StemCell Therapy

According to IMARC Groups latest report, titled Regenerative Medicine Market: Industry Trends, Share, Size, Growth, Opportunity and Forecast 2020-2025,. Looking forward, IMARC Group expects the global regenerative medicine market to continue its strong growth during the next five years.

Regenerative medicine refers to a field of biomedical sciences involved in restoring the structure and function of damaged cells, organs, and tissues. It includes the study of stem cells that are developed in laboratories and then safely inserted into the human body to regenerate damaged bones, cartilage, blood vessels, and organs. Cellular and acellular regenerative medicines are widely adopted in various clinical therapeutic procedures, including cell therapies, immunomodulation, and tissue engineering. They have the potential to treat various chronic diseases, including Alzheimers, Parkinsons, cardiovascular disorders (CVDs), osteoporosis, spinal cord injuries, etc.

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Market Trends

The rising prevalence of chronic diseases and genetic disorders is primarily driving the demand for regenerative medicine across the globe. Moreover, the growing geriatric population who are more prone to musculoskeletal, dermatological, and cardiological disorders is also augmenting the need for regenerative medicines. Furthermore, several technological advancements in cell-based therapies have led to the adoption of 3D bioprinting techniques and artificial intelligence (AI), thereby further propelling the market for regenerative medicine. Moreover, regenerative medicine decreases the risk of organ rejection by the body post-transplant and increases the patients recovery speed, thereby gaining traction in numerous organ transplantation procedures. The increasing investments in extensive R&D activities in the field of medical sciences are expected to drive the market for regenerative medicine.

Regenerative Medicine Market 2020-2025 Analysis and Segmentation:

Competitive Landscape:

The competitive landscape of the market has been studied in the report with the detailed profiles of the key players operating in the market.

Some of these key players include:

The report has segmented the market on the basis of type, application, end user and region.

Breakup by Type:

Breakup by Application:

Breakup by End User:

Explore full report with table of contents: https://bit.ly/2RAf08Y

Breakup by Region:

Key highlights of the report:

If you need specific information that is not currently within the scope of the report, we will provide it to you as a part of the customization.

About Us

IMARC Group is a leading market research company that offers management strategy and market research worldwide. We partner with clients in all sectors and regions to identify their highest-value opportunities, address their most critical challenges, and transform their businesses.

IMARCs information products include major market, scientific, economic and technological developments for business leaders in pharmaceutical, industrial, and high technology organizations. Market forecasts and industry analysis for biotechnology, advanced materials, pharmaceuticals, food and beverage, travel and tourism, nanotechnology and novel processing methods are at the top of the companys expertise.

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Regenerative Medicine Market 2020: Analysis, Top Companies, Size, Share, Demand and Opportunity To 2025 - Crypto Daily

MIAMI--(BUSINESS WIRE)--Organicell Regenerative Medicine, Inc. (OTCBB: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, announced that the U.S. Food and Drug Administration (FDA) granted expanded access for an intermediate size population allowing its proprietary therapeutic, Zofin for the treatment of COVID-19.

This expanded access protocol will provide access to the investigational product Zofin for patients in outpatient and inpatient facilities infected with SARS-CoV-2 who have mild to moderate COVID-19, or who are judged by a healthcare provider to be at high risk of progression to moderate disease. Aside from Convalescent Plasma, Zofin, is the first reported acellular therapy which can be accessed under FDAs approved expanded access program. Zofin is manufactured to retain naturally occurring microRNAs, without the addition of any other substance or diluent.

This recent FDA approval follows the treatment of six outpatients treated under emergency INDs, who have reported significant improvement after being treated with Zofin. Organicell is currently in the process of enrolling moderate to severe COVID-19 patients for a Phase I/II placebo controlled clinical trial (NCT04384445) to evaluate the safety and potential efficacy of Zofin.

Treating patients in an outpatient setting may be critical in helping to prevent the progression of the disease and further hospitalization which could lessen the impact on hospitals, thereby reducing medical costs, said Albert Mitrani, Chief Executive Officer of Organicell.

About Organicell Regenerative Medicine, Inc.:

Organicell Regenerative Medicine, Inc. is a clinical-stage biopharmaceutical company that harnesses the power of nanoparticles to develop innovative biological therapeutics for the treatment of degenerative diseases. The companys proprietary products are derived from perinatal sources and manufactured to retain the naturally occurring microRNAs, without the addition or combination of any other substance or diluent. Based in South Florida, the company was founded in 2008 by Albert Mitrani, Chief Executive Officer and Dr. Maria Ines Mitrani, Chief Science Officer. To learn more, please visit https://organicell.com/.

About Zofin:

Zofin is an acellular biologic therapeutic derived from perinatal sources and is manufactured to retain naturally occurring microRNAs, without the addition or combination of any other substance or diluent. This product contains over 300 growth factors, cytokines, and chemokines as well as other extracellular vesicles/nanoparticles derived from perinatal tissues. Zofin is currently being tested in a phase I/II randomized, double blinded, placebo trial to evaluate the safety and potential efficacy of intravenous infusion of Zofin for the treatment of moderate to SARS related to COVID-19 infection vs placebo.

Forward-Looking Statements

Certain of the statements contained in this press release should be considered forward-looking statements within the meaning of the Securities Act of 1933, as amended (the Securities Act), the Securities Exchange Act of 1934, as amended (the Exchange Act), and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are often identified by the use of forward-looking terminology such as will, believes, expects, potential or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. We remind you that actual results could vary dramatically as a result of known and unknown risks and uncertainties, including but not limited to: potential issues related to our financial condition, competition, the ability to retain key personnel, product safety, efficacy and acceptance, the commercial success of any new products or technologies, success of clinical programs, ability to retain key customers, our inability to expand sales and distribution channels, legislation or regulations affecting our operations including product pricing, reimbursement or access, the ability to protect our patents and other intellectual property both domestically and internationally and other known and unknown risks and uncertainties, including the risk factors discussed in the Company's periodic reports that are filed with the SEC and available on the SEC's website (http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these risk factors. Specific information included in this press release may change over time and may or may not be accurate after the date of the release. Organicell has no intention and specifically disclaims any duty to update the information in this press release.

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FDA Grants Organicell Expanded Access to Treat COVID-19 Patients with Zofin - Business Wire

HOUSTON, Oct. 1, 2020 /PRNewswire/ -- FibroGenesis, the leading developer of fibroblast based therapeutic solutions for unmet medical needs has entered into a clinical collaboration agreement with Brazilian R4D Biotech.Holding the world's largest patent portfolio in the field of cell therapies using fibroblasts, FibroGenesis is expanding its ongoing clinical programs internationally. The partnership will pave the way for clinical studies of PneumoBlast in Brazil as a unique treatment of acute respiratory distress syndrome (ARDS) for patients affected by COVID-19, in parallel to clinical studies in the United States upon approval by the FDA.

Administration of PneumoBlast in pre-clinical and animal studies resulted in dramatic improvement of immunological signaling molecules, reducing concentrations of the inflammatory cytokines interleukin-1 beta, interleukin-6, interleukin-8, interleukin-17, interleukin-18, and Tumor Necrosis Factor alpha TNFa. Company scientists have also demonstrated that PneumoBlast has induced statistically significant reduction of lung fibrosis and lung scarring in COVID-19 infected animals, particularly when compared to more conventional treatments using bone marrow derived mesenchymal stem cells (BMSCs). Furthermore, recent data supports the potential benefits of PneumoBlast for preventing COVID-19 blood clotting. Both companies will collaborate on a clinical study design that meets the needs of Brazilian patients.

"As the scientific and medical community is discovering more about the biological and medical consequences of the COVID-19 infection, FibroGenesis is eager to contribute to the therapeutic cure options currently being created to fight this global war against this virus," commented Pete O'Heeron, Chief Executive Officer, FibroGenesis. "The collaboration with R4D Biotech is another strategic milestone that emphasizes our commitment to expand fibroblast research globally."

"The lab results which indicate our cell therapy approach possesses both therapeutic effects on animal models of the acute stage of COVID-19, and also benefits a cure for residual pathology seen in COVID-19 patients, has our research team extremely excited," said Thomas Ichim, Ph.D., Chief Scientific Officer, FibroGenesis.

"Technology transfer is at the core of this partnership," said Paulo Ferraz, BRICS/Emerging Markets Director of international fund Newstar Ventures and an advisor for FibroGenesis on this transaction. "R4D Biotech has access to sophisticated resources comprising research facilities and hospitals, and its talent pool includes scientific advisors who are recognized academics and distinguished members of the Brazilian Academy of Pharmaceutical Sciences. PneumoBlast clinical study will represent the first step in a long-term relationship designed to aid in the discovery of advanced therapeutic solutions for chronic medical needs."

About R4D Biotech:R4D Biotech is a Brazilian emerging company headquartered in the state of So Paulo focused on research and development for biotechnology and healthcare, with the mission of bringing disruptive technology innovation across all steps of clinical development in life sciences.

About FibroGenesis:Based in Houston, Texas, FibroGenesis is a regenerative medicine company developing an innovative solution for chronic disease treatment using human dermal fibroblasts. Currently, FibroGenesis holds 240+ U.S. and international issued patents/patents pending across a variety of clinical pathways, including Disc Degeneration, Multiple Sclerosis, Parkinson's, Chronic Traumatic Encephalopathy, Cancer, Diabetes, Liver Failure, Colitis and Heart Failure. FibroGenesis represents the next generation of medical advancement in cell therapy.Visit http://www.Fibro-Genesis.com.

SOURCE FibroGenesis

http://www.Fibro-Genesis.com

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FibroGenesis Expands Fight Against COVID-19 In Brazil with International Collaboration - PRNewswire

GOLDEN, CO / ACCESSWIRE / October 1, 2020 / Vitro Diagnostics, Inc. (OTCQB:VODG), dba Vitro Biopharma, announced its 3rd quarter, ended July 31st 2020, financial results of operations.

Vitro Biopharma recorded 3rd quarter revenues of $132,066 vs $225,191 a decrease of 41% over the comparative quarter last year. Revenues were up slightly from the prior quarter which were $128,631. The decrease in revenue is directly attributed to the COVID 19 pandemic. Lockdown extensions and business opening limitations have pushed our expectations of growth and revenue recovery out to the first half of 2021. Feedback from our customers and our partner clinic in the Cayman Islands http://www.DVCstem.com are that patients awaiting treatments are not dropping off, but merely postponing their treatments and as such, a significant backlog is building. The cosmetic clinics http://www.Infinivive.com have started to open up but only with lower occupancy and variations by state, resulting in reduced revenue into the 4th quarter with expectations of a revival of revenue into the first half of 2021.

Gross profit declined 3% from the comparative quarter last year primarily due to the reduced higher margin stem cell product sales versus the mid margin stem cell research and development products.

