were likely to see the identity of cells improve significantly at the same time.

Brain organoids are getting better at recapitulating the activities of small clusters of neurons, says Kriegstein, who is a professor of neurology and director of the Eli & Edythe Broad Center for Regeneration Medicine and Stem Cell Research at U.C.S.F. Scientists often make organoids from the cells of people with different medical conditions to better understand those conditions. But some scientists may have gone too far in making claims about insights they have derived from patient-specific brain organoids. Id be cautious about that, Kriegstein says. Some of those changes might reflect the abnormal gene expression of the cells and not actually reflect a true disease feature. So thats a problem for scientists to address.

A small ball of cells grown in a dish may be able to re-create some aspects of parts of the brain, but it is not intended to represent the entire brain and its complexity, several researchers have asserted. These organoids are no more sentient than brain tissue removed from a patient during an operation, one scientist has said.

Of course, models are never perfect. Although animal models have led to fundamental insights into brain development, researchers have sought out organoids, or organs-in-a-dish, precisely because of the limitations of extrapolating biological insights from another species to humans. Alzheimers has been cured hundreds of times in mice but never in us, for instance.

That said, the current models are already very useful in addressing some fundamental questions in human brain development, says Hongjun Song, a professor of neuroscience at the Perelman School of Medicine at the University of Pennsylvania, who was not involved in the new research. Using brain organoids, he adds, the Zika virus was recently shown to attack neural stem cells, causing a response that could explain why some babies exposed to Zika in utero develop unusually small brains.

Michael Nestor, a stem cell expert, who did not participate in the new study, says his own organoids are very helpful for identifying unusual activity in brain cells grown from people with autism. And he notes that they will eventually be useful for screening potential drugs.

Even though the models will always be a simplification, the organoid work remains crucial, says PaolaArlotta, chair of the department of stem cell and regenerative biology at Harvard University, who was also not involved in the Nature study. Neuropsychiatric pathologies and neurodevelopmental conditions are generally the result of a large number of genetic changes, which are too complex to be modeled in rodents, she says.

Sergiu Pasca, another leader in the field, says that the cellular stress encountered by Kriegstein and his team might actually be useful in some conditions, helping to create in a dish the kinds of conditions that lead to diseases of neurodegeneration, for instance. What I considerthe most exciting feature remains our ability to derive neural cells and glial cells in vitro, understanding their intrinsic program of maturation in a dish, says Pasca, an assistant professor at Stanford University, who was not part of the new paper.

The ability to improve cell quality when exposed to the environment of the mouse brain suggests that it may be possible to overcome some of the current limitations, Arlotta says. There is not yet a single protocol for making brain organoids in a lab, which may be for the best at this early stage of the field. Eventually, she says, scientists will optimize and standardize the conditions in which these cells are grown.

Arlotta, who is also the Golub Family Professor of Stem Cell and Regenerative Biology at Harvard, published a study last year in Nature showing that she and her colleagues canover a six-month periodmake organoids capable of reliablyincluding a diversity of cell types that are appropriate for the human cerebral cortex. She says it is crucial for organoid work to be done within an ethical framework. Arlotta is part of a federally funded team of bioethicists and scientists working together to ensure that such studies proceed ethically. The scientists educate the bioethicists on the state of the research, she says, and the ethicists inform the scientists about the implications of their work.

Nestor feels so strongly about the importance of linking science, policy and public awareness around stem cell research that he has put his own laboratory at the Hussman Institute for Autism on hold to accept a year-long science-and-technology-policyfellowship with the American Association for the Advancement of Science. He says he took the post to make sure the public and policy makers understand what they need to know about organoids and other cutting-edge science and to learn how to communicate about science with them.

One thing all of the scientists interviewed for this article agree on is that these brain organoids are not actual mini brains, and no one is trying to build a brain in a dish. Even as researchers learn to make more cell types and grow them in more realistic conditions, they will never be able to replicate the brains structure and complexity, Kriegstein says. The exquisite organization of a normal brain is critical to its function, he adds. Brains are still the most complicated structure that nature has ever created.

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"Mini Brains" Are Not like the Real Thing - Scientific American

DUBLIN, Jan. 31, 2020 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced it will release fourth quarter and full year 2019 financial results on Monday, February 10, 2020, prior to the open of U.S. financial markets.

For additional materials related to Allergan's fourth quarter and full year 2019 financial results, please visit Allergan's Investor Relations website at https://www.allergan.com/investors.

About Allergan plc

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical leader focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Allergan markets a portfolio of leading brands and best-in-class products primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology. As part of its approach to delivering innovation for better patient care, Allergan has built one of the broadest pharmaceutical and device research and development pipelines in the industry.

With colleagues and commercial operations located in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

For more information, visit Allergan's website atwww.Allergan.com.

Forward-Looking Statement

Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS, on our financial results; risks associated with divestitures, acquisitions, mergers and joint ventures; risks related to impairments; uncertainty associated with financial projections, projected cost reductions, projected debt reduction, projected synergies, restructurings, increased costs, and adverse tax consequences;difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2018 and Allergan's Quarterly Report on Form 10-Q for the period ended September 30, 2019. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

CONTACTS:

Allergan:

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Manisha Narasimhan, PhD

(862) 261-7488

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Allergan to Report Fourth Quarter and Full Year 2019 Financial Results - Yahoo Finance

Three-dimensional printers have now assembled candy, clothing, and even mouse ovaries. But in the next decade, specialized bioprinters could begin to build functioning human organs in space. It turns out, the minimal gravity conditions in space may provide a more ideal environment for building organs than gravity-heavy Earth.

If successful, space-printed organs could help to shorten transplant waitlists and even eliminate organ rejection. Though they still have a long way to go, researchers at the International Space Station (ISS) hope to eventually assemble organs from adult human cells, including stem cells.

The medical field has only recently embraced 3D printing in general, particularly in biomedical fields like regenerative medicine and prosthetics. So far, these printers have produced early versions of blood vessels, bones, and different types of living tissue by churning out repeated layers of bioinka substance comprised of living human cells and other tissue thats meant to mimic the natural environment that surrounds growing organs.

Recently, researchers are finding that Earth might not be the best environment for growing freestanding organs. Because gravity is constantly pushing down on these delicate structures as they grow, researchers must surround the tissues in scaffolding, which can often debilitate the delicate veins and blood vessels and prevent the soon-to-be organs from growing and functioning properly. Within microgravity, however, soft tissues hold their shape naturally, without the need for surrounding supportan observation thats driven researchers to space.

And one manufacturing lab based in Indiana thinks its tech could play a key role in space. The 3D BioFabrication Facility (BFF) is a specialized 3D printer that uses bioink to build layers several times thinner than human hair. It cost about $7 million to build and employs the smallest print tips in existence.

The brainchild of spaceflight equipment developer Techshot and 3D printer manufacturer nScrypt, the BFF headed to the ISS in July 2019 aboard the SpaceX CRS-18.

Currently, the project focuses on building increasingly thick artificial cardiac tissue and delivering it back to Earth. Once the printed cardiac tissue reaches a certain thickness, it gets harder for researchers to ensure that a printed structures layers effectively grow into one another. Ultimately, though, theyd like the organs to arrive here fully formed.

Printed organs would eventually require vasculature and nerve endings to work properly, though that technology doesnt yet exist.

The next stagetesting heart patches under microscopes and within animalscould span over the next four years. As for whole organs, Techshot claims it plans to begin production after 2025. For now, the project is still in its infancy.

If you were to look at what we printed, it looks very modest, says Techshot vice president of corporate advancement Rich Boling. Its just a cuboid-type shape, this rectangular box. Were just trying to get cells to grow one layer into the next.

Cooking organs like pancakes

Compare the manufacturing process to cooking pancakes, Boling says. The space crew first creates a custom bioink pancake mix with the cells sent from Earth, which they load with syringe-like tools into the BFF.

Researchers then insert a cassette into the BFF containing a bioreactora system that mimics the normal bodily functions essential for growing healthy tissue, like providing nutrients and flushing out waste.

Approximately 200 miles below in Greenville, Indiana, Techshot engineers connect with ISS astronauts on a NASA-enabled secure digital pathway. The linkup allows Techshot to remotely command BFF functions like pump pressure, internal temperature, lighting, and print speed.

