StemCell Therapy

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DURHAM, N.C., July 07, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that it will host a key opinion leader (KOL) webinar on its proprietary Human Acellular Vessels (HAV) in the treatment of vascular trauma on Thursday, July 14, 2022 at 11:30 a.m. Eastern Time.

The webinar will feature presentations from KOLs Ernest E. Moore, MD (Denver Health) and Gregory A. Magee, MD, (Keck Medicine, University of Southern California), who will discuss the current treatment landscape and unmet medical need in the vascular trauma field as well as case studies of trauma patients treated with the HAV.

Humacytes HAV are investigational engineered off-the-shelf replacement vessels initially being developed for vascular repair, reconstruction and replacement. HAV is designed to eliminate the need for harvesting a vessel from a patient or using a synthetic graft, and clinical evidence to date suggests that it is non-immunogenic and infection-resistant and can become durable living tissue.

A question and answer session will follow the formal presentations. To register for the event, please click here.

Ernest E. Gene Moore, MD, was the Chief of Trauma at the Denver General Hospital for 36 years, Chief of Surgery for 28 years, and the first Bruce M. Rockwell Distinguished Chair in Trauma Surgery. He continues to serve as Vice Chairman for Research and is a Distinguished Professor of Surgery at the University of Colorado Denver (UCD) and was the Editor of the Journal of Trauma 2011-2021.

Under Dr. Moores leadership, the Rocky Mountain Regional Trauma Center at Denver General became internationally recognized for innovative care of the injured patient, and its trauma research laboratory has been funded by the NIH for 35 consecutive years. In July 2018, the center was renamed the Ernest E Moore Shock Trauma Center at Denver Health.

Dr. Moore has served as president of ten academic societies, including the Society of University Surgeons, American Association for the Surgery of Trauma, International Association for the Trauma and Surgical Intensive Care, and the World Society of Emergency Surgery; and as Vice President for the American Surgical Association.

His awards include the Robert Danis Prize from the Society of International Surgeons, Orazio Campione Prize from the World Society of Emergency Surgery, Philip Hench Award from the University of Pittsburgh, Florence Sabin Award from the University of Colorado, Lifetime Achievement Award from the Society of University Surgeons, Lifetime Achievement Award for Resuscitation Science from the American Heart Association, Distinguished Investigator Award from the American College of Critical Medicine, Distinguished Investigator Award from the Shock Society, Lifetime Service Award from the International Association for Trauma and Surgical Intensive Care, and the Medallion for Scientific Achievement from the American Surgical Association. He has honorary fellowships in the Royal College of Surgeons of Edinburgh, the Royal College of Surgeons in Ireland, the Royal College of Surgeons of Thailand, and the American College of Emergency Physicians; and is an honorary member of the Brazilian Trauma Society, Colombian Trauma Society, Eastern Association for the Surgery of Trauma, European Society for Trauma and Emergency Surgery, North Pacific Surgical Association, and Trauma Association of Canada. Dr. Moore is coeditor of the textbook Trauma, in its 9th edition, Surgical Secrets in its 7th edition, and Trauma Induced Coagulopathy, in its 2nd edition; he has >2000 publications and has lectured extensively throughout the world.

Gregory A. Magee, MD received his BA in Molecular Biophysics & Biochemistry from Yale University and his MSc in Applied Statistics from the University of Oxford. He earned his medical degree from Yale School of Medicine in 2006.

Dr. Magee underwent his general surgery residency at Stanford. During his two research years, Dr. Magee completed the Stanford Biodesign Surgical Innovation Fellowship, developing devices that formed the basis for two venture-funded start-up companies, both of which are currently conducting clinical trials. He continues to pursue his goal of improving medical care through technological innovation.

Dr. Magee completed a surgical critical care and trauma surgery fellowship at USC from 20132015 and a vascular surgery fellowship at the University of Colorado Denver in 2017, where he developed a broad experience in complex endovascular repair of the entire aorta using tailor-made fenestrated grafts. He is board certified in General Surgery, Surgical Critical Care, and Vascular Surgery.

About HAVHuman Acellular Vessels (HAV) are investigational engineered off-the-shelf replacement vessels initially being developed for vascular repair, reconstruction and replacement. HAV is intended to overcome long-standing limitations in vessel tissue repair and replacement it can be manufactured at commercial scale, it eliminates the need for harvesting a vessel from a patient, and clinical evidence suggests that it is non-immunogenic, infection-resistant, and can become durable living tissue. The HAV is currently being evaluated in two Phase 3 trials in arteriovenous access and a Phase 2/3 trial for vascular trauma, and has been used in more than 460 patient implantations. Humacytes 6mm HAV for AV access for performing hemodialysis was the first product to receive Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA), and has also received FDA Fast Track designation. The HAV has received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense.

About HumacyteHumacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues and complex tissue and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries and chronic conditions. Humacytes initial opportunity, a portfolio of human acellular vessels (HAVs), is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous access for hemodialysis, and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacytes 6mm HAV for arteriovenous (AV) access for performing hemodialysis was the first product candidate to receive the FDAs Regenerative Medicine Advanced Therapy (RMAT) designation, and has also received FDA Fast Track designation. The HAV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit http://www.Humacyte.com.

Humacyte Investor Contact:Joyce AllaireLifeSci Advisors LLC+1-617-435-6602[emailprotected][emailprotected]

Humacyte Media Contact:Heather Anderson6 Degrees919-827-5539[emailprotected][emailprotected]

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EVEON, designer and manufacturer of medical devices for the preparation and delivery of drugs, announces the launch of a European consortium project INDENEO, for the Rare Disease Research (RDR) Challenge Call, to develop a delivery system from the nose to the brain for the treatment of rare central nervous system (CNS) diseases like encephalitis in neonates.

The Rare Disease Research Challenge Call, launched by the European Joint Programme for Rare Diseases and co-funded by the biopharmaceutical company Chiesi Group, aims to develop a dropper system from nose to brain for biological drugs and advanced therapies in neonates. For certain rare diseases involving the CNS, for example, neonatal encephalitis, intranasal delivery allows to target the central nervous system, thanks to the transfer from the nose to the brain of the molecules. Minimally invasive and restrictive, this is recognized as one of the most useful and reliable routes for brain drug absorption leading to quick drug action, with greater efficacy and reduced risk of infection.

INDENEO (INtraNasal Device for NEOnates) project brings together an international consortium of 4 partners. EVEON, project leader, brings its expertise in the development of delivery devices and its ability to deliver microdoses; Chiesi contributes with its expertise in pharmaceutical development and neonatology; Les Cliniques universitaires Saint Luc (Belgium) brings its top level clinical expertise and Infectious Disease Models and Innovative Therapies (IDMIT) department at the CEA (Fontenay aux Roses site - France) its expertise in carrying out pre-clinical trials.

INDENEO will last 18 months with two main milestones: the design and development of a functional prototype, then the pre-clinical validation.

At EVEON, we are honored and excited to lead the INDENEO project and work together with Cliniques Saint Luc, CEA and Chiesi Laboratories for the development of a new device. Nose To Brain delivery will open up new ways to address major unmet medical needs for neonates neurological rare conditions. We are proud to work on this innovative project that is at the heart of our goals : developing automatic and controlled devices for allowing safe and efficient delivery of biological drugs. said Claire Authesserre, Technical Pre-Sales Manager and Gladys Corrons-Bouis, Business Development Director, EVEON.

Story continues

As Chiesi Global Rare Diseases we are excited to contribute to such an important project to enhance the possibilities of successfully treating rare central nervous system (CNS) diseases in neonates. Our Company has a long history in the field of neonatology, which is combined here with our commitment to rare diseases - commented Diego Ardig, Head of R&D Rare Disease Unit at Chiesi Group -. We truly believe in the power of collaboration in the advancement of scientific research, because by combining expertise and resources you can answer bigger and more complex scientific questions and generate greater value. We are also driven by our desire to bring new or improved treatments and services to people suffering from rare diseases and debilitating chronic conditions, always focusing on the often-unseen needs, where we can make the biggest difference. We are committed to giving our patients and their loved ones the support they need to lead more active and fulfilling lives.

Stem cells hold tremendous promise for regenerative medicine. Preclinical research suggest that stem cells may represent the next breakthrough in the repair of currently devastating brain injury in neonates, including stroke and hypoxic-ischemic lesions. Recent safety studies in human neonates have suggested that the nasal route may be the most efficient way to deliver stem cells in the neonatal brain. This exciting project will pave the way for a safe, effective, and painless administration of novel therapies for the neonatal brain said Maria-Roberta Cilio, Cliniques universitaires Saint Luc.

INDENEO is one of three projects selected for funding within the Rare Diseases Research (RDR) Challenges call led by the Foundation for Rare Diseases and EJP-RD. We are very excited about this innovative project fostering public-private partnerships to drive rare disease research towards effective treatments, which is at the very heart of this European funding initiative. said Christine Fetro, Foundation for Rare Diseases.

We are enthusiastic to contribute to this European consortium. The development of nasal drug delivery systems is an important challenge for many fields of medicine, beyond the rare pediatric diseases targeted by INDENEO. said Roger Le Grand, executive director of IDMIT, CEA.

Press contact :Charlotte Reverand | cre@eveon.eu | +33 476 414 833 | @EVEON_SAS

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In a recent market survey, ESOMAR-certified consulting firm Future Market Insights (FMI) forecasts an impressive growth outlook for theplatelet-rich plasma (PRP) market. The market valuation reachedUS$ 370.78 Mnin 2021 and is poised to expand at a6% CAGRthrough 2031.

