Category Archives: Regenerative Medicine

A review paper by scientists at the University of Oxford discussed possible benefits of using humanoid musculoskeletal robots and soft robotic systems as bioreactor platforms in producing clinically useful tendon constructs.

The new review paper, published on 15 Sep 2022 in the journal Cyborg and Bionic Systems, summarizes current trends in tendon tissue engineering and discusses how conventional bioreactors are unable to provide physiologically relevant mechanical stimulation given that they largely rely on uniaxial tensile stages. The paper then highlights musculoskeletal humanoid robots and soft robotic systems as platforms for providing physiologically relevant mechanical stimulation that could overcome this translational gap.

Tendon and soft tissue injuries are a growing social and economic problem, with the tendon repair market in the United States being estimated at $ 1.5 billion USD. Tendon repair surgeries have high rates of revision, with upwards of 40% of rotator cuff repairs failing post-operatively. Production of engineered tendon grafts for clinical use is a potential solution for this challenge. Conventional tendon bioreactors mainly provide uniaxial tensile stimulation. The lack of systems which recapitulate in vivo tendon loading is a major translational gap.

The human body provides tendons with three-dimensional mechanical stress in the form of tension, compression, torsion, and shear. Current research suggests that healthy native tendon tissue requires multiple types and directions of stress. Advanced robotic systems such as musculoskeletal humanoids and soft robotics promising platforms that may be able to mimic in vivo tendon loading explained author Iain Sander, a researcher at the University of Oxford with the Soft Tissue Engineering Research Group.

Musculoskeletal humanoid robots were initially designed for applications such as crash test dummies, prostheses, and athletic enhancement. They attempt to imitate human anatomy by having similar body proportions, skeletal structure, muscle arrangement, and joint structure. Musculoskeletal humanoids such as Roboy and Kenshiro use tendon-driven systems with myorobotic actuators that mimic human neuromuscular tissue. Myorobotic units consist of a brushless dc motor which generates tension like human muscles, attachment cables which act as the tendon unit, and a motor driver board with a spring encoder, which act as the neurologic system by sensing variables including tension, compression, muscle length, and temperature. Proposed advantages of musculoskeletal humanoids include the ability to provide multiaxial loading, potential for loading in consideration of human movement patterns, and provision of loading magnitudes comparable to in vivo forces. One recent study has demonstrated the feasibility of growing human tissue on a musculoskeletal humanoid robot for tendon engineering.

Biohybrid soft robotics is focused on developing biomimetic, compliant robotic systems which permit adaptive, flexible interactions with unpredictable environments. These robotic systems are actuated through a number of modalities, including temperature, pneumatic and hydraulic pressure, and light. They are made of soft materials including hydrogels, rubber, and even human musculoskeletal tissue. These systems are already being used to provide mechanical stimulation to smooth muscle tissue constructs and have been implemented in vivo in a porcine model. These systems are attractive for tendon tissue engineering given that: i) their flexible, compliant properties allow them wrap around anatomic structures, mimicking the configuration of native tendon ii) they are capable of providing multiaxial actuation and iii) a number of the techniques used in soft robotics overlap with current tendon tissue engineering practices.Looking forward, the team envision advanced robotic systems as platforms which will provide physiologically relevant mechanical stimulus to tendon grafts prior to clinical use. There are a number of challenges to consider as advanced robotic systems are implemented. Firstly, it will be important for future experiments to compare technologies proposed in this review to conventional bioreactors. With development of systems capable of providing multiaxial loading, it will be important to find methods for quantifying strain in 3D. Finally, advanced robotic systems will need to be more affordable and accessible for widespread implementation.

An increasing number of research groups are showing that it is feasible to use advanced robotics in combination with living cells and tissues for tissue engineering and bioactuation applications. We are now at an exciting stage where we can explore the different possibilities of incorporating these technologies in tendon tissue engineering and examine whether they can really help improve the quality of engineered tendon grafts, said Pierre-Alexis Mouthuy, the review articles senior author. In the long term, these technologies have potential to improve quality of life for individuals, by decreasing pain and risk of tendon repair failure, for healthcare systems, by reducing the number of revision surgeries, and for the economy, by improving workplace productivity and lowering healthcare costs.

Authors of the paper include Iain Sander, Nicole Dvorak, Julie Stebbins, Andrew J Carr, Pierre-Alexis Mouthuy.

This work has been completed with the financial support of the United 16 Kingdoms Engineering and Physical Sciences Research Council (project number: 17 P/S003509/1), and the Rhodes Trust.

The paper, " Advanced Robotics to Address the Translational Gap in Tendon Engineering," was published in the journal Cyborg and Bionic Systems on 15 Sep 2022, at DOI: https://doi.org/10.34133/2022/9842169.

Reference: Iain L. Sander1,2*, Nicole Dvorak1 , Julie A. Stebbins1,2, Andrew J. Carr1 , Pierre-Alexis Mouthuy1,3

Title of original paper: Advanced Robotics to Address the Translational Gap in TendonEngineering

Journal: Cyborg and Bionic Systems

DOI: https://spj.sciencemag.org/journals/cbsystems/2022/9842169/

Affiliations:

A brief introduction about authors

Iain Sander:

Iain Sander is a graduate student in the Mouthuy Soft Tissue Research Group at the University of Oxford, where he completed his M.Sc in Musculoskeletal Sciences as a Rhodes Scholar. He is currently completing his medical training at the University of Alberta in Canada. His research interests include clinical gait analysis, regenerative medicine, tendon injury, and tendon tissue engineering.