Next, the actual printing process occurs within the bioreactor and can take anywhere from moments to hours, depending on the shapes complexity. In the final production step, the cell-culturing ADvanced Space Experiment Processor (ADSEP) cooks the theoretical pancake; essentially, the ADSEP toughens up the printed tissue for its journey back to earth. This step could take anywhere from 12 to 45 days for different tissue types. When completed and hardened, the structure heads home.

The researchers have gone through three testing processes so far, each one getting more exact. This March, theyll begin the third round of experiments.

The bioprinter space race

The BFF lab is the sole team developing this specific type of microgravity bioprinter, Boling says. Theyre not the only ones looking to print human organs in space, though.

A Russian project has also entered the bioprinting space race, however their technique highly differs. Unlike the BFFs bioink layering method, Russian biotechnology laboratory 3D Bioprinting Solutions uses magnetic nanoparticles to produce tissue. An electromagnet creates a magnetic field in which levitating tissue forms the desired structuretechnology that appears ripped from the pages of a sci-fi novel.

After their bioprinter fell victim to an October 2018 spacecraft crash, 3D Bioprinting Solutions rebounded; the team now collaborates with US and Israeli researchers at the ISS. Last month, their crew created the first space-bioprinted bone tissue. Similar to the US project, 3D Bioprinting Solutions aims to manufacture functioning human tissues and organs for transplantation and general repair.

Just because we have the technology to do it, should we do it?

If the 3D BioFabrication Facility prospers in printing working human organs, theyd be subject to thorough regulation here on Earth. The US approval process is stringent for any drug, Rich Boling says, posing a challenge for this unprecedented invention. Techshot predicts at least 10 years for space-printed organs to achieve legal approval, though its an inexact estimate.

Along with regulatory acceptance, human tissue printed in microgravity may encounter societal pushback.

Each country maintains varying laws related to medical transplants. Yet as bioengineering advances into the the final frontier, the international scientific research community may need to shape new guidelines for collaboration among the stars.

As the commercialization of low-Earth orbit continues to ramp up in the next few years, it is certainly true that were going to have to take a very close look at the regulations that apply to that, says International Space Station U.S. National Laboratory interim chief scientist Michael Roberts. And some of those regulations are going to stray into questions related to ethics: Just because we have the technology to do it, should we do it?

Niki Vermeulen, a University of Edinburgh science technology and innovation studies lecturer, has researched the social implications of 3D bioprinting experiments. Like any Earth-bound project, she urges scientists not to get peoples hopes up too early in the process; individuals seeking organ transplants could read about the BFF online and think it could soon be ready to meet their needs.

The most important thing now, I think, is expectation management, Vermeulen says. Because its really quite difficult to do this, and of course we really dont know if its going to work. If it did, it would be amazing.

Another main issue is cost. Like other cutting-edge biotechnology innovations, the organs could also pose a major affordability challenge, she says. Techshot claims that a single space-printed organ could actually cost less than one from a human donor, since some people must pay for a lifetime of anti-rejection meds and/or multiple transplants. Theres currently no telling how long the BFF process would actually take, however, compared to the conventional donor route.

Plus, theres potential health risks for recipients: Techshot chief scientist Eugene Boland says cell manipulation always presents a possibility of genetic mutation. Modified stem cells can potentially cause cancer in recipients, for example.

The team is now working to define and minimize any dangers, he says. The BFF experiment adheres to the FDAs specific regulations for human cells, tissues, and cellular and tissue-based products.

Researchers on the ground now hope to perfect human cell manipulation: Over 100 US clinical trials presently test cultured autologous human cells, and several hundred test cultured stem cells with multiple origins.

What comes next

After the next round of printing tests this March, Techshot will share the bioprinter with companies and research institutions looking to print materials like cartilage, bone, and liver tissue. Theyre currently preparing the bioprinter for these additional uses, Boling says, which could advance health care as a whole.

To speed things up for space crews, Techshot is now building a cell factory that produces multiple cell types in orbit. This technology could cut down the number of cell deliveries between Earth and space.

The ISS has taken in plenty of commercial ventures in recent years, Michael Roberts says, and its getting crowded up there. Space-based experiments ramped up between 40 and 50 years ago, though until recently they mostly prioritized satellite communications and remote observation technology. Since then, satellites have shrunk from bus-sized to smaller than a shoebox.

Roberts has witnessed the scientific areas of interest broaden over the past decade to include medicine. Organizations like the National Institutes of Health are now looking to space to improve treatments, and everything from large pharmaceutical companies to small-scale startups want in.

Theyve got something stuck on every surface up there, he says.

As the ISS runs out of space and exterior attachment points, Roberts predicts that commercial ventures will build new facilities built for specific activities like manufacturing and plant growth. He sees it as a good opportunity for further innovation, since the ISS was originally designed for far more general purposes.

Space, as a whole, may start to look quite different from the first exploration age.

Baby boomers may remember glimpsing at a grainy, black-and-white moon landing five decades ago. Within the same lifetime, they could potentially observe the introduction of space-printed organs.

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Space might be the perfect place to grow human organs - Popular Science

Hitachi Chemical Advanced Therapeutics Solutions (HCATS), a subsidiary of Hitachi Chemical Co., Ltd. representing Hitachi Chemicals Regenerative Medicine Business Sector (RMBS) in North America, has opened its new cell and gene therapy manufacturing facility in Allendale, NJ. The new facility is the companys first to be designed from the ground up to meet the needs of commercial cell and gene therapy products and more than doubles HCATS existing manufacturing capacity in New Jersey.The facility currently includes six classified environment rooms, with the capacity to add more rooms that can be specifically configured to accommodate growing client needs. The new facility includes state-of-the-art manufacturing development laboratories, quality control and microbiological laboratories, warehousing, executive offices and meeting space. The companys ongoing investment in facility expansion complements ongoing investments in the companys quality systems and commercial expertise, all with the aim of meeting its commitments to existing clients with near-term expectations for commercial product manufacturing.The opening of this new facility marks an important milestone for HCATS and will offer a state-of-the-art resource for our clients as they commercialize cell and gene therapies, said Robert Preti, president and chief executive officer, HCATS, and general manager, RMBS. Access to this type of manufacturing space is needed across the industry to ensure the continued growth and momentum of these promising therapeutics. This facility will require up to 500 more employees to reach full operational capacity over the next several years, supporting our growing roster of clients.Governor Phil Murphy of New Jersey, said, I am excited for Hitachi Chemical Advanced Therapeutics Solutions future in New Jersey, and I have no doubt that their new, state-of-the-art facility will not only help New Jersey residents, but also contribute to expanding the innovation economy by bringing up to 500 new jobs to our state. With our highly educated and diverse workforce, New Jersey is the perfect location for expanding biotech firms like Hitachi Chemical.The leadership and employees of HCATS, along with officials of Hitachi Chemical and local dignitaries, commemorated the milestone with a ribbon cutting ceremony on January 29 at the new facility.

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Hitachi Opens Cell And Gene Therapy Facility In NJ - Contract Pharma

In what is a world-first and potentially the dawn of a new medical technology to treat damaged hearts, scientists in Japan have succeeded in transplanting lab-grown heart cells into a human patient for the first time ever. The procedure is part of a cutting-edge clinical trial hoped to open up new avenues in regenerative medicine, with the treatment to be given to a further nine patients over the coming years.

The clinical trial harnesses the incredible potential of induced pluripotent stem cells (IPSCs), a Nobel Prize-winning technology developed at Kyoto University in 2006. These are created by first harvesting cells from donor tissues and returning them to their immature state by exposing them to a virus. From there, they can develop into essentially any cell type in the body.

Professor Yoshiki Sawa is a cardiac surgeon at Osaka University in Japan, who has been developing a technique to turn IPSCs into sheets of 100 million heart muscle cells, which can be grafted onto the heart to promote regeneration of damaged muscles. This was first tested on pigs and was shown to improve organ function, which led Japans health ministry to conditionally approve a research plan involving human subjects.

The first transplantation of these cells is a huge milestone for the researchers, with the operation taking place earlier this month and the patient now recovering in the general ward of the hospital. The sheets are biodegradable, and once implanted on the surface of the heart are designed to release growth factors that encourage new formation of healthy vessels and boost cardiac function.

