FesariusTherapeutics Announces Manufacturing Agreement for DermiSphere hDRT, the first hydrogel Dermal Regeneration Template

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.

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 www.regenity.com.

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SOURCE FesariusTherapeutics Inc