Nicole Dvorak:

Nicole Dvorak a graduate student in the Mouthuy Soft Tissue Research Group at the University of Oxford and is currently completing her D.Phil in Musculoskeletal Sciences funded through the NIHR Oxford Biomedical Research Centre. She previously completed an M.Sc. in Medical and Pharmaceutical Biotechnology at the IMC FH Krems, Austria. Her research interests include tissue engineering and regenerative medicine.

Julie Stebbins:

Dr. Julie Stebbins is a clinician-scientist and director of the Oxford Gait Laboratory. She has published extensively on clinical gait analysis, helped develop the Oxford Foot Model for gait analysis, and serves as Deputy Editor of Gait and Posture. Julie has been sought out internationally for her expertise in clinical gait analysis and helped set up the first gait lab in Ethiopia.

Andrew Carr:

Prof. Carr is the former department head of the University of Oxfords Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences. He is an orthopaedic surgeon who helped develop the Oxford Knee partial knee replacement, which has been implanted in over 2 million patients globally. He has authored over 450 papers, including more than 25 which have been featured in the Lancet and BMJ.

Pierre-Alexis Mouthuy

Prof. Pierre-Alexis Mouthuy is an Associate Professor in the University of Oxfords Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, where he leads the Mouthuy Soft Tissue Research Group. He leads the multidisciplinary Humanoid Bioreactor Project, aimed at growing human tendon on musculoskeletal humanoid robots, and has secured over 1.2 million GBP in funding for this project. He is a recognized researcher in the fields of biomaterials, tissue engineering, and robotics.

Cyborg and Bionic Systems

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Advanced robotics to address the translational gap in tendon engineering - EurekAlert

Humacyte, Inc

Lt. General Bruce Green, M.D., USAF-ret. Joins Board of Directors

Cindy Cao, Ph.D. Appointed as Chief Regulatory Officer

DURHAM, N.C., Sept. 20, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues, today announced the appointments of two distinguished healthcare professionals to the Companys Board of Directors and leadership team. Lt. General Bruce Green, M.D., USAF-ret., former Surgeon General of the U.S. Air Force, joins as a member of the Board of Directors. In addition, pharma industry veteran Yang (Cindy) Cao, Ph.D. joins as the Companys Chief Regulatory Officer. Current Chief Regulatory Officer, Bill Tente, will remain with Humacyte as an Executive Advisor, partnering on key regulatory initiatives for the organization with Dr. Cao and team.

Bruce and Cindy are each accomplished medical and industry professionals with significant and complementary experience in public health, drug, and biotechnology development, as well as deep relationships with the governing authorities in their respective fields, said Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte. We are delighted to welcome them to the Humacyte leadership team, and look forward to their guidance as we advance our Human Acellular Vessels(HAV) toward regulatory approval.

General Green said, With its off-the-shelf availability and resistance to infection, Humacytes HAV technology has enormous potential to aid in the care of vascular trauma, particularly in combat and natural disaster scenarios. This potential is evidenced by the recent case studies from Humacytes humanitarian relief effort where war victims have been treated at multiple front-line Ukrainian hospitals. I am honored to join the Humacyte Board and look forward to working with the leadership team to help bring this important advancement to market.

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Dr. Cao said, Humacytes platform for implantable bioengineered human tissues could potentially lead to first in class regenerative medicine, with compelling applications in vascular trauma repair, arteriovenous access for hemodialysis and peripheral arterial disease. I am very excited to join the talented Humacyte team, and eager to begin working toward regulatory interactions and market authorization submissions of this critical product candidate to benefit the patients in need.

Lt. General Green was commissioned through the Health Professions Scholarship Program and entered active duty in 1978 after earning his Doctorate of Medicine at the Medical College of Wisconsin in Milwaukee. He completed residency training in family practice at Eglin Regional Hospital, Eglin AFB, Fla., in 1981, and in aerospace medicine at Brooks AFB, Texas, in 1989. He is board certified in aerospace medicine. An expert in disaster relief operations, General Green planned and led humanitarian relief efforts in the Philippines after the Baguio earthquake in 1990 and in support of Operation Fiery Vigil following the 1991 eruption of Mount Pinatubo. General Green has served as commander of three hospitals and the Wilford Hall Medical Center. As command surgeon for three major commands, he planned joint medical response for operations Desert Thunder and Desert Fox, and oversaw aeromedical evacuation for operations Enduring Freedom and Iraqi Freedom. General Green served as Assistant Surgeon General for Health Care Operations and Deputy Surgeon General, and was appointed Air Force Surgeon General in 2009. General Green earned a B.S. in chemistry at the University of Wisconsin-Parkside and an M.D. at the Medical College of Wisconsin. General Green is also a graduate of the Air Command and Staff College, and earned a masters degree in public health from Harvard University.