Growth registered in the platelet-rich plasma market is attributable to increasing applications of PRPs in various procedures such as cosmetic, orthopedic, neurological, and maxillofacial treatments. Increasing awareness regarding the advantages of platelet-rich plasma in wound healing and tissue regeneration will further propel sales in the market.

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PRP is being widely used in cosmetic surgeries aimed at improving facial structure and aesthetics, such as skin texture, and color. In addition, PRP is gaining wide acceptance as a key ingredient used in microneedling, botox treatments, acne scar removal, and laser treatments, which is spurring demand in the market.

Besides this, usage of PRPs in orthopedic treatments is fostering market sales, owing to its cost-effectiveness and negligible side effects. PRPs are increasingly finding application in joint pain treatment, cartilage reconstruction, fracture treatments, and other arthritic treatments.

With rising incidence of cosmetic procedures and sports-related injuries in countries including the U.S, the U.K., and Germany, the market is anticipated to garner significant revenue over the forecast period.

Intensive research and development, coupled with the prevalence of leading market players will further augment platelet-rich plasma market growth, with expansion at12.4%by volume.

Additionally, growing investments in healthcare infrastructure and increasing disposable income will provide tailwinds to platelet-rich plasma sales in counties such as India, China, Brazil, and South Korea, shaping the demand outlook positively.

Growing use of platelet-rich plasma in chronic wound healing, cosmetology, and orthopedic procedures, along with product innovations by leading market players will augment market growth in the upcoming years, says an FMI analyst.

Competitive Landscape

Harvest Technologies Corp., Zimmer Biomet Holdings Inc., Arthrex, Inc., Arteriocyte Medical Systems, Inc., Dr. PRP America, Cesca Therapeutics, Inc., and Regen Lab SA are among the prominent players operating in the global platelet-rich plasma market. As per FMIs analysis, tier-1 players will account for15-20%of the total market share.

Growth strategies leveraged by top manufacturers of platelet-rich plasma include strategic partnerships, mergers, acquisitions, and collaborations to launch innovative PRP treatment methods in the market. For instance:

Key Takeaways from Platelet Rich Plasma Market Survey

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More Insights on the Platelet Rich Plasma Market

In its latest report, FMI offers an unbiased analysis of the global platelet-rich plasma market, providing historical data for the period of 2016-2020 and forecast statistics for the period of 2021-2031. In order to understand the global market potential, its growth, and scope, the market is segmented on the basis of product type (pure platelet-rich plasma, leukocyte platelet-rich plasma, leukocyte platelet-rich fibrin), origin type (autologous, homologous, and allogenic), application type (orthopedic surgery, cosmetic surgery, general surgery, neurosurgery and other surgeries including urological, cardiothoracic, periodontal, oral and maxillofacial), and across seven regions (North America, Latin America, Eastern Europe, Western Europe, Asia Pacific excluding Japan (APEJ), Japan, and Middle East & Africa).

Platelet Rich Plasma Market by CategoryBy Product Type:

By Origin Type:

By Application Type:

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Future Market Insights (ESOMAR certified market research organization and a member of Greater New York Chamber of Commerce) provides in-depth insights into governing factors elevating the demand in the market. It discloses opportunities that will favor the market growth in various segments on the basis of Source, Application, Sales Channel and End Use over the next 10-years.

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Platelet Rich Plasma Market is projected to expand at a steady 6% CAGR through 2031 - PharmiWeb.com

Stem Cell Professional market report 2020, discusses various factors driving or restraining the market, which will help the future market to grow with promising CAGR. The Stem Cell Professional market research Reports offers an extensive collection of reports on different markets covering crucial details. The report studies the competitive environment of the Stem Cell Professional market is based on company profiles and their efforts on increasing product value and production.

The research report on Stem Cell Professional market broadly covers the various factors influencing the remuneration of this industry vertical. The study also comprises of an in-depth analysis of the regional spectrum and the regulatory outlook of the said market. Additionally, the document provides with a detailed SWOT analysis as well as the market drivers impacting the overall market outlook.

Additional information regarding the challenges & limitations faced by new entrants as well as the eminent companies alongside their individual effect on the revenues of each company is highlighted. The report measures the impact of COVID-19 pandemic on the future remuneration as well as the overall expansion rate of the market.

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Summarizing the competitive scenario of the Stem Cell Professional market:

From the regional frame of reference of Stem Cell Professional market:

Other details comprised in the Stem Cell Professional market report:

Reasons for Read this Report

This report provides pin-point analysis for changing competitive dynamics

It provides a forward looking perspective on different factors driving or restraining market growth

It provides a five-year forecast assessed on the basis of how the market is predicted to grow

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It helps in making informed business decisions by having complete insights of market and by making in-depth analysis of market segments

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Stem Cell Professional Market Professional Survey 2021 by Manufacturers, Share, Growth, Trends, Types and Applications, Forecast to 2026 - NewsOrigins

North America Is Projected To Account For The Maximum Revenue Share Of 53% In 2022.

Attributed to mounting healthcare research costs, developed countries are increasingly outsourcing biotechnology and pharmaceutical services to developing regions, especially across Asia Pacific, expected to yield substantial growth opportunities, says an analyst at Fact. MR.

Fact.MR, a market research and competitive intelligence provider: The global biotechnology and pharmaceutical services outsourcing market is anticipated to hold a market value of US$ 70 Bn in 2022 and US$ 112.31 Bn by 2032. The projected growth rate is nearly 5% during the forecast period from 2022 to 2032.

Biotechnology and pharmaceutical companies are adopting the consulting services owing to factors such as; the growing number of discrepancies in intellectual property rights and fraudulent cases. Owing to such causes, the adoption of these services is on a rise, making it a lucrative market for the players. The estimation reveals that the industry is projected to secure a market value of US$ 112.31 Bn by 2032.

Biopharmaceutical and pharmaceutical investments in novel and innovative therapies, for instance, regenerative medicine, are driving the R&D activity together with drug development services. The high demand for biologics along with small molecules has led to the expansion of service portfolios of Contract Manufacturing Organizations (CMOs)/Contract Research Organizations (CROs) for biotechnology and pharmaceutical production.

The biotechnology & pharmaceutical services outsourcing, primarily for Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs), has grown in popularity since last decade, and it is expected to grow in the near future. The new outsourcing industry sectors, such as rising screening services, have grown to be prosperous businesses, and many operations that were once considered essential, such as in-house spontaneous animal toxicology testing, are now rare within biotechnology & pharmaceutical services outsourcing market players.

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Growing Demand for Low-Cost Drug Development to Boost Medical Outsourcing

Contract research and manufacturing allow low-cost product manufacturing and development. The growing application of machine learning-based platforms such as; automation in drug manufacturing, artificial intelligence, and innovative trial designs are anticipated to transform the CMO and CRO sphere in the forecast period.

Growing pricing pressure, regulatory challenges, and patent expiration have led to shrinking margins in the biotech and pharmaceutical industry. Contract services offer cost saving to their clients and also help save time utilized in operations and management of a production & research facility. Furthermore, outsourcing services assist in overcoming trade barriers and facilitate the entry of firms into foreign markets. Owing to these advantages, several firms choose to outsource services rather than investing capital in production equipment and hiring skilled labor.

Competitive Landscape

The players of the market are focusing to increase their global influence and adopt strategies such as; acquisition, collaboration, and partnerships. Some of the recent key developments among key players are:

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Key Takeaways from the Market Study

Key Market Segments Covered in the Global Biotechnology and Pharmaceutical Services Outsourcing Market

More Insights Available

Fact.MR, in its new offering, presents an unbiased analysis of the global Biotechnology & Pharmaceutical Services Outsourcing Market, presenting historical analysis from 2015 to 2021 and forecast statistics for the period of 2022-2032.

The study reveals essential insights on the basis of Service (Product Testing & Validation, Training & Education, Product Design & Development, Product Maintenance, Regulatory Affairs, Consulting) & research institutes and others (CROs and CMOs)) across six major regions (North America, Latin America, Europe, East Asia, South Asia & Oceania and Middle East & Africa).

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Fact.MRs Domain Knowledge in Healthcare

Our healthcare consulting team guides organizations at each step of their business strategy by helping you understand how the latest influencers account for operational and strategic transformation in the healthcare sector. Our expertise in recognizing the challenges and trends impacting the global healthcare industry provides indispensable insights and support - encasing a strategic perspective that helps you identify critical issues and devise appropriate solutions.

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Global Biotechnology & Pharmaceutical Services Outsourcing Market Is Expected To Grow At A CAGR Of 5% From 2022 To 2030 To Reach US$ 112.31 Bn by...

Global Amniotic Membrane Market Share, Size, Industry Report with detailed insights on growth factors and strategies. The study segments key regions that includes North America, Europe, Asia-Pacific with country level break-up and provide volume and value related cross segmented information by each country. The report offers a comprehensive evaluation of the Amniotic Membrane market. It does so via in-depth Amniotic Membrane qualitative insights, Amniotic Membrane historical data, and Amniotic Membrane verifiable projections about market size. The Amniotic Membrane projections featured in the report have been derived using proven research methodologies and assumptions

Amniotic Membrane Market is valued at USD 906.4 Million in 2018 and expected to reach USD 1800.3 Million by 2025 with CAGR of 10.3% over the forecast period.