Overall operating expenses increased in the quarter ended July 31st 2020 by $180,326 to $336,442 from $194,682 in the prior year's comparative quarter. The increase in expenses reflects the increased costs of FDA regulatory, legal, consulting, and audit costs. We engaged the audit firm of MaloneBailey LLP to get the company fully reporting around January of 2021.

Vitro Biopharma Announces MaloneBailey L.L.P. as its new Auditors

The company added extra resources to turn its attention to the world-wide challenge of finding therapies to fight COVID-19. Vitro filed an Investigational New Drug ("IND") application and through its collaboration with GIOSTAR, received FDA authorization to treat COVID 19 patients under the Expanded Access Program with its AlloRx Stem Cells . A single patient was treated successfully with no adverse events and the patient showed evidence of improved lung, liver and kidney function while also recovering from a stroke-induced coma.

Critically ill COVID-19 Patient Successfully Treated with Vitro Biopharma’s AlloRx Stem Cells®

The company entered into an MOU with GIOSTAR, a leading global stem cell research company, who operates multiple international stem cell clinics. The supply agreement provides GIOSTAR with the use of our AlloRx Stem Cells to treat COVID 19 patients through FDA-pre and post-market approval.

Vitro Biopharma Signs MOU with GIOSTAR for COVID-19 IND Using AlloRx Stem Cells

During and subsequent to the quarter the company achieved and pursed the following objectives:

During the quarter and subsequent to the quarter, the company continued with its Series A Convertible Preferred Stock offering to accredited investors under the SEC Regulation D exemption. The preferred Stock is priced at $25 per share which is convertible at $0.25 cents per share for a total of 100 shares. The minimum investment is $50,000 per unit. The company has sold $1.0 million of the Series A Convertible Preferred Stock during and subsequent to the quarter. The offering was sold out at $1.0 million and the company has expanded it to a total of up to $3.5 million to ensure sufficient working capital during the Coronavirus pandemic and to start the regulatory process of current reporting audits and funding for its expanded clinical trial activities with the FDA.

As a part of our overall strategy to target both global and US stem cell markets, Vitro submitted a Phase I IND application to the FDA to assess the safety of AlloRx Stem Cells in the treatment of COVID-19. We have established strong communication channels with FDA officials to facilitate our IND review and are providing additional information to the FDA to complete the approval of our IND. Several clinical centers have expressed interest in our stem cell therapy and we continue to enlist multi-center sites to conduct our Phase 1 trial. We are also pursuing other avenues for emergency use under the Expanded Access Program. No adverse events were reported and the patient who had various comorbidities stabilized and exhibited enhanced pulmonary, liver and renal function during the six weeks following AlloRx Stem Cell Therapy. The patient has now recovered and is at home from the hospital after 3 months of intensive care. We are currently pursuing additional emergency use authorizations under expanded access provision applications through our collaboration with GIOSTAR. MSCs have been shown to block the cytokine storm that occurs in COVID-19 patients in acute respiratory distress through their powerful anti-inflammatory effects. The cytokine storm leads to the need for assisted breathing by ventilators, transfer to ICU and related burdens on the US health care system. It is important to note that AlloRx Stem Cells are a possible therapy for other viral attacks including influenza. Stem cells may block acute respiratory distress and may repair damage to other major organs including cardiovascular, pulmonary, hepatic and renal systems. AlloRx Stem Cells have been shown to assist in recovery from failure of various organ systems in COVID-19 survivors, as our case study and results from several other labs are demonstrating.

The Company entered into an exclusive Memorandum of Understanding (MOU) with Global Institute of Stem Cell Therapy and Research, Inc. ("GIOSTAR") a leading stem cell research institute based in San Diego, California. GIOSTAR has filed for a separate IND application using Vitro Biopharma's umbilical cord mesenchymal stem cell product AlloRx Stem Cells in a clinical trial to treat COVID-19 patients. GIOSTAR has already obtained emergency use authorization under expanded access provisions from the FDA for severe COVID-19 hospitalized patients using AlloRx Stem Cells.

Vitro continues to seek FDA authorization of its pending IND. As the approval process proceeds, Vitro will seek AlloRx Stem Cells FDA approval through Phase 2/3 IND filings for other indications such as osteoarthritis while at the same time continuing to supply GIOSTAR AlloRx Stem Cells for treatment of COVID-19 patients in global markets.

The company has delayed the expansion of its laboratory and manufacturing facilities to better reflect the delays in revenue brought on by the pandemic. This new facility is expected to be operating in the second half of 2021. Our present facility has approximately $6M of AlloRx Stem Cell Vitro Biopharma revenue capacity per year. Furthermore, the completion of the 2nd clean room processing facility would expand our potential capacity to approximately 100 Billion AlloRx Stem Cell s a month or approximately $1.7 Million of AlloRx Stem Cell revenue capacity per month. This would give Vitro Biopharma a revenue run rate capacity of $20M a year.

Our increased capacity is rigorously controlled by our Quality Management System, now certified to the ISO9001 Quality Standard and the ISO13485 Medical Device Standard as well. This provides cGMP-compliant manufacturing of the highest quality stem cells/medical devices for clinical trial testing to provide further evidence of safety and efficacy for treatment of a wide variety of indications. Highly regulated cGMP biologics manufacturing within a BLA-compliant facility provides numerous opportunities to the Company to drive strong revenue growth. We are presently focused on our partnerships in the Caribbean with DVC Stem in Grand Cayman Island, InfiniVive MD in the US and emerging opportunities in the The Medical Pavilion of the Bahamas We are actively pursuing other partnership opportunities as well.

We have reformulated with our contract manufacturer to produce STEMulize in large quantity manufacturing runs. STEMulize contains natural substances that activate the body's own stem cells to enhance recovery from injury such as TBI, stroke, MS, PD and other autoimmune, inflammatory and neurological diseases. The STEMulize product will be offered as a private label product to Infinivive MD clinics and is being implemented as supplemental support to clinical treatments now ongoing in the Cayman Islands. Patients report positive benefits fromSTEMulize therapy following stem cell transplants including increased overall energy and enhancement of improved motor function in MS patients. We are currently pursing licensing arrangements with nutraceutical companies that can scale our formulation under their own private label.

The Company's cosmetic stem cell serum private labelled as Infinivive MD is being applied as a topical cosmetic serum in medical spas and plastic surgery offices. Infinivive MD revenue was reduced by the Coronavirus pandemic and as a result, revenues declined by 52% in the current quarter to approximately $50,000 vs $105,000 in the prior comparative quarter in 2019. This revenue has been flat from the prior quarter reflecting the reduced treatments due to the pandemic capacity limitations of various states.

Infinivive MD Cosmetic Serum is revolutionizing the cosmetic industry. Patients are experiencing unparalleled improvements in the appearance of fine lines and wrinkles. This is one of the fastest growing revenue streams for Vitro Biopharma.. We work with a variety of regulatory experts to assist us in the appropriate regulatory pathways.

http://www.jackzamoramd.com http://www.infinivivemd.com

Vitro Biopharma's OEM cosmetic topical serum is being distributed exclusively by Infinivive MD into cosmetic clinics that are providing the topical treatment as a beautification product. To date the company's product is being offered in a number of clinics throughout the United States and soon internationally,; but with the clinics just opening again for business and with limited occupancy rules we do not expect this revenue to recover back to peak levels with growth until the first half of 2021.

The company has brought on Dr. Jack Zamora as its chief medical officer (C.M.O.) and together we have developed a new exosome product, Infinivive MD's Cosmetic Exosome Serum.

Vitro Biopharma Announces Jack Zamora M.D. as it’s Chief Medical Advisor

The product will be distributed by InfiniveMD along with the topical stem cell serum. The product is also used as a topical application for beautification. The product is a compliment to the topical stem cell serum and will provide the customer with a more competitive price point per application depending on the particular clinic. The new Exosome product

is being marketed and sold into the clinics in the first half of 2021. We are jointly working

on a topical Daily Serum. The Exosome market is part of the billion-dollar cosmetic market in the United States. These products will also be sold offshore around the world.

Update on the Clinical Trial of Musculoskeletal Conditions in the Bahamas

This initiative broadens Vitro Biopharma's expansion into highly regulated stem cell trials in collaboration with the Nassau-based Medical Pavilion of the Bahamas (TMPB).

Home

We will now be able to extend stem cell therapy based on our novel, patent-pending AlloRx Stem Cell product to a variety of musculoskeletal conditions. These include OA of any joint, ACL/MCL tear, Achilles tendon rupture, rotator cuff injury, tennis elbow and herniated disc that are highly prevalent and have few disease-modifying options. It is important to note that many stem cell treatments now performed are problematic due to limited potency and failure to meet basic criteria of stem cells. Vitro Biopharma operates a highly regulated, FDA-compliant commercial biologics manufacturing operation for several years and is cGMP compliant, ISO 9001Certified, ISO 13485 Certified, CLIA Certified and FDA registered and BLA-compliant. All manufacturing occurs in a certified sterile clean room with extensive and advanced testing to assure the absence of contamination. Furthermore, in numerous patients treated to date by IV infusion of AlloRx Stem Cells there have been no significant adverse events. The company is partnered with Dr. Conville Brown, MD, MBBS, FACC, FESC, PhD, the founder and CEO of the Medical Pavilion of the Bahamas who is the Principal Investigator of this trial and director of its clinical administration. Dr Brown was instrumental in the establishment of the NSCEC in the Bahamas.

About the Medical Pavilion of the Bahamas: TMPB operates within a 40,000 square foot building as a partnered care specialty medical facility with 10 different centers in various areas including cardiology, cancer, clinical research and kidney disease. One of the centers is the Partners Stem Cell Centre, where the present trial will be conducted. The Partners Stem Cell Centre provides an environment to conduct stem cell research and clinical trials under the model of ''FDA rigor in a Non-FDA Jurisdiction'' TMPB employs 20 medical specialists in various fields. See http://www.tmp-bahamas.com for additional information.

The company has entered into an operating agreement with the Partner's Stem Cell Centre and expects to begin patient enrollment for the clinical trial in QI/QII of 2021 once

the Bahamas opens up without quarantine restrictions.

Due to the Corona virus pandemic the Cayman Islands closed itself and its businesses down for the majority of the quarter and next quarter, the current status is listed as locked down until Oct. 1st 2020. However, our partner reports that customers are staying on the waiting list and will return for their treatments as soon as the island opens back up. There currently is a pending backlog of over 70 patients seeking treatment which exceeds all of the treatments performed in 2019 by over 200%. We expect to see a surge in revenues from this backlog to bring back our revenue stream in the into the first half of 2021.

The Company has 11 patent applications pending in the US and foreign jurisdictions. These patents cover our AlloRx Stem Cell line and various aspects of our STEMulize stem cell activation products and processes as well as specific diagnostic tests of stem cell activity and therapeutic effectiveness. During the quarter, the Company has responded to office actions and continues to vigorously prosecute & expand its patent filings.

