FDA Clears Groundbreaking Corplex P™: The First Human Umbilical Cord-Derived Medical Device
Roswell, GA., February 6, 2024 – StimLabs® announces FDA 510(k) clearance of Corplex P, the pioneering human umbilical cord-derived medical device. This first-of-its-kind clearance marks a significant milestone for the wound care industry and highlights StimLabs’ position at its forefront.
From introducing the first-ever full thickness, intact placental membrane allograft in 2016, to today’s unprecedented 510(k) clearance, StimLabs has consistently set the standard for excellence and innovation in the market. “StimLabs was built as a forward-thinking company, focused on pushing boundaries and driving advancements that redefine standards and progress in healthcare,” says Founder and CEO, John Daniel. “Receiving 510(k) clearance for Corplex P is yet another step in our journey.”
Corplex P is a particulate device derived from human umbilical cord extracellular matrix (ECM) indicated for the management of acute and chronic wounds. Its versatile format, conformability, and retention of ECM components such as collagen and glycosaminoglycans, make it a valuable device in the treating physician’s armamentarium.
StimLabs’ approach to taking Corplex P through the 510(k) pathway is novel; successful FDA clearance was achieved by demonstrating the product’s safety and effectiveness through unique technology, the highest quality standards, rigorous testing, and full compliance with pre-market submission requirements. This designates StimLabs as the first company ever to receive a wound management 510(k) clearance 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,” stated Mr. Daniel. “The clearance of Corplex P changes the landscape for bringing human birth tissue-based products indicated for wound management to the market.”
Corplex P will be available soon for use in medical settings. For further information, visit www.StimLabs.com/CorplexP.
Stimlabs LLC was founded in 2015 with the mission to advance the state of regenerative medicine with a current focus in wound care and surgical applications. Comprised of industry leaders, StimLabs is dedicated to offering patients the best possible care while recognizing the urgency of providing solutions in areas with unmet needs. StimLabs has a comprehensive product portfolio addressing various clinical applications and has established a strong intellectual property catalog. Committed to delivering superior products, StimLabs is a trusted partner to physicians and patients alike. For more information, visit StimLabs' website at www.stimlabs.com.
Data on file. Patents: http://www.stimlabs.com/patents © Stimlabs® LLC; STIMLABS and CORPLEX P are trademarks of Stimlabs LLC. 1225 Northmeadow Parkway, Suite 104, Roswell, GA 30076
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