Market Analysis of Amniotic Membrane-

The amnion is the innermost layer of the placenta and used for wound healing mainly due to its bacteriostatic and pain reduction properties. Rising awareness in the recent past has led to a surge in the number of transplants leading to increasing demand for these tissue-based products. It has also led to a rise in the number of donations thus, propelling the market growth. Typically, amniotic membranes are used for indications, such as pterygium excisions, reconstruction of the conjunctiva surface, corneal ulcers, surgical wounds, pressure and venous leg ulcers, regenerative medicine, and limbal stem cell deficiency. Amniotic membrane transplant is a better alternative for corneal and conjunctival reconstruction. It is used in ophthalmology for the treatment of a number of conditions, such as cicatricial pemphigoid and Stevens-Johnson syndrome; pterygium; persistent epithelial defects with ulceration; conjunctival surface reconstruction; and ocular surface reconstruction in patients with chemical and thermal burns.

Segmentation Analysis:

By Application:

By Product:

By End-User:

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Some of the key players/Manufacturers involved in the Market are:

Applied Biologics LLC, Amnio Technology, LLC, Alliqua BioMedical, Inc., FzioMed, Inc., Human Regenerative Technologies, LLC, Skye Biologics Inc., IOP Ophthalmics, Amniox Medical, Inc., Derma Sciences Inc., and MiMedx Group, Inc. and Others.

Important years considered in the study are:

Historical year 2015-2020; Base year 2020; Forecast period** 2022 to 2028

Amniotic Membrane Market Report is also available for any Specific Regions & Countries:

Chapter 1- Report Methodology

1.1. Research Process

1.2. Primary Research

1.3. Secondary Research

1.4. Market Size Estimates

1.5. Data Triangulation

1.6. Forecast Model

1.7. USPs of Report

1.8. Report Description

Chapter 2 Global Amniotic Membrane Market Overview

2.1. Market Introduction

2.2. Executive Summary

2.3. Global Amniotic Membrane Market Classification

2.4. Market Drivers

2.5. Market Restraints

2.6. Market Opportunity

2.7. Amniotic Membrane Market: Trends

2.8. Porters Five Forces Analysis

2.9. Market Attractiveness Analysis

Continued@..

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Amniotic Membrane Market Is Expected to Witness with Strong Growth rate in the forecast period (2022 to 2028) Designer Women - Designer Women

Most of us know someone affected by hearing loss, but we may not fully appreciate the hardships that lack of hearing can bring. Hearing loss can lead to isolation, frustration, and a debilitating ringing in the ears known as tinnitus. It is also closely correlated with dementia.

The biotechnology company Frequency Therapeutics is seeking to reverse hearing loss not with hearing aids or implants, but with a new kind of regenerative therapy. The company uses small molecules to program progenitor cells, a descendant of stem cells in the inner ear, to create the tiny hair cells that allow us to hear.

Hair cells die off when exposed to loud noises or drugs including certain chemotherapies and antibiotics. Frequencys drug candidate is designed to be injected into the ear to regenerate these cells within the cochlea. In clinical trials, the company has already improved peoples hearing as measured by tests of speech perception the ability to understand speech and recognize words.

Speech perception is the No. 1 goal for improving hearing and the No. 1 need we hear from patients, says Frequency co-founder and Chief Scientific Officer Chris Loose PhD 07.

In Frequencys first clinical study, the company saw statistically significant improvements in speech perception in some participants after a single injection, with some responses lasting nearly two years.

The company has dosed more than 200 patients to date and has seen clinically meaningful improvements in speech perception in three separate clinical studies. Another study failed to show improvements in hearing compared to the placebo group, but the company attributes that result to flaws in the design of the trial.

Now Frequency is recruiting for a 124-person trial from which preliminary results should be available early next year.

The companys founders, including Loose, MIT Institute Professor Robert Langer, CEO David Lucchino MBA 06, Senior Vice President Will McLean PhD 14, and Harvard-MIT Health Sciences and Technology affiliate faculty member Jeff Karp, are already gratified to have been able to help people improve their hearing through the trials. They also believe theyre making important contributions toward solving a problem that impacts more than 40 million people in the U.S. and hundreds of millions more around the world.

Hearing is such an important sense; it connects people to their community and cultivates a sense of identity, says Karp, who is also a professor of anesthesia at Brigham and Womens Hospital. I think the potential to restore hearing will have enormous impact on society.

From the lab to patients

In 2005, Lucchino was an MBA student in the MIT Sloan School of Management and Loose was a PhD candidate in chemical engineering at MIT. Langer introduced the two aspiring entrepreneurs, and they started working on what would become Semprus BioSciences, a medical device company that won the MIT $100K Entrepreneurship Competition and later sold at a deal valued at up to $80 million.

MIT has such a wonderful environment of people interested in new ventures that come from different backgrounds, so were able to assemble teams of people with diverse skills quickly, Loose says.

Eight years after playing matchmaker for Lucchino and Loose, Langer began working with Karp to study the lining of the human gut, which regenerates itself almost every day.

With MIT postdoc Xiaolei Yin, who is now a scientific advisor to Frequency, the researchers discovered that the same molecules that control the guts stem cells are also used by a close descendant of stem cells called progenitor cells. Like stem cells, progenitor cells can turn into more specialized cells in the body.

Every time we make an advance, we take a step back and ask how this could be even bigger, Karp says. Its easy to be incremental, but how do we take what we learned and make a massive difference?

Progenitor cells reside in the inner ear and generate hair cells when humans are in utero, but they become dormant before birth and never again turn into more specialized cells such as the hair cells of the cochlea. Humans are born with about 15,000 hair cells in each cochlea. Such cells die over time and never regenerate.

In 2012, the research team was able to use small molecules to turn progenitor cells into thousands of hair cells in the lab. Karp says no one had ever produced such a large number of hair cells before. He still remembers looking at the results while visiting his family, including his father, who wears a hearing aid.

I looked at them and said, I think we have a breakthrough, Karp says. Thats the first and only time Ive used that phrase.

The advance was enough for Langer to play matchmaker again and bring Loose and Lucchino into the fold to start Frequency Therapeutics.

The founders believe their approach injecting small molecules into the inner ear to turn progenitor cells into more specialized cells offers advantages over gene therapies, which may rely on extracting a patients cells, programming them in a lab, and then delivering them to the right area.

Tissues throughout your body contain progenitor cells, so we see a huge range of applications, Loose says. We believe this is the future of regenerative medicine.

Advancing regenerative medicine

Frequencys founders have been thrilled to watch their lab work mature into an impactful drug candidate in clinical trials.

Some of these people [in the trials] couldnt hear for 30 years, and for the first time they said they could go into a crowded restaurant and hear what their children were saying, Langer says. Its so meaningful to them. Obviously more needs to be done, but just the fact that you can help a small group of people is really impressive to me.

Karp believes Frequencys work will advance researchers ability to manipulate progenitor cells and lead to new treatments down the line.

I wouldn't be surprised if in 10 or 15 years, because of the resources being put into this space and the incredible science being done, we can get to the point where [reversing hearing loss] would be similar to Lasik surgery, where you're in and out in an hour or two and you can completely restore your vision, Karp says. I think we'll see the same thing for hearing loss.

The company is also developing a drug for multiple sclerosis (MS), a disease in which the immune system attacks the myelin in the brain and central nervous system. Progenitor cells already turn into the myelin-producing cells in the brain, but not fast enough to keep up with losses sustained by MS patients. Most MS therapies focus on suppressing the immune system rather than generating myelin.

Early versions of that drug candidate have shown dramatic increases in myelin in mouse studies. The company expects to file an investigational new drug application for MS with the FDA next year.

When we were conceiving of this project, we meant for it to be a platform that could be broadly applicable to multiple tissues. Now were moving into the remyelination work, and to me its the tip of the iceberg in terms of what can be done by taking small molecules and controlling local biology, Karp says.

For now, Karp is already thrilled with Frequencys progress, which hit home the last time he was in Frequencys office and met a speaker who shared her experience with hearing loss.

You always hope your work will have an impact, but it can take a long time for that to happen, Karp says. Its been an incredible experience working with the team to bring this forward. There are already people in the trials whose hearing has been dramatically improved and their lives have been changed. That impacts interactions with family and friends. Its wonderful to be a part of.

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Reversing hearing loss with regenerative therapy | MIT News | Massachusetts Institute of Technology - MIT News

April 1st, 2022

Company Name: Representative:

HEALIOS K.K.

Hardy TS Kagimoto, Chairman & CEO

(TSE Mothers Code: 4593)

Joint Research with the Division of Regenerative Medicine, the Institute of Medical Science for Developing a Mass Production Method of UDC Liver Buds

HEALIOS K.K. ("Healios") is currently developing a regenerative medicine treatment whereby liver organ buds created from iPS cells are injected into the liver and grown into functioning liver tissue, with the aim of improving or restoring the function of a damaged liver (development code: HLCL041). This treatment could potentially replace the need for an organ transplant for certain patients. Liver buds are created by co-culturing liver progenitor cells, which can differentiate into hepatocytes; MSCs, which have the ability to develop into various types of connective-tissues; and vascular endothelial cells, which form blood vessels. Healios has pursued research and generated data on functional assessments and quality standards for these component cells and the liver buds created from them, and it is also proceeding with the development of mass culturing and manufacturing methods.

In addition, as announced on October 20th, 2020, Healios established Universal Donor Cells ("UDCs")*, which are next-generation iPS cells created with gene-editing technology that have a reduced risk of immune rejection regardless of a patient's HLA type, and its proprietary clinical-grade UDC line. We are currently conducting research both internally and through joint collaborations with several institutions on new treatments for diseases for which there is no existing cure.