Dr. Cao brings over twenty years of drug discovery and development experience in pharmaceutical and biotech companies, including Bristol-Myer Squibb, Novartis, Novo Nordisk and Sanofi. Prior to joining Humacyte, Dr. Cao served as Senior Vice President and Head of Regulatory Affairs and Quality Assurance at Ascentage Pharma. Dr. Cao has also served in global and US executive leadership roles in Regulatory Affairs at pharmaceutical and biotech companies, and has functioned as an Executive Leadership Team member in multiple previous positions. Dr. Cao has extensive expertise in global and US regulatory strategy and policy on biologics, small molecules, and devices, and has provided guidance to development teams in various therapeutic areas including oncology, immunology, metabolic disorders, hematology and cardiovascular diseases. Before her industry roles, Dr. Cao was an Assistant Professor at the Huntsman Cancer Institute, conducting basic research in oncology and inflammation. Dr. Cao holds a B.S. in genetics from Fudan University in Shanghai China, a Ph. D. in biomedical sciences from University of New Mexico, and completed an NIH-sponsored post-doctoral fellowship at the University of Utah.

About HAV

Human 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 nearly 500 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 Humacyte

Humacyte, 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, visitwww.Humacyte.com.

Humacyte Investor Contact:Joyce AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com

Humacyte Media Contact:

Elizabeth Miller, M.D.LifeSci Communications LLC+1-646-791-9705emiller@lifescicomms.com

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Humacyte Expands Board of Directors and Leadership Team with New Appointments - Yahoo Finance

All eyes are on the Emerald Isle this week as the Longevity Summit Dublin brings together a host of speakers covering the spectrum of this booming sector. Delegates have been hearing from some of the leading entrepreneurs, companies, investors, and researchers in the field as they address many of the hot-button topics affecting longevity. One of those speakers is the so-called father of genomics Harvard professor of genetics, George Church who closes the conference later today with a keynote on Gene, cell and organ therapies for de-aging.

Longevity.Technology: In addition to his Harvard professorship, Church heads up synthetic biology at the Wyss Institute, where he oversees development of new tools with applications in regenerative medicine. Much of his focus more recently has been on the development of gene therapies targeting age-related disease, a passion that led him to co-found Rejuvenate Bio, with the goal of creating full age reversal gene therapies. We caught up with Church ahead of his Dublin presentation for a brief conversation on longevity.

Dr Churchs name is synonymous with genomic science, and he was a key contributor to the Human Genome Project and technologies including next-generation fluorescent and nanopore sequencing, aimed at understanding genetic contributions to human disease. However, he doesnt feel that those initiatives did a huge amount to move the aging field forward.

They have provided aging researchers with useful reference points to go back and check their work, but the key advances in aging have really been made through the fundamental research on key pathways and drivers of aging, says Church. However, what we can take from those projects was their contribution towards technology improvements that have reduced the cost of DNA sequencing from three billion dollars in 2004 to just three hundred dollars today.

Thanks to technological advances, it was estimated that mapping a human genome cost an estimated $2025 million in 2006, although this was using haploid sequencing unsuitable for phenotype prediction. Skip ahead to today, and start-up Nebula Genomics (a company founded by Church) now offers diploid whole genome sequencing for as little as $300 a remarkable achievement by any standard. (Learn about the differences between haploid and diploid sequencing here.)

Alongside other technical developments, this kind of cost reduction will, Church believes, contribute to making gene therapies viable for everyone to benefit from, not just the wealthy. Public perception of gene therapy has taken a bashing recently thanks to drugs like Zynteglo, which was branded the most expensive medicine in history at $2.8 million per dose earlier this year. But Church doesnt see the same issue being a factor when it comes to future therapies against aging.

Those expensive gene therapies are for rare diseases, and their pricing reflects of the ratio of R&D costs to number of patients, says Church. But aging and its associated diseases affect nearly everyone. When you consider the volume of people that will be able to benefit from an age-reversing therapy, combined with the potentially huge benefits to society that such a treatment would enable, then it is a win-win for governments, healthcare providers and developers alike.

Under current conditions, gene therapies for aging and age-related diseases are likely to take 10 years to get approved, but Church points to how the world acted to fast-track approvals for COVID-19 vaccines in just one year.

The top five vaccines were formulated as gene therapies, and showed how quickly and safely we can move when there are extenuating circumstances, he says. Well, I would say that many more people are dying and in poor health as a result of the effects of aging, so perhaps aging should also be considered an extenuating circumstance.

In addition, Church points out, the cost of the vaccines was around $2 to $20 per dose a figure that healthcare systems around the world could manage if a gene therapy for aging were similarly priced.

So how close are we to seeing an approved gene therapy for aging? Pretty close, thinks Church, while admitting hes biased because of the work going on at Rejuvenate Bio. He co-founded the company in 2019 with his former postdoctoral fellow Noah Davidsohn, with the goal of eliminating aging and age-related diseases and increasing healthspan.

Church believes that gene therapies hold greater promise for age reversal than small molecules, because they might avoid frequent dosing and be more target-specific, while hitting all ten key pathways in one go, so its perhaps no surprise that Rejuvenate Bio is working on therapies that could tackle several age-related conditions at once.