Dr. Jim Musick, CEO of Vitro Biopharma, said, "We are pleased to report our activities in fighting the COVID-19 with filings of our eIND, INDs and partnership with GIOSTAR. While we are disappointed in the extraordinary events of the Corona Virus pandemic and its results on our operations, we have taken the time to advance our clinical applications, partnerships and new product development in further preparation for realized growth in 2021 as a result of these activities. In addition, with have started the intense process of organizing the company for audits and fully reporting status with the SEC targeted for January 2021.

We believe our stem cell products are distinctly superior to stem cell treatments offered in the USA. The latter usually involve use of impure products lacking validation as stem cells and containing insufficient numbers of stem cells to achieve therapeutic benefits. These are produced without regulatory oversight and have been known to cause serious adverse effects. Hence the use of highly purified and well characterized stem cells (AlloRx Stem Cells) is needed to provide safety and efficacy in regenerative medicine therapies.

In summary, Vitro Biopharma is advancing as a key player in regenerative medicine with 10+ years' experience in the development and commercialization of stem cell products for research, recognized by a Best in Practice Technology Innovation Leadership award for Stem Cell Tools and Technology and a growing track record of successful translation to therapy. We plan to leverage our proprietary technology platform to the establishment of international Stem Cell Centers of Excellence and regulatory approvals in the US and worldwide.

Vitro Biopharma has supplied major biopharmaceutical firms, elite university laboratories and clinical trials worldwide with its Umbilical Cord Mesenchymal Stem Cells (AlloRx Stem Cells), and it's MSC-Grow Brand of cell culture media along with advanced stem cell diagnostic services. http://www.vitrobiopharma.com"

Sincerely yours,

James R. Musick, PhD.

President, CEO & Chairman of the Board

http://www.vitrobiopharma.com

Forward-Looking Statements

Statements herein regarding financial performance have not yet been reported to the SEC nor reviewed by the Company's auditors. Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain "forward-looking statements". Such forward looking statements are identified by words such as "intends,"

"anticipates," "believes," "expects" and "hopes" and include, without limitation, statements regarding the Company's plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues and related expenditures.

Factors that could cause actual results to differ materially include, among others, acceptability of the Company's products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company's filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements.

Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT:

Dr. James Musick4621 Technology DriveGolden, CO 80403(303) 999-2130 x1www.vitrobiopharma.com

Vitro Diagnostics, Inc.

Quarter Ended July 31st;

Income Statement

Stem Cell Therapies and Treatments

Stem Cell Products

Other Services

Total Revenues

COGS

Gross Profit

SGA Expenses

Office Expenses

Consulting,Accounting,Legal and Banking Fees

Laboratory R&D & Quality Control

Total Operating Expenses

Net Operating Profit (Loss) EBITDA

Non Cash Depreciation and Amortization

Non Cash Stock for Services

Non Cash Interest on Shareholder Debt

Non Cash Interest on Secured Notes Payable

Net Income (Loss)

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant.

Vitro Diagnositics Inc.

Quarter Ended July 31st;

Balance Sheet

ASSETS

Cash

Accounts Receivable

Inventory

Notes Receivable and Prepaids

Current Assets

Fixed Assets

Intangible and other Assets

Total Assets

LIABILITIES

Trade Accounts Payable

Bank Credit Cards

Capital Lease Obligaitons

Current Liabiities

Secured Convertible Notes with discount

Capital Lease Obligations

Shareholder Accrued Comp. Payable

Shareholder Debts Payable

Long Term Liabilities

Total Liabilities

SHAREHOLDERS EQUITY

Series A Convertible Preferred

Common Stock

Paid in Capital

Treasury Stock

Retained Earnings

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Vitro Biopharma 3rd Quarter ended July 31st 2020 Financial Results of Operations - BioSpace

NEW YORK--(BUSINESS WIRE)--Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) (Rocket), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, today announces two presentations at the European Society for Immunodeficiencies (ESID) 2020 Meeting to be held virtually October 14-17, 2020. An oral presentation will provide an update on data from the Phase 1/2 clinical trial of RP-L201 for Leukocyte Adhesion Deficiency-I (LAD-I). An e-poster will highlight preclinical study data on RP-L401 for Infantile Malignant Osteopetrosis (IMO).

Additional presentation details can be found below:

Oral Presentation

Title: A Phase 1/2 Study of Lentiviral-Mediated Ex-Vivo Gene Therapy for Pediatric Patients with Severe Leukocyte Adhesion Deficiency-I (LAD-I): Results from Phase 1 Session Title: TreatmentPresenter: Donald B. Kohn, M.D., Professor of Microbiology, Immunology and Molecular Genetics, Pediatrics (Hematology/Oncology), Molecular and Medical Pharmacology, and member of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at the University of California, Los AngelesSession Date: Friday, October 16, 2020Session Time: 10:45 a.m. 12:01 p.m. CESTLecture Time: 11:45 a.m. CESTLocation: Hall D

This session will be followed by a Q&A from 12:01 p.m. to 12:30 p.m. CEST

E-Poster

Title: Preclinical Efficacy and Safety of EFS.HTCIRG1-LV Supports IMO Gene Therapy Clinical Trial InitiationPresenter: Ilana Moscatelli, Ph.D., Associate Researcher, Division of Molecular Medicine and Gene Therapy, Lund University, Sweden

About Leukocyte Adhesion Deficiency-I

Severe Leukocyte Adhesion Deficiency-I (LAD-I) is a rare, autosomal recessive pediatric disease caused by mutations in the ITGB2 gene encoding for the beta-2 integrin component CD18. CD18 is a key protein that facilitates leukocyte adhesion and extravasation from blood vessels to combat infections. As a result, children with severe LAD-I (less than 2% normal expression) are often affected immediately after birth. During infancy, they suffer from recurrent life-threatening bacterial and fungal infections that respond poorly to antibiotics and require frequent hospitalizations. Children who survive infancy experience recurrent severe infections including pneumonia, gingival ulcers, necrotic skin ulcers, and septicemia. Without a successful bone marrow transplant, mortality in patients with severe LAD-I is 60-75% prior to the age of 2 and survival beyond the age of 5 is uncommon. There is a high unmet medical need for patients with severe LAD-I.

Rockets LAD-I research is made possible by a grant from the California Institute for Regenerative Medicine (Grant Number CLIN2-11480). The contents of this press release are solely the responsibility of Rocket and do not necessarily represent the official views of CIRM or any other Agency of the State of California.

About Infantile Malignant Osteopetrosis

Infantile Malignant Osteopetrosis (IMO) is a rare, severe autosomal recessive disorder caused by mutations in the TCIRG1 gene, which is critical for the process of bone resorption. Mutations in TCIRG1 interfere with the function of osteoclasts, cells which are essential for normal bone remodeling and growth, leading to skeletal malformations, including fractures and cranial deformities which cause neurologic abnormalities including vision and hearing loss. Patients often have endocrine abnormalities and progressive, frequently fatal bone marrow failure. As a result, death is common within the first decade of life. IMO has an estimated incidence of 1 in 200,000. The only treatment option currently available for IMO is an allogenic bone marrow transplant (HSCT), which allows for the restoration of bone resorption by donor-derived osteoclasts which originate from hematopoietic cells. Long-term survival rates are lower in IMO than those associated with HSCT for many other non-malignant hematologic disorders; severe HSCT-related complications are frequent. There is an urgent need for additional treatment options.

RP-L401 was in-licensed from Lund University and Medizinische Hochschule Hannover.

About Rocket Pharmaceuticals, Inc.

Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) (Rocket) is advancing an integrated and sustainable pipeline of genetic therapies that correct the root cause of complex and rare childhood disorders. The companys platform-agnostic approach enables it to design the best therapy for each indication, creating potentially transformative options for patients afflicted with rare genetic diseases. Rocket's clinical programs using lentiviral vector (LVV)-based gene therapy are for the treatment of Fanconi Anemia (FA), a difficult to treat genetic disease that leads to bone marrow failure and potentially cancer, Leukocyte Adhesion Deficiency-I (LAD-I), a severe pediatric genetic disorder that causes recurrent and life-threatening infections which are frequently fatal, Pyruvate Kinase Deficiency (PKD) a rare, monogenic red blood cell disorder resulting in increased red cell destruction and mild to life-threatening anemia and Infantile Malignant Osteopetrosis (IMO), a bone marrow-derived disorder. Rockets first clinical program using adeno-associated virus (AAV)-based gene therapy is for Danon disease, a devastating, pediatric heart failure condition. For more information about Rocket, please visit http://www.rocketpharma.com.

Rocket Cautionary Statement Regarding Forward-Looking Statements

Various statements in this release concerning Rocket's future expectations, plans and prospects, including without limitation, Rocket's expectations regarding its guidance for 2020 in light of COVID-19, the safety, effectiveness and timing of product candidates that Rocket may develop, to treat Fanconi Anemia (FA), Leukocyte Adhesion Deficiency-I (LAD-I), Pyruvate Kinase Deficiency (PKD), Infantile Malignant Osteopetrosis (IMO) and Danon Disease, and the safety, effectiveness and timing of related pre-clinical studies and clinical trials, may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws and are subject to substantial risks, uncertainties and assumptions. You should not place reliance on these forward-looking statements, which often include words such as "believe," "expect," "anticipate," "intend," "plan," "will give," "estimate," "seek," "will," "may," "suggest" or similar terms, variations of such terms or the negative of those terms. Although Rocket believes that the expectations reflected in the forward-looking statements are reasonable, Rocket cannot guarantee such outcomes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Rocket's ability to monitor the impact of COVID-19 on its business operations and take steps to ensure the safety of patients, families and employees, the interest from patients and families for participation in each of Rockets ongoing trials, our expectations regarding when clinical trial sites will resume normal business operations, our expectations regarding the delays and impact of COVID-19 on clinical sites, patient enrollment, trial timelines and data readouts, our expectations regarding our drug supply for our ongoing and anticipated trials, actions of regulatory agencies, which may affect the initiation, timing and progress of pre-clinical studies and clinical trials of its product candidates, Rocket's dependence on third parties for development, manufacture, marketing, sales and distribution of product candidates, the outcome of litigation, and unexpected expenditures, as well as those risks more fully discussed in the section entitled "Risk Factors" in Rocket's Annual Report on Form 10-Q for the quarter ended June 30, 2020, filed August 5, 2020 with the SEC. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and Rocket undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

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Rocket Pharmaceuticals Announces Two Presentations at the European Society for Immunodeficiencies 2020 Meeting - Business Wire

TAMPA, Fla., Sept. 29, 2020 (GLOBE NEWSWIRE) -- H-CYTE, Inc.(OTCQB: HCYT), a developer of regenerative cellular therapeutics, announced today that Robert Greif has been named the companys new chief executive officer.

Robert brings decades of pharmaceutical experience to H-CYTE, having successfully taken more than a dozen products from discovery to commercialization, said Ray Monteleone, H-CYTE board member and chair of the CEO search committee. We believe he possesses the crucial skill sets necessary to oversee the potential transformation of H-CYTE into a leading biotech company, focused on innovation and meaningful patient outcomes.