As part of these efforts, Healios is pleased to announce that it has entered into a joint research agreement with the Division of Regenerative Medicine (Prof. Hideki Taniguchi) of the Institute of Medical Science at the University of Tokyo, to advance HLCL041 utilizing UDCs. In this joint research, we plan to establish a new method for inducing differentiation of liver buds using UDCs and to develop a highly efficient and scalable cell culturing and mass manufacturing system.

For many diseases where the only effective treatment is an organ transplant, Healios believes that organ buds created from iPSCs, which have the potential to restore organ function, hold significant promise as an alternative to organ transplants and as a means to address the perennial shortage of organ donors.

This agreement does not have a material impact on our consolidated financial results for the current fiscal year. We will promptly make an announcement on any matter that requires disclosure in the future.

Outline of the Collaboration Partner

Name of the Collaborator: Division of Regenerative Medicine, The Institute of Medical Science Adress:4-6-1 Shirokanedai Minato-ku, Tokyo, 108-8639, Japan

Representative: Professor Taniguchi Hideki

* UDCs

UDCs are iPS cells created using gene-editing technology that allows them to avoid and / or reduce the body's immune rejection response. The production of Healios' UDCs involve the removal of certain HLA genes that elicit a rejection response, the introduction of an immunosuppression gene to improve immune evasion, and the addition of a suicide gene serving as a safety mechanism, each in an allogeneic iPS cell. This next-generation technology platform allows for the creation of regenerative medicine products with enhanced safety and a lower risk of immune rejection, while preserving the inherent ability of iPS cells to replicate themselves continuously and their pluripotency in differentiating into various other kinds of cells.

About the Division of Regenerative Medicine, The Institute of Medical Science:

Regenerative medicine is a challenging scientific field that is going to convert the pioneering knowledge of developmental biology and stem cell biology to clinical application. For patients with end-stage organ failure, organ transplantation is the only effective treatment; however, the paucity of transplantable organs hinders the application of this treatment for most patients. Recently, regenerative medicine with transplantable organs has attracted attention. Our laboratory is developing a novel therapeutic strategy to substitute organ transplantation. We have established novel organoid culture technologies to reconstruct human organs from stem cells, including human induced pluripotent stem cells (iPSCs), and we are going to realize transplantation of human liver primordia (liver buds [LBs]) generated from iPSCs for the treatment of liver diseases. https://stemcell-imsut.org/laboratory/?id=en#labo1

About Healios:

Healios is Japan's leading clinical stage biotechnology company harnessing the potential of stem cells for regenerative medicine. It aims to offer new therapies for patients suffering from diseases without effective treatment options. Healios is a pioneer in the development of regenerative medicines in Japan, where it has established a proprietary, gene-edited "universal donor" induced pluripotent stem cell (iPSC) line to develop next generation regenerative treatments in immuno-oncology, ophthalmology, liver diseases, and other areas of severe unmet medical need. Healios' lead iPSC-derived cell therapy candidate, HLCN061, is a next generation NK cell treatment for solid tumors that has been functionally enhanced through gene-editing. Its near-term pipeline includes the somatic stem cell product HLCM051, which is currently being evaluated in Japan in Phase 2/3 and Phase 2 trials in ischemic stroke and acute respiratory distress syndrome (ARDS), respectively. Healios was established in 2011 and has been listed on the Tokyo Stock Exchange since 2015 (TSE Mothers: 4593). https://www.healios.co.jp/en .

Contact:

Department of Corporate Communications, HEALIOS K.K.

E-mail:ir@healios.jp

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Healios K K : Joint Research with the Division of Regenerative Medicine, the Institute of Medical Science for Developing a Mass Production Method of...

Human ES cell derived RASC (respiratory airway secretory cell) transitioning to an Alveolar type 2 cell over time in culture

PHILADELPHIA A new type of cell that resides deep within human lungs and may play a key role in human lung diseases has been discovered by researchers at the Perelman School of Medicine at the University of Pennsylvania.

The researchers, who report their findings today in Nature, analyzed human lung tissue to identify the new cells, which they call respiratory airway secretory cells (RASCs). The cells line tiny airway branches, deep in the lungs, near the alveoli structures where oxygen is exchanged for carbon dioxide. The scientists showed that RASCs have stem-cell-like properties enabling them to regenerate other cells that are essential for the normal functioning of alveoli. They also found evidence that cigarette smoking and the common smoking-related ailment called chronic obstructive pulmonary disease (COPD) can disrupt the regenerative functions of RASCshinting that correcting this disruption could be a good way to treat COPD.

COPD is a devastating and common disease, yet we really dont understand the cellular biology of why or how some patients develop it. Identifying new cell types, in particular new progenitor cells, that are injured in COPD could really accelerate the development of new treatments, said study first author Maria Basil, MD, PhD, an instructor of Pulmonary Medicine.

COPD typically features progressive damage to and loss of alveoli, exacerbated by chronic inflammation. It is estimated to affect approximately 10 percent of people in some parts of the United States and causes about 3 million deaths every year around the world. Patients often are prescribed steroid anti-inflammatory drugs and/or oxygen therapy, but these treatments can only slow the disease process rather than stop or reverse it. Progress in understanding COPD has been gradual in part because micethe standard lab animalhave lungs that lack key features of human lungs.

In the new study, Morrisey and his team uncovered evidence of RASCs while examining gene-activity signatures of lung cells sampled from healthy human donors. They soon recognized that RASCs, which dont exist in mouse lungs, are secretory cells that reside near alveoli and produce proteins needed for the fluid lining of the airway.

With studies like this were starting to get a sense, at the cell-biology level, of what is really happening in this very prevalent disease, said senior author Edward Morrisey, PhD, the Robinette Foundation Professor of Medicine, a professor of Cell and Developmental Biology, and director of the Penn-CHOP Lung Biology Institute at Penn Medicine.

Observations of gene-activity similarities between RASCs and an important progenitor cell in alveoli called AT2 cells led the team to a further discovery: RASCs, in addition to their secretory function, serve as predecessors for AT2 cellsregenerating them to maintain the AT2 population and keep alveoli healthy.

AT2 cells are known to become abnormal in COPD and other lung diseases, and the researchers found evidence that defects in RASCs might be an upstream cause of those abnormalities. In lung tissue from people with COPD, as well as from people without COPD who have a history of smoking, they observed many AT2 cells that were altered in a way that hinted at a faulty RASC-to-AT2 transformation.

More research is needed, Morrisey said, but the findings point to the possibility of future COPD treatments that work by restoring the normal RASC-to-AT2 differentiation processor even by replenishing the normal RASC population in damaged lungs.

The research was supported by the National Institutes of Health (HL148857, HL087825, HL134745, HL132999, 5T32HL007586-35, 5R03HL135227-02, K23 HL121406, K08 HL150226, DK047967, HL152960, R35HL135816, P30DK072482, U01HL152978), the BREATH Consortium/Longfunds of the Netherlands, the Parker B. Francis Foundation, and GlaxoSmithKline.

Penn Medicineis one of the worlds leading academic medical centers, dedicated to the related missions of medical education, biomedical research, and excellence in patient care. Penn Medicine consists of theRaymond and Ruth Perelman School of Medicine at the University of Pennsylvania (founded in 1765 as the nations first medical school) and theUniversity of Pennsylvania Health System, which together form a $9.9 billion enterprise.

The Perelman School of Medicine has been ranked among the top medical schools in the United States for more than 20 years, according toU.S. News & World Report's survey of research-oriented medical schools. The School is consistently among the nation's top recipients of funding from the National Institutes of Health, with $546 million awarded in the 2021 fiscal year.

The University of Pennsylvania Health Systems patient care facilities include: the Hospital of the University of Pennsylvania and Penn Presbyterian Medical Centerwhich are recognized as one of the nations top Honor Roll hospitals byU.S. News & World ReportChester County Hospital; Lancaster General Health; Penn Medicine Princeton Health; and Pennsylvania Hospital, the nations first hospital, founded in 1751. Additional facilities and enterprises include Good Shepherd Penn Partners, Penn Medicine at Home, Lancaster Behavioral Health Hospital, and Princeton House Behavioral Health, among others.

Penn Medicine is powered by a talented and dedicated workforce of more than 52,000 people. The organization also has alliances with top community health systems across both Southeastern Pennsylvania and Southern New Jersey, creating more options for patients no matter where they live.

Penn Medicine is committed to improving lives and health through a variety of community-based programs and activities. In fiscal year 2021, Penn Medicine provided more than $619 million to benefit our community.

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Penn Researchers Discover New Cell Type in Human Lung with Regenerative Properties - Penn Medicine

Ontario says it will provide a $40-million loan to the Centre for Commercialization of Regenerative Medicine for its planned $580-million Hamilton facility where life-science companies can develop and commercialize cell and gene therapies.

The CCRM, a non-profit industry group, said Thursday that the facility will be run by a new subsidiary called OmniaBio Inc., which will operate what it hopes to become the largest contract development and manufacturing facility for these therapies in Canada. Up to 2,000 people could be employed at the planned 400,000-square-foot facility by 2026, and it is expected to it take on life-sciences companies of all sizes as clients.

The Alliance for Regenerative Medicine, an international advocacy group for the sector, said in 2021 that there are nearly 1,200 cell- and gene-therapy developers worldwide with more than 1,300 continuing clinical trials. This growing field of therapies treats or prevents diseases with technologies that alter genes or cells in the human body.

CCRM said the new facility would help improve the supply of cells and other biological tools for these therapies and trials in a market where demand for them is five times greater than whats currently available.

