header logo image


Page 15«..10..14151617..2030..»

Archive for the ‘Regenerative Medicine’ Category

A Painless Future Provides the Incentive Behind Cytonics – InvestorPlace

Tuesday, October 6th, 2020

Thanks to the advent of equity crowdfunding, theres never been a better time for retail investors seeking new opportunities. Innovative companies that may not have traditional venture capital backing can now market their solutions to a wider demographic. And thats the case with Cytonics. But its the promising nature of the treatment platform that has many excited about Cytonics stock.

Source: Shutterstock

Cytonics is a biotechnology firm specializing in regenerative medicine for osteoarthritis patients. According to Cytonics SeedInvest.com investor profile, over 27 million people in the U.S. suffer from arthritis-related pain, imposing a $180 billion burden on our health care system and economy.

However, this number is understated, according to the Centers for Disease Control and Prevention, which states that 32.5 million American adults suffer from osteoarthritis. Right there, the case for Cytonics stock theoretically improves by 20%.

Setting that aside, the osteoarthritis profile in this country makes this biotech firm a compelling equity crowdfunding opportunity. For instance, one of the risk factors for this condition is old age. As you know, the U.S. experienced a baby boom following the end of World War II to sometime in the early 1960s. But that increase in baby-making now means we have a massive population of older people.

Logically, this dynamic increases the probabilities of osteoarthritis, presenting a growing case for Cytonics stock. In addition, obesity is a risk factor because according to the CDC, Extra weight puts more stress on joints, particularly weight-bearing joints like the hips and knees.

You only need to go outside to see our national expanding waistline.

Although we can talk all day about the plentiful and still-expanding market size for osteoarthritis solutions, it wont mean a darn thing if the underlying science backing Cytonics stock was lacking. Fortunately, this biotech firm is all about the science.

What separates Cytonics from other therapies is the discovery of alpha-2-macroglobulin (A2M), which may hold the key for many osteoarthritis sufferers because multiple tests confirm this blood serum protein protects cartilage. Further, the presence of A2M may halt the progression of osteoarthritis.

Therefore, the catalyst behind Cytonics stock came from an idea: what if bioengineers can inject A2M at the source of trouble, providing both pain relief and preventative therapy? And thats exactly the concept here. Under a three-step process, Cytonics take blood from patients, run it through a centrifuge to increase the level of platelets, and then reinject the A2M-rich solution to the source of pain.

In this manner, patients can enjoy relief essentially through their own blood. However, the present technology of platelet-rich plasma injections may not produce enough A2M to restore damaged joints. This is where the second catalyst of Cytonics stock comes into play.

The biotech firm is presently developing a synthetic version of A2M called CYT-108. Based on its hypothesis, Cytonics believes that its synthetic version is more effective, perhaps between two to three times more effective than naturally occurring A2M.

Now, this is the key factor that has many excited about the potential of Cytonics stock. If the Food and Drug Administration approves CYT-108, this may be the only therapy that addresses osteoarthritis root cause, perhaps leading to a cure.

What lends credibility for the biotech firm is that its natural A2M therapy has treated over 7,000 people in the U.S., leading to encouraging results.

While the science of osteoarthritis treatments makes this equity crowdfunding opportunity distinct, its not without risks you must consider. As with all private investing ventures, youve got to do your due diligence. Remember, most startups fail this is just a harsh fact.

But experimental biotech firms are probably among the wildest investments. Yes, if a company passes advanced-stage clinical trials, the target security could fly to the moon. But such successes are rare, as evidenced by the wasteland of failed biotechs. In addition, you should keep in mind that for decades, the FDA has approved relatively few drugs/treatments.

To be fair, the platelet-rich plasma therapy which Cytonics technology is based off has few major demerits. Thats according to a 2018 study exploring the pros and cons of regenerative medicine and published by the National Institutes of Health. Still, under certain circumstances, PRP applications can result in injection-site morbidity, infection or injury to nerves or blood vessels. Scar tissue formation and calcification at the injection site have also been reported.

Also, the report notes that patients with compromised immune system or with predisposed diseases are more susceptible to infection at the injured area.

Are these acceptable risks for Cytonics stock? Possibly. Nevertheless, according to a study on platelet-rich plasma therapy for knee disorders, many methods have been utilized to treat osteoarthritis but with limited success. Plus, this report states that variables such as centrifugation prep work can negative the effectiveness of plasma-based regenerative therapies.

Im not trying to dissuade you from Cytonics stock. Rather, Im pointing out that theres a reason why successful therapies havent been found yet: this is a tough condition to address.

Personally, Im a gun shy regarding most biotech plays. There are so many variables involved, each one levering a possible negative impact. And I dont think Cytonics stock is any different in that sense.

However, the underlying science is very compelling. Thus, if you can handle the heat, plenty of justification exists for taking a shot. To learn more about this equity crowdfunding opportunity, please visit Cytonics SeedInvest profile.

On the date of publication, Josh Enomoto did not have (either directly or indirectly) any positions in the securities mentioned in this article.

A former senior business analyst for Sony Electronics, Josh Enomoto has helped broker major contracts with Fortune Global 500 companies. Over the past several years, he has delivered unique, critical insights for the investment markets, as well as various other industries including legal, construction management, and healthcare.

Investing through equity and real estate crowdfunding or asset tokenization requires a high degree of risk tolerance. Despite what individual companies may promise, theres always the chance of losing a portion, or the entirety, of your investment. These risks include:

1) Greater chance of failure2) Risk of fraudulent activity3) Lack of liquidity4) Economic downturns5) Dearth of investor education

Read more:Private Investing Risks

Originally posted here:
A Painless Future Provides the Incentive Behind Cytonics - InvestorPlace

Read More...

