“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.