Weill Cornell Medicine

Exclusive development, manufacturing and supply agreement with Regenity Biosciences provides FesariusTherapeutics with a reliable, long-term supply of an entirely new class of dermal regenerative templates for the management of full thickness wounds NEW YORK, April 17, 2025 /PRNewswire/ -- FesariusTherapeutics Inc., a commercial-stage bioregenerative surgical company focused on delivering cutting-edge solutions for the wound care, reconstructive surgery and regenerative medicine markets, today announces it has entered into an exclusive, multi-year manufacturing and supply agreement with Regenity Biosciences ("Regenity"), the leading development and manufacturing partner of regenerative technologies for the medical device community. The agreement provides Regenity exclusive manufacturing responsibility for DermiSphere hDRT, an entirely new class of collagen-based dermal regeneration templates designed for improved patient outcomes in the treatment of full-thickness wounds. Continue Reading Full-thickness wounds occur when both the dermal and epidermal layers of the skin are lost; unlike superficial/partial thickness wounds, full-thickness wounds lack the cellular components and structural support necessary to regenerate missing tissue. Without timely surgical intervention, there is delayed time to closure, a heightened risk of infection, and severe scarring and functional impairment. Dermal regeneration templates (DRT) are essential for management of these wounds to regenerate dermis. It is estimated that over 250,000 surgical procedures were performed in the United States last year to treat full thickness skin loss. Fesarius contracted with Regenity in 2022 to establish the transfer and development of the commercial manufacture of DermiSphere hDRT. "Regenity is the world's leading manufacturer of regenerative technologies and is the optimal partner to provide a reliable and scalable supply of our unique hydrogel device," Said Tom Roueche, CEO of Fesarius. "Completing this manufacturing milestone sets the stage for Fesarius to transform the process of advanced wound care and the surgical treatment of full thickness skin loss." Fesarius received FDA 510(k) marketing authorization for DermiSphere hDRT earlier this year to allow for commercial sale in the United States. Completing manufacturing enables surgeons to immediately begin utilizing Fesarius' transformative hDRTs in the treatment of full thickness skin loss. About FesariusTherapeutics Inc FesariusTherapeutics Inc. was founded in 2015 to leverage the unique regenerative technology developed by Jason A. Spector, MD, at his Laboratory of Bioregenerative Medicine and Surgery at Weill Cornell Medicine in NYC where he also serves as Chief of the Division of Plastic and Reconstructive Surgery. Dr. Spector was inspired to develop DermiSphere™ after experiencing the many limitations of products available for treating full thickness skin loss and the negative impact they had on his patients. About Regenity Biosciences Regenity Biosciences, a Linden Capital Partners ("Linden") portfolio company, is the leading global developer and manufacturer of bioresorbable technologies to repair and regenerate natural tissue and bone for a variety of markets including dental, spine, orthopaedic, neurosurgery, ENT, advanced wound and nerve repair. Founded in 1997, Regenity (formerly Collagen Matrix, Inc.) is headquartered in Paramus, New Jersey, with manufacturing locations in Oakland and Allendale, New Jersey and Groningen, the Netherlands. Regenity's product portfolio includes a variety of collagen-based and synthetic polymer solutions that support the company's platform for tissue and bone regeneration. Regenity develops proprietary products that are sold to OEM customers on either a contract or private label basis and offers partnership opportunities including contract product development and manufacturing services. For more information, please visit . PDF Version SOURCE FesariusTherapeutics Inc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

