StemCell Therapy

Global regenerative medicine market was valued at USD 27.29 Billion in 2020. It is expected to increase at a compound annual rate (CAGR of 11.27%) between 2021 and 2027. Tissue Engineering is the segment expected to see the greatest growth in the Global Regenerative Medicine Market. Biomaterials currently hold the largest market share in global regenerative medicine.

Regenerative medicine has the potential to treat chronic, incurable diseases such as Alzheimers disease, Parkinsons disease, diabetes, and other conditions. The Alliance for Regenerative Medicine estimates that around 1,028 clinical trials in regenerative medicine are currently underway. In 2018, regenerative medicine was funded with a total of USD 13.3 billion in global financing. The forecast period will see a significant increase in investment by market leaders in research and development of regenerative medicines.

Driving Factors

Growing prevalence of chronic diseases, genetic disorders, and cancer

Over the past few decades, the prevalence and incidence of chronic diseases like CVD, cancer and diabetes has increased dramatically around the world. Diabetes and obesity can lead to an increase in the number and complexity of wounds like infections, ulcerations (leg and foot ulcers), as well as surgical wounds. These will need treatment and may result in exorbitant medical costs.

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Restraining Factors

High cost of cell and gene therapies

The cell and gene therapies represent significant medical and scientific advancements for patients with serious and terminal illnesses. These therapies are changing the way diseases are treated and could even be cured. Injectable therapies will enable doctors and other medical professionals to infuse cells/genes through injectable methods, thereby avoiding multiple surgeries and the need for a number of drugs. Although these therapies can be life-saving and more effective than traditional treatments, demand is lower than anticipated. This is due to the high cost of these therapies as well as difficulties in obtaining coverage and reimbursements for them.

Market Key Trends

Recent development

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Regenerative Medicine Market to Garner Bursting Revenues [+USD 27.29 Billion] with Top Growing Companies During 2022-2029 - eTurboNews | eTN

Immusoft is heading into the clinic with what it claims is the first engineered B cell gene therapy cleared for in-human study, the company announced Thursday.

The Seattle-based company reported it has received clearance from the FDA to initiate a Phase I study assessing ISP-001 for the treatment of Mucopolysaccharidosis type I. MPS I is a rare lysosomal storage disorder characterized by an abnormal build-up of glycosaminoglycans in the body. Immusoft aims to improve treatment of MPS 1, also known as Hurler Syndrome, with its Immune System Programming platform that uses B cells as re-dosable biofactories for therapeutic protein delivery.

Immusoft stated its platform has been designed to circumvent both immunogenicity associated with virus-delivered gene therapy, as well as chemotherapy preconditioning associated with stem cell-mediated gene therapy. Additionally, the ISP platform has been designed to enable durable therapeutic delivery and the potential to re-dose patients if necessary.

The FDA has granted ISP-001 Orphan Drug designation and Rare Pediatric Disease designation for MPS 1. The Phase I study is expected to launch later this year, the company announced.

Sean Ainsworth, chairman and CEO of Immusoft, expressed excitement over the IND clearance. He called it a huge achievement for the company and a historic moment in the field of cell and gene therapies. Current adeno-associated virus therapies and lentiviral therapies have some safety concerns. The delivery mechanism in those therapies can trigger an immune response in patients, which can limit efficacy. Stem cell treatments also have some drawbacks in some patients.

Ainsworth told BioSpacethat the companys B cell approach has been designed to overcome some of the issues that were seen in other gene therapy modalities. Building on advances made in other cell therapeutic approaches such as CAR-T therapies, Ainsworth said the company is pioneering a gene therapy approach that allows for a durable therapeutic and the potential to re-dose patients.

Our engineered B cell approach is a completely novel modality that opens potential new avenues for treating intractable diseases. Having our lead program cleared to proceed into the clinic - the first B cell approach in the clinic - broadens the potential for our platform and pipeline as we advance other programs to first-in-human studies, Ainsworth said in an email this morning.

B Cell-Focused Competition

Immusoft isnt the only company focused on the development of B cell therapies. Others include Be Biopharma and Walking Fish Therapeutics.

Paul Orchard, a professor in the division of pediatric bone marrow transplantation at the University of Minnesota Medical Center, noted that a non-viral delivery method such as ISP-001 holds promise for the treatment of some diseases, such as MPS I. He said there is a clear need for new treatments for MPS I, as current options are not curative and significant disease-related morbidity still exists.

Although there is no cure for MPS I, there are several treatment options, including hematopoietic stem cell transplant and BioMarins Aldurazyme (laronidase), an enzyme replacement therapy. However, enzyme replacement therapies require frequent infusions, which affect quality of life. Immusoft hopes its therapeutic will mitigate the need for frequent dosing and improve patient outcomes.

Other companies developing therapies for MPS I include Orchard Therapeutics and REGENXBIO.

Beyond MPS I, Immusoft has partnered with the California Institute for Regenerative Medicine on the development of a therapy for MPS II, a carbohydrate metabolism disorder.

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Immusoft Takes First-Ever Engineered B Cell Therapy into Clinic - BioSpace

Photo courtesy of Mayo

With the promise of regenerative medicine comes the risk of widening health care disparities. Sometimes the newest discoveries, such as regenerative interventions, are out of reach for people in diverse ethnic or socioeconomic groups or they may not understand or trust new options for healing.

Mayo Clinicis trying to overcome those barriers by launching community outreach and a bioethics study aimed at improving access to regenerative medicine among underserved groups.

Regenerative medicine sometimes could look like a science fiction movie. It is important to learn from the community about how things could be better explained to them or how we can erase any doubts that they have about what we do, says Jorge Mallea, M.D., a pulmonologist at Mayo Clinic in Florida. Listening to their concerns, and explaining what we know, the things still we dont have solutions for, and what we are trying to accomplish could improve understanding and engagement.

Regenerative medicine is an emerging field of practice that is shifting the focus of health care from fighting disease to rebuilding health, with an emphasis on repairing, replacing or restoring diseased cells and tissues. Mayo ClinicsCenter for Regenerative Medicineis at the vanguard of this movement, supporting the concept of regeneration for all. Dr. Mallea chairs the centers Equity, Inclusion and Diversity Advisory Committee.

More diverse clinical trials

To ensure that regenerative therapies go beyond selected or priority groups, Mayo Clinic is expanding the recruitment for clinical trials to include more diversity in race, age and socioeconomic status. For example, a dermatology study in Rochester is exploring how certain regenerative interventions might affect ethnic groups with different skin tones.

We want to learn more about diverse groups to ensure the therapies we apply would work for people of different genders, races and genetics, says Dr. Mallea. Its important to have representation from diverse groups. We could learn in our clinical trials that certain groups need different doses or distinct ways of applying the interventions.

In other research,Zubin Master, Ph.D., a bioethicist in Mayo ClinicsBiomedical Ethics Research Program, is leading a bioethics study that seeks to understand possible economic, social and ethnic barriers toplatelet-rich plasma platelets spun from a persons own blood and containing growth factors as an orthobiologic treatment for kneeosteoarthritis. Platelet-rich plasma is a new regenerative intervention that shows healing potential. However, the Food and Drug Administration has not yet approved it. Therefore, patients must pay out of pocket for it.

Mohamed Addani, aMayo Clinic Graduate School of Biomedical Sciencesstudent within Dr. Masters team, will interview patients across Mayo Clinic who choose platelet-rich plasma as an intervention for knee osteoarthritis and those who opt instead for standard care. The team will compare those responses to a more demographically diverse group of patients whove made similar care choices at Detroit Medical Center. Researchers will examine race, ethnicity, socioeconomic and demographic variables, beliefs, attitudes, and understanding of regenerative medicine.

This study will provide the first scientifically based data on whether health disparities exist among patients seeking next-generation regenerative interventions such as platelet-rich plasma, says Dr. Master. The results will give us the unique opportunity to identify factors that are creating barriers to regenerative care and proactively address ways to overcome them.

The project seeks to improve access and make regenerative medicine more equitable among diverse and underserved groups.

Showcasing the cool stuff

Attracting a more diverse pool of regenerative medicine scientists and practitioners is another strategy to boost inclusivity. Mayo Clinic is taking regenerative medicine on the road to high schools and colleges near its destination locations in Arizona, Florida and Minnesota, showcasing what Dr. Mallea describes as the cool stuff in research and development. The hope is that it might inspire students, particularly those from underrepresented and disadvantaged communities, to consider a career in regenerative medicine.

We are sharing examples of our research, such as bioprinting of organs and developing new medicines from living organisms like cells to fight different diseases and cancers, says Dr. Mallea. We hope to plant a seed in their minds that regenerative medicine holds promise not only as a future therapy, but also a future career.