We have already published on work conducted in mice, which showed that four age-related diseases (obesity, type II diabetes, heart failure, and renal failure) can be treated simultaneously with a single combination gene therapy, says Church. And weve gone on to show we can do it with five diseases as well.

But Rejuvenate Bio isnt stopping at mice. The company also has a significant animal health pipeline, which is already engaged in the development and commercialisation of a gene therapy for Mitral Valve Disease (MVD) in dogs.

Our animal health pipeline also gives us a unique advantage in that the results directly inform the direction of our work in our human therapies, and I believe this will allow us to deliver results faster.

The companys lead therapy (RJB-01) targets the FGF21 and sTGFR2 genes, and it is hoped it will deliver cardiovascular, metabolic and renal benefits. Following results from the trial in dogs, it is expected that RJB-01 will move into IND-enabling studies ahead of Phase 1 clinical trials likely next year.

Church is also enthusiastic about the recent uptick in investment and the growing interest in the longevity field.

Its clearly a good thing not only because it helps drive the field forward, but it also validates a lot of the great work that has been done in academia over the years, he says. Not that long ago, people were avoiding the field because of the sketchy image it had. Now we are attracting young, talented scientists, which is what we need to keep progressing.

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George Church: Learn from COVID and fast-track therapies that reverse aging - Longevity.Technology

Stem cell therapy, which can avert or delay total knee replacement surgeries in patients suffering from acute knee osteoarthritis, has been launched in India by Bengaluru-based biotech company Stempeutics under the brand name StemOne.

A group company of the Manipal Education and Medical Group, Stempeutics has partnered with pharma major Alkem for marketing of the therapy, which promises to be disease modifying.

StemOne was granted approval by the Central Drugs Standards Control Organisation recently.

Life-changing potential

The therapy, priced at Rs 1.25 lakh, may offer 35 million patients across the country a chance of substantially improvingtheir quality of life without going under the scalpel.

Knee osteoarthritis is a chronic disease that affects a large number of the elderly and the obese and is characterised by degeneration of the cartilage inside the knee, which leads to pain, stiffness and tenderness.

The latest drug, which will be in the form of an intra-articular injection, can be given on an outpatient basis without the need for anaesthesia.

Stempeutics and Alkem said in a joint statement that clinicaltrials held in India have demonstrated significant improvement in pain relief and physical functions, as well as indicators towards decreased progression of the disease and improvements in joint structure.

The allogeneic or off-the-shelf drug could provide an alternative to traditional treatment and surgery or delay the progression of knee osteoarthritis to minimise the need for multiple surgical interventions, it added.

Benefits over traditional treatment

While conventional treatments such as physiotherapy or drugs offer temporary relief from the clinical symptoms of knee osteoarthritis, restoration of normal cartilage function has been difficult to achieve, and in extreme cases, a total knee replacement may be required, said BN Manohar, managing director of Stempeutics, in an interaction with Moneycontrol.

Also read|Cancer treatment costs: Little respite from new list of essential drugs

Currently, treatment options available include NSAIDs, glucosamine & chondroitin sulphate, Diacerin (IL-1 inhibitor), Hyaluronic Acid injections, steroid injections, PRP injections and, ultimately, total knee replacement.

But total knee replacements are expensive and may not always be successful. In such a situation, stem cell therapy has emerged as a ray of hope over traditional approaches aimed at restoration of cartilage function in the knee, said Manohar.

It is estimated that Rs 4,000 crore is spent annually on total knee replacement surgeries in India.

Our product is something novel, launched for the first time in India, and one of the firsts globally, said Manohar, adding that it took about 13-14 years to develop StemOne and get regulatory approval.

The therapy has two major benefits, explained Manohar. It reduces pain in patients, eases their day-to-day living and also maintains the cartilage, preventing further deterioration.

Manohar insisted that even though the price may be higher than other invasive therapies such as intra-articular steroids, it prevents disease progression, something that other therapies dont.

Total knee replacement surgery, on the other hand, for patients in whom this therapy may be indicated, costs at least Rs 2 lakh and this therapy would therefore be cost-effective for them, he said.

Insurance and regulatory approvals

The company is now also trying to get the therapy covered by private insurance and Manohar said that since this therapy is in the category of regenerative medicine, considered a new class of therapeutics, even the regulatory process is still evolving.

The firm took around 14 years to develop and launch the product.

One is the science part to see how the stem cell works and what it can do and what it cannot do and then we need to see the safety of this compound, said the MD.

Manohar added that subsequently, the company carried out multiple sets of clinical trials to assess safety and efficacy and also needed to work with the drug regulators.

Since there is no proper regulatory framework to cover stem-cell based products, the manufacturer had to coordinate with the Indian Council of Medical Research on how it could be regulated. It took some time to develop the guidelines and now stem cells are considered to be a drug, said Manohar.

Other products

Stempeutics is the only company to have launched a stem cell therapy for Critical Limb Ischemia, a peripheral vascular disease, where blood doesnt flow due to blockages in peripheral arteries.