The team will continue to monitor the first patient over the coming year, and over the next three years aims to carry out the procedure on a total of 10 patients suffering from ischemic cardiomyopathy, a condition caused by a heart attack or coronary disease that has left the muscles severely weakened.

I hope that [the transplant] will become a medical technology that will save as many people as possible, as Ive seen many lives that I couldnt save, Sawa said at a news conference on Tuesday, according to The Japan Times.

Source: The Japan Times

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Lab-grown heart cells implanted into human patient for the first time - New Atlas

Company Expects to Add Up to 500 Employees in New Jersey

Hitachi Chemical Advanced Therapeutics Solutions, LLC ("HCATS"), a subsidiary of Hitachi Chemical Co., Ltd. representing Hitachi Chemicals Regenerative Medicine Business Sector ("RMBS") in North America, today announced the opening of its new cell and gene therapy manufacturing facility in Allendale, New Jersey. The new facility is the companys first to be designed from the ground up to meet the unique needs of commercial cell and gene therapy products and more than doubles HCATS existing manufacturing capacity in New Jersey.

The facility ("75 Commerce") currently includes six classified environment rooms, with the capacity to add more rooms that can be specifically configured to accommodate growing client needs. The new facility includes state-of-the-art manufacturing development laboratories, quality control and microbiological laboratories, warehousing, executive offices and meeting space. The companys ongoing investment in facility expansion complements ongoing investments in the companys Quality Systems and commercial expertise, all with the aim of meeting its commitments to existing clients with near-term expectations for commercial product manufacturing.

"The opening of this new facility marks an important milestone for HCATS and will offer a state-of-the-art resource for our clients as they commercialize cell and gene therapies. Access to this type of manufacturing space is needed across the industry to ensure the continued growth and momentum of these promising therapeutics," said Robert Preti, Ph.D., President and CEO, HCATS, and General Manager, RMBS. "This facility will require up to 500 more employees to reach full operational capacity over the next several years, supporting our growing roster of clients."

"I am excited for Hitachi Chemical Advanced Therapeutics Solutions future in New Jersey, and I have no doubt that their new, state-of-the-art facility will not only help New Jersey residents, but also contribute to expanding the innovation economy by bringing up to 500 new jobs to our state," said Governor Phil Murphy of New Jersey. "With our highly educated and diverse workforce, New Jersey is the perfect location for expanding biotech firms like Hitachi Chemical."

The leadership and employees of HCATS, along with officials of Hitachi Chemical and local dignitaries, commemorated the milestone with a ribbon cutting ceremony on January 29 at the new facility. For a selection of images from the ceremony please visit https://www.pctcelltherapy.com/pct-pulse/HCATS-Opens-Second-New-Jersey-Facility

About the Hitachi Chemical Regenerative Medicine Business Sector

The Hitachi Chemicals Regenerative Medicine Business Sector provides contract development and manufacturing organization (CDMO) services at current Good Manufacturing Practices (cGMP) standards, including clinical manufacturing, commercial manufacturing, and manufacturing development. The global footprint of the business is over 200,000 square feet and includes operations in North America (Allendale, New Jersey and Mountain View, California), Europe (Munich, Germany), and Japan (Yokohama). The business leverages two decades of experience exclusively focused on the cell therapy industry.

For more information on North America services, please visit http://www.pctcelltherapy.com.

For more information on Europe services, please visit http://www.apceth.com.

For more information on Japan services, please visit http://www.hitachi-chem.co.jp/english/

View source version on businesswire.com: https://www.businesswire.com/news/home/20200130005221/en/

Contacts

Hitachi Chemical Advanced Therapeutics Solutions, LLC Gregory Johnsongregory.johnson.jt@hitachi-chem.com Tel: +1 201 515 2153

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Hitachi Chemical Advanced Therapeutics Solutions Announces Opening of Its New Facility Designed to Manufacture Commercial Cell and Gene Therapies -...

Six patients with a rare blood disease are now in remission thanks to a new gene therapy. The condition, known as X-CGD, weakens the immune system leaving the body vulnerable to a range of nasty infections and shortens a persons lifespan. It is normally treated using bone marrow transplants, but matching donors to patients can be tricky and time-consuming and the procedure comes with risks.

A team led by UCLA recently treated nine people with the disease and six successfully went into remission, allowing them to stop other treatments. All six patients are doing well and havent suffered any adverse effects.

X-CGD is a form of chronic granulomatous disease (CGD). People with CGD have an inherited mutation in one of five genes involved in helping their immune system attack invading microbes with a burst of chemicals. This means that CGD sufferers have weaker immune systems than healthy people, so they have a greater risk of getting infections. These infections can be life-threatening, particularly if they affect the bones or cause abscesses in vital organs.

X-CGD is the most common type of CGD and only affects males. It is caused by a mutation in a gene on the X-chromosome. Current treatments are limited to targeting the actual infections with antibiotics as well as bone marrow transplants. Bone marrow contains stem cells that develop into white blood cells, so bone barrow from a healthy donor can provide a CGD patient with healthy white blood cells that can help their body to fend off disease.

However, bone marrow transplants are far from ideal. The patient has to be matched to a specific donor, and the body can reject the implanted bone marrow. That means that following a transplant, the patient needs to take anti-rejection drugs for at least six months.

For their new treatment, researchers removed blood cell-forming stem cells from the patients themselves and genetically modified them so that they no longer carried the unwanted mutation. Then, the edited stem cells were returned to their bodies, ready to produce healthy new infection-fighting white blood cells.

This is the first time this treatment has been used to try to correct X-CGD. The researchers followed up with the nine patients but sadly, two passed away within three months of the treatment. Its important to note that their deaths were not a result of the treatment but of rather severe infections that they had been suffering from for a long time. The remaining seven were followed for 12 to 36 months all remain free from infections related to their condition, and six have been able to stop taking preventative antibiotics entirely. The results are reported in Nature Medicine.

None of the patients had complications that you might normally see from donor cells and the results were as good as youd get from a donor transplant or better, said Dr Donald Kohn, a member of theEli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLAand a senior author of the paper.

Whats more, four new patients have also been treated since the initial research was conducted. None experienced any adverse reactions and all remain infection-free. Now, the team plans to conduct a bigger clinical trial to further test the safety and efficacy of their new treatment, with the hopes that it may one day become available to the masses.

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New Gene Therapy Successfully Sends Six Patients With Rare Blood Disorder Into Remission - IFLScience

WASHINGTON, D.C. This is a pivotal time in the field of gene therapy as the FDA continues its efforts to support innovators developing new medical products for Americans and others around the world. To date, the FDA has approved four gene therapy products, which insert new genetic material into a patients cells.

The agency anticipates many more approvals in the coming years, as evidenced by the more than 900 investigational new drug (IND) applications for ongoing clinical studies in this area. The FDA believes this will provide patients and providers with increased therapeutic choices.

In that spirit, the FDA announced the release of a number of important policies: six final guidances on gene therapy manufacturing and clinical development of products and a draft guidance, Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations.

The growth of innovative research and product development in the field of gene therapy is exciting to us as physicians, scientists and regulators, said FDA Commissioner Stephen M. Hahn, M.D. We understand and appreciate the tremendous impact that gene therapies can have on patients by potentially reversing the debilitating trajectory of diseases. These therapies, once only conceptual, are rapidly becoming a therapeutic reality for an increasing number of patients with a wide range of diseases, including rare genetic disorders and autoimmune diseases.

As the regulators of these novel therapies, we know that the framework we construct for product development and review will set the stage for continued advancement of this cutting-edge field and further enable innovators to safely develop effective therapies for many diseases with unmet medical needs, said Peter Marks, M.D., Ph.D., director of the FDAs Center for Biologics Evaluation and Research. Scientific development in this area is fast-paced, complex, and poses many unique questions during a product review; including how these products work, how to administer them safely, and whether they will continue to achieve a therapeutic effect in the body without causing adverse side effects over a long period of time.

One of the most important steps the FDA can take to support safe innovation in this field is to create policies that provide product developers with meaningful guidance to answer critical questions as they research and design their gene therapy products.

The six final guidances issued today provide the agencys recommendations for product developers on manufacturing issues and recommendations for those focusing on gene therapy products to address specific disease areas.