In addition, Mayo is using the Community Scientist Program to open its doors to scientists from the community who want to learn more. This program pairs community scientists with regenerative medicine researchers. Mayo hopes these strategies will improve the interaction and understanding needed to ensure access to new regenerative therapies as they are introduced in the practice.

Envision yourself working for a global leader in an industry fueled by innovation and growth. Mayo Clinic has opportunities for you. Join us at Floridas No. 1 hospital by visiting https://jobs.mayoclinic.org/. For more information on health care topics please visit Mayo Clinic Jacksonville at mayoclinic.org.

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Addressing Diversity Barriers to Regenerative Medicine Free Press of Jacksonville - Jacksonville Free Press

VIKEN, Sweden, Aug. 31, 2022 /PRNewswire/ -- TikoMed, a biopharmaceutical company focused on harnessing the medical potential of the body's ability to self-repair and regenerate, today announced the publication in Frontiers in Phamacology of peer-reviewed research supporting the unique broad spectrum mechanism of action of TikoMed's ILB neuroprotective drug platform. In multiple preclinical and clinical studies across a variety of neuroinflammation-driven diseases, the low molecular weight dextran sulfate compound both mobilized and modulated naturally occurring tissue repair mechanisms and restored cellular homeostasis and function by releasing heparin-binding growth factors. TikoMed believes this approach to enhancing the body's self-repair and regeneration capabilities has the potential to transform current cell and gene therapy paradigms.

"These studies show that ILB releases, re-distributes and modulates the bioactivity of endogeneous heparin-binding growth factors that target disease compromised nervous tissues to initiate a cascade of transcriptional, metabolic and immunological effects that play a key role in controlling glutamate toxicity, normalising tissue bioenergetics, and resolving inflammation to improve tissue function. ILB's unique mechanism of action supports the potential to treat various acute and chronic neurodegenerative disease, including sTBI and ALS," said Ann Logan, Scientific Director at Axolotl Consulting and, Professor of Regenerative Medicine at the University of Warwick.

In summary, the studies provided evidence that ILB has a profound therapeutic effect on molecular and cellular dysfunctions causing neurodegenerative diseases. Gene expression analysis demonstrated substantial similarities in the functional dysregulation induced by severe traumatic brain injury (sTBI) and various human neurodegenerative conditions including ALS. Changes in gene expression following ILB treatment supported a cascading beneficial effect of ILB on growth factor activation resulting in the observed therapeutic effect. The transcriptional signature after ILB treatment is relevant to cell survival, inflammation, glutamate signalling, metabolism and synaptogenesis, and is consistent with the activation of neuroprotective growth factors. The ability of ILB to elevate circulating levels of heparin-binding growth factors in animal models and humans also supports its neuroprotective and regenerative effects in vivo.

Story continues

"ILB is currently being in development both as a therapeutic and as an enabling technology for advanced therapies, and this peer-reviewed research indicates even wider potential. We have initiated development programs for Amyotrophic Lateral Sclerosis (ALS), Traumatic Brain Injury (TBI) and islet cell transplantation and will now consider broader use across a wider range of diseases," said Anders Kristensson, CEO of TikoMed.

Contact: info@tikomed.com or +46 42 23 84 40

Media:

International: Richard Hayhurst richard@rhapr.eu or +44 7711 821527

Nordics: Ola Bjorkman ola.bjorkman@letemknow.se or +46 70 245 7497

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/tikomed/r/tikomed-s-ilb--mobilizes-and-modulates-key-growth-factors-that-trigger-a-cascade-of-neuroprotective-,c3623306

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TikoMed's ILB mobilizes and modulates key growth factors that trigger a cascade of neuroprotective mechanisms able to target all...

LEXINGTON, Mass.--(BUSINESS WIRE)--Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage regenerative medicine company focused on developing therapeutics to activate a persons innate potential to restore function, today announced that members of its management team will participate in investor and medical conferences later this month.

A live webcast of the presentations from the HC Wainwright and Baird conferences can be accessed on the Investors & Media section of Frequencys website. A replay will be posted following the event.

About Frequency Therapeutics

Frequency Therapeutics is leading a new category in regenerative medicine that aims to restore human function first in hearing loss and then in multiple sclerosis by developing therapeutics that activate a persons innate regenerative potential within the body through the activation of progenitor cells. Frequencys hearing research focuses on cochlear restoration and auditory repair, and its lead asset, FX-322, is a small-molecule product candidate that is the first to show statistically significant and clinically meaningful hearing improvements in clinical trials for sensorineural hearing loss. Frequency is also advancing a pre-clinical program for remyelination in multiple sclerosis.

Headquartered in Lexington, Mass., Frequency has an ex-U.S. license and collaboration agreement with Astellas Pharma Inc. for FX-322, as well as additional collaboration and licensing agreements with academic and nonprofit research organizations including Massachusetts Eye and Ear, Mass General Brigham, the Massachusetts Institute of Technology, and the Scripps Research Institute.

For more information, visit http://www.frequencytx.com and follow Frequency on Twitter @Frequencytx.

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Frequency Therapeutics to Participate in September Investor and Medical Conferences - Business Wire

A new study led by the University of Oviedo in Spain has unlocked the genetic code of the immortal jellyfish, an animal capable of repeatedly reverting into a juvenile state after sexual reproduction. The experts hope that better understanding the factors leading to this creatures unique longevity could offer new perspectives on human aging.

Although many species of jellyfish have some capacity to reverse aging and revert to a larval state, most of them lose this ability once they reach sexual maturity. However, Turritopsis dohrnii appears to be the only known species able to repeatedly revert back into a larval stage even after sexual reproduction. According to the experts, the immortal jellyfish uses this superpower to avoid predators, allowing it to revert to a cyst which turns into a polyp attached to the seafloor when threaten by other animals. Once the threat is gone, the creature starts to mature once again.

To better understand what makes T. dohrnii special, the scientists sequenced its genome and compared it to that of Turritopsis rubra, a close genetic relative which lacks the capacity to rejuvenate after reaching sexual maturity. The analysis revealed that T. dohrnii had twice as many copies of the genes associated with DNA repair and protection, which helps producing greater amounts of protective and repairing proteins. Moreover, this jellyfish also had unique mutations which stunted cell division and prevented telomeres (chromosomes protective caps) from deteriorating.

Our results suggest that gene amplification and point variants unique ofT. dohrniicould affect its replicative efficiency, as well as DNA repair and telomere maintenance activity, which may be pivotal processes for cell rejuvenation and proliferation, the study authors explained.

In addition, expansions and sequence variations of genes associated with DNA repair, mitochondrial dysfunction and intercellular communication could increase its capacity to maintain redox environment and reduce cellular damage during stress events.

These findings could inspire developments in regenerative medicine and provide insights into age-related diseases such as cancer or neurodegeneration. However, as Monty Graham, a jellyfish expert and director of the Florida Institute of Oceanography put it, we cant look at it as, hey, we are going to harvest these jellyfish and turn them into a skin cream. Instead, exploring such gene variants in T. dhornii and other animals including humans could shed more light on the nature of aging, and help scientists slowly build an arsenal to combat its most unwanted effects.

The study is published in the journal Proceedings of the National Academy of Sciences.

By Andrei Ionescu, Earth.com Staff Writer

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Can the immortal jellyfish teach us how to reverse aging? - Earth.com

MILPITAS, Calif.--(BUSINESS WIRE)--Applied StemCell, Inc. (ASC), a leading cell and gene therapy CRO/CDMO focused on supporting the research community and biotechnology industry for their needs in developing and manufacturing cell and gene products, today announced the expansion of its Current Good Manufacturing (cGMP) facility. ASC has successfully carried out cell banking and product manufacturing projects in its current cGMP suite and is now set on building 4 additional cGMP cleanrooms, cryo-storage space, and a process development and QC/QA space. The expansion of the facility will increase its cell banking and cell product manufacturing capacity and allow ASCs team of experts to work simultaneously on multiple manufacturing projects such as iPSC generation, gene editing, differentiation, and cell bank manufacturing for safe and efficacious therapeutic products.

We are very excited to move forward with the expansion of our cGMP facility, said Dr. David Lee, Ph.D., Head of GMP and Quality. Our team has been working closely with our clients to ensure delivery of high-quality clinical grade products. We thank our customers for their support and trust. With the addition of 4 cGMP cleanrooms, we will be able to assist a greater number of researchers focused on cell and gene therapy.

President and CEO, Dr. Ruby Yanru Chen-Tsai, Ph.D. stated, We are committed to becoming a CDMO leader to support regenerative medicine and cell/gene therapy development and manufacturing. We aim to expand our bio-manufacturing capacity to meet the fast-growing demand in the cell and gene therapy industry. Our unique platform of GMP-grade allogeneic iPSC and TARGATTTM gene editing technology provides our partners great advantages, including shorter manufacturing timelines, non-viral gene editing, and genomic stability and safety.