Michael May, the chief executive officer of CCRM, said in an interview that his organization has been working toward such a facility since launching nearly a decade ago. From Day 1, we understood that to drive commercialization and create companies that stay in Ontario, we needed to build manufacturing capability and capacity, he said.

The organization has built that capacity gradually, including through a partnership with the MaRS Discovery District entrepreneurship centre and the University Health Network to manufacture therapeutics for use in clinical trials. CCRM has been working over the past three years on developing the Hamilton facility, which was first announced in 2020. There is already a pipeline of potential customers, added Mr. May, who is also OmniaBios chair.

Of the $580-million costs, he said that $480-million would come from the private sector for real estate and construction at the McMaster Innovation Park. The remaining $100-million would be directed toward OmniaBios operations, and includes the $40-million loan from the province and a further $60-million from the private sector.

Economic Development Minister Vic Fedeli said that OmniaBio was the first-ever client for the provinces new Invest Ontario agency, which has earmarked $400-million to encourage businesses to set up in the province over the next four years. He told The Globe and Mail that he hoped the loan would be a signal to other businesses that his government wants to establish Ontario as a biomanufacturing hub.

It tells all of the vaccine and medical manufacturers that were open for business, he said. But it also tells the Ontario patients that theyre going to be able to have access to breakthrough technology, innovative medicines, right here with a with a made-in-Ontario stamp on it.

The provincial Progressive Conservatives used the Thursday OmniaBio news to announce they would make efforts to encourage life-sciences companies to set up in Ontario, establishing a council of medical experts and private-sector leaders to guide its work. The government said it plans to bring more vaccine, medicine, personal-protective-equipment and medical-supply manufacturing to the province.

The province also said it would work to encourage more Ontario businesses to commercialize their research, and to more easily allow locally made innovations to be used in the health care system removing roadblocks that Mr. Fedeli acknowledged in March could be a problem for innovators in the province.

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New gene- and cell-therapy manufacturing facility to launch in Hamilton with $580-million commitment - The Globe and Mail

Maryland will be committing $216 million to expand and accelerate cancer detection, screening, prevention, treatment, and research through Governor Larry Hogans recently announced Maryland Cancer Moonshot Initiative.

Governor Larry Hogan explained the personal significance of the initiative in a press release:

The reality is that cancer is a disease that has touched nearly every one of us, through family or loved ones, saidGovernor Hogan. On the day I found out I was cancer-free, I pledged that as long as I am governor and long after, I will stand with all those who are fighting this terrible disease. That is why today, I am announcing the Maryland Cancer Moonshot, to dramatically accelerate all of our efforts to detect, prevent, treat, and find a cure for cancer, so that more lives can be saved. This is a watershed moment in the fight against cancer in our state and the region.

The substantial initial investment is a part of Governor Hogans fifth supplemental budget and will include funding for the following:

Greenebaum Cancer Center:$100 million for the expansion of the University of Maryland Medical Systems Greenebaum Comprehensive Cancer Center (UMGCCC) in downtown Baltimore to providestate-of-the-art inpatient and outpatient cancer services. UMGCCC, which is a National Cancer Institute-designated comprehensive cancer center, treats approximately 3,000 new patients annually. This investment completes the states commitment to the project.

Prince Georges Comprehensive Cancer Center:$67 million to fully fund the construction of a new comprehensive cancer center on the campus of the newUniversity of Maryland Capitol Region Medical Centerin Largo. This best-in-class cancer will be a premiere clinical and research center to serve the residents of Prince Georges County and the region. The state funding includes a $27 million commitment by the governor, a $13.5 million commitment by the Maryland Senate and a $26.5 million commitment by the Maryland House of Delegates.

Cancer Research:$25 million for the University of Maryland School of Medicine and Johns Hopkins University to accelerate cancer research projects.

Pediatric Cancer Research:$1 million to support expanding pediatric cancer research at the University of Maryland School of Medicine.

Stem Cell Research Fund:$20.5 million for the Maryland Stem Cell Research Fund (MSCRF) to catalyze investment in regenerative medicine projects to develop novel cures and groundbreaking treatments for prevalent cancers.

Maryland Tech Council:$2.5 million for the BioHub Maryland Initiative to expand the states life sciences and biotechnology research workforce, with a focus on talent development, upskilling opportunities, and outreach to students in underserved communities. Maryland is proud to be home to one of thetop biotech clustersin the United States.

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Maryland Cancer Moonshot Initiative Promises $216 Million for Research and Treatment Conduit Street - Conduit Street

The most advanced, quickest and easiest, single-use kit for macro, micro, and nano fat tissue harvesting, processing, and transfer.

CARLSBAD, Calif., March 29, 2022 /PRNewswire/ -- Cellmyx, the authority on autologous adipose grafting and transfer, and a leader in medical technologies for orthopedic physicians,pain management and regenerative medicine, announces U.S. Food and Drug Administration (FDA) 510(k) clearance for intelliFat BOD (Ref.# K210528). The most advanced, quickest and easiest, single usekit for macro, micro, and nano fat tissue harvesting, processing,and transfer.

U.S. regulators have cleared the way for this groundbreaking new medical appliance and technology for use in orthopedic, plastic, and cosmetic surgery procedures. intelliFat BOD successfully uses a patient's own body fat, clinically referred to as adipose tissue, to aid in patient recovery and healing. In some cases, intelliFat BOD is used in conjunction with traditional orthopedic surgery to further advance patient outcomes. intelliFat BOD is particularly attractive to physicians because it's compliant with the latest FDA guidelines, preserving cellular and tissue micro-architecture of adipose, eliminating residual oil emulsion and blood, thereby providing a tissue byproduct that is minimally manipulated in accordance with FDA guidelines for Human Cell and Tissue Products.

Kits are sterile, and disposable, and contain a full suite of proprietary and stand-alone components toharvest, process, and transfer autologous adipose tissue for use as an alternative, and/or as an adjunct, to surgery for filling soft tissue defects and promoting healing in orthopedics, plastic, and cosmetic surgery, and a multitude of other surgical procedures and specialties.

Physicians feel empowered. They have the assets they need right at their fingertips to perform this revolutionary procedure without incising, stitching, or scarring the patient. intelliFat BOD streamlines procedure times to under 30 minutes with its patented and unparalleled harvesting, processing, and transfer system. Patients experience no discomfort or downtime during or post-procedure and may return to normal social activities immediately with clearance from their provider.

According to Associate Clinical Professor of Medicine, University of Connecticut School of Medicine, Fellow of the American Osteopathic Academy of Sports Medicine, and Board Certified in Sports Medicine & Regenerative Medicine Dr. Paul D. Tortland, D.O. FAOASM, RSMK:

"I began performing autologous fat derived treatments for orthopedic regenerative medicine in 2009, the first physician in New England, and among the earliest in the country. Over the years I've trialed most commercially available systems to harvest and prepare adipose for injection. I have found these systems are cumbersome to use, time-consuming, or produce suboptimal product for injection.But with intelliFat BODCellmyx hit the mark. Their kit is elegantly simple, fast and easy to use, and produces a superlative final product that's easy to inject. Most importantly, I'm seeing outstanding clinical results."

The intelliFat510(k) specifically includes procedures for neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, plastic, cosmetic, and reconstructive surgery, general surgery, orthopedic surgery, gynecological surgery, laparoscopic surgery, arthroscopic surgery, and thoracic surgery.

About Cellmyx:

Millennium Medical Technologies dba Cellmyx is a U.S. Food and Drug Administration (FDA) registered manufacturer committed to providing comprehensive solutions and support for harvesting, isolation, and deployment of PHSA 361 compliant tissue and cells. Cellmyx is committed to advancing the art of cosmetic surgery and regenerative medicine and continues to explore and develop novel concepts to enhance their proprietary product portfolio bringing physicians the most advanced technology in adipose tissue transfer.

Media Contact:

Terence Kazlow, Director of Sales and Marketing Greg Miles, CEO and Founder 949-215-8560 [emailprotected]

SOURCE Cellmyx

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Medical Technologies Leader Cellmyx Announces US Food and Drug Administration (FDA) 510(k) Clearance for intelliFat BOD (Ref.# K210528) - PR Newswire

SILVER SPRING, Md., March 31, 2022 (GLOBE NEWSWIRE) -- Aziyo Biologics, Inc. (Nasdaq: AZYO), a commercial-stage regenerative medicine company focused on creating the next generation of differentiated products and improving outcomes in patients undergoing surgery, today announced that it will be participating in the Lytham Partners Spring 2022 Investor Conference taking place virtually on April 4-7, 2022.

The Companys webcast presentation will be available for viewing at 11:00am ET on Monday, April 4, 2022, on the Company's website at http://www.aziyo.com. The webcast will also be archived and available for replay.

Management will be participating in virtual one-on-one meetings throughout the event. To arrange a meeting with management, please contact Lytham Partners at 1x1@lythampartners.com or register at http://www.lythampartners.com/spring2022invreg.

About Aziyo Biologics

Aziyo Biologics is a commercial-stage regenerative medicine company focused on creating the next generation of differentiated products and improving outcomes in patients undergoing surgery, concentrating on patients receiving implantable medical devices. Since its founding in 2015, the Company has created a portfolio of commercial-stage products used in cardiovascular, orthopedic, and reconstructive specialties. For more information, visit http://www.Aziyo.com.

