StimLabs has received the 510(k) clearance from the US Food and Drug Administration (FDA) for Corplex P, a human umbilical cord-derived medical device for wound care.
Corplex P is a particulate device made from the extracellular matrix (ECM) of the human umbilical cord. It is designed to treat both acute and chronic wounds.
The medical device is said to have a versatile format, offers conformability, and retains ECM components like collagen and glycosaminoglycans. This helps in the treating physician’s armamentarium.
StimLabs founder and CEO John Daniel said: “StimLabs was built as a forward-thinking company, focused on pushing boundaries and driving advancements that redefine standards and progress in healthcare.
“Receiving 510(k) clearance for Corplex P is yet another step in our journey.”
The FDA clearance was obtained by proving the product’s efficacy and safety using technology, the strictest quality standards, extensive testing, and complete adherence to pre-market submission guidelines, said the company.
The US-based StimLabs has now become the first ever company to secure a wound management 510(k) clearance for human birth tissue products.
Daniel said: “We commend the FDA for recognising our deliberate and transparent pathway for delivering essential solutions upon which clinicians and patients rely.
“The clearance of Corplex P changes the landscape for bringing human birth tissue-based products indicated for wound management to the market.”
The company introduced a first-of-its-kind full-thickness, intact placental membrane allograft in 2016.
Founded in 2015, Stimlabs aims to advance the state of regenerative medicine. The firm currently focuses on wound care and surgical applications.
StimLabs offers a wide range of products that target different clinical applications.
In 2022, the regenerative technologies company announced the commercial availability of its new placental membrane-based product, called Enverse.
Enverse is said to be a translucent dehydrated complete human placental membrane (dCHPM) allograft product. It is designed to act as a covering for acute and chronic wounds.
