FDA Clears StimLabs' Corplex P Medical Device

StimLabs, founded in 2015 to advance regenerative medicine, announced the FDA 510(k) clearance of Corplex P, a medical device derived from the human umbilical cord. This first-of-its-kind approval is an important milestone for the wound care industry and reinforces StimLabs' leadership position.

From the launch of the first ultra-thick self-contained membrane in 2016 to the current 510(k) clearance, StimLabs has continued to set the standard for excellence and innovation in the market. "StimLabs was founded as a forward-thinking company that pushes boundaries and drives breakthroughs that define standards and advance healthcare," said John Daniel, founder and CEO. "Obtaining 510(k) approval for Corpex P is another step in our journey."

Corplex P is a particulate device derived from the human umbilical cord extracellular matrix (ECM) used in acute and chronic wound care. The flexibility, consistency, and retention of ECM components such as collagen and glycosaminoglycans make them useful tools in the physician's arsenal.

StimLabs' approach to using Corpex P in a 510(k) way is innovative. Successful FDA approval was achieved by demonstrating product safety and efficacy through unique technology, high-quality standards, rigorous testing and strict compliance with pre-launch requirements. This makes StimLabs the first company to receive 510(k) wound care clearance for a human reproductive tissue product

"We are grateful to the FDA for recognizing our careful and transparent approach to delivering critical solutions that doctors and patients trust," said Daniel. "Approval of Corpex P will change the landscape of bringing to market organic, human-derived products indicated for wound care."