Yufan inks deal with Abound to develop antibodies directing CAR T cells against cancer targets – BioWorld Online

Tuesday, October 6th, 2020

HONG KONG Xian, China-based Yufan Biotechnologies Co. Ltd. has partnered with Pittsburgh-based Abound Bio Inc. to discover and develop antibodies directing CAR T cells against cancer targets.

The three-year partnership will see the two companies incorporate antibodies for novel cancer targets into the enhanced, HPK1 (hematopoietic progenitor kinase 1)-inhibited CAR T-cell platform, they said. The agreement covers 10 cancer targets, including difficult to treat solid tumors such as liver cancer, Abounds CEO John Mellors told BioWorld.

Although both companies declined to reveal financial details, Mellors said, I calculate that Yufans technology added to Abounds antibodies gives a value greater than two." Yufan declined to comment for the article, but CEO Yan Zhang said, "The partnership with Abound will improve CAR T-cell products for cancer therapy.

The two companies will also share expertise and any potential commercial upside, as well as inventorship and development rights. Yufan definitely benefits, both financially and non-financially, particularly via development rights in China, Mellors said.

The companies will conduct preclinical, then clinical testing of the new CAR T cells against solid tumors, with trials expected to start in the first or second quarter of 2021, Mellors said. They will target the greater China market initially, with the rest of the world to follow. No other firms have been targeted as future partners yet.

Academic roots

The partnership between Yufan and Abound started with an academic collaboration between the National Cancer Institute and Tsinghua University, based on the work led by the universitys professor of pharmaceutical science, Xuebin Liao, who co-founded Yufan along with Zhang. That work demonstrated that HPK1 promotes T-cell exhaustion through NFkB-Blimp1 activation, and that blocking HPK1, via either gene knockout or small-molecule inhibitors, improves CAR T-cell immunotherapy.

Yufan was founded in July 2016 as part of the Xi'an Hi-tech Industries Development Zone Central Organization Departments Thousand Talents program. It focuses on upstream technology development, services and antibody screening for immuno-oncology therapy. The company is developing CAR T cells with a deleted HKP1 gene to prevent cell exhaustion, with a first-in-human clinical study of the XYF-19 HPK1 knockout CD19 CAR T product currently underway in patients with relapsed or refractory CD19+ leukemia or lymphoma.

Other projects include CAR T-cell therapy, CAR T-cell GMP production, immune cell gene editing CRISPR/Cas9 technology, a phage antibody library, phage display technology, and the buildout of a human antibody screening platform. The company is currently collaborating with the Air Force Military Medical Universitys Xijing Hospital on an investigational CAR T-cell therapy.

Yufan plans to invest 100 million (US$14.72 million) to build manufacturing facilities for CAR T-cell therapies to treat refractory and relapsed leukemia and lymphoma and expects to generate annual sales of between 200 million to 400 million once those candidates reach market.

Across the Pacific, Abound is an early stage biotechnology company developing antibody-based biological therapeutics for cancer and infectious diseases.

One infectious disease that the company is concentrating on is COVID-19, with the number of global cases topping 35 million as of Oct. 5, according to Johns Hopkins University data. An Abound team led by Mellors and the companys chief scientific officer, Dimiter Dimitrov, discovered human monoclonal antibodies with neutralizing activity in the laboratory against SARS-CoV-2, the virus that causes COVID-19, from antibody libraries.

Although the antibodies have proved effective in low doses in mouse and hamsters, human trials have not yet started. However, the antibodies are ready for testing in CAR T cells in preclinical models, and we hope to rapidly progress to clinical studies, Mellors said.

The company is currently proceeding with production and clinical development for regulatory approval and commercialization in the MENA and ASEAN regions, clinching an agreement with Saudi-U.S. joint venture Saudivax earlier in the year.

The Yufan-Abound partnership also aims to tap the lucrative T-cell market, which was valued at $2.7 billion in 2017 and is expected to reach $8.21 billion in 2025, growing at a compounded annual growth rate (CAGR) of 14.9% between 2017 and 2025, according to Frost & Sullivans report Growth Opportunities in the Global Cell Therapy Market, Forecast to 2025.

Amendments in regulatory and reimbursement policies, as well as the implementation of conditional approval policies for regenerative medicine, will further drive the market by expediting product launches, Aarti Chitale, Frost & Sullivan senior research analyst for transformational health, wrote. Additionally, improvements in cell culturing techniques alongside the use of different stem cells such as adipose-derived stem cells, mesenchymal stem cells, and induced pluripotent stem cells will strengthen the market with superior treatment options for non-oncological conditions such as neurological, musculoskeletal, and dermatological conditions, she added.

See original here:
Yufan inks deal with Abound to develop antibodies directing CAR T cells against cancer targets - BioWorld Online

Read More...

Regenerative medicine Market will Register a Significant CAGR During Period 2020-2026 | 23% CAGR| Know the Companies List Could Potentially Benefit or…

Tuesday, October 6th, 2020

The Global Regenerative medicine Market size is projected to reach USD 55.67 Mn by 2026 from USD 13.56 Mn in 2018, at a CAGR of 23% during the forecast period.

AllTheResearch has added Latest Research Report on Regenerative medicine Market 2020 Future Growth Opportunities, Development Trends, and Forecast 2026. The Global Regenerative medicine Market market report cover an overview of the segments and sub-segmentations including the product types, applications, companies & regions. This report describes overall Regenerative medicine Market size by analyzing historical data and future projections.