I am honored to be joining the H-CYTE team to innovate and implement novel growth strategies in our biologics development, said Greif. With a focus on evidence-based medicine, it is my hope for H-CYTE to immediately begin clinical research and development of a diverse pipeline of next-generation regenerative therapeutics to meet the needs of patients with a variety of diseases and chronic health conditions.

Greif joins H-CYTE with a strong track record leading high-growth pharmaceutical and biotech businesses. Most recently, he was Chief Commercial Officer and Business Development Leader at Atox Bio, where he built the North American commercial organization in preparation for the launch of a first-in-class immunomodulator. Prior to that, he led the Commercial Operations of rEVO Biologics, an orphan disease biotechnology company. He has also held a variety of business unit and commercial leadership roles at United Health Group, Boehringer Ingelheim and Sanofi.

Greif joins H-CYTE as CEO and President effective immediately. He replaces William E. Horne, who is stepping down as CEO but will remain on the companys Board of Directors.

We are thrilled to have someone with Roberts background and experience join H-CYTE as our new CEO, especially as we transition to a biotech company, said Horne. I look forward to helping the company as a board member, assisting Robert in his transition, and watching H-CYTE thrive and prosper under his leadership.

About H-CYTE, Inc.H-CYTE is a medical biosciences company focused in the field of regenerative medicine. H-CYTEs mission is to become a leader in next-generation, cellular therapeutics for the treatment of chronic health conditions. For more information about H-CYTE, please visitwww.HCYTE.com.

Safe Harbor StatementCertain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While H-CYTE believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those outlined in H-CYTEs filings with the SEC, including but not limited to Risk Factors relating to its business contained therein. Thus, actual results could be materially different. H-CYTE expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

CONTACTS

H-CYTE Media RelationsSherry Yeamansyeaman@HCYTE.com214-725-4315

H-CYTE Investor RelationsJason AssadJassad@HCYTE.com678-570-6791

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Robert Greif named Chief Executive Officer of H-CYTE - GlobeNewswire

Scientists have created a detailed cellular and molecular map of the healthy human heart to understand how this vital organ functions and to shed light on what goes awry in cardiovascular disease.

The work, published in Nature Sept. 24 was led by investigators at Harvard Medical School, Harvard-affiliated Brigham and Womens Hospital, the Wellcome Sanger Institute, Max Delbrck Center for Molecular Medicine (MDC) in Germany, Imperial College London and their global collaborators.

The team analyzed almost a half million individual cells to build the most extensive cell atlas of the human heart to date. The atlas shows the huge diversity of cells and reveals heart muscle cell types, cardiac protective immune cells and an intricate network of blood vessels. It also predicts how the cells communicate to keep the heart working.

The research is part of the Human Cell Atlas initiative to map every cell type in the human body. The new molecular and cellular knowledge of the heart promises to enable better understanding of heart disease and guide the development of highly individualized treatments.

The work also sets the stage for therapies based on regenerative medicine in the future, the researchers said.

Over a lifetime, the average human heart delivers more than 2 billion life-sustaining beats to the body. In doing so, it helps deliver oxygen and nutrients to cells, tissues and organs and enables the removal of carbon dioxide and waste products. Each day, the heart beats around 100,000 times with a one-way flow through four different chambers, varying speed with rest, exercise and stress. Every beat requires an exquisitely complex but perfect synchronization across various cells in different parts of heart. When this complex coordination goes bad, it can result in cardiovascular disease, the leading cause of death worldwide, killing an estimated 17.9 million people each year.

Detailing the molecular processes inside the cells of a healthy heart is critical to understanding how things go awry in heart disease. Such knowledge can lead to more precise, better treatment strategies for various forms of cardiovascular illness.

Millions of people are undergoing treatments for cardiovascular diseases. Understanding the healthy heart will help us understand interactions between cell types and cell states that can allow lifelong function and how these differ in diseases, said study co-senior author Christine Seidman, professor of medicine in the Blavatnik Institute at Harvard Medical School and a cardiovascular geneticist at Brigham and Womens.

Ultimately, these fundamental insights may suggest specific targets that can lead to individualized therapies in the future, creating personalized medicines for heart disease and improving the effectiveness of treatments for each patient, Seidman said.

This is what researchers set out to do in the new study.

The team studied nearly 500,000 individual cells and cell nuclei from six different regions of the heart obtained from 14 organ donors whose hearts were healthy but unsuitable for transplantation.

Using a combination of single-cell analysis, machine learning and imaging techniques, the team could see exactly which genes were switched on and off in each cell.

The researchers discovered major differences in the cells in different areas of the heart. They also observed that each area of the heart had specific subsets of cells a finding that points to different developmental origins and suggests that these cells would respond differently to treatments.

This project marks the beginning of new understandings into how the heart is built from single cells, many with different cell states, said study co-first author Daniel Reichart, research fellow in genetics at Harvard Medical School. With knowledge of the regional differences throughout the heart, we can begin to consider the effects of age, exercise and disease and help push the field of cardiology toward the era of precision medicine.

This is the first time anyone has looked at the single cells of the human heart at this scale, which has only become possible with large-scale single-cell sequencing, said Norbert Hbner, co-senior author and professor at Max Delbrck Center for Molecular Medicine. This study shows the power of single-cell genomics and international collaboration, he added. Knowledge of the full range of cardiac cells and their gene activity is a fundamental necessity to understand how the heart functions and to start to unravel how it responds to stress and disease.

As part of this study, the researchers also looked at blood vessels running through the heart in unprecedented detail. The atlas showed how the cells in these veins and arteries are adapted to the different pressures and locations and how this could help researchers understand what goes wrong in blood vessels during coronary heart disease.

Our international effort provides an invaluable set of information to the scientific community by illuminating the cellular and molecular details of cardiac cells that work together to pump blood around the body, said co-senior author Michela Noseda of Imperial College, London. We mapped the cardiac cells that can be potentially infected by SARS-CoV-2 and found that specialized cells of the small blood vessels are also virus targets, she said. Our datasets are a goldmine of information to understand subtleties of heart disease.

The researchers also focused on understanding cardiac repair, looking at how the immune cells interact and communicate with other cells in the healthy heart and how this differs from skeletal muscle.

Further research will include investigating whether any heart cells could be induced to repair themselves.

This great collaborative effort is part of the global Human Cell Atlas initiative to create a Google map of the human body, said Sarah Teichmann of the Wellcome Sanger Institute, co-senior author of the study and co-chair of the Human Cell Atlas Organising Committee.

Openly available to researchers worldwide, the Heart Cell Atlas is a fantastic resource, which will lead to new understanding of heart health and disease, new treatments and potentially even finding ways of regenerating damaged heart tissue, she said.

This study was supported by the British Heart Foundation, European Research Council, Federal Ministry of Education and Research of Germany, Deutsches Zentrum fr Herz-Kreislaufforschung e.V., Leducq Fondation, German Research Foundation, Chinese Council Scholarship, the Alexander von Humboldt Foundation, EMBO, Canadian Institutes of Health Research, Heart and Stroke Foundation of Canada, Alberta Innovates, Chan Zuckerberg Initiative, Wellcome Sanger Institute, Wellcome, U.S. National Institutes of Health and Howard Hughes Medical Institute.

Jonathan Seidman, the Henrietta B. and Frederick H. Bugher Foundation Professor of Genetics in the Blavatnik Institute at HMS, is also co-senior author. Monika Litviukov and Carlos Talavera-Lpez of the Sanger Institute and Henrike Maatz of the Max Delbrck Center are co-first authors with David Reichart.

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Map of the human heart could guide treatments - Harvard Gazette

[co-authors: Dan Meckley, Preston Tran, and Heather Hatcher, Ph.D.]

Photo by National Cancer Institute on Unsplash

Innovative technologies are being deployed to address the Western worlds major killer: cancer. Traditionally, cancer treatment has included surgery, chemotherapy, and radiation, but recently, the development of targeted immunotherapies such as monoclonal antibodies and immune checkpoint inhibitors (e.g., PD-1, PD-L1 and CTLA-4 inhibitors) are showing considerable promise in immunooncology.

The fields of immunology and oncology have been linked since the late 19th century, when studies showed that killed and denatured bacteria injected into sites of sarcoma (a tumor that starts in the bone or muscle) resulted in tumor shrinkage. The intersection between immune surveillance and tumor biology has led to broad therapeutic advances, including the search for a cancer vaccine.

Traditional prophylactic vaccines work to prevent disease by preparing the bodys immune system against a pathogenic infection such as influenza or polio. Over the last decade, the US Food and Drug Administration (FDA) has approved prophylactic vaccines that prevent development of cancer by protecting against cancer-causing pathogens such as human papillomavirus (HPV) (GARDASIL 9; Merck Sharp & Dohme Corp., Whitehouse Station, NJ) and hepatitis B virus (HEPLISAV-B; Dynavax Technologies Corp., Emeryville, CA).

A cancer vaccine is a therapeutic vaccine that targets pre-existing tumors in cancer patients who have a fundamentally different immune response relative to that of healthy individuals. Cancer is characterized by an accumulation of genetic alterations, and every tumor has its own unique composition of mutations and novel surface antigens, or neo-antigens, with only a small fraction shared between patients. Not surprisingly, therapeutic vaccines have been challenging to develop; however, tumor neo-antigens present an antigenic target for pharmaceutical companies to design and develop cancer vaccines.

Within the past several years, there has been an explosion in early-stage clinical activity in gene-modified and cell-based immunooncology, which now encompasses about 58% of Phase I trials. The FDAs Center for Biologics Evaluation and Research (CBER) provided sponsors with guidance on Clinical Considerations for Therapeutic Cancer Vaccines (October 2011) to determine optimal dosing, potential biological and clinical activity, and safety profile during early phase clinical trials, as well as endpoint selection in late phase clinical trials to support a subsequent Biologics License Application (BLA) for marketing approval. Many trials have shown potent therapeutic responses in a proportion of patients with late stage cancer, but it has been rare for trials to obtain more than a 510% partial or complete response. However, this limited success has not lessened the enthusiasm for development of potential cancer vaccines. In 2019, there were nearly 700 oncology clinical trials utilizing specific regenerative medicine and advanced therapy technologies to treat leukemia, lymphoma, and cancers of the brain, breast, bladder, cervix, colon, esophagus, ovaries, pancreas and others (ARM 2019 Annual Report, https://alliancerm.org/sector-report/2019-annual-report/). The 2010 FDA approval of the first cancer vaccine (Provenge (sipuleucel-T); Dendreon Corp., Seattle, WA), was supported by clinical trials showing that the vaccine prolongs survival in patients with metastatic, castration-resistant prostate cancer, though the effect was modest. In 2015, the FDA approved a therapeutic cancer vaccine for the treatment of advanced melanoma (IMLYGIC or T-VEC, talimogene laherparepvec; Amgen, Thousand Oaks, CA).