The six guidance documents incorporate input from many stakeholders and take a significant step toward helping to shape the modern structure for the development and manufacture of gene therapies.

The agency is issuing this suite of documents to help advance the field of gene therapy while providing recommendations to help ensure that these innovative products meet the FDAs standards for safety and effectiveness.

The scientific review of gene therapies includes the need to evaluate highly complex information on product manufacturing and quality. In addition, the clinical review of these products frequently poses more challenging questions to regulators than reviews of more conventional drugs, such as questions about the durability of response, and these questions often cant be fully answered in pre-market trials of reasonable size and duration.

For some gene therapy products, therefore, although they have met the FDAs standards for approval, the agency may need to accept some level of uncertainty around questions of the duration of the response at the time of marketing authorization.

Effective tools for reliable post-market follow up, such as post-market clinical trials, are going to be key to advancing this field and helping to ensure that the agencys approach fosters safe and innovative treatments.

The draft guidance on interpreting sameness of gene therapy products under the orphan drug regulations provides the FDAs proposed current thinking on an interpretation of sameness between gene therapy products for the purposes of obtaining orphan-drug designation and eligibility for orphan-drug exclusivity.

The draft guidance focuses on how the FDA will evaluate differences between gene therapy products when they are intended to treat the same disease. As laid out in the FDAs draft guidance and regulations, the agencys determination will consider the principal molecular structural features of the gene therapy products, which includes transgenes (the transferred gene) and vectors (the vehicle for delivering the transgene to a cell).

With the large volume of products currently being studied, gene therapy product developers have asked the agency important questions about orphan-drug designation incentives to develop products for rare diseases with very small patient populations.

The draft guidance has potential positive implications both for product developers and patients by providing insight into the agencys most current thinking on the sameness of products, and thus, not discourage the development of multiple gene therapy products to treat the same disease or condition.

For patients, this policy could help lead to the development and approval of multiple treatments, creating a more competitive market with choices. The FDA encourages stakeholders to provide their comments.

In sum, these policy documents are representative of efforts to help advance product development in the field of gene therapy. The FDA will continue to work with product innovators, sponsors, researchers, patients, and other stakeholders to help make the development and review of these products more efficient, while putting in place the regulatory controls needed to ensure that the resulting therapies are both safe and effective.

The agency also encourages developers of new gene therapy products to make full use of FDAs expedited programs available for products intended to address unmet medical needs in the treatment of serious or life-threatening conditions.

These programs include breakthrough therapy designation, regenerative medicine advanced therapy designation, and fast track designation, as well as priority review and accelerated approval. Developers should pursue these programs whenever possible to help bring the benefits of important advances to patients as soon as possible.

The FDA believes their work will help advance innovations in a way that assures their safety and effectiveness, provides new therapeutic choices to patients and providers and continues to build confidence in this novel and emerging area of medicine.

Source: Food and Drug Administration

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FDA Continues Strong Support of Innovation in Development of Gene Therapy Products - MyChesCo

Image: Nur Yucer, PhD, a project scientist, and Clive Svendsen, PhD, director of the Cedars-Sinai Board of Governors Regenerative Medicine Institute and Professor of Biomedical Sciences and Medicine at Cedars-Sinai. Photo by Cedars-Sinai.

Parkinson's disease is a neurodegenerative disorder that affects predominately dopamine-producing neurons in the brain. Nearly one million will be living with Parkinson's disease in the US this year, according to the Parkinson's Foundation. This is more than the number of people diagnosed with multiple sclerosis, muscular dystrophy and Lou Gehrig's diseasecombined.

About 60,000 Americans are diagnosed with Parkinson's disease each year, and more than 10 million people worldwide are living with it. Incidence of Parkinsons disease increases with age, but an estimated 10 percent of people with Parkinson's disease are diagnosed before age 50. This is called young-onset Parkinson's.

Researchers at Cedars-Sinai, led by Clive Svendsen, PhD, director of the Cedars-Sinai Board of Governors Regenerative Medicine Institute and Professor of Biomedical Sciences and Medicine at Cedars-Sinai, reported in a study published in Nature Medicine that they found that patients who develop young-onset Parkinsons disease may have been born with dysfunctional brain cells that go undetected for decades.

The research team generated special stem cells, known as induced pluripotent stem cells (iPSCs), from cells of patients suffering from young-onset Parkinsons disease. These iPSCswhich can produce any cell type of the human body, all genetically identical to the patients own cellswere used to produce dopamine neurons from each patient to analyze their functions.

Two key abnormalities were observed in these neurons:

- Dr. Clive Svendsen

After testing a number of drugs on the abnormal dopamine neurons, the researchers discovered that a drug called PEP005 (ingenol mebutate) reduced the elevated levels of alpha-synuclein in both the dopamine neurons in the dish and in laboratory mice. A gel formulation of PEP005 is marketed by LEO Pharma as Picato and is FDA-approved for the treatment of actinic keratosis, a scaly skin patch that develops from years of exposure to the sun. According to the Mayo Clinic, a small percentage of actinic keratosis lesions can eventually become skin cancer.

Michele Tagliati, PhD, Director of the Movement Disorders Program and Vice Chair and Professor in the Department of Neurology at Cedars-Sinai, said the research team next will study how PEP005 might be delivered to the brain and whether or not the abnormalities found in young-onset Parkinson's patients also exist in other forms of Parkinsons.

- Dr. Michele Tagliati.

Edward Kim is Managing Editor of Equities.com.

_____

Sources: Equities News, Cedars-Sinai

DISCLOSURE:The views and opinions expressed in this article are those of the authors, and do not represent the views of equities.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure, please go to: http://www.equities.com/disclaimer.

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Cedars-Sinai Study Indicates That Parkinson's Disease May Start Before Birth - Equities.com

Nanomedicine Marketwas valued US$ XX Bn in 2018 and is expected to reach US$ XX Bn by 2026, at CAGR of XX% during forecast period of 2019 to 2026.

Nanomedicine Market Drivers and Restrains:Nanomedicine is an application of nanotechnology, which are used in diagnosis, treatment, monitoring, and control of biological systems. Nanomedicine usages nanoscale manipulation of materials to improve medicine delivery. Therefore, nanomedicine has facilitated the treatment against various diseases. The nanomedicine market includes products that are nanoformulations of the existing drugs and new drugs or are nanobiomaterials. The research and development of new devices as well as the diagnostics will become, more effective, enabling faster response and the ability to treat new diseases are likely to boost the market growth.

The nanomedicine markets are driven by factors such as developing new technologies for drug delivery, increase acceptance of nanomedicine across varied applications, rise in government support and funding, the growing need for therapies that have fewer side effects and cost-effective. However, long approval process and risks associated with nanomedicine (environmental impacts) are hampering the market growth at the global level. An increase in the out-licensing of nanodrugs and growth of healthcare facilities in emerging economies are likely to create lucrative opportunities in the nanomedicine market.

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Nanomedicine Market Segmentation Analysis:Based on the application, the nanomedicine market has been segmented into cardiovascular, neurology, anti-infective, anti-inflammatory, and oncology. The oncology segment held the dominant market share in 2018 and is projected to maintain its leading position throughout the forecast period owing to the rising availability of patient information and technological advancements. However, the cardiovascular and neurology segment is projected to grow at the highest CAGR of XX% during the forecast period due to presence of opportunities such as demand for specific therapeutic nanovectors, nanostructured stents, and implants for tissue regeneration.

Nanomedicine Market Regional Analysis:Geographically, the Nanomedicine market has been segmented into North America, the Europe, Asia Pacific, Latin America, and Middle East & Africa. North America held the largest share of the Nanomedicine market in 2018 due to the rising presence of patented nanomedicine products, the availability of advanced healthcare infrastructure and the rapid acceptance of nanomedicine. The market in Asia Pacific is expected to expand at a high CAGR of XX% during the forecast period thanks to rise in number of research grants and increase in demand for prophylaxis of life-threatening diseases. Moreover, the rising investments in research and development activities for the introduction of advanced therapies and drugs are predicted to accelerate the growth of this region in the near future.