Get Exclusive Sample Report on Regenerative medicine Market is available at https://www.alltheresearch.com/sample-request/232

Market Segmentation:

The report features unique and relevant factors that are likely to have a significant impact on the Regenerative medicine market during the forecast period. This report also includes the COVID-19 pandemic impact analysis on the Regenerative medicine market. This report includes a detailed and considerable amount of information, which will help new providers in the most comprehensive manner for better understanding. The report elaborates the historical and current trends molding the growth of the Regenerative medicine market

View complete Report, https://www.alltheresearch.com/report/232/Regenerative-medicine

The segmentation of the Regenerative medicine market has been offered on the basis of product type, application, Major Key Players and region. Every segment has been analyzed in detail, and data pertaining to the growth of each segment has been included in the analysis

Top Players Listed in the Regenerative medicine Market Report are

Based on type, report split into

Based on Application Regenerative medicine market is segmented into

Get Chance of 20% Extra Discount, If your Company is Listed in Above Key Players List;https://www.alltheresearch.com/speak-to-analyst/232

Impact of COVID-19: Regenerative medicine Market report analyses the impact of Coronavirus (COVID-19) on the Regenerative medicine industry. Since the COVID-19 virus outbreak in December 2019, the disease has spread to almost 180+ countries around the globe with the World Health Organization declaring it a public health emergency. The global impacts of the coronavirus disease 2019 (COVID-19) are already starting to be felt, and will significantly affect the Regenerative medicine market in 2020

COVID-19 can affect the global economy in 3 main ways: by directly affecting production and demand, by creating supply chain and market disturbance, and by its financial impact on firms and financial markets.

Get the Sample ToC to understand the CORONA Virus/COVID19 impact and be smart in redefining business strategies. https://www.alltheresearch.com/impactC19-request/232

Regenerative medicineMarket: Key Questions Answered in Report

The research study on the Regenerative medicinemarket offers inclusive insights about the growth of the market in the most comprehensible manner for a better understanding of users. Insights offered in the Regenerative medicinemarket report answer some of the most prominent questions that assist the stakeholders in measuring all the emerging possibilities.

FOR ALL YOUR RESEARCH NEEDS, REACH OUT TO US AT:Contact Name: Rohit B.Email:[emailprotected]Phone: 1-888-691-6870

See the article here:
Regenerative medicine Market will Register a Significant CAGR During Period 2020-2026 | 23% CAGR| Know the Companies List Could Potentially Benefit or...

Read More...

Reven Strengthens Its Clinical Team With Three New Members – BioSpace

Tuesday, October 6th, 2020

Oct. 5, 2020 11:30 UTC

GOLDEN, Colo.--(BUSINESS WIRE)-- Reven Holdings, Inc. (Reven) is a privately held clinical stage biotechnology and pharmaceutical company dedicated to the discovery and development of novel treatment platforms for cancer, viral illnessesincluding COVID-19and inflammatory disorders.

Reven is planning to initiate a randomized, double-blind, placebo-controlled, multi-institutional clinical trial of its lead anti-inflammatory/anti-oxidant investigational drug product Rejuveinix (RJX) in the treatment of COVID-19. The upcoming clinical trial is designed to evaluate the safety and efficacy of RJX in COVID-19 patients.

Reven today announced that three new members with extensive experience and knowledge in clinical research and quality assurance have joined its multi-disciplinary team to work on the COVID-19 clinical project:

Nancy Oehlke has assumed the role of Manager of Regulatory Affairs and Quality Assurance. Nancy has 20+ years of experience in drug development, Good Manufacturing Practice (GMP) / Good Laboratory Practice (GLP) compliance, regulatory aspects of drug product manufacturing and testing, and clinical research.

Renae Townsend has assumed the role of Director of Clinical Operations and Jenny Daniels has assumed the role of Director of Clinical Quality Assurance. Both Renae and Jenny have 15+ years of Good Clinical Practice (GCP), clinical research and clinical monitoring experience.

These new team members will help us provide sponsor oversight for the services rendered by the clinical research organizations (CRO) and other vendors who will support our clinical RJX program and execution of the clinical trial. I am excited to welcome these very experienced new members to Reven. I look forward to the opportunity to work side by side with them as we try to diligently advance the clinical development of RJX, said Fatih Uckun, MD PhD, Chief Medical Officer and Chief Scientific Officer of Reven.

Our IND (Investigational New Drug) application package for COVID-19 is completed and we are planning to roll out our clinical program against COVID-19 in the coming month, said Michael Volk, Director and Chief Strategy Officer of Reven.

Our new team members each will have a very important role in our efforts aimed at evaluating the clinical impact potential of RJX, added Peter Lange, CEO of Reven.

About Rejuveinix (RJX) RJX is an intravenous (IV) formulation of a patented first-in-class pharmaceutical composition containing a specific mixture of anti-oxidant and anti-inflammatory ingredients that is being developed for more effective treatment of patients with inflammatory disorders, including COVID-19 patients with viral sepsis and acute respiratory distress syndrome (ARDS). The clinical safety and tolerability of RJX was confirmed in a recently completed double blind, placebo-controlled Phase 1 dose-escalation study in healthy volunteers (ClinicalTrials.gov Identifier: NCT03680105).

About Reven Holdings, Inc. Reven Holdings, Inc., a Delaware corporation, through its Golden/Colorado-based operating company Reven, LLC, is developing new drugs for difficult-to-treat diseases. As a clinical stage biopharmaceutical company, Revens overarching goal is to develop effective treatments for serious health conditions caused by infectious, inflammatory, cardiovascular, and metabolic diseases. Its lead product, RJX, is being developed as a treatment platform against complications of COVID-19, sepsis, cardiovascular diseases, and diabetes.