Construction will begin within the next month, and the company has already begun the staff hiring process. ASC hopes to have the expansion completed and a team built that will be ready to take on as much as 4 times more new projects early next year.

About Applied StemCell, Inc.

ASC has a Drug Manufacturing License from the California Department of Public Health, Food and Drug Branch (FDB). It has a Quality Management System (ISO 13485 certified) and established cGMP-compliant protocols for cell banking and manufacturing, iPSC generation, genome editing, iPSC differentiation, and cell product manufacturing. With over 13 years of gene-editing and stem cell expertise, ASC offers comprehensive and customized cell and gene CRO/CDMO solutions. Its core iPSC and genome editing (CRISPR and TARGATTTM) technologies, facilitate site-specific, large cargo (up to 20kb) transgene integration and the development of allogenic cell products.

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Applied StemCell Announces the Expansion of its cGMP Manufacturing Facility to Support Cell and Gene Therapy - Business Wire

CAMBRIDGE, Mass., Sept. 1, 2022 /PRNewswire/ -- Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega"), a clinical-stage biotechnology company pioneering the first systematic approach to using mRNA therapeutics as a new class of programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programing platform, today announced the appointment of Rainer Boehm as an independent director to its Board of Directors. Mr. Boehm will serve on Omega's audit and compensation committees.

"Rainer's growth-oriented perspective and global strategic management experience will be invaluable to Omega in this next phase of the Company's trajectory," said Noubar Afeyan, Ph.D., Co-founder and Chairman of the Board for Omega Therapeutics and Founder and Chief Executive Officer of Flagship Pioneering. "I look forward to working closely with him as Omega continues to advance its clinical pipeline and demonstrate the broad capabilities of its pioneering drug development platform."

"We are thrilled to welcome Rainer to our Board and look forward to leveraging his significant drug development expertise, strategic thought-leadership and executive management skills as we work to advance our new class of programmable epigenetic medicines," said Mahesh Karande, President and Chief Executive Officer of Omega. "Rainer is a recognized industry leader with a strong track record of working with and growing innovative clinical stage companies and has extensive experience managing global drug development and commercialization."

"Omega is pioneering a new class of programmable mRNA therapeutics that have the potential to transform the way we approach difficult-to-treat diseases," said Mr. Boehm. "This is an exciting time for the Company, and I look forward to partnering with this accomplished board of directors and management team and sharing insights as they continue to pave new roads through the discovery and development of epigenomic controllers for patients in need."

Mr. Boehm brings over 30 years of clinical and managerial experience to Omega. He held several senior management positions during his extensive tenure at Novartis Pharma AG and its predecessor, CIBA-Geigy, spanning from 1988 to 2017, most recently as Chief Commercial & Medical Affairs Officer. He was a key figure in the successful establishment of Novartis Oncology. He oversaw the launch and life cycle management of many blockbuster brands in different geographies globally, amongst them Femara, Zometa and Glivec in oncology, as well as Cosentyx and Entresto and the immunology and cardiovascular disease areas. Prior to joining Novartis, he served as unit head at the Psychiatric Hospital in Zwiefalten, Germany. Mr. Boehm serves on the boards of Cellectis SA (Nasdaq: CLLS), Humanigen Inc. (Nasdaq: HGEN), BioCopy, AG (private) and Berlin Cures, AG (private). He holds a medical degree from the University of Ulm in Germany, and a Master of Business Administration from Schiller University, Strasbourg Campus in France. Recently he commenced a Master of Public Health program at the Universities of Basel / Bern / Zurich in Switzerland.

About Omega Therapeutics

Omega Therapeutics, founded by Flagship Pioneering, a clinical-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as a new class of programmable epigenetic medicines. The company's OMEGA Epigenomic Programming platform harnesses the power of epigenetics, the mechanism that controls gene expression and every aspect of an organism's life from cell genesis, growth, and differentiation to cell death. Using a suite of technologies, paired with Omega's process of systematic, rational, and integrative drug design, the OMEGA platform enables control of fundamental epigenetic processes to correct the root cause of disease by returning aberrant gene expression to a normal range without altering native nucleic acid sequences. Omega's modular and programmable mRNA medicines, Omega Epigenomic Controllers, target specific epigenomic loci within insulated genomic domains, EpiZips, from amongst thousands of unique, mapped, and validated genome-wide DNA-sequences, with high specificity to durably tune single or multiple genes to treat and cure diseases through Precision Genomic Control. Omega is currently advancing a broad pipeline of development candidates spanning a range of disease areas, including oncology, regenerative medicine, multigenic diseases including immunology, and select monogenic diseases, including alopecia.

For more information, visit omegatherapeutics.com, or follow us on Twitter and LinkedIn

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our product candidate pipeline, including our development of OTX-2002 and other drug candidates and Mr. Boehm's impact on the Company. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the novel technology on which our product candidates are based makes it difficult to predict the time and cost of preclinical and clinical development and subsequently obtaining regulatory approval, if at all; the substantial development and regulatory risks associated with epigenomic controller machines due to the novel and unprecedented nature of this new category of medicines; our limited operating history; the incurrence of significant losses and the fact that we expect to continue to incur significant additional losses for the foreseeable future; our need for substantial additional financing; our investments in research and development efforts that further enhance the OMEGA platform, and their impact on our results; uncertainty regarding preclinical development, especially for a new class of medicines such as epigenomic controllers; the fact that our product candidates may be associated with serious adverse events, undesirable side effects or have other properties that could halt their regulatory development, prevent their regulatory approval, limit their commercial potential, or result in significant negative consequences; the impact of increased demand for the manufacture of mRNA and LNP based vaccines to treat COVID-19 on our development plans; difficulties manufacturing the novel technology on which our OEC candidates are based; our ability to adapt to rapid and significant technological change; our reliance on third parties for the manufacture of materials; our ability to successfully acquire and establish our own manufacturing facilities and infrastructure; our reliance on a limited number of suppliers for lipid excipients used in our product candidates; our ability to advance our product candidates to clinical development; and our ability to obtain, maintain, enforce and adequately protect our intellectual property rights. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

Contacts

Investor contact: Kevin MurphyArgot Partners212.600.1902[emailprotected]

Media contact: Jason BracoLifeSci Communications646.751.4361[emailprotected]

SOURCE Omega Therapeutics

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Omega Therapeutics Announces Appointment of Rainer Boehm to its Board of Directors - PR Newswire

Rise In Research And Development Projects In Various Regions Such As East Asia, South Asia Are Expected To Offer An Opportunity Of US $ 0.5 Bn In 2022-2026 Period.

Fact.MR A Market Research and Competitive Intelligence Provider: The global induced pluripotent stem cell (iPSC) market was valued at US $ 1.8 Bn in 2022, and is expected to witness a value of US $ 2.3 Bn by the end of 2026.

Moreover, historically, demand for induced pluripotent stem cells had witnessed a CAGR of 6.6%.

Rise in spending on research and development activities in various sectors such as healthcare industry is expected to drive the adoption of human Ips cell lines in various applications such as personalized medicine and precision.

Moreover, increasing scope of application of human iPSC cell lines in precision medicine and emphasis on therapeutic applications of stem cells are expected to be driving factors of iPSC market during the forecast period.

Surge in government spending and high awareness about stem cell research across various organizations are predicted to impact demand for induced pluripotent stem cells. Rising prevalence of chronic diseases and high adoption of stem cells in their treatment is expected to boost the market growth potential.

For more insights into the Market, Request Brochure of this Report

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Besides this, various cells such as neural stem cells, embryonic stem cells umbilical cord stem cells, etc. are anticipated to witness high demand in the U.S. due to surge in popularity of stem cell therapies.

Key Takeaways:

Growth Drivers:

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Many key players in the market are increasing their investments in R&D to provide offerings in stem cell therapies, which are gaining traction for the treatment of various chronic diseases.

For instance:

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Cardiac Mapping System Market - The advent of cardiac mapping systems enabled electrophysiologists to target and treat complex arrhythmias more effectively than ever. According to the Centers for Disease Control and Prevention, more than 600,000 people die of heart disease in the United States, every year, making it essential for the medical professionals to take strong awareness initiatives to tell people about the availability of cardiac mapping technology, in a move to control the ever-growing cardiac deaths.

Cardiac Ablation Technologies Market - A surge in atrial fibrillation cases is proving to be a growth generator as cardiac ablation technology is prominently used for its treatment. Revenue across the radiofrequency segment is expected to gather considerable momentum, anticipated to account for over50%of global revenue.

Cardiac Patch Monitor Market - A cardiovascular monitor screen is a gadget that you control to record the electrical movement of your heart (ECG). This gadget is about the size of a pager. Cardiac patch monitors are utilized when you need long haul observing of side effects that happen not exactly day by day.

