Institute of Good Manufacturing Practices India®

(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)

StimLabs’ Corplex P, a human umbilical cord-derived medical device, receives US FDA 510(k) approval

StimLabs, founded in 2015 to advance regenerative medicine, announces FDA clearance of Corplex P, a groundbreaking medical device derived from human umbilical cord tissue. It marks a significant milestone in wound care and showcases StimLabs' leadership in innovation.

Since introducing the first full-thickness placental membrane allograft in 2016, StimLabs has set the standard for excellence. Corplex P, derived from human umbilical cord extracellular matrix (ECM), effectively manages acute and chronic wounds due to its adaptability and retention of essential ECM components like collagen.

StimLabs' unique approach to securing FDA clearance involved demonstrating safety and efficacy through cutting-edge technology, stringent quality standards, rigorous testing, and full compliance with pre-market submission requirements. Now, StimLabs is the first company to receive a wound management 510(k) clearance for products derived from human birth tissue, solidifying its position as an industry leader in advancing wound care.