Nanomedicine Market Competitive landscapeMajor Key players operating in this market are Abbott Laboratories, CombiMatrix Corporation, General Electric Company, Sigma-Tau Pharmaceuticals, Inc, and Johnson & Johnson. Manufacturers in the nanomedicine are focusing on competitive pricing as the strategy to capture significant market share. Moreover, strategic mergers and acquisitions and technological innovations are also the key focus areas of the manufacturers.

The objective of the report is to present a comprehensive analysis of Nanomedicine Market including all the stakeholders of the industry. The past and current status of the industry with forecasted market size and trends are presented in the report with the analysis of complicated data in simple language. The report covers all aspects of the industry with a dedicated study of key players that includes market leaders, followers and new entrants by region. PORTER, SVOR, PESTEL analysis with the potential impact of micro-economic factors by region on the market are presented in the report. External as well as internal factors that are supposed to affect the business positively or negatively have been analyzed, which will give a clear futuristic view of the industry to the decision-makers. The report also helps in understanding Nanomedicine Market dynamics, structure by analyzing the market segments and project the Nanomedicine Market size. Clear representation of competitive analysis of key players By Type, Price, Financial position, Product portfolio, Growth strategies, and regional presence in the Nanomedicine Market make the report investors guide.

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Scope of the Nanomedicine Market:

by Modality:

Diagnostics Treatmentsby Diseases:

Oncological Diseases Infectious Diseases Cardiovascular Diseases Orthopedic Disorders Neurological Diseases Urological Diseases Ophthalmological Diseases Immunological Diseases

by Application:

Neurology Cardiovascular Anti-Inflammatory Anti-Infectives Oncology

by Region:

Asia Pacific North America Europe Latin America Middle East Africa

Major Players:

Abbott Laboratories CombiMatrix Corporation General Electric Company Sigma-Tau Pharmaceuticals, Inc Johnson & Johnson Mallinckrodt plc. Merck & Company, Inc. Nanosphere, Inc. Pfizer, Inc. Teva Pharmaceutical Industries Ltd. Celgene Corporation UCB (Union Chimique Belge) S.A. AMAG Pharmaceuticals Nanospectra Biosciences, Inc. Arrowhead Pharmaceuticals, Inc. Leadiant Biosciences, Inc. Epeius Biotechnologies Corporation Cytimmune Sciences, Inc.

Browse Full Report with Facts and Figures of Nanomedicine Market Report at:https://www.maximizemarketresearch.com/market-report/nanomedicine-market/39223/

MAJOR TOC OF THE REPORT

Chapter One: Nanomedicine Market Overview

Chapter Two: Manufacturers Profiles

Chapter Three: Global Nanomedicine Market Competition, by Players

Chapter Four: Global Nanomedicine Market Size by Regions

Chapter Five: North America Nanomedicine Revenue by Countries

Chapter Six: Europe Nanomedicine Revenue by Countries

Chapter Seven: Asia-Pacific Nanomedicine Revenue by Countries

Chapter Eight: South America Nanomedicine Revenue by Countries

Chapter Nine: Middle East and Africa Revenue Nanomedicine by Countries

Chapter Ten: Global Nanomedicine Market Segment by Type

Chapter Eleven: Global Nanomedicine Market Segment by Application

Chapter Twelve: Global Nanomedicine Market Size Forecast (2019-2026)

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Maximize Market Research provides B2B and B2C market research on 20,000 high growth emerging technologies & opportunities in Chemical, Healthcare, Pharmaceuticals, Electronics & Communications, Internet of Things, Food and Beverages, Aerospace and Defense and other manufacturing sectors.

Contact info:

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Nanomedicine Market: Industry Analysis and forecast 2026 - Expedition 99

With the outbreak of the Wuhan coronavirus in China and the increasing death toll, there is little doubt that global financial markets are going to be impacted negatively. As Trump considers banning all flights to China, airline and travel companies like United Airlines (NASDAQ:UAL), Expedia (NASDAQ:EXPE), American Airlines (NASDAQ:AAL) and many more have seen their stock prices crash. There is a strong negative sentiment on the Chinese economy as a whole as the virus has shaken up many of the erstwhile strong sectors.

Overview of the virus

For those readers who are not aware, the Wuhan coronavirus first emerged in the central Chinese city of the same name through the meat and seafood markets and has spread across the country with over a thousand cases and more than a hundred deaths confirmed. It belongs to the same family of viruses as SARS (severe acute respiratory syndrome) and the MERS (Middle East respiratory syndrome). This group of crown-shaped viruses can become deadly if it causes the patient to develop lower respiratory tract illnesses such as pneumonia or bronchitis. It is highly contagious in nature, spreading through the slightest form of saliva contact, whether it is coughing or kissing. The story of the Wuhan coronavirus sounds like history repeating itself after SARS shook up global markets in 2002-03.

It is worth recalling that pharma and biotech companies catering to the respiratory system and providing anti-viral medications were the ones that appreciated the most during the time of SARS, and the current situation does not appear very different. With a strong negative sentiment prevailing in most other sectors, pharma and biotech are perhaps the only sectors that could get a boost from a new bullish sentiment resulting from this virus. Based on the nature of the virus and the expected treatments, the following four stocks could benefit hugely given their presence in the field of anti-viral respiratory medication.

GlaxoSmithKline plc

Since the Wuhan coronavirus belongs to the same family as the SARS, it is important to recall those companies which benefitted the most from the SARS outbreak. While SARS may not have a defined cure even today, the most commonly prescribed form of treatment is the same as that for pneumonia. GlaxoSmithKline plc (NYSE:GSK) is one of the leaders in the space of anti-viral treatments for respiratory disorders like pneumonia.

The above chart shows how the company's stock grew as much as 35% during the SARS phase, which is quite significant for its size. It is worth highlighting that GlaxoSmithKline is a global player with its biggest markets being the U.S. and the UK. Respiratory oral health is one of its strongest segments, and it has a monopolistic position in many anti-viral medications. For example, its Shingrix vaccine for shingles is the only preventive vaccine for the disease across the globe. It has also performed strong research on HIV. The stock has appreciated by over 20% in the past twelve months and also provided a dividend yield of 4.32%, making it an excellent bet for investors.

Abbott Laboratories

Abbott Laboratories (NYSE:ABT) is more of a play on the diagnostics aspect rather than the treatment aspect of the Wuhan virus. The company is one of the largest global biotech giants, and one of its most important offerings relevant to the Wuhan virus situation is its diagnostic capabilities. Abbott is known to provide rapid diagnostics systems for infectious diseases along with remote patient monitoring, informatics and automation solutions that are all very relevant to diagnose the Wuhan virus victims. It also has molecular point-of-care testing for HIV, influenza A and B and RSV.

Story continues

Abbott's relevance was so strong in the SARS era that it appreciated by over 30% in those times and is already up by around 22% in the past 12 months. Given the current situation, the upward momentum of the stock might continue for a while.

Gilead Sciences, Inc.

Biotech giant Gilead Sciences, Inc. (NASDAQ:GILD) was easily one of the biggest beneficiaries in the SARS outbreak, as it saw its stock appreciate more than 200% throughout the outbreak.

The reason for this appreciation is that Gilead gets most of its revenues from the anti-viral segment. The company's stock price has been stable throughout economic downturns and it is not without reason that the company has a 4.5-star business predictability rating on Gurufocus. Not only is it debt-free, it is known to distribute a good amount of dividend (current yield of 3.93%) to shareholders over and above capital appreciation. Not only has it done remarkable research on HIV, Gilead also has some very well known anti-viral brands in the market such as Atripla, Cayston, Sovaldi, Odefsey, Truvada, Biktarvy and so on. It is certainly going to be moving fast in the race to provide strong anti-viral treatments for the Wuhan coronavirus.

NanoViricides, Inc.

NanoViricides, Inc. (NNVC) is the only small, development-stage company on this list, but it is here for a reason. Since the news of the Wuhan virus outbreak, NanoViricides has seen its stock shoot up by as much as 349%.

The company, led by biotech veteran Dr. Anil Diwan, specializes in anti-viral research and had actively worked on MERS in the past. Its current research is also focused on treating viruses through its proprietary nanomedicine technology, where it uses anti-viral nanomachines known as "nanoviricides." The company has a decent pipeline of anti-viral drug candidates catering to diseases such as shingles, herpes, seasonal and potentially-epidemic influenzas, bird flu, HIV, cold sores, viral eye diseases and dengue viruses.