Also read|Generic versions of diabetes drug Sitagliptin now available at govt stores at affordable prices

In some cases, Critical Limb Ischemia can get so bad that patients may need to have their forearms or legs amputated. The therapy for this disease was launched in partnership with Cipla.

Another new product, in the pipeline, targets non-healing diabetic foot ulcers.

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First time in India: Stem cell therapy to treat knee osteoarthritis - Moneycontrol

Company on track to submit European marketing application in Q4 2022

No additional studies required

PITTSBURGH, Sept. 21, 2022 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the Company) (NASDAQ: KRYS), the leader in redosable gene therapy, announced today that the European Medicines Agency (EMA) Pediatric Committee (PDCO) has adopted a positive opinion on the Pediatric Investigation Plan (PIP) for beremagene geperpavec (B-VEC) for the treatment of dystrophic epidermolysis bullosa.

As part of the regulatory process for the registration of new medicines inEurope, the EMA requires companies to provide a PIP outlining their strategy for investigation of the new medicinal product in the pediatric population. An approved PIP is a prerequisite for filing a Marketing Authorization Application (MAA). The positive opinion is based on the B-VEC non-clinical safety program as well as data from the clinical studies conducted in the US that will be included in the upcoming MAA.

The approval of the PIP provides a clear path forward, and we look forward to working with the EMA and PDCO to bring this important treatment to the European market as soon as possible, said Suma Krishnan, President, Research & Development.

Based on this positive opinion, the Company would be eligible for up to an additional two years of marketing exclusivity in the EU, on top of the ten-year EU market exclusivity after market approval in the EU.

The U.S. Food and Drug Administration (FDA) and EMA have each granted B-VEC orphan drug designation for the treatment of DEB. The FDA has granted B-VEC fast track designation, Regenerative Medicine Advanced Therapy (RMAT) and rare pediatric disease designation for the treatment of DEB. B-VEC is eligible to receive a Priority Review Voucher (PRV) following approval of B-VEC in the US. The EMA granted PRIority MEdicines (PRIME) eligibility for B-VEC to treat DEB.

About Dystrophic Epidermolysis Bullosa (DEB)DEB is a rare and severe disease that affects the skin and mucosal tissues. It is caused by one or more mutations in a gene calledCOL7A1, which is responsible for the production of the protein type VII collagen (COL7) that forms anchoring fibrils that bind the dermis (inner layer of the skin) to the epidermis (outer layer of the skin). The lack of functional anchoring fibrils in DEB patients leads to extremely fragile skin that blisters and tears from minor friction or trauma. DEB patients suffer from open wounds, which leads to skin infections, fibrosis which can cause fusion of fingers and toes, and ultimately an increased risk of developing an aggressive form of squamous cell carcinoma which, in severe cases, can be fatal.

About B-VECB-VEC is an investigational non-invasive, topical, redosable gene therapy designed to deliver two copies of theCOL7A1gene when applied directly to DEB wounds. B-VEC was designed to treat DEB at the molecular level by providing the patients skin cells the template to make normal COL7 protein, thereby addressing the fundamental disease-causing mechanism.

AboutKrystal Biotech, Inc.Krystal Biotech, Inc.(NASDAQ: KRYS) is a pivotal-stage gene therapy company leveraging its proprietary, redosable gene therapy platform and in-house manufacturing capabilities to develop life-changing medicines for patients with serious diseases, including rare diseases in skin, lung, and other areas. For more information please visithttp://www.krystalbio.com, and follow @KrystalBiotech onLinkedInandTwitter.

Forward-Looking StatementsAny statements in this press release about future expectations, plans and prospects for the Company including statements about the timing of the submission of the Companys EMA marketing authorization application and other statements containing the words anticipate, believe, estimate, expect, intend, may, plan, predict, project, target, potential, likely, will, would, could, should, continue, and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of product candidates including B-VEC, the sufficiency of cash resources and need for additional financing and such other important factors as are set forth under the caption Risk Factors in the Companys annual and quarterly reports on file with theU.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Companys views as of the date of this release. The Company anticipates that subsequent events and developments will cause its views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Companys views as of any date subsequent to the date of this press release.

CONTACT:Investors and Media:Meg DodgeKrystal Biotechmdodge@krystalbio.comSource: Krystal Biotech, Inc.

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Krystal Biotech Receives Positive Opinion from EMA Pediatric Committee on the Pediatric Investigation Plan for B-VEC for the treatment of Dystrophic...

The EpiBone team is proud to play a role in driving innovation to transform the future of health and quality of life with cutting-edge technology and research in tissue engineering.

NEW YORK (PRWEB) September 21, 2022

EpiBone CEO and Co-Founder Dr. Nina Tandon participated as a speaker at the White House Summit on Biotechnology & Biomanufacturing for the American Bioeconomy on September 14, 2022. The summit brought together government and private sector leaders as a first step in launching the Biden Administration's National Biotechnology and Biomanufacturing Initiative, a whole-government approach to advancing biotechnology and biomanufacturing to create innovation in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security.

The half-day summit included a bioeconomy roundtable discussion with government officials and private sector leaders and two panels, one exploring biotechnology for global change and another discussing biomanufacturing and the bioeconomy. Tandon spoke during the morning roundtable discussion, sharing her perspectives on biotechnology, and its relevance as the future of medicine, as well as the pressing need for government support.