About Dr. Fatih Uckun, M.D., Ph.D, Chief Medical Officer of Reven. Dr. Uckun is an Active Member of the American Society for Clinical Investigation (ASCI), an honor society for physician-scientists, and an active member of several professional organizations. He earned his doctoral degrees at University of Heidelberg in Germany and completed his residency training in Pediatrics, fellowship training in Hematology/Oncology/Blood and Bone Marrow Stem Cell Transplantation, as well as postdoctoral research training in immunology and microbiology at the University of Minnesota in the US.

Dr. Uckun has more than 30 years of professional experience in developmental therapeutics and biopharmaceuticals in oncology/immuno-oncology as well as infectious diseases and immunology. In addition, Dr. Uckun has deep knowledge and 20+ years of experience in treatment of infectious diseases and their complications. In particular, he has extensive experience in viral, fungal, and bacterial infections of immunocompromised hosts, septic shock, ARDS as well as systemic capillary leak syndrome and cytokine release syndrome (CRS). Dr. Uckun served as a Defense Advanced Research Projects Agency (DARPA)-funded principal investigator and directed a universal virus neutralizer program project as part of a countermeasures initiative against viruses that can be used as bioweapons and therefore pose a biothreat for our national security. Prior to joining Reven, Dr. Uckun was a Vice President, Clinical Strategy Lead, Oncology-Hematology and Member of the COVID-19 Task Force at Worldwide Clinical Trials.

Dr. Uckun worked 11 years as a Professor of Bone Marrow Transplantation, Therapeutic Radiology-Radiation Oncology, Pharmacology, and Pediatrics as well as Director of the Biotherapy Institute at the University of Minnesota, where he became the first recipient of the Endowed Hughes Chair in Biotherapy. He worked 6 years as a Professor and Head of Translational Research in Leukemia and Lymphoma of the CCBD and a Principal Investigator of the Stem Cell-Regenerative Medicine Initiative at the at the University of Southern California. During that time, Dr. Uckun served as the Chair of the Biotargeting Working Group for the National Cancer Institute (NCI)s Nanotechnology Alliance in Cancer.

He has held executive positions in multiple biotechnology companies and has extensive regulatory experience. He has published more than 500 peer-reviewed papers, received numerous awards, and served as a member of several medical journal editorial boards and NIH grant review/special emphasis panels. Website: https://www.linkedin.com/in/fatihuckun/

Revens Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. Words such as may, on-track, expect, anticipate hope, vision, optimism, design, exciting, promising, will, conviction, estimate, intend, believe and similar expressions are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about future plans, the progress, timing, clinical development, scope and success of future clinical trials, the reporting of clinical data for the companys product candidates and the potential use of the companys product candidates to treat various disease indications. Each of these forward-looking statements involves risks and uncertainties, and actual results may differ materially from these forward-looking statements. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing market competition, changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates, and unexpected litigation or other disputes. These risks are not exhaustive; the company faces known and unknown risks, including the risk factors described in the companys periodic SEC filings. Forward-looking statements are based on expectations and assumptions as of the date of this press release. Except as required by law, the company does not assume any obligation to update forward-looking statements contained herein to reflect any change in expectations, whether as a result of new information regarding future events, or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201005005298/en/

See more here:
Reven Strengthens Its Clinical Team With Three New Members - BioSpace

Read More...

Global Regenerative Medicine Partnering Report 2014-2020: Access to Cell Therapy, Organ Regeneration, Stem Cells and Tissue Regeneration Partnering…

Sunday, October 4th, 2020

DUBLIN, Sept. 30, 2020 /PRNewswire/ -- The "Global Regenerative Medicine Partnering Terms and Agreements 2014 to 2020" report has been added to ResearchAndMarkets.com's offering.

The Global Regenerative Medicine Partnering Terms and Agreements 2014-2020 report provides comprehensive understanding and unprecedented access to the regenerative medicine including cell therapy, organ regeneration, stem cells and tissue regeneration partnering deals and agreements entered into by the worlds leading healthcare companies.

The report provides a detailed understanding and analysis of how and why companies enter Regenerative Medicine partnering deals. These deals tend to be multicomponent, starting with collaborative R&D, and proceed to commercialization of outcomes.

This report provides details of the latest Regenerative Medicine agreements announced in the life sciences since 2014.

The report takes the reader through a comprehensive review Regenerative Medicine deal trends, key players, top deal values, as well as deal financials, allowing the understanding of how, why and under what terms, companies are entering Regenerative Medicine partnering deals.

The report presents financial deal term values for Regenerative Medicine deals, listing by headline value, upfront payments, milestone payments and royalties, enabling readers to analyse and benchmark the financial value of deals.

The middle section of the report explores the leading dealmakers in the Regenerative Medicine partnering field; both the leading deal values and most active Regenerative Medicine dealmaker companies are reported allowing the reader to see who is succeeding in this dynamic dealmaking market.

One of the key highlights of the report is that over 1100 online deal records of actual Regenerative Medicine deals, as disclosed by the deal parties, are included towards the end of the report in a directory format - by company A-Z, stage of development, deal type, therapy focus, and technology type - that is easy to reference. Each deal record in the report links via Weblink to an online version of the deal.

In addition, where available, records include contract documents as submitted to the Securities Exchange Commission by companies and their partners. Whilst many companies will be seeking details of the payment clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not.

A comprehensive series of appendices is provided organized by Regenerative Medicine partnering company A-Z, stage of development, deal type, and therapy focus. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each deal on demand.

The report also includes numerous tables and figures that illustrate the trends and activities in Regenerative Medicine partnering and dealmaking since 2014.