Cardiac Resynchronization Therapy Market - Newly-released Cardiac Resynchronization Therapy industry analysis report by Fact.MR shows that global sales of Cardiac Resynchronization Therapy in 2021 were held atUS$ 5.7 Bn. With7.9%, the projected market growth during 2022-2032 is expected to be slightly lower than the historical growth. CRT-Defibrillator is expected to be the higher revenue-generating product, accounting for an absolute dollar opportunity of nearlyUS$ 4 Bnduring 2022 2032.

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Rise In Number Of CROS In Various Regions Such As Europe Is Expected To Fuel The Growth Of Induced Pluripotent Stem Cell Market At An Impressive CAGR...

DUBLIN--(BUSINESS WIRE)--The "Global Regenerative Medicine Partnering Terms and Agreements 2015 to 2022" report has been added to ResearchAndMarkets.com's offering.

This report is intended to provide the reader with an in-depth understanding and access to Regenerative Medicine trends and structure of deals entered into by leading companies worldwide.

Regenerative Medicine Partnering Terms and Agreements includes:

In Global Regenerative Medicine Partnering Terms and Agreements 2015-2022, the available deals are listed by:

Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand.

The Global Regenerative Medicine Partnering terms and Agreements 2015-2022 report provides comprehensive access to available deals and contract documents for over 1600 Regenerative Medicine deals.

Analyzing actual contract agreements allows assessment of the following:

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/pu1ymr

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Regenerative Medicine Partnering 2015 to 2022: Terms and Agreements Entered Into by the Leading Companies Worldwide - ResearchAndMarkets.com -...

A lot of people are intrigued byregenerative medicine and have heard promising information about the incredible power it has to promote healing. But theres also some confusion about what it really does and how it works.

So let's break down how and why we use these innovative therapies from head to toe and most importantly the benefits that patients see from them.

Headaches and Upper Neck Pain

Cervicogenicheadaches result from a neck issue and cause pain right below the junction of the head and neck in the cervical facet joints that allow you to turn your head side to side or forward to backwards. You may be dealing with this pain as a result of a traumatic injury, or because youre aggravated by repetitive motions like looking down and texting too much, watching TV in a poor position or having a desk set up that isnt ergonomic. Arthritis can exacerbate this problem, too.

When more traditional measures like physical therapy and massage therapy dont help, regenerative medicine can come into play. First, we usually try platelet-rich plasma (PRP) therapy, which is concentrated platelet-rich plasma protein that comes from your blood after we run it through a centrifuge to remove the red blood cells. Injecting PRP into the cervical facet joints can provide relief of acute and chronic neck pain by promoting the bodys natural healing potential. The reduction of pain combined with healing promotion can allow improvements in motion as well.

Stem cell therapy is another option. We harvest bone marrow from the pelvis and break it down to get stem cells and platelets. When we inject this into the problem area, it not only adds stem cells but also attracts more stem cells in your body at a greater rate speeding up recovery.

Both procedures change pathology and promote healing. Results can be long-term unless you injure or damage the tissue again and they can be dramaticstaving off surgery or providing a solution when surgery isnt an option.

Shoulder Pain

This most commonly presents as a rotator cuff tear and when that happens you have three options. Physical therapy helps most people get better but when it doesnt, regenerative medicine is an option if the tear affects 75 percent or less of the shoulder. If the tear is too extreme, surgery is needed.

Platelet rich plasma or PRP is the most commonly used regenerative medicine option for this injury. Its a non-operative solution that utilizes the bodys natural healing process. PRP therapy is a concentration of the patients own blood plasma injected into damaged ligaments, tendons, and joints to promote tissue repair and accelerate healing. It is rich in growth and healing factors and on average, an injured patient can get back to a pain-free life in four to six weeks.

This is a great option for shoulder injuries because most people are looking to avoid shoulder surgery given the risks and recovery.

Back Pain

Lowerback pain is the No. 1 reason people come to see me for regenerative treatment options, but this can be used to treat upper and mid-back pain too.

Regenerative medicine can help with facet joint issues, disc related pain, degeneration, a tear in disc space or irritated nerves (which can be a result of stenosis, nerve injury, surgery, etc.).

Platelet-rich plasma (PRP) therapy and stem cell therapy are both options to treat these conditions. The one we choose generally depends on individual factors with patients and their pain. The wonderful news is 100 percent improvement is possible but I should stress these therapies dont work well in the most severe cases, which likely still require surgery.

Hip Pain

The most typical cause of this pain is osteoarthritis in thehip joint but labral tears are common, too, especially among athletes.The type of treatment we opt for in the case of hip arthritis depends on how much narrowing of the joint is at play. Our top options include platelet-rich plasma (PRP) therapy and stem cell therapy.

Another option we havent yet discussed is lipoaspirate prolotherapy or adipose-derived stem cell therapy. These are also injections like PRP and stem cell therapybut they involve micro fragmented fat. We take fat from the belly and break it down to a thin paste and place it in a joint to provide cushioning and start the healing cycle. This procedure can be used for any joint hip, knee, shoulder or ankle.

Knee Pain

This is the second most common cause of pain that brings people to me for treatment (after lower back pain). The most typical triggers are arthritis but we also see a lot of meniscus and ACL tears too. PRP therapy, stem cell therapy and lipoaspirate prolotherapy are all options for this joint. But heres what you need to know withknee pain, because I know it can be concerning when it happens it is absolutely possible to heal this injury and get back to a place where you can limit and manage the problems.

Regenerative medicine makes that possible. Plenty of people come in with a meniscus tear and have been told they need surgery. Instead, we treat the tear with one of these options and have seen up to 100 percent relief. Many patients never end up in an OR, which is the goal.

It happens most often when the damage isnt too severe which is all the more reason to seek advice and help early in your pain cycle rather than waiting too long.

Ankle Pain

Treatingankle pain can be a bit trickier than other sources because we need to make sure ligaments of the ankle are intact. We can use regenerative medicine to treat both the ankle joint and the ligaments around it depending on the problem, which is generally caused by arthritis or an ankle injury maybe from rolling it.

Treatment options include PRP therapy and stem cell therapy. We have the option of using lipoaspirate prolotherapy as well when were targeting the ankle joint. One thing I havent mentioned previously is that sometimes we tap into more than one healing treatment. Its not unusual that we combine regenerative medicine therapies to accelerate healing.

Although we expect to complete the treatment one time, there are times when we also repeat the procedure to extend the benefit duration to include other nearby structures, or patients that request the procedure be repeated to continue avoiding surgery.

Regenerative medicinewhen done right, by a professionaltruly does have the ability to help you from head to toe and get you "back" to a pain-free, healthy life.

The content on 30Seconds.com is for informational and entertainment purposes only, and should not be considered medical advice. The information on this site should not be used to diagnose or treat a health problem or disease, and is not a substitute for professional care. Always consult your personal healthcare provider. The opinions or views expressed on 30Seconds.com do not necessarily represent those of 30Seconds or any of its employees, corporate partners or affiliates.

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Pain Relief Treatments: The Benefits of Regenerative Medicine From Head to Toe - 30Seconds.com

The Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) updated its Guidance Agenda in June 2022,1which provides that the agency plans to issue 18 guidance documents in 2022, including eight guidance documents on tissues and advanced therapies. In this alert, we highlight some key considerations from three draft guidance documents on human gene therapy products that incorporate gene editing (GE) components, chimeric antigen receptor (CAR) T cell products, and regenerative medicine therapies that can benefit biopharmaceutical developers and sponsors. Recognizing the challenges of developing such complex, multi-component biologic drug products, including unanticipated risks associated with on-target and off-target activities, these draft guidance documents describe the FDA's recommendations for preclinical and clinical testing, chemistry, manufacturing, and controls (CMC), as well as information that should be included in investigational new drug (IND) applications to ensure proper identity, potency/strength, quality, and purity of the investigational drug products. FDA recommends sponsors of such complex products to communicate with the Office of Tissues and Advanced Therapies (OTAT) in CBER early in product development before submission of an IND, to discuss the product-specific considerations in preparation for transitioning to the clinical phase.

FDA expects detailed information and data IND applications before sponsors can transition to clinical testing. We recommend biopharmaceutical developers and sponsors review the applicable FDA draft guidance documents early in their product development process to identify these needs. Work closely with both FDA regulatory counsel and intellectual property/patent counsel to ensure there is sufficient data to support an IND application, including adequate testing and quality control measures, and that CMC, preclinical, and clinical development plans are coordinated with intellectual property and patent strategies to ensure robust protection of their intellectual property and to maximize the benefits of their patents and FDA regulatory exclusivities. We also encourage interested persons to submit comments to shape the policies proposed in FDA's draft guidance documents prior to finalization.