Investors:Leigh Salvo Gilmartin Groupinvestors@aziyo.com

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Aziyo Biologics to Participate in the Lytham Partners Spring 2022 Investor Conference - GlobeNewswire

Regenerative medicine specialist CollPlant (NASDAQ: CLGN) has revealed that the 3D bioprinted breast tissues its developing are set to enter animal trials in the very near future.

Alongside the release of its FY 2021 results, which show that it generated $15.6 million in revenue, 155.7% more than the $6.1 million it reported in FY 2020, CollPlant announced that its bioprinted implants will enter in-vivo testing from Q2 2022.

Currently being developed with BICO firm CELLINK, the grafts are designed to gradually degrade and be replaced by native tissues, in a safer alternative to breast augmentation procedures. With further R&D, the companies believe their approach could be deployed in up to 2.2 million surgeries, enabling them to address a market worth an estimated $2.8 billion.

In the year ahead, we anticipate reaching development milestones for some of our leading programs, including the start of a large animal study for our 3D bioprinted regenerative breast implant program, said Yehiel Tal, CEO of CollPlant. We are also making continued progress with the development of bio-inks for 3D bioprinting applications, and with development of a photocurable dermal filler.

CollPlants FY 2021 financials

Although CollPlant hasnt provided a division-by-division breakdown of its annual revenue, its clear from what has been revealed, that its rate of growth is beginning to accelerate. In large part, the firms rapid rise in revenue last year was down to a $103 million bioprinting contract it signed with AbbVie company Allergan Aesthetics during March 2021.

As part of this agreement, the latter has begun to use CollPlants artificial collagen to create dermal and soft tissue fillers, and it could go on to develop two more products in future. The deal has also seen CollPlant receive an initial $14 million, and while this represented 90% of its FY 2021 revenue, it could gain another $89 million in milestone payments should any of Allergan Aesthetics products make it to market.

In addition to generating more revenue in FY 2021 than FY 2020, the company improved its profitability as well, raising its gross profit from $3.1 million to $13.6 million. This was primarily due to the fact that over this period, its cost of revenue fell from $3 million to $2 million, owing to expenses related to royalties, bio-ink and rhCollagen sales, and the ending of its deal with United Therapeutics in FY 2020.

Thanks largely to a registered direct offering in February 2021, which saw it raise $31.8 million in net proceeds and $6 million from the exercise of warrants, CollPlant was able to attract $38.8 million in financing across last year. As it happens, some $31.6 million of this funding was deployed immediately in short-term cash deposits, the likes of which generated up to $172,000 for the firm in FY 2020.

CollPlants breast implant trials

Since announcing the creation of its first regenerative breast implants in 2019, the firm has steadily sought to improve their clinical and commercial viability. The tissues themselves are made from patient fat cells and ECM components, as well as rhCollagen, CollPlants tobacco plant-grown alternative to animal or cadaver-sourced collagen.

In theory, once these grafts are injected into patients tissues, they foster the regeneration of native cells before slowly degrading, leaving behind no foreign contaminants. CollPlant says this procedure could offer a revolutionary alternative to silicone implants or fat transfer operations which come with a risk of adverse events, but they arent yet ready for market, and continue to undergo clinical trials.

One way the company has sought to accelerate the development of its bioprinted breast implants is via its recently-established partnership with CELLINK. When the collaboration was announced last month, CollPlant said that CELLINKs high-throughput bioprinters and expertise could enable it to overcome the hurdles facing its implants scalability.

That being said, the firm has also worked with 3D Systems before to develop breast reconstruction treatments for cancer survivors, and its possible that its current work will allow it to build on some of the findings it made as part of this project too.

In the case of its newly-announced trials, CollPlant has let little slip about their exact set up, but theyre understood to offer an opportunity to put its learnings from preclinical studies into practice, while taking a significant step forward in its breast implants R&D, in that their viability will now be tested in-vivo at scale.

Advances in breast implant bioprinting

Even though 3D bioprinting itself remains an emerging technology, a significant amount of progress has already been made in using it to produce viable breast implants. Earlier this year, Healshape raised $6.8 million towards the R&D of its patient-specific breast tissues, designed to treat those who have undergone a mastectomy.

In the past, Plcoskin has also announced plans to work with Yonsei University and LipoCoat with the aim of coming up with a novel 3D printed breast implant. In essence, the project was set up to combine LipoCoats lipid film coating technology and Plcoskins PCL-collagen coating approach, as a means of developing a uniquely-glazed graft that offers a reduced risk of infection or rejection.

Elsewhere, similar technologies are being developed to create all sorts of other tissues as well, ranging from the 3D bioprinted human tescticle cells produced at the University of British Columbia, to the bioprinted liver tissues of T&R Biofab.

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Featured image shows a 3D bioprinted breast implant produced by CollPlant. Photo by Valerie Arad, CollPlant.

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CollPlant to trial 3D bioprinted breast implants in breakthrough animal study - 3D Printing Industry

Newswise WINSTON-SALEM, N.C. March 31, 2022 Cancer of the appendix is rare, affecting only 1 in 100,000 people in the United States annually. However, because its so rare, theres limited research to help guide treatment decisions. But now, researchers at Atrium Health Wake Forest Baptists NCI-designated Comprehensive Cancer Center hope to change that with support from a $2.5 million grant from the National Cancer Institute.

Because the appendix is part of the gastrointestinal system, appendiceal cancers have traditionally been treated in the same way as colon cancer, said Lance Miller, associate professor of cancer biology at Wake Forest School of Medicine and co-principal investigator of the study. However, were learning that these cancers are molecularly very different. By increasing our molecular understanding of appendiceal cancer, we hope to have greater insight on how best to treat, which will lead to better outcomes.

According to Miller, appendiceal cancer is often diagnosed at late stages when it has already spread throughout the peritoneal cavity, the space within the abdomen that contains the stomach, liver and intestines. As a result, current treatment options are limited.

One treatment forpatients withappendiceal tumors with spread to the peritoneal cavityis cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC). TheCRS/HIPECprocedureinvolvessurgicallyremoving the cancerous tumors followed by the administration of heated chemotherapy directly into the abdomen to kill any residual cancer cells.

Wake Forest Baptist Medical Center was among the first hospitals in the U.S. to offer the procedure in 1991. The program is led by Dr. Edward Levine, professor of surgical oncology at Wake Forest School of Medicine and co-investigator of this study.

A major challenge is that some patients respond well to CRS/HIPEC, and some do not, said Dr. Konstantinos Votanopoulos, professor of surgery and director of the Wake Forest Organoid Research Center (WFORCE), a joint effort between the Wake Forest Baptist Comprehensive Cancer Center and the Wake Forest Institute for Regenerative Medicine (WFIRM) to tailor personalized therapy for patients. CRS/HIPEC is an aggressive, yet often effective, treatment in prolonging survival, but we dont know how patients will respond ahead of time.

Votanopoulos, who is also a co-principal investigator of the study, said the grant will support three objectives. One, researchers will build on previous research to develop a genetic test that will help identify patients who will benefit from CRS/HIPEC. Two, researchers will study gene expression patterns of high-grade tumors and how they impact survival. And three, the grant will support the use of patient-derived tumor organoids to study how mutations in the cancer might make a tumor more sensitive or resistant to certain chemotherapy drugs.

The creation of an organoid begins with a tissue biopsy of a tumor. Cells from this biopsy are then used to grow three-dimensional, patient-specific tumor organoids in the lab. By exposing the organoids to various chemotherapy drugs and observing their response, scientists can possibly predict how a patient will respond to treatment.

This research has the potential to create new possibilities for personalized medicine in the treatment of appendiceal cancer, Miller said.

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Researchers Receive $2.5 Million Grant to Study Appendiceal Cancer - Newswise

Tender Foods, a food technology startup co-founded by four Harvard-affiliated researchers that produces alternative meats, is preparing for a product launch later this year.

The company, which produces plant-based meat spun from liquid polymers, is one of 27 startups launched in fiscal year 2021 to commercialize innovations from Harvard research labs. Tender Foods specializes in products that have a unique texture, structure, and ultimately taste, according to its founders.

A lot of the stuff that tries to mimic meat is textured, but its not fibrous, so its aligned and its a block of stuff, but its not individual fibers, said Luke A. MacQueen, one of the startups co-founders and a Harvard postdoctoral researcher in Bioengineering.

The Tender Foods products will better mimic the texture of real meat, MacQueen said.

MacQueen co-founded the company alongside three other Harvard affiliates: Bioengineering and Applied Physics professor Kevin K. Kit Parker, Grant M. Gonzalez 13, and SEAS researcher Christophe Chantre.

The fibers in Tender Foods meat are made using technology developed by Parker and his colleagues. The research group studied rotary jet-spinning, which uses centrifugal force to elongate liquid polymers into fibers. MacQueen likened the device to a cotton candy machine that works with different kinds of proteins.

The technology was initially used for various other purposes, including organ regeneration: in 2017, the researchers managed to spin nanofibers into biocompatible heart valves. Two years later, they showed the same could be done with gelatin scaffolds to hold animal muscle cells.

Every lesson learned from building tissues for regenerative medicine was applicable to building tissue to eat, Parker wrote in an email.

MacQueen said he is excited to see the variety of meats that might emerge from the startups technology.

When those fibers are spun and collected into a system, they can be tailored to be like the meat products people enjoy, whether they be as simple as a chicken breast or much more complicated layered structures, he said. Those can all be made in an artisanal way, starting with this very basic building block.

The research received funding from the Harvard Office of Technology Development and Harvards Wyss Institute for Biologically Inspired Engineering.