A panel of experts who decide the national immunization schedule will meet on Tuesday for the first time in 2025, providing an opportunity for the nation’s top vaccine scientists to publicly discuss the value of products that the new administration has cast doubt on. The CDC’s Advisory Committee on Immunization Practices meeting was postponed from February and is one of three scheduled for this year. The group is expected to discuss a number of vaccines, including shots protecting against the flu, Covid-19, RSV and meningitis. The group will vote on updated recommendations for chikungunya vaccines, meningococcal vaccines for teens and young adults, and RSV vaccination for adults. The administration’s scrutiny of these routine meetings reflects how much anti-vaccine sentiment has risen in recent years, and how HHS Secretary Robert F. Kennedy Jr. stands to reinforce those concerns. “I’m just praying that there will be an ACIP meeting,” Laura Riley, a former ACIP member and chair of obstetrics and gynecology at Weill Cornell Medicine, said in an interview on Monday. A spokesperson for HHS did not immediately respond when asked about Kennedy’s views of the committee and whether he plans to replace members in the future. Vaccine policy in the US is effectively divided into two parts. The FDA and its own advisory group review and decide what vaccines to approve. The CDC and ACIP recommend which Americans should get the approved vaccines. Recommended vaccines are usually covered by insurance. The decisions that ACIP makes, which the CDC director ultimately has final say over, are based on a number of factors, primarily the safety and efficacy of the vaccine. But the committee also considers the cost-effectiveness of the vaccine and the ethics of how certain recommendations, or lack thereof, will impact uptake. The committee reviews vaccine safety data post-licensure, and considers them when updating recommendations. “Unfortunately, there are so much data out there, and people are not aware of how to interpret it, which is why you need an advisory committee like ACIP poring through all of the data in order to make informed decisions,” said Henry Bernstein, a pediatrics professor at the Zucker School of Medicine at Hofstra University and another former ACIP member who served from 2017 to 2021. Not in recent memory has ACIP existed under an administration that so frequently questions the benefits of vaccination. Kennedy leads a separate MAHA Commission that he tasked with investigating the childhood vaccine schedule. He’s continuously questioned whether vaccines are the source of rising autism rates, and has initiated plans for the CDC to study just that, despite numerous studies concluding they do not. Specific kinds of vaccines, including mRNA-based and single-antigen vaccines, have been singled out by either Kennedy or key voices in the MAHA movement he leads. Riley said that acceptance of the committee’s work boils down to effective communication, which she says could be improved. “I don’t think people understand the benefits of science period,” Riley said. “I don’t think that we have communicated clearly enough how important scientific discovery is.” She pointed to the Covid pandemic as a time when the committee could have more directly explained what it did and didn’t know, given how swiftly new data about the vaccines and the virus were being produced. “I don’t think that it was clear to people that we didn’t know everything,” she said, adding that it created a vacuum for alternative sources of information to seep in. Sometimes the decisions themselves were polarizing, like when the committee decided in June 2021 that the benefits of the two-shot mRNA Covid vaccine regimen in men outweighed the risk of vaccine-related heart inflammation known as myocarditis. Kennedy has also questioned whether federal vaccine advisors have a too-cozy relationship with industry. Politico previously reported he was considering replacing some members because of their perceived conflicts. Former ACIP members dismissed the concern, saying the required conflict of interest submissions before each meeting were rigorous and that members frequently erred on the side of caution. Arthur Reingold, a former committee member and an epidemiology professor at the University of California, Berkeley, told Endpoints News that he was barred from voting on a vaccine against HPV because his wife was the director of the CDC’s division of sexually transmitted diseases at the time. “So if people are saying that all of that was basically hiding things or not fully transparent, I don’t know where that accusation comes from, frankly, or what it’s based on,” he said. The CDC now publishes past conflict of interest disclosures. Moving forward, Bernstein hopes there isn’t “dramatic change” to the group, calling its work “incredibly successful.” “What’s being done is critically important, but if we don’t communicate and educate the public at all levels around these vaccines, it’s going to be problematic,” he said. Editor’s note: This story was updated to include the full titles of Henry Bernstein and Arthur Reingold.

TUESDAY, April 8, 2025 -- Pregnancy might offer women some protection from developing long COVID, a new study says. Women infected with COVID-19 during pregnancy were 14% to 30% less likely to develop lasting symptoms from their illness, researchers reported recently in the journal Nature Communications . “Though we observed that pregnant women have a significant risk of long COVID, it was surprisingly lower than those who were not pregnant when they had SARS-CoV-2 infection,” lead researcher Dr. Chengxi Zang , an instructor in population health sciences at Weill Cornell Medicine in New York City, said in a news release. For the study, researchers tapped into real-world data from two large electronic health record databases, the National Patient-Centered Clinical Research Network (PCORnet) and the National COVID Cohort Collaborative (N3C). The databases contained records for about 72,000 women infected with COVID during pregnancy between March 2020 and June 2023. Researchers compared them to about 208,000 other women who weren’t pregnant but got COVID around the same time. Long COVID symptoms tend to crop up weeks after a person’s initial bout with COVID-19. These symptoms can be widely varied, and can last for months or even years, according to the U.S. Centers for Disease Control and Prevention. About 16 of 100 pregnant women developed long COVID, compared with 19 of 100 women who weren’t pregnant, results showed. Among pregnant women, certain groups were at greater risk for long COVID than others, researchers said. Black women, women 35 or older, and women with obesity were more likely to develop long COVID despite being pregnant, results show. However, their risk for long COVID was still lower than that for similar women who weren’t pregnant. “Further research on factors such as inequitable healthcare access, socioeconomic factors and structural racism may help us understand the elevated long COVID risk in these groups and find ways to protect them,” Zang said. Pregnancy can alter the way a woman’s immune and inflammatory systems work, and this might contribute to a lower risk of long COVID, Zang said. Thus, pregnant women might provide clues to researchers regarding how to help people avoid long COVID. “The observed risk differences in this analysis suggest future dedicated studies of long COVID in pregnant individuals are needed,” Zang said. Researchers also are investigating ways to protect pregnant women from long COVID using drugs already on the market. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.