Draft Guidance for Industry: Human Gene Therapy Products Incorporating Genome Editing2

Draft Guidance for Industry: Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products3

Draft Guidance for Industry: Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies4

Stakeholders have until September 14, 2022, to submit comments to this draft guidance to ensure they are considered by FDA before finalization of the guidance.

For More Information

For questions regarding FDA strategy, approval, and regulatory compliance, please contact any member of Wilson Sonsini'sFDA regulatory, healthcare, and consumer productspractice. For questions regarding intellectual property and patent counseling, please contact any member of Wilson Sonsini'spatents and innovationspractice.

Andrea Chamblee,Paul Gadiock, andEva Yincontributed to the preparation of this Wilson Sonsini Alert.

[1] FDA, Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2022 (Updated June 2022), available at https://www.fda.gov/media/120341/download.

[2] FDA, Draft Guidance for Industry: Human Gene Therapy Products Incorporating Genome Editing (March 2022), available at https://www.fda.gov/media/156894/download.

[3] FDA, Draft Guidance for Industry: Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products, available at https://www.fda.gov/media/156896/download.

[4] FDA, Draft Guidance for Industry: Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies (June 2022), available at https://www.fda.gov/media/159237/download.

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FDA Issues Draft Guidance to Facilitate Development of Human Gene Therapy, CAR T Cell, and Regenerative Medicine Products - Wilson Sonsini Goodrich...

image:The ARDD Meeting 2022 will be hosted on August 29 - September 2, 2022 view more

Credit: Insilico Medicine Hong Kong Limited

August 18, 2022 Marco Quarta, Ph.D., will present the latest research on the topic From Single Cell AI-enabled Discovery of Cellular Senescence to Targeted Senolytic Drug Development at the worlds largest annual Aging Research and Drug Discovery conference (9th ARDD). Dr. Quarta is the CEO and Co-founder at Rubedo Life Sciences.

Marco co-founded and leads Rubedo Life Sciences driving its mission to develop treatments for age-related diseases and extend healthspan by selectively targeting pathological cells involved in the biological aging process. As a scientist, he earned a Masters degree in Biotechnology, a PhD in Neuroscience, and post-doctoral training in Aging and Stem Cells Biology in the lab of his mentor Prof. Thomas Rando at Stanford University School of Medicine. He then directed at Stanford/VA Hospital Palo Alto a research team focused on translational medical research in the fields of aging and regenerative medicine. He is backed by over 20 years of research with a track record of scientific publications in top tier journals. Marco is an inventor and entrepreneur, he co-founded and led the international biotech umbrella organization Young European Biotech Network (YEBN), and later joined the European Federation of Biotechnology (EFB) executive board.

Marco Quarta founded and led the biotech company WetWare Concepts in Europe. In California, with the Stanford colleague Prof. Vittorio Sebastiano he also co-founded Turn Biotechnologies based on their work on epigenetic reprogramming of cellular aging, where he served as CSO and he is a Board Director. Quarta sits on the advisory board of the California Institute for Regenerative Medicine (CIRM) Calpoly program in regenerative medicine. He is in the advisory and research board at the Center for Healthcare Innovation (CHI). He is a member of the Paul F Glenn Center for the Biology of Aging Studies at Stanford University. Quarta keeps fostering and championing high standards of compliance, ethics and patient safety in the development of innovative translational therapeutics, putting patients and society at the center of all actions.

The conference proceedings of the ARDD are commonly published in peer-reviewed journals with the talks openly available at http://www.agingpharma.org. Please review the conference proceedings for 2019, 2020 and 2021https://www.aging-us.com/article/203859/text .

Aging is emerging as a druggable condition with multiple pharmaceuticals able to alter the pace of aging in model organisms. The ARDD brings together all levels of the field to discuss the most pressing obstacles in our attempt to find efficacious interventions and molecules to target aging. The 2022 conference is the best yet with top level speakers from around the globe. Im extremely excited to be able to meet them in person at the University of Copenhagen in late summer. said Morten Scheibye-Knudsen, MD, Ph.D., University of Copenhagen.

Aging research is growing faster than ever on both academia and industry fronts. The ARDD meeting unites experts from different fields and backgrounds, sharing with us their latest groundbreaking research and developments. Our last ARDD meeting took place both offline and online, and it was a great success. I am particularly excited that being a part of the ARDD2022 meeting will provide an amazing opportunity for young scientists presenting their own work as well as meeting the experts in the field. said Daniela Bakula, Ph.D., University of Copenhagen.

Many credible biopharmaceutical companies are now prioritized aging research for early-stage discovery or therapeutic pipeline development. It is only logical to prioritize therapeutic targets that are important in both aging and age-associated diseases. The patient benefits either way. The best place to learn about these targets is ARDD, which we organize for nine years in a row. This conference is now the largest in the field and is not to be missed, said Alex Zhavoronkov, Ph.D., founder and CEO of Insilico Medicine and Deep Longevity.

Building on the success of the ARDD conferences, the organizers developed the Longevity Medicine course series with some of the courses offered free of charge at Longevity.Degree covered in the recent Lanced Healthy Longevity paper titled Longevity medicine: upskilling the physicians of tomorrow.

About Aging Research for Drug Discovery Conference

At ARDD, leaders in the aging, longevity, and drug discovery field will describe the latest progress in the molecular, cellular and organismal basis of aging and the search for interventions. Furthermore, the meeting will include opinion leaders in AI to discuss the latest advances of this technology in the biopharmaceutical sector and how this can be applied to interventions. Notably, this year we are expanding with a workshop specifically for physicians where the leading-edge knowledge of clinical interventions for healthy longevity will be described. ARRD intends to bridge clinical, academic and commercial research and foster collaborations that will result in practical solutions to one of humanity's most challenging problems: aging. Our quest? To extend the healthy lifespan of everyone on the planet.

About Scheibye-Knudsen Lab

In the Scheibye-Knudsen lab we use in silico, in vitro and in vivo models to understand the cellular and organismal consequences of DNA damage with the aim of developing interventions. We have discovered that DNA damage leads to changes in certain metabolites and that replenishment of these molecules may alter the rate of aging in model organisms. These findings suggest that normal aging and age-associated diseases may be malleable to similar interventions. The hope is to develop interventions that will allow everyone to live healthier, happier and more productive lives.

About Deep Longevity

Deep Longevity has been acquired by Edurance RP (SEHK:0575.HK), a publicly-traded company. Deep Longevity is developing explainable artificial intelligence systems to track the rate of aging at the molecular, cellular, tissue, organ, system, physiological, and psychological levels. It is also developing systems for the emerging field of longevity medicine enabling physicians to make better decisions on the interventions that may slow down, or reverse the aging processes. Deep Longevity developed Longevity as a Service (LaaS) solution to integrate multiple deep biomarkers of aging dubbed "deep aging clocks" to provide a universal multifactorial measure of human biological age. Originally incubated by Insilico Medicine, Deep Longevity started its independent journey in 2020 after securing a round of funding from the most credible venture capitalists specializing in biotechnology, longevity, and artificial intelligence. ETP Ventures, Human Longevity and Performance Impact Venture Fund, BOLD Capital Partners, Longevity Vision Fund, LongeVC, co-founder of Oculus, Michael Antonov, and other expert AI and biotechnology investors supported the company. Deep Longevity established a research partnership with one of the most prominent longevity organizations, Human Longevity, Inc. to provide a range of aging clocks to the network of advanced physicians and researchers. https://longevity.ai/

About Endurance RP (SEHK:0575.HK)

Endurance RP is a diversified investment group based in Hong Kong currently holding various corporate and strategic investments focusing on the healthcare, wellness and life sciences sectors. The Group has a strong track record of investments and has returned approximately US$298 million to shareholders in the 21 years of financial reporting since its initial public offering. https://www.endurancerp.com/

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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Marco Quarta to present at the 9th Aging Research & Drug Discovery Meeting 2022 - EurekAlert

With age, it is common joint degeneration, especially of the hips and knees, which support the greatest load in our day to day life and commonly develop which is known as osteoarthritis, This deterioration of articular cartilage causes pain, stiffness, and loss of function, Therefore, it may represent a significant reduction in the quality of life of those who suffer from it. There is no treatment capable of curing osteoarthritis, but therapeutic avenues have emerged in recent years to reduce its symptoms, slow its development, and achieve an improvement in the patients quality of life.

it is a matter loss Treatment with plasma and stem cells rich in growth factorsApplied to prevent the progression of osteoarthritis, especially in large load-bearing joints. But its benefits go even further, explains the doctor. Jesus Villa y RicoHead of the Orthopedic Surgery and Traumatology Service at the Ruber Juan Bravo Hospital Complex in Madrid. These treatments also promote cartilage repair and reduce typical symptoms of osteoarthritis, including synovial swelling, effusion, deformity, pain or loss of motion.