Despite the challenges, each translation of cancer vaccines to the clinical setting has yielded a deeper understanding of the immunologic response produced by cancer.

Several platforms for cancer vaccination are being tested, including peptides, proteins, antigen presenting cells, tumor cells, and viral vectors. Prior clinical trials have shown that cancer vaccines are well tolerated, target tumor neo-antigens and induce antigen cascade. Current trials seek to improve cancer vaccine efficacy either by targeting novel tumor antigens or employing vaccines in combination with other therapeutic approaches. Additionally, provisions in the 21st Century Cures Act have allowed the FDA to use an accelerated approval pathway for cancer vaccines that have been designated as regenerative medicine advanced therapy (RMAT).

Cancer vaccination comprises an array of approaches that seek to generate, amplify, or skew (or a combination thereof) antitumor immunity. Cancer immunotherapy may ultimately establish its position as the fourth pillar of anti-cancer therapy, complementing surgery, chemotherapy, and radiation.

[View source.]

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Cancer Vaccines: The Fourth Pillar of Anti-Cancer Therapy? - JD Supra

DUBLIN--(BUSINESS WIRE)--The "Global Regenerative Medicine Market Analysis & Forecast to 2025; Stem Cells, Tissue Engineering, BioBanking & CAR-T Industries" report has been added to ResearchAndMarkets.com's offering.

This report provides a comprehensive overview of the size of the regenerative medicine market, segmentation of the market (stem cells, tissue engineering and CAR-T therapy), key players and the vast potential of therapies that are in clinical trials. The analysis indicates that the global regenerative medicine market was worth $35 billion in 2019 and will grow to over $124 billion by 2025, with a CAGR of 23.3% between this time frame. This report describes the evolution of such a huge market in 15 chapters supported by over 350 tables and figures in 700 pages.

Key Questions Answered

Key Topics Covered:

1.0 Report Synopsis

2.0 Introduction

3.0 Stem Cells and Clinical Trials

4.0 Stem Cells, Disruptive Technology, Drug Discovery & Toxicity Testing

5.0 Stem Cell Biomarkers

6.0 Manufacturing Stem Cell Products

7.0 Investment & Funding

8.0 Regenerative Medicine Market Analysis & Forecast to 2025

9.0 Stem Cell Market Analysis & Forecast to 2025

10.0 Tissue Engineering Tissue Engineering Market Analysis and Forecast to 2025

11.0 Biobanking Market Analysis

12.0 Global Access & Challenges of the Regenerative Medicine Market

13.0 Cell and CAR T Therapy

14.0 Company Profiles

15.0 SWOT Industry Analysis

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/dfpyeg

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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Global Regenerative Medicine Market Analysis & Forecast to 2025 - ResearchAndMarkets.com - Business Wire

VALENCIA, Calif. & MELBOURNE, Australia--(BUSINESS WIRE)--AVITA Therapeutics, Inc. (NASDAQ: RCEL, ASX:AVH), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, announced today the initiation of the pivotal study assessing the use of the RECELL System to treat stable vitiligo with the enrollment of the first patient at Miami Dermatology and Laser Institute in Miami, FL. The study will evaluate the safety and effectiveness of AVITA Therapeutics RECELL System to repigment skin in patients who have vitiligo that has been stable for at least one year.

The initiation of the vitiligo clinical study is a milestone in advancing AVITA Therapeutics pipeline to leverage the utility and full potential of our innovative RECELL technology platform to address unmet medical needs in dermatological applications, said Dr. Mike Perry, AVITA Therapeutic Chief Executive Officer. Globally, there have been several published case series and pilot randomized clinical trials reporting positive results with the use of RECELL for treating patients with stable vitiligo and repigmenting depigmented skin lesions. We are pleased to initiate this pivotal study as a next step toward offering a treatment option for the millions of Americans who live with vitiligo.

Vitiligo is an autoimmune disease that attacks the epidermis layer of skin resulting in loss of color or pigmentation. This serious skin condition affects up to 2% of the population worldwide, including an estimated 6.5 million Americans.i Vitiligo has a comparable market size & psychosocial impact to other major dermatology diseases including psoriasis (thick, scaly skin) and atopic dermatitis (red, cracked skin). IV-VI Like these diseases, patients with vitiligo may suffer from poor body image along with low self-esteem, leading to an impaired quality of life.ii There is currently no cure for vitiligo, nor a universally accepted method for limiting the spread of the disease. Although many treatments are being used for the management of vitiligo, they are often temporary with a high rate of recurrence.iii

While often considered a cosmetic issue, vitiligo can greatly impact the quality of life of those living with the disease, and treatment options are limited, said Jill Waibel, MD, owner and Medical Director of Miami Dermatology and Laser Institute. We look forward to assessing the safety and efficacy of the RECELL System in restoring skin color in stable vitiligo lesions and potentially offering those who live with vitiligo hope with a new, easy in-office treatment.

The multi-center pivotal study will assess the safety and effectiveness of the RECELL System in treatment of depigmented vitiligo lesions at 24 weeks in patients whose vitiligo is stable, meaning they have not had new vitiligo lesions or lesions that have expanded for at least one year. Clinicians will obtain a small amount of the study participants own healthy skin at the point-of-care to prepare a suspension of Spray-On Skin Cells using the RECELL System that will then be applied to the vitiligo lesion. Additional long-term safety and effectiveness data, including sustained repigmentation of the vitiligo lesion, will be collected over the course of the study.

In parallel with the clinical study, AVITA Therapeutics is partnering with the University of Massachusetts Medical School on a complementary and more scientifically-oriented vitiligo feasibility study.

Of note: Use of the RECELL System in patients undergoing reconstruction of skin defects not associated with a burn injury is limited by the Federal law to investigational use.

Authorized for release by the Chief Executive Officer of AVITA Therapeutics, Inc.

ABOUT AVITA THERAPEUTICS, INC.

AVITA Therapeutics is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Therapeutics patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patients own skin. The medical devices work by preparing a RES REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension comprised of the patients skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.

AVITA Therapeutics first U.S. product, the RECELL System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin Cells using a small amount of a patients own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 8,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings and precautions.

In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe.

To learn more, visit http://www.avitamedical.com.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This letter includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as anticipate, expect, intend, could, may, will, believe, estimate, look forward, forecast, goal, target, project, continue, outlook, guidance, future, other words of similar meaning and the use of future dates. Forward-looking statements in this letter include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward- looking statement contained in this letter is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the companys control. Investors should not place considerable reliance on the forward-looking statements contained in this letter. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this letter speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements.

PR20200914

i Advances in Vitiligo: An Update on Medical and Surgical Treatments. A. Dillon, et al. J Clin Aesth Derm. 2017ii Willingness-to-pay and quality of life in patients with vitiligo. Radtke, et al. BJD. 2009iii Vitiligo Research Foundation Treatment Guidelines. https://vrfoundation.org/treatment_guidelines Accessed 4/18/20 V The burden of vitiligo: Patient characteristics associated with quality of life. Homan, et al. JAAD. 2009VI Comparison of the Psychological Impacts of Asymptomatic and Symptomatic Cutaneous Diseases: Vitiligo and Atopic Dermtitis. Noh, et al. Annals of Derm. 2013

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First Patient Enrolled in AVITA Therapeutic's Pivotal Study Evaluating the RECELL System for Repigmentation of Stable Vitiligo - Business Wire

ARLINGTON, Va. & REYKJAVIK, Iceland--(BUSINESS WIRE)--Kerecis, the company pioneering the use of fish skin and fatty acids for tissue regeneration and protection, is donating its Kerecis Omega3 Burn product for burn victims of the fires in California, Oregon and Washington. Qualified medical personnel wanting to take advantage of this offer should contact wildfires@kerecis.com.

These horrific fires are having a devastating effect on human lives and habitat, said G. Fertram Sigurjonsson, founder and CEO of Kerecis. We want to help those who have been burned to heal as quickly and easily as possible. We encourage medical professionals to contact us to get a supply of Kerecis Omega3 Burn for their patients.

About Kerecis Omega3 Burn

Kerecis Omega3 Burn is intact fish skin that, when grafted onto damaged human tissue, recruits the bodys own cells and ultimately is converted into living tissue. Because no disease-transfer risk exists between cold-water fish and humans, the Kerecis fish skin is only gently processed and retains its similarity to human skin, making it an ideal skin substitute. The fish skin contains Omega3 fatty acids and multiple proteins that help the product to become incorporated into the body quickly, while providing a much-needed bacterial barrier to protect the wound bed. Clinical studies have found that the Kerecis products heal wounds faster than competitive products, so patients can be ready for additional tissue building and/or move directly to split-thickness skin grafting in record time. Kerecis Omega3 Burn is available for the treatment of humans as well as for animals.

About Kerecis

Kerecis is pioneering the use of fish skin and fatty acids in the globally expanding cellular- therapy and regenerative-medicine market. The Kerecis fatty-acid-rich intact fish skin protects the bodys tissues and enables the body to regenerate tissues. The Kerecis sprayable fatty-acid topical and oral formulations protect the body from bacterial and viral infections.

The Kerecis products, which are based on fish skin and fatty acids, are currently being used to regenerate tissue in diabetic and trauma wounds (including burns), and for infection control. Kerecis is also developing products for areas such as oral surgery, plastic surgery and neurological applications.

The companys mission is to extend human life by supporting the bodys own ability to regenerate, and its vision is to become the world leader in tissue regeneration by sustainably harnessing natures own remedies. For more information, visit http://www.kerecis.com

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Kerecis to Donate its FDA-Approved Fish Skin Treatment for Burn Victims of West Coast Fires - Business Wire

TOKYO--(BUSINESS WIRE)--SanBio Co., Ltd. (headquarters: Chuo-ku, Tokyo, Representative Director and President: Keita Mori, hereafter SanBio) hereby announces that it has obtained new analytical results from the Phase 2b clinical trial (the trial) of SB623 for the treatment of chronic motor deficit resulting from ischemic stroke the SanBio Group (SanBio Co., Ltd. and its subsidiary SanBio, Inc.) conducted in the US. It also announces that based on the newly obtained results, it has updated its development plans, including in regard to late-stage clinical trials for the ischemic stroke and hemorrhagic stroke programs of SB623 in Japan.

The trial evaluated efficacy and safety of SB623 in 163 patients suffering from chronic motor dysfunction from ischemic stroke. On January 29, 2019, SanBio announced that the trial did not meet its primary endpoint, as it failed to demonstrate statistical significance in the difference in the proportion of patients whose Fugl-Meyer Motor Scale (FMMS) score improved by 10 or more points from the baseline (primary endpoint) between the treatment group that received SB623 and the control group. Since then, the SanBio Group had continued to work on additional analysis of the trial data, and results of the additional analysis are as follows.