The first efforts to patent discoveries from my lab pertaining to meat were shot down by OTD around 2006, Parker wrote. We kept pushing.

MacQueen said he is excited to introduce Tender Foods products to the public.

As a young startup, weve had to kind of stay under the radar a little bit, but theres good things coming down the road, he said.

I ate some this morning, Parker added in an email. It was delicious.

Staff writer Felicia He can be reached at felicia.he@thecrimson.com.

Staff writer James R. Jolin can be reached at james.jolin@thecrimson.com.

Link:
Company Founded by Harvard Researchers to Launch Alternative Meat Product | News - Harvard Crimson

C-CAR039 showed positive efficacy and safety data in patients with relapsed or refractory B-cell non-Hodgkin lymphoma.

Officials with the FDA have granted both Regenerative Medicine Advanced Therapy (RMAT) Designation and Fast Track Designation to C-CAR039, a novel autologous bi-specific chimeric antigen receptor (CAR) T-cell therapy, for the treatment of patients with relapsed or refractory (r/r) diffuse large B cell lymphoma (DLBCL).

C-CAR039 targets both the CD19 and CD20 antigens, and early results from an investigator-led trial demonstrate positive efficacy and safety data in patients with r/r B-cell non-Hodgkin lymphoma. As of April 20, 2021, 34 patients received the therapy, 28 of whom were eligible for safety analyses and 27 of whom were evaluable for efficacy analyses. Patients median age was 55.5 years and 75% had cancer of Ann Arbor stage 3/4. Participants had a median of 3 prior lines of therapy and bridging therapy had been given to 17.9% of patients.

According to a press release, the best overall response rate was 92.6%, with a complete response rate of 85.2%. Patients had a median time to response of 1 month and at a median follow-up of 7 months, 74.1% of patients were still in complete remission. Furthermore, the 6-month estimated progression-free survival rate was 83.2%.

This is great news for CBMG that the FDA has granted C-CAR039 both RMAT and fast track designations based on its potential to increase objective and complete response rate in r/r DLBCL, said Tony Liu, chairman and CEO of Cellular Biomedicine Group, in the press release. The clinical data based on our clinical trials in China continue to support the hypothesis that C-CAR039 is the best-in-class CAR T asset for patients in this indication.

Cytokine release syndrome (CRS) was reported in 96% of patients, 92% of which was grade 1/2. Only 1 patient had grade 3 CRS. Immune effector cell-associated neurotoxicity syndrome occurred at grade 1 in 2 patients and no grade 2 or higher neurologic events were reported, according to the press release. The researchers will continue to evaluate patients with longer follow-up.

Separately, the FDA Office of Orphan Products Development granted an Orphan Drug Designation to C-CAR039 for the treatment of follicular lymphoma in June 2021. The Investigational New Drug application was cleared by the FDA on December 10, 2021.

We are working toward initiating 1b/2 trials for C-CAR039 in the US soon, Liu said in the press release. And we will work closely with the FDA to seek the best path forward to deliver the drug to patients in the US and EU.

REFERENCE

CBMG Receives FDA Regenerative Medicine Advanced Therapy and Fast Track Designations. News release. CBMG; January 12, 2022. Accessed January 13, 2022. https://www.cellbiomedgroup.com/newsroom/fda-rmat?lang=en

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FDA Grants Regenerative Medicine Advanced Therapy, Fast Track Designations to Novel CAR T-Cell Therapy for Relapsed, Refractory B-cell Non-Hodgkin...

NEW YORK, Jan. 10, 2022 /PRNewswire/ --Reports and Data has published its latest report titled "Stem Cells Market By Product (Adult Stem Cells, Human Embryonic Stem Cells, IPS Cells, and Very Small Embryonic-Like Stem Cells), By Technology (Cell Acquisition, Cell Production, Cryopreservation, and Expansion & Sub-Culture), By Therapies (Allogeneic Stem Cell Therapy and Autologous Stem Cell Therapy), and By Application (Regenerative Medicine and Drug Discovery & Discovery), and By Region Forecast To 2028."

According to the latest report by Reports and Data, the global stem cells market size was USD 10.13 billion in 2020 and is expected to reach USD 19.31 Billion in 2028 and register a revenue CAGR of 8.4% during the forecast period, 2021-2028.

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Drivers, Restraints, & Opportunities

Stem cells are cells that have the potential to differentiate into different types of cells in the body. Stem cells have the ability of self-renewal and differential into specialized adult cell types. Stems cells are being explored for their potential in tissue regeneration and repair and in treatment of chronic diseases. Increasing number of clinical trials are underway to assess and establish safety and efficacy of stem cell therapy for various diseases and disorders. Rapid advancement in stem cell research, rising investment to accelerate stem cell therapy development, and increasing use of stem cells as therapeutic tools for treatment of neurological diseases and malignancies are some key factors expected to drive market revenue growth over the forecast period. in addition, growing incidence of type 1 diabetes, spinal cord injuries, Parkinson's diseases, and Alzheimer's disease, among others have further boosted adoption of stem cell therapies and is expected to fuel revenue growth of the market going ahead.

Stem cells are basic cells in the body from which cells with specialized functions are generated such as heart muscle cells, brain cells, bone cells, or blood cells. Maturation of stem cells into specialized cells have enabled researchers and doctors better understand the pathophysiology of diseases and conditions. Stem cells have great potential to be grown to become new tissues for transplant and in regenerative medicine. Stem cells that are programmed to differentiate into tissue-specific cells are widely being used to test new drugs that target specific diseases, such as nerve cells can be generated to test safety and efficacy of drugs that are being developed for nerve disorders and diseases. Stem cells are of two major types: pluripotent cells that can differentiate into any cells in the adult body and multipotent cells that are restricted to differentiate into limited population of cells. Increasing clinical research is being carried out to advance stem cell therapy to improve cardiac function and to treat muscular dystrophy and heart failure. Recent progress in preclinical and clinical research have expanded application scope of stem cell therapy into treating diseases for which currently available therapies have failed to be effective. This is expected to continue to drive revenue growth of the market going ahead.

However, immunity-related concerns associated with stem cell therapies, increasing incidence of abnormalities in adult stem cells, and rising number of ethical issues associated with stem cell research such as risk of harm during isolation of stem cells, therapeutic misconception, and concerns surrounding safety and efficacy of stem cell therapies are some key factors expected to restrain market growth to a certain extent over the forecast period.

To identify the key trends in the industry, research study at https://www.reportsanddata.com/report-detail/stem-cells-market

COVID-19 Impact Analysis

Rising use of Human Embryonic Stem Cells in Regenerative Medicine to Drive Market Growth:

Human embryonic stem cells (ESCs) segment is expected to register significant revenue growth over the forecast period attributable to increasing use of human embryonic stem cells in regenerative medicine and tissue repair, rising application in drug discovery, and growing importance of embryonic stem cells as in vitro models for drug testing.

Cryopreservation Segment to Account for Largest Revenue Share:

Cryopreservation segment is expected to dominate other technology segments in terms of revenue share over the forecast period. Cryopreservation techniques are widely used in stem cell preservation and transport owing to its ability to provide secure, stable, and extended cell storage for isolated cell preparations. Cryopreservation also provides various benefits to cell banks and have numerous advantages such as secure storage, flexibility and timely delivery, and low cost and low product wastage.

Regenerative Medicine Segment to Lead in Terms of Revenue Growth:

Regenerative medicine segment is expected to register robust revenue CAGR over the forecast period attributable to significant progress in regenerative medicine, increasing research and development activities to expand potential of stem cell therapy in treatment of wide range of diseases such as neurodegenerative diseases, diabetes, and cancers, among others, and rapid advancement in cell-based regenerative medicine.

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North America to Dominate Other Regions in Terms of Revenue Share:

North America is expected to dominate other regional markets in terms of revenue share over the forecast period attributable to increasing adoption of stem cell therapy to treat chronic diseases, rising investment to accelerate stem cell research, approval for clinical trials and research studies, growing R&D activities to develop advanced cell-based therapeutics, and presence of major biotechnology and pharmaceutical companies in the region.

Asia Pacific Market Revenue to Expand Significantly:

Asia Pacific is expected to register fastest revenue CAGR over the forecast period attributable to increasing R&D activities to advance stem cell-based therapies owing to rapidly rising prevalence of chronic diseases such as cancer and diabetes, rising investment to accelerate development of state-of-the-art healthcare and research facilities, establishment of a network of cell banks, increasing approval for regenerative medicine clinical trials, and rising awareness about the importance of stem cell therapies in the region.

Major Companies in the Market Include:

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Market Segmentation:

For the purpose of this report, Reports and Data has segmented the stem cells market based on product, technology, therapies, application, and region:

Product Outlook (Revenue, USD Billion; 2018-2028)

Technology Outlook (Revenue, USD Billion; 2018-2028)

Therapy Outlook (Revenue, USD Billion; 2018-2028)

Application Outlook (Revenue, USD Billion; 2018-2028)

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Regional Outlook (Revenue, USD Billion, 2018-2028)

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Genotyping assay marketsize was USD 17.7 Billion in 2020 and is expected to register a robust CAGR of 22.4% during the forecast period. Key factors driving market revenue growth are increasing prevalence of genetic disorders such as Turner syndrome, Alzheimer's, hemophilia, and Parkinson's, and rising demand for genotyping assays globally.

Nurse call system marketsize was USD 1.61 Billion in 2020 and is expected to register a revenue CAGR of 8.8% during the forecast period. Increasing need to improve communication among doctors and nurses, growing focus on reducing patient disturbances, and higher adoption of real-time location systems are key factors expected to drive market revenue growth over the forecast period. Moreover, increasing need to improve patient response time is another factor expected to drive market growth in the near future.