Im humbled to have had the opportunity to speak alongside my colleagues who are all industry luminaries as part of this critical White House Summit roundtable discussing industry advancements that will help move the entire field forward, said Tandon. Biotechnology holds immeasurable possibility to improve the quality and capacity of our lives, and this new White House initiative speaks to that possibility while positioning the US as a global leader in the industry. The EpiBone team is proud to play a role in driving innovation to transform the future of health and increasing quality of life by bringing game-changing tissue engineered products to patients."

As CEO and co-founder of EpiBone, Inc., Tandon bridges the realms of business and science, with decades of experience in tissue engineering and bioreactor design. She has completed a Ph.D. in biomedical engineering and an MBA from Columbia University. Tandon has been named one the 40 under 40 by Crains New York, an Ernst & Young Winning Woman, and one of Goldman Sachs 100 Most Intriguing Entrepreneurs. She is also a WEF Young Global Leader and McKinsey alumni. Tandons passion for science and innovation is dwarfed only by her desire to see the promise of regenerative medicine fully realized.

In her work at EpiBone, Tandon leads the company in its mission to use groundbreaking research to transform skeletal repair. The team uses advanced science and technology to solve problems that once seemed unsolvable, developing processes that uses cells to grow new bone and cartilage tissues. This work has been recently underscored by the successful implantation of all the patients in their first-in-human clinical trial using the most advanced product in their pipeline, a customized living bone graft grown from a patients own cells.

To learn more about Dr. Nina Tandon and the work of the EpiBone team, visit https://www.epibone.com/.

About EpiBoneEpiBone, Inc. is privately-held clinical-stage regenerative medicine company focused on skeletal reconstruction. Sitting at the intersection of biology and engineering, the company harnesses the power of cells to create living solutions that can become a seamless part of a patients body. EpiBone is currently developing a pipeline of bone, cartilage, and compound (bone and cartilage) products.

For more information, please visit: https://www.epibone.com/

DisclaimerThis communication contains forward-looking statements which can generally can be identified by words such as plans, change, will, following, strengthening, developing, the negative of these words and similar words and expressions, which are based on EpiBones current expectations, assumptions, estimates and projections about its business, technology, product development and industry. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and include, without limitation, EpiBones ability to (1) adequately protect or enforce its intellectual property rights, (2) develop and commercialize new products and technologies on a timely basis (or at all), (3) risks associated with acquisitions and strategic investments and (4) attract and retain qualified personnel. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. Additionally, this communication does not constitute an offer to sell or a solicitation of an offer to buy securities.

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EpiBone CEO and Co-Founder Dr. Nina Tandon Selected to Participate in White House Summit - PR Web

There are several specific nutrients that are involved in female fertility.

Not only is vitamin D important for maintaining the health of your bones and immune system, it may also be involved in fertility. In fact, a small study in Fertility and Sterility found that women with low levels of vitamin D were less likely to conceive compared to those with normal levels. Additionally, a new 2022 meta-analysis found that vitamin D insufficiency and deficiency are associated with miscarriage.

Because vitamin D is found naturally in few food sources and is usually obtained through sun exposure, supplementation may be recommended for those at risk for deficiency.

Folic acid is a B vitamin frequently found in prenatal supplements and fortified foods. Interestingly, folic acid has also been shown to increase the chances of conception, especially in women with irregular cycles.

Eli Reshef, M.D. a reproductive endocrinologist at the Integris Bennett Fertility Institute in Oklahoma City, recommends folic acid supplementation before and during pregnancy to prevent neural tube defects. Specifically, he recommends taking an over-the-counter prenatal supplement that contains at least 800 milligrams of folic acid to support fertility.

The Centers for Disease Control and Prevention (CDC) notes that women of reproductive age should get at least 400 micrograms of folate per day, which can come from a combination of foods or supplements. Leafy greens, legumes and whole grains are all excellent sources of folate.

Selenium is an essential trace mineral needed for the production of hormones and selenoproteins, a type of protein involved in reproductive health. Not only can a deficiency in selenium impair fertility, but it could also increase the risk of miscarriage and other pregnancy complications.

Most people can get enough of this important micronutrient by following a balanced diet that contains selenium-rich foods like meat, fish and eggs. Its also commonly added to multivitamins and prenatal supplements.

Though most well-known for its positive effects on heart health and inflammation, omega-3 fatty acids may have an impact on fertility as well. In fact, studies show these healthy fats can help balance levels of reproductive hormones, regulate menstruation and improve egg quality and implantation.

Enjoying a few weekly servings of fatty fish, such as salmon, sardines or tuna, is a great way to bump up your intake of omega-3 fatty acids. If you dont regularly eat fish, consider taking a supplement sourced from fish oil or algal oil instead.

Coenzyme Q10 (CoQ10) is a type of antioxidant that is produced naturally by the body and found in many foods, including organ meats and fish. Some studies have found that CoQ10 could improve ovarian response and increase rates of conception in women undergoing fertility treatments.