In fact, its most rapidly advancing drug candidate is a topical cream for the treatment of shingles, which is now advancing to the stage of IND application before progressing to human trials. While the company may not have significant revenues today, it hopes to start monetizing the progress of this cream through licensing agreements after the initial phases of the human trials. It has been one of the biggest beneficiaries of the Wuhan virus outbreak so far in terms of stock appreciation, and the upward momentum is expected to remain strong with the IND application results arriving soon.

Conclusion

The Wuhan coronavirus may have a huge negative impact on global markets over a span of time, but the pharma and biotech space is one where it presents a good opportunity. As its fears grip the world, companies like the ones mentioned above are working hard to capitalize on this opportunity and maximize their revenues. In such a situation, it is often beneficial for investors to be opportunistic and make the most returns through investing in these companies.

Disclosure: No positions.

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These 4 Biotech Stocks Are the Silver Lining on the Wuhan Coronavirus - Yahoo Finance

Global Nanorobotics Marketwas valued at US$ 3.7 Bn in 2017 and is expected to reach US$ 9.2Bn by 2026, at a CAGR of 12.06%during a forecast period.Global Nanorobotics MarketDevelopments in nanotechnology coupled with demand for minimally aggressive procedures are expected to drive market growth over the forecast period. Nanobots possess likely in the medical sector for destroying cancerous cells at the genetic level. Increasing support for nanomedicine by many nations and the increasing geriatric population are factors which can augur market demand.

Utilization of nanobots in the ranostics can be beneficial for the market in the near future. A rise in miniaturization and demand for automation across various sectors are anticipated to fuel market growth. Training of new personnel to use nanobots can restrain market growth in the upcoming years.Nanomedicine application segment to grow at the highest CAGR during the forecast period. Nanorobotics is widely used in nanomedicine owning to its healthcare features. The large share of this application aspects to the large level of commercialization in the healthcare sector for drug delivery, in vivo imaging, biomaterial, in vitro diagnostic, active implants, and drug therapy.

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North America region accounted for the largest share of 12.2%, in terms of value, of the nanorobotics market globally. Presence of many nanotechnology companies, well-developed healthcare infrastructure, and government initiatives to create patient awareness are factors driving the market. The U.S is anticipated to contribute to market revenue owing to the increase in cardiovascular diseases and the rising elderly populace.

Europe follows North America as the second biggest nanorobotics market. Presence of chronic diseases and the burgeoning population are factors expected to indicate the Europe nanobots market. Establishment of organizations to develop standards pertaining to nanotechnology can expand market growth. In 2018, DNA-Robotics, an organization including 12 European companies, has outlined steps to expedite production of nanobots on a large scale. These standards can help scale the market exponentially in the upcoming years.

A recent development in nanorobotics market: In March 2018, Thermo Fisher Scientific acquired Gatan, an exclusively owned subsidiary of Roper Technologies. Gatan is an electron microscopy solutions provider in the U.S, which accompaniments the Thermo Fisher Scientifics electron microscopy solutions business.In March 2017, Oxford Instruments (U.K) Asylum Research introduced its new SurfRider HQ-Series of high quality, budget-priced AFM probes, which are also existing in a model suitable for nanomechanical image mode.

The objective of the report is to present a comprehensive assessment of the market and contains thoughtful insights, facts, historical data, industry-validated market data and projections with a suitable set of assumptions and methodology. The report also helps in understanding Global Nanorobotics Market dynamics, structure by identifying and analyzing the market segments and project the global market size. Further, the report also focuses on the competitive analysis of key players by product, price, financial position, product portfolio, growth strategies, and regional presence. The report also provides PEST analysis, PORTERs analysis, SWOT analysis to address the question of shareholders to prioritizing the efforts and investment in the near future to the emerging segment in the Global Nanorobotics Market.

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Scope of the Global Nanorobotics Market

Global Nanorobotics Market, By Type

Nanomanipulatoro Electron Microscope (EM) Scanning Electron Microscope (SEM) Transmission Electron Microscope (TEM)o Scanning Probe Microscope (SPM) Atomic Force Microscopes (AFM) Scanning Tunneling Microscope (STM) Bio-Nanorobotics Magnetically Guided Bacteria-BasedGlobal Nanorobotics Market, By Application

Nanomedicine Biomedical Mechanical OthersGlobal Nanorobotics Market, By Region

North America Europe Asia Pacific Middle East and Africa South AmericaKey players operating in Global Nanorobotics Market:

Bruker JEOL Thermo Fisher Scientific Ginkgo Bioworks Oxford Instruments EV Group Imina Technologies Toronto Nano Instrumentation KlockeNanotechnik KleindiekNanotechnik Xidex Synthace Park Systems Smaract Nanonics ImagingKey Innovators:

Novascan Technologies Angstrom Advanced Hummingbird Scientific NT-MDT Spectrum Instruments Witec

Browse Full Report with Facts and Figures of Nanorobotics Market Report at:https://www.maximizemarketresearch.com/market-report/global-nanorobotics-market/30888/

MAJOR TOC OF THE REPORT

Chapter One: Nanorobotics Market Overview

Chapter Two: Manufacturers Profiles

Chapter Three: Global Nanorobotics Market Competition, by Players

Chapter Four: Global Nanorobotics Market Size by Regions

Chapter Five: North America Nanorobotics Revenue by Countries

Chapter Six: Europe Nanorobotics Revenue by Countries

Chapter Seven: Asia-Pacific Nanorobotics Revenue by Countries

Chapter Eight: South America Nanorobotics Revenue by Countries

Chapter Nine: Middle East and Africa Revenue Nanorobotics by Countries

Chapter Ten: Global Nanorobotics Market Segment by Type

Chapter Eleven: Global Nanorobotics Market Segment by Application

Chapter Twelve: Global Nanorobotics Market Size Forecast (2019-2026)

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Maximize Market Research provides B2B and B2C market research on 20,000 high growth emerging technologies & opportunities in Chemical, Healthcare, Pharmaceuticals, Electronics & Communications, Internet of Things, Food and Beverages, Aerospace and Defense and other manufacturing sectors.

Contact info:

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Organization: MAXIMIZE MARKET RESEARCH PVT. LTD.

Email: sales@maximizemarketresearch.com

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Global Nanorobotics Market : Industry Analysis and Forecast (2018-2026) - Expedition 99

Today well evaluate GeneReach Biotechnology Corp. (GTSM:4171) to determine whether it could have potential as an investment idea. To be precise, well consider its Return On Capital Employed (ROCE), as that will inform our view of the quality of the business.

First of all, well work out how to calculate ROCE. Second, well look at its ROCE compared to similar companies. Then well determine how its current liabilities are affecting its ROCE.

ROCE measures the return (pre-tax profit) a company generates from capital employed in its business. In general, businesses with a higher ROCE are usually better quality. Overall, it is a valuable metric that has its flaws. Renowned investment researcher Michael Mauboussin has suggested that a high ROCE can indicate that one dollar invested in the company generates value of more than one dollar.

Analysts use this formula to calculate return on capital employed:

Return on Capital Employed = Earnings Before Interest and Tax (EBIT) (Total Assets Current Liabilities)

Or for GeneReach Biotechnology:

0.11 = NT$72m (NT$713m NT$61m) (Based on the trailing twelve months to September 2019.)

Therefore, GeneReach Biotechnology has an ROCE of 11%.

View our latest analysis for GeneReach Biotechnology

One way to assess ROCE is to compare similar companies. Using our data, GeneReach Biotechnologys ROCE appears to be around the 9.5% average of the Medical Equipment industry. Regardless of where GeneReach Biotechnology sits next to its industry, its ROCE in absolute terms appears satisfactory, and this company could be worth a closer look.

GeneReach Biotechnology has an ROCE of 11%, but it didnt have an ROCE 3 years ago, since it was unprofitable. That implies the business has been improving. The image below shows how GeneReach Biotechnologys ROCE compares to its industry, and you can click it to see more detail on its past growth.

When considering this metric, keep in mind that it is backwards looking, and not necessarily predictive. ROCE can be misleading for companies in cyclical industries, with returns looking impressive during the boom times, but very weak during the busts. ROCE is only a point-in-time measure. Since the future is so important for investors, you should check out our free report on analyst forecasts for GeneReach Biotechnology.