In conducting the additional analysis, from the perspective of minimal clinically important difference (MCID, or the minimal change in scores or other metrics that could be interpreted to mean the change in a patient is clinically meaningful) and based on the results of the Phase 2 clinical trial of SB623 for the treatment of chronic motor deficit from traumatic brain injury (TBI; STEMTRA trial), the company reevaluated trial data using composite FMMS. Of the total 163 patients enrolled in the trial, the company specifically looked at 77 patients who had infarct areas smaller than a certain size (47% of all patients enrolled in this trial). The SanBio Group evaluated the proportion of patients that met one or more of the following FMMS score improvement criteria 24 weeks after treatment: 6-point improvement on FMMS score for upper extremity, 4-point improvement on FMMS score for lower extremity, and 9-point improvement on FMMS total score (all from the baseline). Of the 51 patients in the treatment group that received SB623, improvement was seen in 49%, versus in 19% of 26 patients in the control group that received sham surgery, the difference between the two groups being statistically significant (p-value of 0.02). SanBio Group thinks that even compared to the primary endpointthe proportion of patients whose FMMS score improved by 10 or more points over the baseline six months after treatmentthe endpoint using composite FMMS can adequately explain clinical significance of the treatment efficacy. Details of the additional analysis results will be announced at the financial results briefing for institutional investors and the media held on September 15, 2020. The briefing video will be made available to the public on our website on the 16th of September or thereafter.

Based on the above results, the SanBio Group has begun preparations for the next late-stage clinical trials in the ischemic stroke and hemorrhagic stroke programs of SB623. 2021. Specific designs of the clinical trials and the contents of development for those two programs will be announced promptly upon being finalized. To maximize the value of SB623 at an early stage by selecting areas to focus the Groups management resources on, the SanBio Group plans to prioritize the development of the ischemic stroke and hemorrhagic stroke programs in Japan at the same time as it prepares to file for approval of SB623 for the treatment of chronic motor deficit resulting from TBI in Japan by the end of the current fiscal year (ending January 2021). The Group, however, postponed the global Phase 3 clinical trial for the TBI program of SB623 it had planned to commence this fiscal year to the next or subsequent fiscal years.

Many patients suffering from the chronic effects of ischemic stroke are said to be regularly taking drugs to prevent recurrence. However, because there is no drug that can fundamentally cure motor dysfunction, there is high unmet need for therapeutic drugs to restore motor functions for patients in the chronic phase of stroke. The SanBio Group aims to contribute to improving the lives of these patients, as well as of their family members, suffering from motor impairment and difficulties it causes in carrying out their daily lives through SB623.

About SB623

SB623 is an allogeneic mesenchymal stem cell produced by modifying and culturing bone marrow derived from healthy donors. Implantation of SB623 cells into nerve tissues is expected to promote regeneration of damaged nerve cells. Because SB623 is made from allogeneic cells, large-scale production is possible and there is no need for complex cell processing required for treatments using autologous cells, e.g., cell preparation for each patient at medical institutions. Hence, pharmaceutical products made from allogeneic cells, such as SB623, can be provided to many patients in uniform quality.

About SanBio Co., Ltd. and SanBio, Inc.

SanBio Group is engaged in the regenerative cell medicine business, spanning research, development, manufacture, and sales of regenerative cell medicines. The Companys propriety regenerative cell medicine product, SB623, is currently being investigated for the treatment of several conditions including chronic neurological motor deficit resulting from traumatic brain injury and ischemic stroke. The Company is headquartered in Tokyo, Japan and Mountain View, California, and additional information about SanBio Group is available at https://sanbio.com.

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Additional Analytical Results of the US-Based Phase 2b Clinical Trial of Regenerative Cell Medicine SB623 for the Treatment of Chronic Motor Deficit...

VANCOUVER, B.C., Sept. 14, 2020 /PRNewswire/ -- The Global Femtech Marketis expected to reach USD 60.01 Billion by 2027, according to a new report by Emergen Research. Demand for the femtech industry is motivated mainly by the growing burden of both chronic and infectious diseases among the world's female population. An increase in the number of health problems relating to women would stimulate competition for technologically innovative healthcare solutions. Growing women's emphasis on reproductive health and sexual empowerment in developing economies would further encourage development in the industry.

Increasing awareness among women of the detection and management of early illness as part of the patient care program would improve the market outlook. Various efforts by government and other agencies in developing countries to raise awareness of women's health would accelerate the development of the industry. Furthermore, an increasing tendency towards daily preventive care check-ups, as well as the advancement of user-friendly technology to track individual health problems, may prove beneficial to the developments in the women's health industry.

While more and more people today choose to be more transparent about their health concerns and treatment, in some of the lesser developed regions, women's health issues remain stigmatized. For these places, Femtech applications are likely to be favored because the scanning is less invasive and more secure. Increasing population growth is related to being one of the main factors behind the case.

Request free sample of this research report at: https://www.emergenresearch.com/request-sample/37

Key Highlights From The Report

Read more at: https://www.emergenresearch.com/industry-report/femtech-market

For the purpose of this report, Emergen Research has segmented into the Global Femtech Market on the basis of type, end-use, application, and region:

Type Outlook (Revenue: USD Billion; 2017-2027)

End Use Outlook (Revenue: USD Billion; 2017-2027)

Application Outlook (Revenue: USD Billion; 2017-2027)

Regional Outlook (Revenue, USD Billion; 2017-2027)

Find more research reports on healthcare and pharmaceuticals industry, by Emergen Research:

Regenerative Medicine MarketRegenerative Medicine Market By Product (Tools, Therapeutics), By Therapeutic Category (Musculoskeletal, Dermatology, Immunology & Inflammation, Cardiovascular), and By Applications (Wound Care, Musculoskeletal Disorders, Ocular Disorders), Forecasts to 2027

Next-Generation Sequencing MarketNext-Generation Sequencing Market by Technology (Whole Exome, Whole Genome, Others), By Workflow (Sequencing, Pre-Sequencing, Others), By Application (Consumer Genomics, HLA Typing, Others) and By End-Use (Academic, Clinical, Others), Forecasts to 2027

RFID in Healthcare MarketBy Product (Tags, Systems & Software) and By Application (Asset Tracking, Patient Tracking, Pharmaceutical Tracking, Blood Tracking, Others), Forecasts to 2027

Non-Invasive Prenatal Testing MarketBy Method, By End-Use, By Application, By Region, Forecasts to 2017-2027

Viral Vector and Plasmid Manufacturing MarketBy Vector Type (Retrovirus, Adenovirus, Others), By Workflow (Upstream, Downstream), By Disease (Cancer, Genetic Disorders, Others), By Application (Gene Therapy, Retailers) and By End-User, Forecasts to 2027

Interoperability Solutions in Healthcare MarketBy Level (Foundational, Structural, Semantic), By Product Type (Services, Solutions), and By Application (Diagnostics, Treatments, Others), Forecasts to 2027

About Emergen Research

At Emergen Research, we believe in advancing with technology. We are a growing market research and strategy consulting company with an exhaustive knowledge base of cutting-edge and potentially market-disrupting technologies that are predicted to become more prevalent in the coming decade.

With market-leading insights and an in-depth understanding of leading and niche technologies, our solutions address the most pertinent questions for your business needs. A major technological shift has been witnessed towards creating a 'Circular Economy,' fuelled by factors, such as the increased adoption of bio-based materials, along with other methods for achieving carbon neutrality. We are conversant in technologies, viz., Artificial Intelligence (AI), Augmented Reality (AR), Virtual Reality (VR), Robotic Process Automation (RPA), Smart Manufacturing, Internet of Things (IoT), Big Data Analytics, Machine learning, Nanotechnology, Edge Computing, Blockchain Technology, Cloud Computing, Vehicle Electrification, Advanced Maintenance Analytics, and Predictive Maintenance, among other prevalent and emergent technologies.

Contact Us:Eric LeeCorporate Sales SpecialistEmergen Research | Web: https://www.emergenresearch.comE-mail: [emailprotected]

Read full Press Release at :https://www.emergenresearch.com/press-release/global-femtech-market

SOURCE Emergen Research

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Femtech Market to Reach USD 60.01 Billion By 2027 | CAGR of 15.6%: Emergen Research - PRNewswire

"On behalf of our entire board of directors, we wholeheartedly welcome Terry to his new role as President and CEO of Vizgen," said Dr. David R. Walt, Cofounder of Vizgen; Hansjrg Wyss Professor of Biologically Inspired Engineering, Harvard Medical School; Professor of Pathology, Brigham and Women's Hospital; Core Faculty, Wyss Institute for Bioinspired Engineering, Harvard University; HHMI Professor. "Terry's technical savvy combined with his demonstrated business acumen in building out product and service offerings on a global scale will benefit Vizgen as the Company enters the next phase of commercial development."

Prior to joiningVizgen, Terry was President of Akoya Biosciences, a post he assumed after an acquisition from PerkinElmer where he served as General Manager, Quantitative Pathology Solutions. Previously, he held several executive positions at global biopharma and diagnostic companies including Roche, Hologic, and Bristol-Myers Squibb, and has extensive experience in launching innovative technologies in new markets. He holds an MBA from the University of Chicago Booth School of Business, an MS in Microbiology from Virginia Tech, and dual BS degrees in Molecular Genetics and Psychology from The Ohio State University.

"I'm excited to take the helm at Vizgen to work together with an incredibly talented team of scientists and innovators to bring an unsurpassed spatial profiling technology to market," said Mr. Lo. "Gene expression with spatial context has now become the new research frontier in unlocking core biological questions, and Vizgen's technology is regarded as a premier solution to gain insight into the molecular underpinnings of health, the progression to disease, and the development of new therapies and vaccines."

Vizgen's MERFISHtechnology was developed in the laboratory of Dr. Xiaowei Zhuang, a Howard Hughes Medical Institute Investigator and David B. Arnold, Jr. Professor of Science at Harvard University. Dr. Zhuang and Dr. Jeffrey Moffitt, a former postdoctoral fellow in Dr. Zhuang's lab andnow an Assistant Professor at the Program in Cellular and Molecular Medicine at Boston Children's Hospital and the Department of Microbiology at Harvard Medical School, are also cofounders of Vizgen. MERFISH enables spatially resolved, single-cell genomic profiling at extremely high levels of throughput and accuracy. The novel technology is used as a tool for several Human Cell Atlasprojects and was named a "Technology to Watch" by Nature for mapping the transcriptome.

Vizgen launched in January 2020 with a $14M Series A Financing led by ARCH Venture Partners and Northpond Ventures. Last month the Company announced an early release program for its spatial genomics platformto provide scientific investigators an opportunity to gain access to the proprietary technology to accelerate their research. Vizgen's technology is already being employed by world-leading academic research institutions including the Broad Institute of MIT and Harvard and The Rockefeller University.

