FDA OKs First Human Umbilical Cord-Derived Medical Device

StimLabs has achieved U.S. Food and Drug Administration (FDA) 510(k) clearance for Corplex P, a pioneering human umbilical cord-derived medical device.
 
The first-of-its-kind clearance is a significant milestone for wound care. StimLabs introduced the first full-thickness, intact placental membrane allograft in 2016.
 
Corplex P, derived from umbilical cord extracellular matrix (ECM), is a particulate device to manage acute and chronic wounds. It has a versatile format and conformability, and retains collagen and glycosaminoglycans.
 
Indications include: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, tunneling/undermined wounds, certain surgical and trauma wounds, and draining wounds.
 
StimLabs marks the first company to earn a wound management 510(k) for human birth tissue products.
 
“We commend the FDA for recognizing our deliberate and transparent pathway for delivering essential solutions upon which clinicians and patients rely,” said CEO John Daniel. “The clearance of Corplex P changes the landscape for bringing human birth tissue-based products indicated for wound management to the market.”
 
StimLabs was born following Daniel’s extensive research and industry experience in regenerative medicine. Following Marine Corps service, he worked at CryoLabs, RTI Surgical, and Tutogen Medical. He then founded a consultancy business and invented the Purion process, forming the first dual-layer placental allograft and creating Surgical Biologics LLC.
 
Following more years of research and refinement, Daniels created the first placental membrane allograft that kept all three layers of the native tissue and dubbed it Clearify. Shortly thereafter, StimLabs was formally launched.
 
“StimLabs was built as a forward-thinking company, focused on pushing boundaries and driving advancements that redefine standards and progress in healthcare,” Daniel said.