In conclusion, this report provides everything a prospective dealmaker needs to know about partnering in the research, development and commercialization of Regenerative Medicine technologies and products.

Key benefits

Global Regenerative Medicine Partnering Terms and Agreements 2014-2020 provides the reader with the following key benefits:

In Global Regenerative Medicine Partnering Terms and Agreements 2014-2020, the available deals are listed by:

Key Topics Covered:

Executive Summary

Chapter 1 - Introduction

Chapter 2 - Trends in Regenerative Medicine dealmaking2.1. Introduction2.2. Regenerative Medicine partnering over the years2.3. Most active Regenerative Medicine dealmakers2.4. Regenerative Medicine partnering by deal type2.5. Regenerative Medicine partnering by therapy area2.6. Deal terms for Regenerative Medicine partnering2.6.1 Regenerative Medicine partnering headline values2.6.2 Regenerative Medicine deal upfront payments72.6.3 Regenerative Medicine deal milestone payments2.6.4 Regenerative Medicine royalty rates

Chapter 3 - Leading Regenerative Medicine deals3.1. Introduction3.2. Top Regenerative Medicine deals by value

Chapter 4 - Most active Regenerative Medicine dealmakers4.1. Introduction4.2. Most active Regenerative Medicine dealmakers4.3. Most active Regenerative Medicine partnering company profiles

Chapter 5 - Regenerative Medicine contracts dealmaking directory5.1. Introduction5.2. Regenerative Medicine contracts dealmaking directory

Chapter 6 - Regenerative Medicine dealmaking by technology type

Chapter 7 - Partnering resource center7.1. Online partnering7.2. Partnering events7.3. Further reading on dealmaking

AppendicesAppendix 1 - Regenerative Medicine deals by company A-ZAppendix 2 - Regenerative Medicine deals by stage of developmentAppendix 3 - Regenerative Medicine deals by deal typeAppendix 4 - Regenerative Medicine deals by therapy area

For more information about this report visit https://www.researchandmarkets.com/r/dcq9uu

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Media Contact:

Research and Markets Laura Wood, Senior Manager [emailprotected]

For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716

SOURCE Research and Markets

http://www.researchandmarkets.com

View original post here:
Global Regenerative Medicine Partnering Report 2014-2020: Access to Cell Therapy, Organ Regeneration, Stem Cells and Tissue Regeneration Partnering...

Read More...

3 new degrees approved, including Ph.D. in regenerative medicine – IU Newsroom

Sunday, October 4th, 2020

The Indiana University Board of Trustees has approved three new degrees, including a doctorate in the medical field and a master's in the accounting field.

During its meeting Oct. 1, the trustees supported three proposed degrees:

Regenerative medicine is a field that involves replacing or regenerating human cells, tissues or organs to establish, restore or enhance normal function.

The Ph.D. program in regenerative medicine and technologies will be offered by the Indiana Center for Regenerative Medicine and Engineering and the Department of Surgery at the IU School of Medicine. The program, open to practicing medical doctors, will provide an avenue for cutting-edge research that can be used in new ways to treat patients.

Before this approval, IU had no graduate-level programs for students seeking a degree in regenerative medicine and technologies. The labor market demand for such graduates is considered strong, with jobs in biotechnology companies, academic laboratories, and medical device manufacturing and logistics companies.

Changes in the accounting field and large employers' expressed needs have prompted the development of a new Master of Science in accounting curriculum that will prepare students for the emerging data-focused professional services workplace. With the proliferation of data and analytics techniques applications in the business world, integrated accounting, data and analytics competencies are required for the best job placements.

The new Master of Science in accounting with data and analytics degree will be offered by the Kelley School of Business. It will replace the current, traditional Master of Science in accounting degree as the residential offering on the Bloomington campus. The traditional Master of Science in accounting will continue to be offered through the Kelley School's online programs and will target "career switchers."

Students who seek the flexibility of an online format, have an interest in studying the foundations of sustainability and want to apply that knowledge to complex socio-environmental problems can find that opportunity in a new offering at IU Northwest, through the College of Arts and Sciences. The Bachelor of Arts in sustainability studies is a collaborative online degree, and was previously approved at IUPUI, IU East, IU Kokomo, IU South Bend and IU Southeast.

Regional demand for energy and sustainability specialists and the demand for "green" jobs are expected to grow over the next 10 years. Graduates with the degree could find jobs such as an energy analyst, environmental health and safety specialist, or an occupational health and safety technician.

The degrees approved by IU's trustees still await final approval by the Indiana Commission for Higher Education.

Read the rest here:
3 new degrees approved, including Ph.D. in regenerative medicine - IU Newsroom

Read More...

Global Regenerative Medicine Market 2020 Growth Analysis, Trends, COVID-19 Analysis and Forecast to 2024, Key Manufacturers- Novartis AG, Medtronic…

Sunday, October 4th, 2020

Aimed at offering Global Regenerative Medicine Market: Size and Forecast with Impact Analysis of COVID-19 (2020-2024) report readers with updated information as well as market relevant cues to leverage uninhibited growth in the Global Regenerative Medicine market, this intricately researched, designed, and articulated real-time reference of the market is a culmination of in-depth research mettle and best in class primary and secondary research initiatives that collectively influence a favorable growth trajectory in the Global Regenerative Medicine market.

In continuation with all the above market specific information furnished above, the report further in its subsequent sections also throws light upon other additional yet pertinent details that further channelize revenue generation in the Global Regenerative Medicine market. The report highlights massively the core growth propellants such as market driving factors, prevailing challenges and the like that tend to have a negative growth impact on the global Global Regenerative Medicine market.