There are many patients who are benefiting from advances in regenerative medicine in areas such as aesthetic medicine, ophthalmology or dentistry, but also in traumatology. It finds its use not only in reducing recovery time in bone, muscle and tendon injuries, but in the treatment of cases of disabling osteoarthritis or where conservative treatments are not sufficient.

It has no side effects or risk of rejection or intolerance, because the plasma comes from the patients own blood

Dr. Jesus Villa y Rico in Madrid, Ruber Juan Bravo Hospital

Platelet-rich plasma from the patients own blood is able to promote the regeneration of tissues damaged by osteoarthritis, thanks to the proteins and substances it contains. Stem cell treatments also allow the regeneration of these tissues. Growth factors produce biological effects such as cell proliferation and differentiation, the generation of blood vessels and the migration of cells to sites where regeneration is necessary, explains Dr. Villa. No exogenous agent can mediate all of these processes so effectively.

Treatment is carried out under medical prescription, in a sterile environment and with local anesthesia. For its application, blood is first taken from the patient, then it is processed and part of the plasma rich in growth factors is infiltrated into the area to be treated. This process may take 25 to 40 minutes, says the traumatologist.

With regard to the number of infiltrates, the protocol varies depending on the pathology. The Head of the Orthopedic Surgery and Traumatology Service of the Ruber Juan Bravo Hospital Complex in Madrid specifies that, In the specific case of joint pathologyWhat happens most often, is done three sessions for three consecutive weeks, with a refresher session after six months or one year if growth is favourable. Infiltration does not mean a period of recovery, so that the patient can lead a normal life from the very first moment.

The main benefit of this type of treatment is improvement in symptoms, namely reduction of pain and swelling. In case of tendon and muscle injuries, it has been proven that it accelerates healing. Too No side effects or risk of rejection or intolerance, because the plasma comes from the patients own blood, Dr. Villa says. This treatment is contraindicated only in case of local infections, neoplastic processes, and certain blood diseases, he explains.

In the specific case of stem cell treatment, infiltration represents an alternative to reconstructive surgery for chronic tendinopathies, acute tendon tears, chronic tendon tears and ligament tears, and osteonecrosis. In ligament surgery, such as the anterior cruciate ligament of the knee, exceptional results have also been obtained. in case of muscle injuryMore important than the reduction in recovery time is the use of plasma rich in growth factors. Allows recovery without the formation of fibrous tissue, experts say. It is also used in adjuvant treatment of osteochondral injuries in favor of the regenerative process of fibrocartilage, as well as in patellar tendon pathology, acute or chronic tendinitis, and ligamentous injuries.

Health

A holistic approach about our health is essential for achieving complete well-being and the highest quality of life. Its not about something organic and isolated that can []

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Osteoarthritis In The Hip Or Knee? Regenerative Medicine Revolutionizes Your Treatment - Nation World News

3D Systems Inc.

New 3D Systems Medical Advisory Board Members

Dr. Toby Cosgrove & Dr. Bon Ku

ROCK HILL, S.C., Aug. 18, 2022 (GLOBE NEWSWIRE) -- 3D Systems (NYSE:DDD) today announced the appointment of Dr. Toby Cosgrove, former president & chief executive officer of the Cleveland Clinic, and Dr. Bon Ku, director of the Health Design Lab at Thomas Jefferson University, as the fourth and fifth members of the companys recently established Medical Advisory Board (MAB). Dr. Cosgrove and Dr. Ku will join former Health & Human Services Secretary Alex Azar, Dr. Stephen K. Klasko, and former U.S. Secretary of Veterans Affairs David J. Shulkin as members of the advisory board. The Boards primary mission is to provide strategic input, guidance, and recommendations for the companys expanding efforts in regenerative medicine.

Dr. Cosgrove has distinguished himself as a leader of one of the worlds most recognized healthcare institutions, a renowned medical practitioner, and as a forward-looking healthcare innovator. Having been affiliated with the Cleveland Clinic healthcare system for nearly 50 years, Dr. Cosgrove served as President and Chief Executive Officer from 2004 to 2017 and is currently an Executive Advisor to the Clinic. As President and CEO, Dr. Cosgrove oversaw a $6 billion annual revenue institution comprised of the Cleveland Clinic, over 20 Ohio-based hospitals, family health centers, and surgical facilities, as well as Cleveland Clinic affiliates in other U.S. states and internationally. During Dr. Cosgroves tenure leading the Cleveland Clinic, it was ranked among the top three hospitals in America by U.S. News and World Report, and he championed a broad range of initiatives to improve clinical outcomes, increase patient satisfaction, and focus the Clinics delivery of health care services around specific organ systems and diseases.

Prior to serving as the Cleveland Clinics top executive, Dr. Cosgrove was a cardiac surgeon at the Clinic and served as Chairman of its Department of Thoracic and Cardiovascular Surgery from 1989 to 2004. He has performed more than 22,000 operations over the course of his career and is widely regarded as a pioneer in the field of advanced surgical techniques. Deeply committed to medical innovation and to applying new technologies for the benefit of patients, Dr. Cosgrove has over 30 patents filed for new medical and clinical products used in surgical environments.

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Dr. Bon Ku has enjoyed a distinguished career as both a practicing medical clinician and as a visionary proponent of using technology-based innovations to solve pressing healthcare challenges. Dr. Ku is the Marta and Robert Adelson Professor of Medicine and Design at Thomas Jefferson University as well as an emergency physician at the Universitys Sidney Kimmel Medical College.

Dr. Ku is widely regarded as an authority on accelerating healthcare innovation through the use of modern technological tools such as virtualization, digital modeling, prototyping, and additive manufacturing. He is the co-founder and Director of Thomas Jefferson Universitys Health Design Lab, a unique institution that works with medical students, researchers, and physicians to develop new medical devices and innovative design concepts for the healthcare sector. The Health Design Lab led by Dr. Ku features a clinical 3D printing and bioprinting lab and is home to the JeffSolves MedTech initiative, which serves as a center for the incubation and commercialization of new medical technologies. Dr. Ku is also the author of numerous peer-reviewed publications focusing on the application of 3D-printed medical devices and digital models to improve surgical outcomes, optimize treatments, and make advancements in personalized medicine.

Commenting on the appointments of Drs. Cosgrove and Ku, 3D Systems President and CEO, Dr. Jeffrey Graves stated, We are exceptionally pleased to welcome Dr. Cosgrove and Dr. Ku to our Medical Advisory Board. These two professionals have impeccable track records of combining hands-on medical practice experience with a clear passion for utilizing innovative approaches and modern technology to transform healthcare outcomes. Both Dr. Cosgrove and Dr. Ku will be uniquely positioned to advise 3D Systems as we build a world-class regenerative medicine business and pursue 3D printing-based advancements in areas such as accelerated pharmaceutical development, human tissue and organ printing, medical device innovation, and personalized medicine.

Forward-Looking StatementsCertain statements made in this release that are not statements of historical or current facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to be materially different from historical results or from any future results or projections expressed or implied by such forward-looking statements. In many cases, forward-looking statements can be identified by terms such as "believes," "belief," "expects," "may," "will," "estimates," "intends," "anticipates" or "plans" or the negative of these terms or other comparable terminology. Forward-looking statements are based upon managements beliefs, assumptions, and current expectations and may include comments as to the companys beliefs and expectations as to future events and trends affecting its business and are necessarily subject to uncertainties, many of which are outside the control of the company. The factors described under the headings "Forward-Looking Statements" and "Risk Factors" in the companys periodic filings with the Securities and Exchange Commission, as well as other factors, could cause actual results to differ materially from those reflected or predicted in forward-looking statements. Although management believes that the expectations reflected in the forward-looking statements are reasonable, forward-looking statements are not, and should not be relied upon as a guarantee of future performance or results, nor will they necessarily prove to be accurate indications of the times at which such performance or results will be achieved. The forward-looking statements included are made only as of the date of the statement. 3D Systems undertakes no obligation to update or revise any forward-looking statements made by management or on its behalf, whether as a result of future developments, subsequent events or circumstances or otherwise, except as required by law.

About 3D Systems More than 35 years ago, 3D Systems brought the innovation of 3D printing to the manufacturing industry. Today, as the leading additive manufacturing solutions partner, we bring innovation, performance, and reliability to every interaction - empowering our customers to create products and business models never before possible. Thanks to our unique offering of hardware, software, materials, and services, each application-specific solution is powered by the expertise of our application engineers who collaborate with customers to transform how they deliver their products and services. 3D Systems solutions address a variety of advanced applications in healthcare and industrial markets such as medical and dental, aerospace & defense, automotive, and durable goods. More information on the company is available at http://www.3dsystems.com.