Cellular health screening marketsize was USD 2.84 billion in 2020 and is expected to register a CAGR of 10.3% during the forecast period. Increasing application of cellular health screening in precision medicine, rising emphasis on preventive healthcare, rapidly and growing geriatric population globally are key factors expected to drive market revenue growth over the forecast period.

Live cell encapsulation marketsize was USD 269 million in 2020 and is expected to register a CAGR of 3.6% during the forecast period. Key factors, such as increasing awareness about cell encapsulation techniques to treat several chronic disorders and growing need for clinical potency of cell encapsulation techniques, are escalating global market revenue growth.

Blood preparation marketsize was USD 41.30 billion in 2020 and is expected to register a CAGR of 5.8% during the forecast period. The global market is projected to gain rapid traction in the upcoming years owing to various favorable factors.

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Rising Focus on Exploring Potential of Stem Cells as Therapeutic Tools in Drug Targeting and Regenerative Medicine to Fuel Revenue Growth of Stem...

Cell and gene therapy developers globally raised an all-time annual record in 2021. However, European firms missed out on the funding growth.

Companies around the world developing cell and gene therapies raised 20.1B ($23.1B) over 2021, said the advanced therapy advocacy organization the Alliance for Regenerative Medicine (ARM) in a briefing this week. This bumper catch beat 2020s total of 17.3B ($19.9B) by 16%.

The growth from 2020 to 2021 was primarily driven by companies in the US. With a fresh 15.7B ($18B) in the bank, US-based companies saw an impressive 53% jump in investments compared to 2020. In contrast, their European counterparts raised 2.9B ($3.3B), 8% less funding than in 2020.

Both European and US gene and cell therapy players had seen record funding growth in 2020 compared to 2019, said Stephen Majors, ARMs Director of Public Affairs. However, its too early to establish why European and Asian companies havent matched the rapid cash growth seen in the US over 2021.

Its something well watch closely over the next year to determine what the causes may be and whether they are region-specific, said Majors.

Nonetheless, the funding numbers need to be interpreted in the correct context, said Antoine Papiernik, Chairman and Managing Partner of the venture capital (VC) firm Sofinnova Partners. European contributions to the field of cell and gene therapy remain immense.

Its not about how much you raise in one year; its about the level of expertise, competencies, and technologies, said Papiernik. These are the fundamentals for long-term excellence and growth, which we strongly believe in.

If there is one area where Europe is, without a doubt, on par with the US, its in new modalities, which include gene and cell therapies.

Of the various funding sources going to cell and gene therapies, VC funding increased the most in 2021, with a huge 73% jump to 8.5B ($9.8B). This trend mirrored the deluge in life sciences VC funding in the last year.

Simultaneously, gene and cell therapy companies were hit by struggling stock markets affecting the rest of the biotech sector. This mismatch is creating a bulge in funding for VC firms and potentially limiting exit options.

Inflation concerns made it particularly difficult for smaller, early-stage companies that are not yet profitable, said Majors. If inflation concerns subside in 2022, and with positive data readouts, we could see stronger performance for biotech public equities.

When the total is broken down by the types of technology getting funded, cell therapies in immuno-oncology such as CAR-T cell therapies saw the biggest funding increase: a jump of 26% since 2020. This was followed by gene therapy firms with 14% more incoming cash, and tissue engineering players, whose investments went up by 10%.

Cell therapy companies outside of immuno-oncology experienced a tighter year for financing in 2021 than in 2020, taking in 15% less funding at 1.7B ($2B). However, Majors told me that funding in this field has regularly fluctuated in the last several years.

The decrease over 2021 is not an outlier in comparison to historical trends, Majors noted. Due to the smaller size of this technology segment, just one or two financing deals can have a large impact on total financing on an annual basis.

Another important trend in the ARMs report was the rising importance of gene-editing technology. Of the total gene therapy financing, 45% was raised by companies developing gene-editing technology, up from 38% in 2018.

Investor interest in gene editing has been buoyed by clinical successes from frontrunner gene therapy players in the last year. One example from June 2021 was the promising performance of an in vivo CRISPR treatment developed by Intellia Therapeutics and Regeneron in patients with the rare disease transthyretin amyloidosis.

Gene-editing firms CRISPR Therapeutics and Vertex Pharmaceuticals are causing excitement with progress in tackling the blood disorder sickle cell disease. They are gunning to file for approval of their CRISPR gene-edited therapy for this condition in late 2022.

Investors have taken note of these early successes and see this approachs potential to treat a wide range of diseases, said Majors. Also, as this technology continues to progress, the number of companies with at least one clinical or preclinical asset in gene editing continues to rise.

Another outcome to look forward to for gene and cell therapy in 2022 is a potential record number of drug approvals. A bunch of gene therapy hopefuls including GenSight, uniQure, and BioMarin are poised to bring their candidates to the regulatory finish line in the US and Europe.

The EMA is slated to make decisions on therapies targeting aromatic l-amino acid decarboxylase deficiency, Leber hereditary optic neuropathy, and two types of hemophilia, said Majors. By the end of 2022, the number of EMA-approved gene therapies for rare diseases may have doubled from a year earlier.

However, some of the major hurdles for the field will likely be the delivery of gene and cell therapies to their target in the body as well as deciding the right dosage. The manufacture of these complex therapies is also a big bottleneck that many startups aim to tackle.

Additionally, the withdrawal of bluebird bios gene therapy from Germany in May 2021 over pricing disagreements demonstrates that regulatory approval is just the beginning for developers of gene and cell therapies. Their pricing strategy will need to walk the tightrope of making a profit while avoiding clashes with healthcare systems.

In any case, European companies will continue to play a strong role in the evolution of the cell and gene therapy sphere.

Lets not forget that the first gene therapy to be brought to the market was European, said Papiernik, referring to the gene therapy Strimvelis, which was sold by GlaxoSmithKline to Orchard Therapeutics in 2018.

Europe continues to excel in the development of gene and cell therapies and never has there been more opportunities for investment.

Cover image via Elena Resko. Inline images via the Alliance for Regenerative Medicine

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Europe Trailed US in Record Gene and Cell Therapy Funding in 2021 - Labiotech.eu

News Release

Tuesday, January 11, 2022

Use of patient-derived stem cells will enable high-throughput drug screening for potential therapeutics.

Researchers at the National Eye Institute (NEI) have developed the first patient-derived stem cell model for studying eye conditions related to oculocutaneous albinism (OCA). The models development is described in the January issue of the journal Stem Cell Reports. NEI is part of the National Institutes of Health.

This disease-in-a-dish system will help us understand how the absence of pigment in albinism leads to abnormal development of the retina, optic nerve fibers, and other eye structures crucial for central vision, said Aman George, Ph.D., a staff scientist in the NEI Ophthalmic Genetics and Visual Function Branch, and the lead author of the report.

OCA is a set of genetic conditions that affects pigmentation in the eye, skin, and hair due to mutation in the genes crucial to melanin pigment production. In the eye, pigment is present in the retinal pigment epithelium (RPE), and aids vision by preventing the scattering of light. The RPE is located right next to the eyes light-sensing photoreceptors and provides them nourishment and support. People with OCA lack pigmented RPE and have an underdeveloped fovea, an area within the retina that is crucial for central vision. The optic nerve carries visual signals to the brain.

People with OCA have misrouted optic nerve fibers. Scientists think that RPE plays a role in forming these structures and want to understand how lack of pigment affects their development.

Animals used to study albinism are less than ideal because they lack foveae, said Brian P. Brooks, M.D., Ph.D., NEI clinical director and chief of the Ophthalmic Genetics and Visual Function Branch. A human stem cell model that mimics the disease is an important step forward in understanding albinism and testing potential therapies to treat it.

To make the model, researchers reprogrammed skin cells from individuals without OCA and people with the two most common types of OCA (OCA1A and OCA2) into pluripotent stem cells (iPSCs). The iPSCs were then differentiated to RPE cells. The RPE cells from OCA patients were identical to RPE cells from unaffected individuals but displayed significantly reduced pigmentation.

The researchers will use the model to study how lack of pigmentation affects RPE physiology and function. In theory, if fovea development is dependent on RPE pigmentation, and pigmentation can be somehow improved, vision defects associated with abnormal fovea development could be at least partially resolved, according to Brooks.

Treating albinism at a very young age, perhaps even prenatally, when the eyes structures are forming, would have the greatest chance of rescuing vision, said Brooks. In adults, benefits might be limited to improvements in photosensitivity, for example, but children may see more dramatic effects.

The team is now exploring how to use their model for high-throughput screening of potential OCA therapies.

NEI leads the federal governments research on the visual system and eye diseases. NEI supports basic and clinical science programs to develop sight-saving treatments and address special needs of people with vision loss. For more information, visit https://www.nei.nih.gov.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

Aman George, Ruchi Sharma, Tyler Pfister, Mones Abu-Asab, Nathan Hotaling, Devika Bose, Charles DeYoung, Justin Chang, David R. Adams, Tiziana Cogliati, Kapil Bharti, Brian P. Brooks. In Vitro Disease Modeling of Oculocutaneous Albinism Type I and II Using Human Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium (2022). doi: 10.1016/j.stemcr.2021.11.01.https://www.cell.com/stem-cell-reports/fulltext/S2213-6711(21)00597-X.

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NIH researchers develop first stem cell model of albinism to study related eye conditions - National Institutes of Health