Current liabilities are short term bills and invoices that need to be paid in 12 months or less. Due to the way the ROCE equation works, having large bills due in the near term can make it look as though a company has less capital employed, and thus a higher ROCE than usual. To counteract this, we check if a company has high current liabilities, relative to its total assets.

GeneReach Biotechnology has total assets of NT$713m and current liabilities of NT$61m. As a result, its current liabilities are equal to approximately 8.6% of its total assets. With low current liabilities, GeneReach Biotechnologys decent ROCE looks that much more respectable.

This is good to see, and while better prospects may exist, GeneReach Biotechnology seems worth researching further. GeneReach Biotechnology shapes up well under this analysis, but it is far from the only business delivering excellent numbers . You might also want to check this free collection of companies delivering excellent earnings growth.

If you like to buy stocks alongside management, then you might just love this free list of companies. (Hint: insiders have been buying them).

If you spot an error that warrants correction, please contact the editor at editorial-team@simplywallst.com. This article by Simply Wall St is general in nature. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. Simply Wall St has no position in the stocks mentioned.

We aim to bring you long-term focused research analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Thank you for reading.

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Is GeneReach Biotechnology Corp. (GTSM:4171) Investing Effectively In Its Business? - Simply Wall St

In the Editorial page article, The flawed spin to Indias cotton story (January 23, 2020), there are unfounded claims about a technology that has in reality been a boon to farmers across the world.

The first point made in the article is that GM cotton covers 95% of the area under cotton and that there are no choices for farmers. The fact: Indian farmers have voted for choice of seeds with biotechnologies by planting hybrid cotton biotech seeds on over 90% of the countrys cotton acreage. They want seeds and technologies that provide optimal yield, income and convenience in cultivation. Today, they choose from over 800 hybrid Bt cotton seed brands from over 40 Indian and global seed companies, with five approved in-the-seed insect protection Bt cotton technologies and non-Bt varietal cotton seeds. Farmers have not shown any preference for planting non-Bt cotton seeds including the quantity supplied along with the Bt cotton seed by seed companies as per regulatory guidelines.

Several key studies by third-party economists and sociologists have established that 85% of hybrid Bt cotton seed farmers and farm labourers invested in better education for children; 77% reported better intake of nutritious food; 75% reported better health of their family members; 64% invested on the health of livestock; female workers on Bt cotton fields earned an average 55% higher income; and 42.4 crore additional days of rural employment have been generated, thereby doubling cotton production.

Indias farmers are the ones who have reposed trust in biotechnology, making India the worlds second largest cotton producer and exporter by doubling cotton production over the past decade.

Cotton Corporation of India data show that the highest production of 398 lakh bales of cotton in India was achieved in 2013-14, valued at around 72,000 crore. Additional incomes were generated from cotton seeds oil (1.3 million tons) and cotton seed oilmeal (11 million tons) worth 13,000 crore and 22,000 crore, respectively. The Bt cotton seed market is about 3,000 crore, making it hardly 2.5% of the total value generated.

The articles second point is about low productivity as compared to the global scene. The fact is that technology has not only increased yields but also greatly reduced pesticide use. Biotechnology in cotton, post its introduction in 2002, has led to transformational changes in Indias cotton cultivation. These have helped increase cotton yields by over 1.8 times from 241 kg/hectare in 2002-2003 to 541 kg/hectare in 2018-2019. A BKS-CSD study shows that the significant increase in farmer incomes from higher yields and reduced pesticide use has generated additional farm income of over 42,300 crore. India is moving to first place as the largest producer of cotton in the world.

However, it is not just the technology that increases yields. Indias farmers face numerous uncertainties and crop management challenges, affecting farm yield and incomes; knowledge of cultivation and correct agronomic practices can make a significant impact. This is being addressed by numerous extension efforts.

There is an opportunity to increase yields further in India when compared to other countries that have been using even more advanced GM traits than what is being used in India. New technology introduction has stopped in India since 2005, affecting growth of yields.

The articles third point is about the availability of low cost manual labour. The fact is that one of the major challenges lies in securing labour to conduct field operations. Today, labour accounts for over 58% of a farmers cost of cultivation per acre. In a fast-evolving global market, Indias farmers instead need the best technologies to remain competitive.

The next claim is about varieties offering farmers increased benefits than hybrid cotton seeds. The fact is that Indian farmers who were using varieties for years switched to hybrids in the mid-1980s mainly because of the enormous benefits. Cotton Advisory Board data show that Indias cotton yields which were at 169 kg/hectare in 1980-81 increased to 278 kg/hectare in 2000-01 and then 542 kg/ hectare in 2016-17.

The writers argument that High Density Planting (HDP) took place in various countries after introduction of biotech cotton is inaccurate. Planting rates are determined by several agronomic and environmental conditions and not based on biotech versus non-biotech. There is also no change in the seed rate in any of the countries in which biotech cotton has been adopted. HDP has done well in India because of the better quality of germplasm.

Also, Turkey is not a large cotton producer. USDA statistics in 2017-18 shows that India leads with 35m bales, followed by China (28m bales), the U.S. (21m bales), Brazil (9m bales) and Australia (5m bales). All of them are GM cotton countries, contributing to more than 90% of global cotton production. GM cotton was introduced in Brazil in 2006-07.

India also produces hybrid cotton seed because of the availability of labour to carry out the hand pollination at reasonable cost; this is not available in the U.S., Brazil, Australia and China. Hybrid cotton has delivered not only higher yields but also provided resistance to some pests and diseases.

The article also claims that Indian farmers need to buy seeds repeatedly. The fact is that not just biotech cotton, but all hybrid seeds lose their benefits if replanted, creating reduced and erratic yields. New seeds help farmers sustain high yields year on year.

In the case of biotech cotton in India, it is the farmers who adopted the technology wholeheartedly because they saw a solution in it to some of their biggest on-field pest challenges. The choice made by the Indian farmer to plant hybrid cotton seeds on over 90% of cotton acreage, and see increased cotton production is testament to the value created by better seeds, technologies and farming practices when compared with the alternative of low tech seed and insecticide sprays.

Bt cotton was released in varieties by some public institutions but it did not get much traction. There is always a debate about the use of hybrids versus varieties in any crop. The writer appears to be giving too much power to the seed industry in terms of influencing the farmer to prefer hybrids over varieties. This has not happened in the case of rice, mustard, many oilseeds, and pulses in which the farmers grow varietal crops in 90-100% of the area. The lesson is that the farmer adopts technologies which are beneficial to him and does not go by the recommendations of the industry or any other persons.

Seeds with biotechnologies have helped conserve biodiversity: with higher production from the same area, the expansion of agricultural land into forest areas has been slowed.

A one-sided depiction not only harms agriculture and the industry but also spreads misconceptions about biotechnology.

Ram Kaundinya is Director General, Federation of Seed Industry of India (FSII), New Delhi

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A case of wholehearted biotechnology adoption - The Hindu

Oncolytics Biotech, Inc. (ONCY) is near the top in its industry group according to InvestorsObserver. ONCY gets an overall rating of 78. That means it scores higher than 78 percent of stocks. Oncolytics Biotech, Inc. gets a 94 rank in the Biotechnology industry. Biotechnology is number 55 out of 148 industries.

Click Here to get the full Stock Score Report on Oncolytics Biotech, Inc. (ONCY) Stock.

Finding the best stocks can be tricky. It isnt easy to compare companies across industries. Even companies that have relatively similar businesses can be tricky to compare sometimes. InvestorsObservers tools allow a top-down approach that lets you pick a metric, find the top sector and industry and then find the top stocks in that sector.

These scores are not only easy to understand, but it is easy to compare stocks to each other. You can find the best stock in an industry, or look for the sector that has the highest average score. The overall score is a combination of technical and fundamental factors that serves as a good starting point when analyzing a stock. Traders and investors with different goals may have different goals and will want to consider other factors than just the headline number before making any investment decisions.

Oncolytics Biotech, Inc. (ONCY) stock is trading at $3.11 as of 9:57 AM on Monday, Jan 27, a loss of -$0.16, or -5.05% from the previous closing price of $3.27. The stock has traded between $3.00 and $3.35 so far today. Volume today is below average. So far 349,770 shares have traded compared to average volume of 2,557,054 shares.