As we age, the bodys production of CoQ10 slows down, making it increasingly challenging to protect eggs from oxidative damage and making it harder for women to conceive, notes Rosmy Barrios, M.D., a regenerative medicine specialist at the IM Clinic in Belgrade, Serbia.

Consider asking your doctor if a CoQ10 supplement might be right for you.

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Fertility Supplements And Vitamins For Women: What You Need To Know - Forbes

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DURHAM, N.C., Sept. 23, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues, complex tissue systems, and organs at commercial scale, today announced the presentation of a clinical update on the Human Acellular Vessel (HAV) for the treatment of vascular trauma. The update was presented by Ukrainian surgeon collaborators, Oleksandr Sokolov, M.D., Ph.D. and Vasyl Shaprynskyi, M.D., Ph.D., at the 36th European Society for Vascular Surgery (ESVS) Annual Meeting in Rome, Italy taking place from September 20-23, 2022. Humacytes investigational HAV is designed to offer off-the-shelf availability and resistance to infection and to address long-standing limitations in vascular tissue repair and replacement.

Dr. Shaprynskyi attended the conference in-person and presented a live talk entitled, The First Experience of Using the Human Acellular Vessels in Ukraine for the Treatment of Patients with Vascular Trauma, while Dr. Sokolov spoke virtually from Ukraine and presented, Vascular Trauma Due to Blast Injury. Experience of Dnipro in Russian-Ukrainian War 2022. Drs. Shaprynskyi and Sokolov have been instrumental in establishing their hospitals as medical strongholds during the Russian-Ukrainian war and reported that blast trauma, causing massive tissue damage and infected wounds, accounts for approximately 82% of incoming vascular trauma cases to their medical centers. Trauma to the extremities makes up the majority of injuries, primarily vascular injuries to the lower extremities and shoulders.

Access to the HAV, a biologic conduit, has improved our ability to perform vascular reconstructions by eliminating the need to harvest a venous conduit and saving time required to look for useable vein, assisting greatly in limb salvation. While we continue to face this crisis in our country, partnerships with groups like Humacyte allow us to overcome many limitations in wartime medical care that we previously experienced such as lack of readily available conduits that are resistant to infection, particularly important in the contaminated battlefield setting, said Dr. Shaprynskyi.

Drs. Shaprynskyi and Sokolov reported that surgeons in Ukraine have utilized the HAV to treat patients with a multitude of wartime injuries. Dr. Sokolov provided a clinical update on a patient with a blast injury to the shoulder who received a repair using the HAV. The patient is now beyond three-month follow up without complication. Another patient who suffered a blast injury to the lower leg underwent successful HAV implantation and is now one-month past surgery without complication. Dr. Shaprynskyi reported on a patient with a gunshot wound to the right thigh that was initially treated with a synthetic graft, but ultimately the graft failed due to infection, putting the patient at risk of limb loss. The HAV was used to replace the infected graft, and three months later the HAV is supplying blood flow to the limb and is infection free.

Humacyte worked closely with the Office of International Programs of the U.S. Food and Drug Administration (FDA) and the Ukrainian Ministry of Health to provide the HAV as an additional treatment option to those affected with vascular injury in Ukraine. Humacyte is currently evaluating the HAV in a Phase 2/3 clinical trial in vascular trauma for use as a vascular replacement to restore blood flow to a limb, when saphenous veins or synthetic grafts are not feasible. The HAV has received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. The HAV is an investigational product and has not been approved for sale by the FDA or any international regulatory agency.

Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte, added, As we progress in our humanitarian efforts with the HAV, being able to witness these firsthand patient cases from surgeons in Ukraine is a powerful experience. We set out to develop engineered replacement vessels that are durable, infection-resistant and off-the-shelf to address long-standing limitations in vessel repair, both for civilians and for military personnel. Given our existing designation as a Priority Product from the U.S. Department of Defense, it is gratifying to see that the HAV is helping patients suffering from wartime injuries in Ukraine right now.

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 500 patients. 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.

Forward-Looking Statements This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: may, will, could, would, should, expect, intend, plan, anticipate, believe, estimate, predict, project, potential, continue, ongoing or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials; the anticipated characteristics and performance of our HAVs; our ability to successfully complete, preclinical and clinical trials for our HAVs; the anticipated benefits of our HAVs relative to existing alternatives; the benefits and risks related to our humanitarian efforts in the Ukraine; the anticipated commercialization of our HAVs and our ability to manufacture at commercial scale; the implementation of our business model and strategic plans for our business; our rights and obligations under our partnership with Fresenius Medical Care; the scope of protection we are able to establish and maintain for intellectual property rights covering our HAVs and related technology; the timing or likelihood of regulatory filings and approvals; timing, scope, and rate of reimbursement for our HAVs; and our estimated available market opportunity. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, the impact of COVID-19 on Humacytes business, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those included under the header Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2021, filed by Humacyte with the SEC and in future SEC filings. Most of these factors are outside of Humacytes control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

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

Humacyte Media Contact:Elizabeth Miller, M.D.LifeSci Communications LLC+1-646-791-9705[emailprotected]

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Humacyte Announces Presentations by Ukrainian Surgeons on Use of the Human Acellular Vessel to Treat Wartime Vascular Trauma at the European Society...