Request a sample of Global Regenerative Medicine Market report @ https://www.orbisresearch.com/contacts/request-sample/4707408

Key Manufacturers Analysis:

Novartis AGMedtronic PlcBristol Myers Squibb (Celgene Corporation)Smith+Nephew (Osiris Therapeutics, Inc.)

Global Regenerative Medicine market Segmentation by Type:

Type IType IIType III

Global Regenerative Medicine market Segmentation by Application:

Application IApplication IIApplication III

Access full report @ https://www.orbisresearch.com/reports/index/global-regenerative-medicine-market-size-and-forecast-with-impact-analysis-of-covid-19-2020-2024

Various other dynamics of the Global Regenerative Medicine market pertaining to the growth prospects have been mentioned and well elaborated in the course of the report documentation thus ushering a novel perspective for the players to instrument growth propelling business decisions, defying stringent competition in the Global Regenerative Medicine market. Based on a thorough analytical review leading players comprising both established and new market aspirants in the Global Regenerative Medicine market can have a thorough understanding about the market and subsequently chalk out elaborate plans to steer remunerative returns in the aforementioned Global Regenerative Medicine market.

Key Regions:

North AmericaEuropeAsia PacificROW

All the mentioned updates about the Global Regenerative Medicine market specified in the report have been derived post a dedicated research initiative comprising primary and secondary research practices. Proceeding into unraveling new developments in the report pertaining to the Global Regenerative Medicine market, the report is committed to offer a decisive, problem solving approach based on which readers are encouraged to unravel the various discerning factors and inputs that collectively orchestrate an optimistic growth trail in the discussed Global Regenerative Medicine market.

Ready-to refer Market Insider Reports: Top Reason to Buy the Report

1. A team of expert research veterans, practicing best in industry roles to derive real time developments in the Global Regenerative Medicine market, affecting growth.2. Systematic segment-wise analysis to identify growth reckoning segment.3. A thorough historical study to decode future growth trajectory.4. Rear view analysis of opportunity landscape and barrier analysis and threat identification.5. Astute analysis of the competition spectrum to identify market leaders and their growth favoring business tactics.

Make an enquiry of this report @ https://www.orbisresearch.com/contacts/enquiry-before-buying/4707408

ABOUT US:

Orbis Research (orbisresearch.com) is a single point aid for all your market research requirements. We have vast database of reports from the leading publishers and authors across the globe. We specialize in delivering customized reports as per the requirements of our clients. We have complete information about our publishers and hence are sure about the accuracy of the industries and verticals of their specialization. This helps our clients to map their needs and we produce the perfect required market research study for our clients.

CONTACT US:

Hector CostelloSenior Manager Client Engagements4144N Central Expressway,Suite 600, Dallas,Texas 75204, U.S.A.Phone No.: +1 (972)-362-8199; +91 895 659 5155

Excerpt from:
Global Regenerative Medicine Market 2020 Growth Analysis, Trends, COVID-19 Analysis and Forecast to 2024, Key Manufacturers- Novartis AG, Medtronic...

Read More...

Remember how urgent it was to support embryonic stem cell research? That was then; this is now – BioEdge

Sunday, October 4th, 2020

Remember how urgent it was to support embryonic stem cell research? That was then; this is now

The hot button bioethical issue of 2004 was embryonic stem cell research. Supporters spoke of life-saving cures and dismissed ethical misgivings. Surfing a wave of hope, Californian voters voted for a US$3 billion bond issue to establish the California Institute for Regenerative Medicine.

Sixteen years later, the CIRM has almost run out of money and its backers are rattling the tin in the hope that voters will approve a $5.5 billion bond issue to support its research.

Some of the states major newspapers have editorialised against it. With many of its critics, they contend that the CIRM has not delivered on its miracle cures, that its governance has been poor and that there was too much potential for conflict of interest.

The Los Angeles Times decried the earlier over-sell:

[The CIRM] hasnt yet yielded a significant financial return on investment for the state or the cures that were ballyhooed at the time. Though no one ever promised quick medical miracles, campaign ads strongly implied they were around the corner if only the funding came through. Proponents oversold the initiatives and voters cant be blamed if they view this new proposal with skepticism.

The San Francisco Chronicle, which exposed some of the CIRMs deficiencies in a 2018 expos, criticised the way its funds had been spent:

More than half the original funding went to buildings and other infrastructure, education and training, and the sort of basic research that, while scientifically valuable, is a long way from medical application. Theres nothing inherently wrong with that, but it is at odds with the vision of dramatic advancements put to voters."

Michael Cook is editor of BioEdge

Read the rest here:
Remember how urgent it was to support embryonic stem cell research? That was then; this is now - BioEdge

Read More...

What You Need to Know About Prop 14, The Stem Cell Research Bond (Transcript) – KQED

Sunday, October 4th, 2020

Olivia Allen-Price [00:01:55] OK, so what exactly does this bond fund?

Danielle Venton [00:01:59] This would fund $5.5 billion in stem cell research and treatments in California. Some of the diseases that stem cell research is seeking to cure or treat include cancer, Alzheimer's disease, diabetes, spinal cord injuries, blindness, and even COVID-19. I spoke recently with a guy named Jake Javier. He supports this bond initiative because he knows firsthand how life changing stem cell research can be.

Jake Javier [00:02:25] I am in my last year at Cal Poly.

Danielle Venton [00:02:28] So, Jake grew up locally in Danville and was just graduating high school when he suffered a life altering injury.

Jake Javier [00:02:35] On the last day of high school, I drove in to a pool and hit my head on the bottom and broke my neck and was immediately paralyzed.