For more information email: [emailprotected]

About Vizgen Vizgen is developing the next generation of spatially resolved genomic profiling tools that enable researchers to gain new insight into the biological systems that underlie human health and disease. The company's patented MERFISH technology enables massively multiplexed, genome-scale nucleic acid imaging with high accuracy and unrivaled detection efficiency at subcellular resolution. MERFISH provides transformative insight into a wide range of tissue-scale basic research and translational medicine in oncology, immunology, neuroscience, infectious disease, developmental biology, and regenerative medicine. For more information, go towww.vizgen.com, connect on social media

@Twitter,@LinkedInandFacebook, and join the MERFISH Group at: https://bit.ly/merfishgroup.

SOURCE Vizgen

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Vizgen Taps Akoya Biosciences Executive Terry Lo As New President and CEO - PRNewswire

Silence Therapeutics Appoints Mark Rothera as President and Chief Executive Officer

Experienced biotech executive to lead the next phase of growth

14 September 2020

LONDON, Silence Therapeutics plc, AIM:SLN and Nasdaq: SLN (Silence or the Company), a leader in the discovery, development and delivery of novel short interfering ribonucleic acid (siRNA) therapeutics for the treatment of diseases with significant unmet medical need, today announces the appointment of Mark Rothera as President and Chief Executive Officer (CEO) and Board member, effective immediately. Iain Ross, who has been Executive Chairman since December 2019, has today assumed his previous position of Non-Executive Chairman.

Mr. Rothera brings more than 30 years of experience in the biopharmaceutical industry, with a strong record of commercial and operational leadership, including driving the successful build of multiple biotech companies, predominantly in the field of rare or specialty diseases. Prior to joining Silence, Mr. Rothera served as CEO of Orchard Therapeutics (Orchard), where he oversaw its transformation from a small U.K.-based, privately held company with two clinical-stage programmes into a leading gene therapy company with seven clinical-stage programmes and fully integrated capabilities. Under his leadership, Orchard completed an initial public offering of American Depositary Shares on the Nasdaq Global Market and during his tenure that company secured more than $600 million in financing and grew from a market capitalization of $250 million to more than $1.7 billion at its peak.

Prior to Orchard, Mr. Rothera served as Chief Commercial Officer of PTC Therapeutics (PTC), where he helped transition that company from a privately held R&D biotechnology company to a publicly traded, commercial-stage company with a global footprint, including the successful launch of two rare disease therapies. He also previously served as Global President of Aegerion Pharmaceuticals Inc. and Vice President and General Manager of commercial operations at Shire Human Genetic Therapies for Europe, Middle East and Africa. Mr. Rothera received an M.A. in Natural Sciences from Cambridge University and an M.B.A. from the European Institute for Business Administration (INSEAD).

Based out of Silences New York City office, Mr. Rothera will lead the continued global expansion of the Company. His appointment follows the completion of Silences Nasdaq listing on 8 September 2020 and aligns with the strategy of increasing the Companys presence in the United States.

Iain Ross, Chairman of Silence Therapeutics plc, said: "On behalf of the Silence Board and the entire Silence team, I welcome Mark to the Company. Following a thorough search, Marks appointment reflects his proven leadership skills and strong track record in growing successful biotechnology companies and building shareholder value. I believe he will now provide the leadership necessary to grow Silence into a leading international biotechnology company built upon our innovative siRNA technology platform, proprietary product pipeline and validating industry partnerships.

On a personal note, and on behalf of the Board, I would like to thank the management team and staff at Silence for their support, hard work and tremendous resilience during the current COVID-19 pandemic and over the past nine months whilst I have been Executive Chairman. The Company has made great strides during this period, and is now in a strong position, both operationally and financially, and ready for Mark to take the helm.

Mark Rothera, President and CEO of Silence Therapeutics plc, added: It is an honour to take the role of leading Silence at this time in the Companys history. I believe the Company is poised to capitalise on its important siRNA technology platform, pipeline and research capabilities built over 18 years, and position itself as a leader in the RNAi field. The Company has made great strides under Iains leadership and I look forward to working with the Board, the management team and Silence employees to build upon this momentum.

Director disclosures

The following information is being disclosed pursuantto Rule 17 and paragraph (g) of Schedule 2 of the AIM Rules for Companies.

Mark Rothera

Full name and age: Mark Andrew Rothera (aged 58)

Current Directorships or Partnerships:Genpharm

Previous Directorships or Partnerships in the last 5 years:Orchard Therapeutics plcPTC Therapeutics International LimitedAlliance for Regenerative Medicine

No further information in connection with his appointment is required to be disclosed under Schedule Two, paragraph (g) of the AIM Rules for Companies.

Enquiries:

About Silence TherapeuticsSilence Therapeutics is developing a new generation of medicines by harnessing the bodys natural mechanism of RNA interference, or RNAi, to inhibit the expression of specific target genes thought to play a role in the pathology of diseases with significant unmet medical need. Silences proprietary technology can be used to engineer short interfering ribonucleic acids (siRNAs) that bind specifically to and silence, through the RNAi pathway, almost any gene in the human genome to which siRNA can be delivered. Silences wholly owned product candidates include SLN360 designed to address the high and prevalent unmet medical need in reducing cardiovascular risk in people born with high levels of Lipoprotein(a) and SLN124 to address beta-thalassemia and myelodysplastic syndrome. Silence is also developing SLN500 in partnership with Mallinckrodt Pharmaceuticals to reduce the expression of the C3 protein for the treatment of complement pathway-mediated diseases. Silence maintains ongoing research and collaborations with AstraZeneca, Mallinckrodt Pharmaceuticals and Takeda. For more information, please visit: https://www.silence-therapeutics.com/

The person who arranged for the release of this announcement on behalf of the Company was Rob Quinn, Chief Financial Officer.

Forward-Looking StatementsCertain statements made in this announcement are forward-looking statements, including with respect to the Companys clinical and commercial prospects. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

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Silence Therapeutics Appoints Mark Rothera as President and Chief Executive Officer - GlobeNewswire

Daniel Dennett has inspired many people, but perhaps none more than his former student Jeff Stibel, A95, an entrepreneur and brain scientist. Now Stibel is ensuring that the influential philosophers legacy will continue at Tufts, with a generous gift to create a consortium at the university focused on cognitive and brain science.

Stibels gift will launch the Stibel Dennett Consortium for Brain and Cognitive Science, which will bring together important research and teaching in the field. The consortium will cross university departments and schools, including psychology, biology, philosophy, education, engineering, and medicine, and will serve students, faculty, alumni, and the wider community.

I was inspired to create a new consortium at Tufts that will serve as a center of gravity, to explore important and groundbreaking cognitive and brain science issues through teaching and research, said Stibel, who is the author of two books and a USA Today column on the workings of the mind.

With his fellow partners Stibel has also given to the university BrainGate, Inc., a company that holds intellectual property enabling technologies to read and translate brain signals through a computer interface. The brain's motor cortex sends out electrical pulses that can be recorded by this technology and decoded into motor commands. In the future, the companys technology could help people with spinal injuries or locked-in syndrome control devices, such as a robotic arm or an exoskeleton that would allow a paralyzed person to walk.

The donation of BrainGate, Inc., combined with Stibels support for faculty, promises to spur new research at the university. Stibels gift includes funds to endow two professorships in the School of Arts and Sciences. Gina Kuperberg has been appointed the inaugural Dennett Stibel Professor of Cognitive Science, and Stephanie Badde has been recruited to the faculty as the Stibel Family Assistant Professor of Brain and Cognitive Science.

Kuperberg and Badde plan to build upon the BrainGate technology, exploring a deeper understanding of how the brain processes language as well as how the brain gathers information from our senses and tells our body how to move. Other faculty at Tufts also plan to explore research opportunities related to the BrainGate intellectual property.

What Jeff Stibel has given us is priceless, said James Glaser, dean of the School of Arts and Sciences. The two professorships have enabled us to recognize the excellence of Gina Kuperberg, an important cognitive science faculty member, and to recruit a talented new colleague to the program. And the gift of BrainGate, Inc., will help solidify Tufts international reputation as a locus of excellence in cognitive science.

In just one of its potential applications, the Stibel gift may lead to a deeper understanding of the very nature of human memory, said Michael Levin, A92, the Vannevar Bush Professor of Biology and director of the Allen Discovery Center at Tufts . Levin studies regenerative biologythe process of replacing or "regenerating" human or animal cells, tissues, or organs to restore or establish normal function.

Advances in regenerative medicine depend on understanding electrical anatomical memory, which is like memory in the brain. BrainGates technology could offer key insights into how cells communicate to signal growth, adaptation to trauma, or even the storage of memories.

Using the technology to interpret the communication between cells, we could find out how memories are stored and encoded in tissue, and learn to decode them, Levin said. We also could learn how memories can survive remodeling of the tissue, how memories can be moved or copied, and how memories can belong to a unified self. Levin is currently collaborating with Dennett on research and a publication related to cellular memory and cognition

Tufts will launch the Stibel Dennett Consortium in the fall, through an online event for the Tufts community with other programming to follow.

Angela Nelson can be reached at angela.nelson@tufts.edu.

Stephanie Badde, Stibel Family Assistant Professor of Brain and Cognitive Science: We think our senses give us a good impression of the physical reality around us, but that's just not true. The information were getting is actually very spottyit's as if were wearing blurry glasses with a small hole in the middle. The brain performs a lot of work to take in this input and give us the impression we have. My research asks, How does the brain do this miracle?

With the BrainGate patents, we hope to find out more about how movements and sensory information are connected in the brain, and how this might be leveraged so that people can regain the sense of touch and sense of body posture where theyve lost them.

Gina Kuperberg, Dennett Stibel Professor of Cognitive Science: We take it for granted that as we talk to one another, we are literally transferring thoughts from one mind to another. Language is what enables humans to communicate, and ultimately, language is a code. My research program is aimed at understanding this code. We're trying to figure out not only where, when, and how the brain uses language to communicate, but also the nature of the neural code itself.

The whole idea of decoding brain activity is so important, not only medically for people in the future, but for understanding the nature of the human brain and thought. And were really on the cutting edge of being able to do that, particularly now with the BrainGate intellectual property.

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Getting Smarter About the Mind | Tufts Now - Tufts Now

8/24, StemoniX Inc.-Cancer Genetics Inc." Cancer Genetics and StemoniX have launched a joint proof-of-concept program to assess central nervous system (CNS) safety and toxicity of novel compounds.

8/25, Altivon LP-ConvergeOne: ConvergeOne, an IT-services provider of collaboration and digital infrastructure solutions, has acquired Altivon, a contact center solutions provider.

8/25, Emerson Resources Inc.-Pace Analytical Services: Pace Analytical Services has acquired Emerson Resources, a pharmaceutical contract development and manufacturing organization specializing in dosage form development and clinical trial material manufacturing.

8/26, Reardon Office Equipment-Loffler Cos. Inc.: Loffler Cos. has acquired Reardon Office Equipment to expand its market in North Dakota and northern Minnesota.