Investor Contact: investor.relations@3dsystems.comMedia Contact: press@3dsystems.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/2b14f06b-98f9-4c66-8c02-b57375cab66d

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3D Systems Announces Appointment of Dr. Toby Cosgrove and Dr. Bon Ku as Members of its Medical Advisory Board - Yahoo Finance

The remarkable power of stem cells - which can be programmed to become almost any type of cell in the body - means they are key to many scientific studies.

Increasingly, they are also being used for new cell-based therapies to treat a range of diseases.

While originally we could only get stem cells from embryos, now we can derive them from a range of adult tissues, including skin or blood, using Nobel Prize-winning technology.

But Cambridge researchers have found DNA damage caused by factors such as ultraviolet radiation affected 72 per cent of the stem cell lines they studied that had been derived from human skin cells. This has important implications for research and medicine.

Prof Serena Nik-Zainal, from the Department of Medical Genetics at the University of Cambridge, said: Almost three-quarters of the cell lines had UV damage. Some samples had an enormous amount of mutations sometimes more than we find in tumours. We were all hugely surprised to learn this, given that most of these lines were derived from skin biopsies of healthy people.

Induced pluripotent stem cells (iPSCs), as those derived from other cell types or tissues are known, hold huge potential for tackling diseases, including rare conditions.

It is even suggested that iPSCs programmed to grow into nerve cells could be used to replace those lost to neurodegeneration in diseases such as Parkinsons.

The new research, published in Nature Genetics, represents the largest genetic study to date of iPSCs to date.

Dr Foad Rouhani, who carried out the work while at the University of Cambridge and the Wellcome Sanger Institute, said: We noticed that some of the iPS cells that we were generating looked really different from each other, even when they were derived from the same patient and derived in the same experiment.

The most striking thing was that pairs of iPS cells would have a vastly different genetic landscape one line would have minimal damage and the other would have a level of mutations more commonly seen in tumours.

One possible reason for this could be that a cell on the surface of the skin is likely to have greater exposure to sunlight than a cell below the surface and therefore eventually may lead to iPS cells with greater levels of genomic damage.

[Read more: Evidence of new causes of cancer uncovered as genomic data of 12,000 NHS patients is studied by University of Cambridge researchers]

DNA comprises three billion pairs of nucleotides - molecules represented by the letters A, C, G and T.

Damage from sources such as ultraviolet radiation or smoking leads to mutations, meaning a letter C might change to T, for example.

Studying the mutational fingerprints on our DNA can reveal what is responsible for the damage.

An accumulation of mutations can have a profound effect on cell function and in some cases lead to tumours.

Using whole genome sequencing, the researchers inspected the entire DNA of stem cell lines from different sources, including the HipSci cohort at the Wellcome Sanger Institute.

They found blood-derived iPSCs - which are increasingly common, due to the ease with which blood can be taken - also carried mutations but at a lower level than skin-derived iPS cells, and they had no UV damage.

Some 26.9 per cent of them, however, carried mutations in a gene called BCOR, which is an important gene in blood cancers.

Next the researchers investigated whether these BCOR mutations had any functional impact.

They differentiated the iPSCs, turning them into neurons and tracking their progress along the way.

[Read more: 4m funding for Cambridge scientists under Cancer Grand Challenges initiative]

Dr Rouhani said: What we saw was that there were problems in generating neurons from iPSCs that have BCOR mutations they had a tendency to favour other cell types instead. This is a significant finding, particularly if one is intending to use those lines for neurological research.

Analysis of the blood samples showed the BCOR mutations were not present within the patient.

So it seemed that the process of culturing cells increased the frequency of the mutations, which could have implications for other researchers working with cells in culture.

Typically, scientists using cell lines will screen them at the chromosomal level checking, for example, that the requisite 23 pairs of chromosomes are present.

Such analysis would not pick up the potentially major problems that this new study has identified, however,

The researchers warn that without looking in detail at the genomes of these stem cells, researchers and clinicians would be unaware of the underlying damage in them.

The DNA damage that we saw was at a nucleotide level, explained Prof Nik-Zainal. If you think of the human genome as like a book, most researchers would check the number of chapters and be satisfied that there were none missing. But what we saw was that even with the correct number of chapters in place, lots of the words were garbled.

Using whole genome sequencing, however, would enable errors to be discovered at the outset..

The cost of whole genome sequencing has dropped dramatically in recent years to around 500 per sample, though it's the analysis and interpretation that's the hardest bit, said Prof Nik-Zainal.

If a research question involves cell lines and cellular models, and particularly if we're going to introduce these lines back into patients, we may have to consider sequencing the genomes of these lines to understand what we are dealing with and get a sense of whether they are suitable for use.

Dr Rouhani adds: In recent years we have been finding out more and more about how even our healthy cells carry many mutations and therefore it is not a realistic aim to produce stem cell lines with zero mutations.

The goal should be to know as much as possible about the nature and extent of the DNA damage to make informed choices about the ultimate use of these stem cell lines.

If a line is to be used for cell based therapies in patients for example, then we need to understand more about the implications of these mutations so that both clinicians and patients are better informed of the risks involved in the treatment.

The research was funded by Cancer Research UK, the Medical Research Council and Wellcome, and supported by NIHR Cambridge Biomedical Research Centre and the UK Regenerative Medicine Platform.

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Many stem cell lines used for research and therapies carry large number of mutations, Cambridge researchers find - Cambridge Independent

VALENCIA, Calif. and MELBOURNE, Australia, Aug. 17, 2022 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, announced today that a poster presentation on cell characterization and potential clinical benefits of the RECELL Autologous Cell Suspension System (RECELL System) for the treatment of stable vitiligo will be shared at the Controversies and Conversations in Laser & Cosmetic Surgery Annual Meeting. The conference will be held in Santa Barbara, CA, on August 19-21 bringing experts together to discuss controversial issues in cutaneous and aesethetic surgery or challenging therapeutic problems within dermatology.

Given the unique format of this meeting, we look forward to the presentation of RECELL and, more importantly, the conversation amongst dermatology experts as they discuss the unique attributes of this platform, including the potential for in-office point-of-care treatment in about 30 minutes, said Dr. Mike Perry, Chief Executive Officer of AVITA Medical. Following review by the FDA, we believe the RECELL System may well offer a welcome treatment option for patients seeking repigmentation for stable vitiligo lesions.

RECELL System Presentations

In the U.S., the RECELLSystem is indicated for the treatment of acute thermal burn wounds in patients 18 years of age and older or application in combination with meshed autografting for acute full-thickness thermal burn wounds in pediatric and adult patients. Physician-initiated research beyond the FDA approved indicationis not sponsored by AVITA Medicaland contains independentdata.

AVITA Medical is currently completing a pivotal trial for the use of the RECELL System for treatment of stable vitiligo. The vitiligo clinical trial aims to demonstrate safe and effective repigmentation when using the RECELL System in combination with phototherapy. AVITA anticipates FDA approval in 2023.

ABOUT AVITA MEDICAL, INC.

AVITA Medical, Inc. is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medical Inc.s patented, and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patients own skin. The Companys lead product is the RECELL System, a device that enables healthcare professionals to Spray-On Skin Cells using a small sample of the patients own skin to create an autologous suspension. The RES Regenerative Epidermal Suspension is then sprayed onto the areas of the patient requiring treatment to regenerate natural healthy epidermis.

AVITA Medicals first U.S. product, the RECELL System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is approved for acute partial-thickness thermal burn wounds in patients 18 years of age and older or application in combination with meshed autografting for acute full-thickness thermal burn wounds in pediatric and adult patients. In February 2022, the FDA reviewed and approved the PMA supplement for RECELL Autologous Cell Harvesting Device, an enhanced RECELL System aimed at providing clinicians a more efficient user experience and simplified workflow.

The RECELL System is used to prepare Spray-On Skin Cells using a small amount of a patients own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 15,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL Autologous Cell Harvesting Device ( https://recellsystem.com/ ) for a full description of indications for use and important safety information including contraindications, warnings, and precautions.

In international markets, our products are approved under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds, and aesthetics. The RECELL System is TGA-registered in Australia, received CE-mark approval in Europe, and received Japans Pharmaceuticals and Medical Devices Act (PMDA) approval for burns in Japan.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

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

This press release was authorized by the review committee of AVITA Medical, Inc.

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RECELL System Data to be Presented at the Controversies and Conversations in Laser & ... - The Bakersfield Californian

PRINCETON, N.J., Aug. 16, 2022 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (NASDAQ:IART), a leading global medical technology company, today announced that Dr. Richard Caruso, founder and former chairman and CEO of Integra LifeSciences passed away over the past weekend.