To see InvestorsObserver's Sentiment Score for Oncolytics Biotech, Inc. click here.

See the article here:
Is Oncolytics Biotech, Inc. (ONCY) a Winner or a Loser in the Biotechnology Industry - InvestorsObserver

Vir Biotechnology, Inc. (VIR) is priced at $22.47 after the most recent trading session. At the very opening of the session, the stock price was $20.63 and reached a high price of $26.29, prior to closing the session it reached the value of $21.31. The stock touched a low price of $20.21.

Price records that include history of low and high prices in the period of 52 weeks can tell a lot about the stocks existing status and the future performance. Presently, Vir Biotechnology, Inc. shares are logging -18.22% during the 52-week period from high price, and 92.87% higher than the lowest price point for the same timeframe. The stocks price range for the 52-week period managed to maintain the performance between $11.65 and $27.48.

The companys shares, operating in the sector of healthcare managed to top a trading volume set approximately around 2.14 million for the day, which was evidently higher, when compared to the average daily volumes of the shares.

When it comes to the year-to-date metrics, the Vir Biotechnology, Inc. (VIR) recorded performance in the market was 78.69%, having the revenues showcasing 48.32% on a quarterly basis in comparison with the same period year before. At the time of this writing, the total market value of the company is set at 2.19B, as it employees total of 217 workers.

Raw Stochastic average of Vir Biotechnology, Inc. in the period of last 50 days is set at 68.37%. The result represents improvement in oppose to Raw Stochastic average for the period of the last 20 days, recording 67.66%. In the last 20 days, the companys Stochastic %K was 70.12% and its Stochastic %D was recorded 78.51%.

Now, considering the stocks previous presentation, multiple moving trends are noted. Year-to-date Price performance of the companys stock appears to be pessimistic, given the fact the metric is recording 78.69%. The shares increased approximately by 1.27% in the 7-day charts and went down by 35.85% in the period of the last 30 days. Common stock shares were driven by 48.32% during last recorded quarter.

Read more here:
Vir Biotechnology, Inc. (VIR) distance from 20-day Simple moving Average is 47.94% : What to Expect? - The InvestChronicle

GIOSTAR/HEAMGEN has developed and secured patented technology to manufacture lifesaving mature red blood cells from stem cells. The red blood cells are made utilizing a bioreactor that permits the production of mature red blood cells, under strictly controlled conditions, for transfusion therapy and replaces the need for a human blood donor. GIOSTAR/HEAMGEN mature red blood cells are safe and not compromised by inadequate pathogen detection and inactivation of diseases such as hepatitis C, HIV, hepatitis B and syphilis. The red blood cells are O-Negative (Universal Donor) to eliminate incompatibility and allosensitization reactions.

ATLANTA (PRWEB) January 29, 2020

GIOSTAR/HEAMGEN has developed and secured patented technology to manufacture lifesaving mature red blood cells from stem cells. The red blood cells are made utilizing a bioreactor that permits the production of mature red blood cells, under strictly controlled conditions, for transfusion therapy and replaces the need for a human blood donor. GIOSTAR/HEAMGEN mature red blood cells are safe and not compromised by inadequate pathogen detection and inactivation of diseases such as hepatitis C, HIV, hepatitis B and syphilis. The red blood cells are O-Negative (Universal Donor) to eliminate incompatibility and allosensitization reactions. Trauma situations often do not allow for adequate blood typing due to time restrictions, so the GIOSTAR/HEAMGEN red blood cells address that need effectively.

"There are three main problems for blood transfusions," stated Dr. Anand Srivastava, Founder and Chairman of GIOSTAR. "First we have to match the blood type. Second, there's not enough blood available every single time. And third, when we transfer blood from one person to another person, there is always a chance of the transfer of disease."

Watch a feature interview with Dr. Anand Srivastava on The DM Zone with host Dianemarie Collins.

The World Health Organization (WHO) published the first detailed analysis on the global supply and demand for blood in October 2019 and found that 119 out of 195 countries do NOT have enough blood in their blood banks to meet hospital needs. In those nations, which include every country in central, eastern, and western sub-Saharan Africa, Oceania (not including Australasia), and south Asia are missing roughly 102,359,632 units of blood, according to World Health Organization (WHO) goals. While total blood supply around the world was estimated to be around 272 million units, in 2017, demand reached 303 million units. That means the world was lacking 30 million units of blood, and in the 119 countries with insufficient supply, that shortfall reached 100 million units.

The global market opportunity for GIOSTAR/HEAMGEN technology presents not only a profitable and scalable business opportunity but also a significant social and environmental impact. The global market is estimated to be at least $ 85 Billion/year.

GIOSTAR/HEAMGEN has identified early entry global markets to include Military, Trauma, Asia (replace Hepatitis C contaminated blood products), Africa (AIDS contaminated blood), Newborns, Thalassemia patients, Allosensitized sickle cell disease patients. South Sudan was found to have the lowest supply of blood, at 46 units per 100,000 people. In fact, the country's need for blood was deemed 75 times greater than its supply. In India, which had the largest absolute shortage, there was a shortfall of nearly 41 million units, with demand outstripping supply by over 400 percent. Strategic investments are needed in many low-income and middle-income countries to expand national transfusion services and blood management systems. Oncology is a major user of blood transfusion but if countries don't have the capacity to manage the bulk of oncology, it will limit complex surgery options.

GIOSTAR/HEAMGEN has acquired the exclusive license to the patent for the technique for stem cell proliferation from University of California San Diego (UCSD). The founding team of GIOSTAR/HEAMGEN is comprised of the scientists and clinicians who were involved in creating the Intellectual Property at UCSD and has already achieved PROOF OF CONCEPT - the optimized lab scale proliferation of mature red blood cells - at UCSD as part of their research.

GIOSTAR/HEAMGEN is currently looking for strategic partnerships (Contact Doug@DMProductionsLLC.com) to accelerate the development of donor-independent red blood cells manufacturing capabilities and advance the proof of concept work already done (patented) around the manufacture of safe, universal donor, human red blood cells. GIOSTAR/HEAMGEN will also develop a full automated proprietary bioreactor using robotic technology to produce abundant quantities of red blood cells with a goal for cost-effective commercialization of fresh, human, universal donor Red Blood Cells (RBCs).

ABOUT GIOSTAR

Dr. Anand Srivastava is a Chairman and Cofounder of California based Global Institute of Stem Cell Therapy and Research (GIOSTAR) headquartered in San Diego, California, (U.S.A.). The company was formed with the vision to provide stem cell based therapy to aid those suffering from degenerative or genetic diseases around the world such as Parkinson's, Alzheimer's, Autism, Diabetes, Heart Disease, Stroke, Spinal Cord Injuries, Paralysis, Blood Related Diseases, Cancer and Burns. GIOSTAR is a leader in developing most advance stem cell based technology, supported by leading scientists with the pioneering publications in the area of stem cell biology. Company's primary focus is to discover and develop a cure for human diseases with the state of the art unique stem cell based therapies and products. The Regenerative Medicine provides promise for treatments of diseases previously regarded as incurable.

GIOSTAR is world's leading Stem cell research company involved with stem cell research work for over a decade. It is headed by Dr Anand Srivastava, who is a pioneer and a world-renowned authority in the field of Stem Cell Biology, Cancer and Gene therapy. Several governments and organizations including USA, India, China, Turkey, Kuwait, Thailand, Philippines, Bahamas, Saudi Arabia and many others seek his advice and guidance on drafting their strategic and national policy formulations and program directions in the area of stem cell research, development and its regulations. Under his creative leadership, a group of esteemed scientists and clinicians have developed and established Stem Cell Therapy for various types of autoimmune diseases and blood disorders, which are being offered to patients in USA and soon it will be offered on a regular clinical basis to the people around the globe.

For the original version on PRWeb visit: https://www.prweb.com/releases/giostar_announces_medical_breakthrough_in_biotechnology_and_lifesciences_to_manufacture_abundant_safe_red_blood_cells_from_stem_cells/prweb16854975.htm

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GIOSTAR Announces Medical Breakthrough in Biotechnology and Lifesciences To Manufacture Abundant, Safe Red Blood Cells From Stem Cells - Benzinga