Editors note: Each week WRAL TechWire focuses itsInnovation Thursdayreport on companies, people and technology that could make a big difference in our collective future.

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RESEARCH TRIANGLE PARK A Georgia company that specializes in placental biologics is the latest company to establish a presence in Winston-Salems Regenerative Medicine Hub, a growing ecosystem for regenerative medicine research, development and manufacturing.

MIMEDXwill have a laboratory in the RegeneratOR Innovation Accelerator in Winston-Salems Innovation Quarter. There the company will draw on the RegenMed Hubs resources to advance the use of placental technologies in wound care and regenerative medicine.

MIMEDX

As a growth company within the Innovation Accelerator, MIMEDXs research, development and manufacturing teams can collaboratively advance the process efficiencies, biomanufacturing techniques and cutting-edge technologies required to drive innovation in regenerative medicine, specifically in the field of placental biologics, said Robert B. Stein, M.D., Ph.D., president of regenerative medicine and biologics innovation at MIMEDX. This opportunity furthers our ability to create and engineer products that address the unmet clinical needs of patients and providers and advance the next generation of therapies for a broad range of disease states.

The company declined to say how many employees would be based in Winston-Salem or what its future staffing might be.

MIMEDXs presence in the Innovation Accelerator will give it access to strategic partners, biomanufacturing equipment, technologies, industry expertise, talent, a training program and other resources. The Innovation Accelerator supports innovation from research to commercialization for startups, growth companies and established companies developing emerging technologies in regenerative medicine.

We are looking forward to supporting MIMEDX through access to our Test Bed, which really offers up manufacturing-in-a-box solutions to optimize any manufacturing process with state-of-the-art equipment, technologies and resources, said Anthony Atala, M.D., director of theWake Forest Institute for Regenerative Medicine(WFIRM).

WFIRM, a part of Wake Forest School of Medicine,is in theInnovation Quarter, and is the worlds largest institute of its kind. It employs more than 400 scientists and staff who translate scientific discoveries into clinical therapies involving more than 40 different tissues and organs.

Atala, an internationally recognized scientist in regenerative medicine, was recently appointed to MIMEDXs new Regenerative Medicine Scientific Advisory Board, created to guide the companys clinical product pipeline and support its focus on placental biologics innovation.

The Regen Med Hub is a unique distinction and important opportunity for this region, said Nancy Johnston, executive director of the North Carolina Biotechnology Centers Piedmont Triad Office. It is exciting to welcome new companies and see continued growth of this cluster in North Carolina.

MIMEDX joins an expanding roster of about 30 bioscience companies that have established a presence in the Innovation Accelerator to gain access to the regions resources in regenerative medicine.

We believe this region has a lot to offer in terms of helping these companies be successful, and, at the same time, we can advance the regenerative medicine field nationally, said Joshua Hunsberger, Ph.D., chief technology officer of theRegenMed Development Organization(ReMDO), the non-profit organization that runs the Innovation Accelerator.

Gary Green, Ed.D., chief operating officer of ReMDO, added, Addressing manufacturing process optimization for companies in this space is the most critical need to enable these technologies to become widespread, affordable and the next standard of care.

MIMEDX is a placental biologics company and a pioneer in placental tissue engineering. The company has distributed more than two million tissue allografts thus far, primarily to address the needs of patients with acute and chronic non-healing wounds, and is also advancing a late-stage biologics pipeline targeted at decreasing pain and improving function for patients with degenerative musculoskeletal conditions including knee osteoarthritis.

The company, headquartered in Marietta, Ga., was founded in 2008 and has about 800 employees. Its shares are publicly traded on the Nasdaq stock market under the ticker symbol MDXG.

(C) N.C. Biotech Center

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Regenerative Medicine Hub at W-S Innovation Quarter keeps growing with new addition - WRAL TechWire

Brian Cummings, UCI professor of physical medicine & rehabilitation and founding member of the Sue & Bill Gross Stem Cell Research Center, has received a five-year, $2.7 million grant from the California Institute for Regenerative Medicine to establish a training program that supports first-generation and underserved students pursuing careers in public health and regenerative medicine. The Creating Opportunities Through Mentorship and Partnership Across Stem Cell Science program will pair student scholars with faculty mentors. With their tuition covered and a stipend provided during their two years as scholars, the students will learn hands-on lab skills and human cell culture; be introduced to good manufacturing procedures in UCIs new GMP facility; and earn a certificate in clinical research coordination. COMPASS provides the opportunity for students to explore a variety of ways in which their education and research skills can be applied toward improving human health through career paths in the public and private sectors. UCIs COMPASS scholars program will produce a cadre of well-trained individuals who are ready to contribute to the workforce, said Cummings, who is also the School of Medicines associate dean for faculty development. A parallel objective is to foster greater awareness and appreciation of diversity, equity and inclusion in trainees, mentors and other program participants. Administered via the Sue & Bill Gross Stem Cell Research Center, the program will train 25 undergraduate and two-year college transfer students.

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CIRM awards UCI $2.7 million to create regenerative medicine training program - UCI News