Danielle Venton [00:02:47] He says his injury was complete, with very little hope of recovery. But a doctor at Stanford reached out to Jake and his family and said, you can be part of this clinical trial where we, with a one time surgery, will inject stem cells into the damaged area and you may possibly see some benefits.

Danielle Venton [00:03:07] Now, Jake is still injured.

Jake Javier [00:03:09] I'm a quadriplegic. I use a wheelchair.

Danielle Venton [00:03:11] But he says after the surgery, he noticed more movement in his arms, in his hands.

Jake Javier [00:03:17] So, I mean, with my injury, I'm at a level where I would normally not have any function at all in my hands and very, very little function like in my triceps and things like that. Muscles that are really important for functionality and, you know, being able to get through day to day activities that could help me push myself around more, help me transfer in and out of my chair independently. And then also, I notice, you know, I got some some finger movement. It doesn't seem like much, but even that little movement has helped me so much with picking things up and things like that. So it was really, I was really blessed to see that happen.

Danielle Venton [00:03:51] So he doesn't know how much of his recovery is due to the stem cells. How much is natural, or how much is due to physical therapy. But today he's able to live independently, to go to college and he wants to pursue a career in medicine. And he is a big believer in stem cell research, regenerative medicine, and is really hoping that California voters will support this proposition.

Olivia Allen-Price [00:04:20] Now, what exactly are stem cells and how do they work, I guess?

Danielle Venton [00:04:25] Yeah, stem cells are types of cells that can be turned into any type of specialized cell. Scientists have known about them since the eighteen hundreds, but it wasn't until the late 90s that researchers developed a method to derive them from human embryos and grow them in a laboratory. And then people really began to get excited about their potential for medicine. Now these cells came from unused embryos created for in vitro fertilization, and they were donated with informed consent. But many anti-abortion groups felt that using the cells were tantamount to taking a human life. So in 2001, then President George W. Bush banned federal funding for any research using newly created stem cell lines.

Olivia Allen-Price [00:05:09] OK. And how does that get us now to bonds in California?

Danielle Venton [00:05:13] Well, Californians wanted to circumvent these federal restrictions, and in 2004 voted for a bond that gave the state $3 billion to create a research agency called the California Institute of Regenerative Medicine, or CIRM. There was a lot of public support for it. And it just felt like these wonderful cures could be right around the corner. Celebrities like Michael J. Fox appeared in TV commercials.

Michael J. Fox TV commercial [00:05:36] My most important role lately is as an advocate for patients, and for finding new cures for diseases. That's why I'm asking you to vote yes on Proposition 71, Stem Cell Research Initiative.

Danielle Venton [00:05:48] And the money for that research, that $3 billion, has now run out. And to continue their work, the stem cell advocacy group, Americans for Cures, is asking voters for more money.

Olivia Allen-Price [00:06:00] So we're basically voting on whether we want to refill the stem cell research piggy bank here.

Danielle Venton [00:06:05] Yeah, exactly. Some question if the state can afford this at this time when budgets are going to be so tight. Others have been disappointed by the slow pace of cures coming out of the field. Now, there are people who credit this research, such as Jake, with improving or restoring their health or the health of their loved ones. Or maybe they hope that one day it will, and they would balk at the idea that this is not worthy research. They point to achievements that the agency has funded. That includes effectively a cure for bubble baby disease. This is when someone is born without a functioning immune system. That mutation can now be corrected with genetically modified stem cells. And recently, just within the last year or so, the FDA approved two new treatments for blood cancer, developed with CIRM support. These achievements are what the agency points to when they're criticized for not having accomplished more. And they say the process of scientific discovery is long and unpredictable.

Olivia Allen-Price [00:07:04] Now, wasn't that Bush-era ban on stem cell research that you were talking about earlier wasn't that overturned?

Danielle Venton [00:07:11] Yes, that was overturned by President Obama. However, there are current members of Congress who are lobbying President Trump to ban the research again. And if that happens, then California would be the only major player in stemcell research once again in the United States.

Olivia Allen-Price [00:07:30] All right, so who is supporting Prop 14?

Danielle Venton [00:07:32] Governor Gavin Newsom, for one. Many patient advocacy organizations and medical and research institutions, including the California Board of Regents. These people don't want to see the pace of this research slow. They want it to accelerate. The political action committee supporting this proposition is reporting more than six million dollars in contributions.

Olivia Allen-Price [00:07:53] All right. And what about the opposition? Who's against it?

Danielle Venton [00:07:55] Well, so far, there's no organized, funded opposition. There have been several newspaper editorials coming out against it, including locally, the Mercury News and the Santa Rosa Press Democrat. They basically say state bonds aren't the way to fund research and the situation isn't like it was in 2004 and that the institute should now seek other sources of funding and move forward as a nonprofit.

Olivia Allen-Price [00:08:19] All right, Danielle. Well, thanks, as always for your help.

Danielle Venton [00:08:21] My pleasure. Thanks.

Olivia Allen-Price [00:08:28] In a nutshell, a vote yes on Proposition 14 says you think Californians should give $5.5 billion to the state's stem cell research institute. That money will be raised by selling bonds, which the state would pay back, with interest, out ofthe general fund over the next 30 years. A vote no means you think we shouldn't spend public money on this research.

Olivia Allen-Price [00:08:54] That's it on Proposition 14. We'll be back tomorrow with an episode on Prop 15. And oh, it is a doozy. Commercial property tax! A partial rollback of one of California's most controversial propositions! It's going to be fire. In the meantime, you can find more of KQED election coverage at KQED.org/elections. Two reminders on the way out: October 19th is the last day to register to vote and mail in ballots must be postmarked on or before November 3rd.