8/27, Collagen Solutions PLC-Rosens Diversified Inc.: Rosens Diversified, a food-production, agrochemical and distribution company, will acquire Collagen Solutions, a developer of medical-grade collagen, tissues and related devices and components for use in regenerative medicine, tissue engineering and research.

8/27, Open Systems International-Emerson Electric Co.: Emerson Electric will acquire Open Systems International, an operations technology software provider, for $1.6 billion.

8/28, Bluestem Brands Inc.-BLST Operating Co. LLC: BLST Operating Co., a privately held multibrand e-retailer, has acquired multibrand e-retailer Bluestem Brands.

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Minnesota mergers and acquisitions - Minneapolis Star Tribune

Rheumatoid Arthritis Stem Cell Therapy Market: Outlook

Regenerative medicine has made extensive advancements over the years to cure the populace of certain disorders or diseases. Stem cell therapy is a category of regenerative medicine that has gained considerable traction over the years as an efficient treatment option for a plethora of disorders including rheumatoid arthritis. Therefore, the global rheumatoid arthritis stem cell therapy market will bank on the efficacy of bringing rheumatoid arthritis in control across the forecast period of 2020-2030.

Based on treatment type, the global rheumatoid arthritis stem cell therapy market can be classified into bone marrow transplant, Allogeneic Mesenchymal stem cells, and adipose tissue stem cells. On the basis of the distribution channel, the rheumatoid arthritis stem cell therapy market can be segmented into ambulatory surgical centers, specialty clinics, and hospitals.

Request a sampleto get extensive insights into the Rheumatoid Arthritis Stem Cell Therapy Market

This upcoming research report by Transparency Market Research on the rheumatoid arthritis stem cell therapy market enlightens the stakeholder about numerous aspects such as competitive landscape, geographical analysis, current and upcoming trends, and others. The report also sheds light on the pain points and helps the stakeholder in preparing efficient business strategies to overcome them.

The report also covers the changing dynamics of growth across the rheumatoid arthritis stem cell therapy market due to the novel coronavirus outbreak. The researchers have analyzed every small aspect of the COVID-19 impact and then added them in the report.

To understand how our report can bring difference to your business strategy,Ask for a brochure

Rheumatoid Arthritis Stem Cell Therapy Market: Competitive Landscape

The rheumatoid arthritis stem cell therapy market can be categorized as highly fragmented due to the presence of numerous players competing for the top position. Research and development activities form an important part to discover novel insights across varied rheumatoid arthritis stem cell therapy mechanisms.

Some well-established participants in the rheumatoid arthritis stem cell therapy market are International Stem Cell Corporation, Mesoblast Ltd., Regeneus Ltd, International Stem Cell Corporation, ReNeuron Group plc, and TiGenix.

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Rheumatoid Arthritis Stem Cell Therapy Market: Growth-Inducing Advantages

Many advantages are attached to the rheumatoid arthritis stem cell therapy market that helps in bringing extensive growth opportunities. Although rheumatoid arthritis stem cell therapy is not a full-proof treatment for curing arthritis, it can reduce inflammation and also aid in the stabilization of the immune system. In addition, the rheumatoid arthritis stem cell therapy has also shown long-term efficacy in overcoming inflammation caused due to arthritis. Government support is also proving to be a major growth factor for the rheumatoid arthritis stem cell therapy market.

Furthermore, research has also highlighted the improvement in sleep, diet, and physical strength among the patients after cell therapy.

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Rheumatoid Arthritis Stem Cell Therapy Market: Key Findings

The research and development activities in the rheumatoid arthritis stem cell therapy market are always in full swing and are involved in exploring novel findings that help in increasing the graph of growth. For instance, scientists recently discovered a new cell, known as PRIME cell that appears in the bloodstream of rheumatoid arthritis patients just before the inflammation begins. Such findings may help the players in the rheumatoid arthritis stem cell therapy market to discover novel mechanisms of rheumatoid arthritis stem cell therapy.

Rheumatoid Arthritis Stem Cell Therapy Market: Geographical Analysis

The rheumatoid arthritis stem cell therapy market can be geographically segmented into North America, Latin America, the Middle East and Africa, Asia Pacific, and Europe. North America may emerge as a champion growth contributor for the rheumatoid arthritis stem cell therapy market during the forecast period of 2020-2030. The presence of numerous key players in the region can serve as a major growth factor.

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Rheumatoid Arthritis Stem Cell Therapy Market Business Opportunities and Growth Challenges Report - The Daily Chronicle

VALENCIA, Calif. & MELBOURNE, Australia--(BUSINESS WIRE)--AVITA Therapeutics, Inc. (NASDAQ: RCEL, ASX:AVH), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, announced today that management will participate in the following upcoming investor conferences.

Authorized for release by the Chief Executive Officer of AVITA Therapeutics, Inc.

ABOUT AVITA THERAPEUTICS, INC.

AVITA Therapeutics is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Therapeutics patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patients own skin. The medical devices work by preparing a RES REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension comprised of the patients skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.

AVITA Therapeutics first U.S. product, the RECELL System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin Cells using a small amount of a patients own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 8,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings and precautions.

In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe.

To learn more, visit http://www.avitamedical.com.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This letter includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as anticipate, expect, intend, could, may, will, believe, estimate, look forward, forecast, goal, target, project, continue, outlook, guidance, future, other words of similar meaning and the use of future dates. Forward-looking statements in this letter include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward- looking statement contained in this letter is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the companys control. Investors should not place considerable reliance on the forward-looking statements contained in this letter. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this letter speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements.

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AVITA Therapeutics to Participate in Upcoming Investor Conferences - Business Wire

MediSpin XL high-volume industrial electrospinning platform for both medical devices and new drug delivery applications

WAALRE, The Netherlands, September 03, 2020 / B3C newswire / -- IME Medical Electrospinning, a global leader in electrospun medical devices and regenerative medicine, today announced it has successfully raised 3 million in equity financing and debt from existing shareholder TIIN Capital, new investors Borski Fund and Lumana Invest, and from Rabobank Region Eindhoven.

In 2019 IME launched the MediSpin XL production platform for large-scale industrial manufacturing of reproducible and scalable electrospun nanofiber-based scaffolds for Class I, II and III medical devices, marking a global breakthrough in the controlled large-scale production of batch-consistent, high-quality end-products in volume. To be able to manage the electrospinning control parameters unlocks its full potential for industrial medical applications.

MediSpin XL creates nanometer solutions that mimic the natural extracellular matrix in the human body. Human cells recognize and infiltrate these scaffolds, encouraging quick and efficient tissue integration, resulting in natural tissue restoration while minimizing medical complications.

The vast array of innovative applications include fully bioresorbable stents, heart valves, nanofibrous meshes and many other new devices for a.o. local drug delivery, implantables and tissue engineering.

Judith Heikoop, Managing Director of IME Medical Electrospinning, says: The additional financing and support of new shareholders Borski Fund, Lumana Invest and existing shareholder TIIN Capital will enable us to further strengthen our MediSpin XL electropinning platform and industrial production capabilities for medical devices and drug delivery applications. Combining our state of the art production platform with our broadened focus, underpins our strong belief in the strategic goal of becoming the leader in large-scale production of both medical devices and drug delivery solutions. Now we can jointly develop other breakthrough medical solutions with our pharma partners and expand our operations. The support of both our existing and new investors fills me with pride and shows that they recognize the large value-adding component of our game-changing capabilities.

Ramon Solberg, Founder and together with Judith Heikoop, Managing Director of IME Medical Electrospinning, adds: This new successful financing round enables us to further capitalize on our scientific and technical findings over the past decade, growing our product portfolio from regenerative medtech solutions to the even broader and promising global market for targeted drug delivery solutions.

About Medical ElectrospinningApplying specific polymers, IMEs advanced equipment creates fiber-based medical device solutions that mimic the natural human extracellular matrix in nanometer and micrometer format for implants and membranes in the human body. Human cells recognize this artificial matrix (scaffold) as the bodys own facilitating the repair of the damaged tissue for heart valves, blood vessels, nerves, tendons, skin and bone etc. This is in contrast to implants and membranes of traditional structures, which are seen as foreign and therefore can lead to scar tissue or rejection phenomena. The MediSpin XL platform has been developed specifically for MedTech industrial manufacturing of medical devices and is now also suitable for pharmaceutical drug delivery applicaitons and ensures the firm control of the crucial parameters of the electrospinning process, leading to identical and consistent end-products.

About Borski FundDutch Borski Fund believes in diversity, gender equality and fair opportunities. It invests in female entrepreneurs because it wants to build good companies with them, because their talent needs to be better utilized, because Borski Fund is their natural partner, because is has the network that matters to them. Because it is important that innovation is stimulated by female entrepreneurs.

About Lumana InvestDutch Lumana is an investment company founded by entrepreneurs. Lumana Invest stands for committed stakeholdership supporting management in strategic issues. With an investment horizon for an indefinite period, Lumana has a unique investment approach. In addition, the fund managers responsible for entering into and supervising participations are also founders and co-shareholders of Lumana. Lumana prefers to invest in start-ups in new markets and new techniques. Exploring boundaries with management and, if possible, pushing them further. Forward-looking and with the ambition to permanently change the future. "Lumanai" has been freely translated from Samoan meaning future.

About TIIN Capital TIIN Capital is a Naarden, the Netherlands, based fund manager and uses a network of approximately 1.000 angel investors. Entrepreneurship, knowledge of the market, technology (from the network) and capital are of great added value for the investments. As entrepreneurial investors, TIIN Capital accelerates growth-oriented companies with active growth and buy & build strategies, where innovative entrepreneurship is central to be able to take the next step.

About IME Medical ElectrospinningFor over ten years, IME Medical Electrospinning has been a leading player in the field of developing and implementing electrospinning processes and equipment for the manufacturing of medical devices for (regenerative) medicine and drug delivery. Electrospinning is a flexible process for producing extremely thin fibers and structures that have excellent properties to help regenerate human tissue. IME Medical Electrospinning has developed an unique set of innovations in electrospinning technology for the reproducible and scalable production of electrospun material under tightly controlled conditions required for the MedTech and Pharma market. Customers and scientific partners include the MedTech and Pharma industry, scientists and health institutions.

Contacts

IME Medical Electrospinning, Waalre, The NetherlandsJudith Heikoop M.Sc. Ph.D.+31 40 28 27 956This email address is being protected from spambots. You need JavaScript enabled to view it.

For mediaLifeSpring Life Sciences Communication, AmsterdamLon Melens+31 6 538 16 427This email address is being protected from spambots. You need JavaScript enabled to view it.

Keywords: Humans; Nanofibers; Equipment and Supplies; Drug Delivery Systems; Biomimetics; Extracellular Matrix; Capital Financing; Industry; Tissue Engineering; Heart Valves; Drug Delivery Systems; Stents

Published by B3C newswire

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IME Medical Electrospinning Secured 3 Million in New Financing From Dutch VCs Borski Fund, Lumana Invest, TIIN Capital and From Rabobank to Further...