Dr. Richard Caruso made an impact on not only the medical technology industry, but more importantly, on the countless lives around the world who have benefited from the products and technologies that Integra LifeSciences has today, said Stuart Essig, chairman of the board at Integra LifeSciences. His vision, transformative ideas and entrepreneurial spirit have revolutionized the way surgeons treat their patients in the field of regenerative medicine.

Dr. Caruso founded Integra LifeSciences in 1989 with a vision that the human body could be enabled to regenerate many of its own damaged or diseased tissues, paving the way for a new discipline back then known as regenerative medicine. Through his vision, Integra became the first company to develop and bring to market a tissue regeneration product, Integra Dermal Regeneration Template, which was approved by the FDA in 1996 as a skin replacement system with a claim for regeneration of dermal tissue for the treatment of life-threatening burns and repair of scar contractures. That technology led to the development of DuraGen Dural Graft Matrix, for repair of the dura mater, the protective covering of the brain after cranial and spine surgery, and NeuraGen Nerve Guide, which creates a conduit for axonal growth across a severed nerve.

Dr. Caruso served as Integra's chairman from 1992 until 2011, and served as CEO from 1992 to 1997. In addition, he served on the Board of Susquehanna University and the Baum School of Art. Dr. Caruso received his B.S. degree from Susquehanna University, an M.S.B.A. degree from Bucknell University, and a Ph.D. degree from the London School of Economics, University of London. He was also the founder and director of The Uncommon Individual Foundation, a non-profit foundation that encourages individuals to form and follow their dreams of personal success and become the entrepreneurs of their personal lives.

About Integra LifeSciencesIntegra LifeSciences is a global leader in regenerative tissue technologies and neurosurgical solutions dedicated to limiting uncertainty for clinicians so they can focus on providing the best patient care. Integra offers a comprehensive portfolio of high quality, leadership brands that include AmnioExcel, Aurora, Bactiseal,BioD, CerebroFlo, CereLinkCertasPlus, Codman, CUSA, Cytal, DuraGen, DuraSeal, Gentrix, ICP Express, Integra, Licox, MAYFIELD, MediHoney, MicroFrance, MicroMatrix, NeuraGen, NeuraWrap, PriMatrix, SurgiMend, TCC-EZand VersaTru. For the latest news and information about Integra and its products, please visitwww.integralife.com.

Investor Relations Contact:Chris Ward(609) 772-7736chris.ward@integralife.com

Media Contact:Laurene Isip(609) 208-8121laurene.isip@integralife.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/fe4238dd-d2f8-487f-8f14-19e855e9b041.

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Integra LifeSciences Announces the Passing of Dr. Richard Caruso, Founder and Former Chairman and CEO - GlobeNewswire

NEW YORK Tessa Therapeutics said on Wednesday that it has dosed the first lymphoma patient in a Phase Ib trial of its investigational CAR T-cell therapy TT11 plus Bristol Myers Squibb's Opdivo (nivolumab).

The trial, dubbed ACTION, is designed to evaluate the autologous CD30-directed CAR T-cell therapy plus the PD-1 inhibitor as second-line treatment for up to 14 patients with CD30-positive relapsed or refractory classical Hodgkin lymphoma after chemotherapy.

Singapore-based Tessa Therapeutics is calling the treatment regimen evaluated in the trial a "sandwich" design. Patients enrolled in the trial will receive two cycles of Opdivo followed by a lymphodepleting chemotherapy regimen, then a single infusion of the autologous TT11 CAR T-cell therapy, then another two cycles of Opdivo. The primary goal of the trial is to evaluate the treatment's safety and tolerability, and secondary aims include overall response rate, duration of response, and progression-free survival.

Tessa is also evaluating TT11 as a monotherapy for CD30-positive relapsed or refractory classical Hodgkin lymphoma in the Phase II CHARIOT trial. Initial data from that study showed that the cell therapy had a favorable safety profile and promising efficacy, with a 57.1 percent complete response rate and a 71.4 percent overall response rate among 14 patients. Tessa expects to begin the pivotal Phase II portion of that trial later this year.

"We welcome the opportunity to capitalize on this clinical progress by investigating TT11 as a second-line combination therapy, which offers the opportunity to greatly increase the patient population who could potentially benefit from this course of care," John Ng, chief technology officer and acting CEO of Tessa, said in a statement.

The firm believes that combining the CAR T-cell therapy with Opdivo will improve its efficacy and offer classical Hodgkin lymphoma patients a second-line treatment option that is more tolerable than chemotherapy. The US Food and Drug Administration has designated TT11 a regenerative medicine advanced therapy and the European Medicines Agency has designated it a priority medicine.

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Tessa Therapeutics Starts Trial of CAR T-Cell Therapy, BMS's Opdivo in Classical Hodgkin Lymphoma - Precision Oncology News

Under-resourced high school students need to be familiarized with multiple components of research in order to give back to their communities, said Dolores Caffey Fleming, MS, MPH.

Fleming is the director of Project STRIDE (Students Training in Research Involving Disparity Elimination), Project STRIDE II, and Project ExSTRM (Exposing Students To Regenerative Medicine).

The STRIDE programs are funded by the Doris Duke Charitable Foundation while the ExSTRM program is funded by the California Institute of Regenerative Medicine (CIRM). According to Fleming, the goal of all the programs is to allow students to be exposed to research and various healthcare careers in order for them to give back to their communities.

This year, these programs were sort of combined as a lot of the activities that they did were interconnected. These research programs for high schoolers at Charles R. Drew University (CDU) have been consistently supported by Jay Vadgama, Ph.D., the Vice President for Research and Health Affairs (CDU), and have continued to operate for the past several years

Before actually going onto campus, we had to do CITI (Collaborative Institutional Training Initiative) training before we entered any labs or facilities. We took seven courses ranging from Biosafety for Researchers to Good Clinical Practice. After finishing, I had a virtual introduction with my mentor, Dr. Juanita Booker-Vaughns, and we talked about potential project ideas and her experience in research.

For the first week, Elizabeth Delgado, a project coordinator, taught us and administered quizzes from the university about lab safety, chemical hazards, and the Code of Conduct. The next week, I personally got to shadow some professionals in the Cancer Division lab and was able to watch them perform procedures like the Western Blot Test and Polymerase Chain Reactions (PCR). Although this was not related to my project, it was cool to learn and observe an important procedure. Many Tuesdays and Thursdays were also reserved for leadership training and resume-building classes.

A Polymerase Chain Reaction, or PCR. (Photo by Shaun Thomas)

My research project was centered around examining colorectal cancer (CRC) risk factors in a specific area of Los Angeles County known as Service Planning Area (SPA) 6. With my mentors help, we looked at public health data about all these risk factors in SPA 6, as opposed to L.A. County as a whole.

I first conducted literature about colorectal cancer risk factors in general ranging from biological factors like Inflammatory Bowel Disease (IBD) to behavioral health factors like diet. After that, using the data from the Key Indicators of Health Report (2017) by Los Angeles Countys Department of Public Health, I created graphs and analyzed the data. To put everything together, I created a poster showcasing my findings.

I had the chance to interview one student from each of the three cohorts.

I first interviewed Ivan Ixtlilco, a Project STRIDE senior at King Drew Magnet High School, whose project was about how urban ecology affects epigenetics and how this, in turn, increases the risk of cardiovascular disease, he said. He added on about how his mentor introduced him to a whole variety of careers in research that he had no idea about.

Afia Ahmed, a Project STRIDE II rising second-year student at UC Irvine said, Project STRIDE allowed [her] to gain a foundation for building a whole manuscript, skimming through articles for crucial information. She said these skills were beneficial for her public health classes at UCI.

She also pointed out some key differences between the two. Now that she is doing STRIDE II, she mentioned doing a manuscript and going more into depth with her research on the mental health of Asian American females who are infertile in order to build an abstract and submit her abstract to conferences. She noted that there was a significant literature gap between Asian American female infertility and female infertility in general.

Ricardo Rodriguez, an ExSTRM senior at St. John Bosco High School, focused on a project that involved more lab work: ancestry-specific expression of stem-like markers in breast cancer cells. He believes stem cells are the future of research and can even be key to processes like regeneration. However, he also believes that governments will decide the fate of using this research. He had the opportunity to present his poster at the CIRM SPARK conference which took place on August 3 in Oakland, Calif.

Shaun Thomas with Dr. Jay Vadgama at the symposium. (Photo courtesy of Shaun Thomas)

The climax of the program was the Charles Drew Symposium which took place on August 5. At the symposium, some of us were chosen to present our projects in front of guests, university faculty, and all of our mentors. After the presentations, we all presented our posters in a gallery. The two-hour event showcased the culmination of our work over.

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Column: My summer research experience at Charles R. Drew University for Medicine and Science - Los Angeles Times