Olivia Allen-Price [00:09:28] Bay Curious is made in San Francisco at member supported KQED. I'm Olivia Allen-Price. See you tomorrow.

Follow this link:
What You Need to Know About Prop 14, The Stem Cell Research Bond (Transcript) - KQED

Read More...

Regenerative Medicine Market Potential Growth, Size, Share, Demand and Analysis of Key Players Research Forecasts to 2027 – The Daily Chronicle

Sunday, October 4th, 2020

Fort Collins, Colorado The Regenerative Medicine Market is growing at a rapid pace and contributes significantly to the global economy in terms of turnover, growth rate, sales, market share and size. The Regenerative Medicine Market Report is a comprehensive research paper that provides readers with valuable information to understand the basics of the Regenerative Medicine Report. The report describes business strategies, market needs, dominant market players and a futuristic view of the market.

The report has been updated to reflect the most recent economic scenario and market size regarding the ongoing COVID-19 pandemic. The report looks at the growth outlook as well as current and futuristic earnings expectations in a post-COVID scenario. The report also covers changing market trends and dynamics as a result of the pandemic and provides an accurate analysis of the impact of the crisis on the market as a whole.

Global Regenerative Medicine Market valued approximately USD 49.68 billion in 2018 is anticipated to grow with a healthy growth rate of more than 24.2% over the forecast period 2019-2026.

Get a sample of the report @ https://reportsglobe.com/download-sample/?rid=28424

Industry Regenerative Medicine Study provides an in-depth analysis of key market drivers, opportunities, challenges and their impact on market performance. The report also highlights technological advancements and product developments that drive market needs.

The report contains a detailed analysis of the major players in the market, as well as their business overview, expansion plans and strategies. Key players explored in the report include:

The report provides comprehensive analysis in an organized manner in the form of tables, graphs, charts, pictures and diagrams. Organized data paves the way for research and exploration of current and future market outlooks.

Request a Discount on the report @ https://reportsglobe.com/ask-for-discount/?rid=28424

The report provides comprehensive data on the Regenerative Medicine market and its trends to help the reader formulate solutions to accelerate business growth. The report provides a comprehensive overview of the economic scenario of the market, as well as its benefits and limitations.

The Regenerative Medicine Market Report includes production chain analysis and value chain analysis to provide a comprehensive picture of the Regenerative Medicine market. The research consists of market analysis and detailed analysis of application segments, product types, market size, growth rates, and current and emerging industry trends.

By Technology:

By Application:

Request customization of the report @https://reportsglobe.com/need-customization/?rid=28424

The market is geographically spread across several key geographic regions and the report includes regional analysis as well as production, consumption, revenue and market share in these regions for the 2020-2027 forecast period. Regions include North America, Latin America, Europe, Asia Pacific, the Middle East, and Africa.

Radical Coverage of the Regenerative Medicine Market:

Key Questions Addressed in the Report:

To learn more about the report, visit @ https://reportsglobe.com/product/global-regenerative-medicine-market-size-study/

Thanks for reading our report. It is possible to adapt this report to the wishes of the customer. Contact us to learn more about the report and our team will make sure you create a report based on your needs.

How Reports Globe is different than other Market Research Providers

The inception of Reports Globe has been backed by providing clients with a holistic view of market conditions and future possibilities/opportunities to reap maximum profits out of their businesses and assist in decision making. Our team of in-house analysts and consultants works tirelessly to understand your needs and suggest the best possible solutions to fulfill your research requirements.

Our team at Reports Globe follows a rigorous process of data validation, which allows us to publish reports from publishers with minimum or no deviations. Reports Globe collects, segregates, and publishes more than 500 reports annually that cater to products and services across numerous domains.

Contact us:

Mr. Mark Willams

Account Manager

US: +1-970-672-0390

Email:[emailprotected]

Web:reportsglobe.com

View original post here:
Regenerative Medicine Market Potential Growth, Size, Share, Demand and Analysis of Key Players Research Forecasts to 2027 - The Daily Chronicle

Read More...

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

Sunday, October 4th, 2020

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.

Request for a free sample copy of this report: https://www.imarcgroup.com/regenerative-medicine-market/requestsample

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.

Contact US:IMARC Group30 N Gould St, Ste RSheridan, WY 82801, USAWebsite: https://www.imarcgroup.com/Email: [emailprotected]USA: +1-631-791-1145Follow us on twitter: @imarcglobalLinkedin: https://www.linkedin.com/company/imarc-group

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

Read More...

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

Sunday, October 4th, 2020

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.

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

Read More...

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

Sunday, October 4th, 2020

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

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

Read More...

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

Sunday, October 4th, 2020

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

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

Read More...

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

Sunday, October 4th, 2020

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.

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

Read More...

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

Sunday, October 4th, 2020

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

Read more from the original source:
Robert Greif named Chief Executive Officer of H-CYTE - GlobeNewswire

Read More...

Map of the human heart could guide treatments – Harvard Gazette

Sunday, October 4th, 2020

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.

Here is the original post:
Map of the human heart could guide treatments - Harvard Gazette

Read More...

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

Sunday, October 4th, 2020

[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.]

See the original post here:
Cancer Vaccines: The Fourth Pillar of Anti-Cancer Therapy? - JD Supra

Read More...

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

Tuesday, September 15th, 2020

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.

View original post here:
Global Regenerative Medicine Market Analysis & Forecast to 2025 - ResearchAndMarkets.com - Business Wire

Read More...

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

Tuesday, September 15th, 2020

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

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

Read More...

Page 15«..10..14151617..2030..»


2024 © StemCell Therapy is proudly powered by WordPress
Entries (RSS) Comments (RSS) | Violinesth by Patrick