Regenity Biosciences Marks 63rd FDA 510(k) Clearance with Expansion of Neurosurgical Portfolio

PARAMUS, N.J., Nov. 25, 2025 /PRNewswire/ -- Regenity Biosciences, a global leader in regenerative medicine and Linden Capital Partners portfolio company, today announced its 63rd FDA 510(k) clearance for DuraMatrix® Repair – Collagen Dura Regeneration Membrane, a resorbable membrane composed of highly purified Type I and Type III bovine collagen for the repair of dura mater defects during neurosurgery. This latest clearance reinforces Regenity's established regulatory strength and its disciplined approach to product development. The company's consistent track record of successful FDA submissions reflects deep regulatory expertise, operational excellence, and a clear commitment to delivering safe, effective regenerative solutions to market.

"This latest FDA clearance underscores Regenity's steadfast execution and expanding capabilities in neurosurgery," said Shawn McCarthy, CEO of Regenity Biosciences. "As our 63rd 510(k) approval, it reflects our continued focus on providing our customer partners and surgeons advanced regenerative solutions that make a meaningful impact for patients."

Engineered to provide high mechanical strength and conformability, the graft provides surgeons with a strong, flexible, and easy-to-handle option designed to support optimal outcomes in dural repair.

"This new membrane was designed with surgeon needs in mind, offering a reliable and intuitive solution for complex dural repairs," McCarthy added.

Today's announcement reinforces Regenity's continued regulatory momentum and its commitment to delivering differentiated innovation for customers. Regenity's proven ability to navigate complex approval pathways provides partners with confidence in the company's capacity to deliver safe, high-quality products and bring new solutions to market efficiently and reliably.

About Regenity Biosciences
Regenity Biosciences, a Linden Capital Partners portfolio company, is a leading global developer and manufacturer of bioresorbable technologies to repair and regenerate natural tissue and bone for a variety of markets including dental, spine, orthopedic, sports medicine, advanced wound, neurosurgery, ENT, 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 Regenity Biosciences