StimLabs has announced that the US FDA has granted clearance for Theracor, the first human umbilical cord-derived medical device offered in sheet form. 

 

The approval builds on the earlier clearance of Corplex P, the company’s particulate-format device, expanding StimLabs’ offerings to better serve diverse patient needs.

 

"After 10 years, StimLabs continues to focus on innovating technologies and driving advancements that redefine standards and progress in healthcare," said John Daniel, Founder and Chief Executive Officer of StimLabs. 

 

"Receiving 510(k) clearance for Theracor underscores our leadership and offers greater options to clinicians and patients who benefit from human tissue-based solutions for the management of acute and chronic wounds."

 

Theracor is derived from human umbilical cord extracellular matrix (ECM) and is designed to cover, protect, and maintain a moist wound environment. It is indicated for a wide range of wounds, including partial and full-thickness wounds, pressure ulcers, venous and diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds, trauma wounds, and draining wounds. 

 

By offering a sheet format, StimLabs now provides clinicians with a continuous, FDA-cleared option alongside its particulate-based Corplex P.

 

"We are thrilled to announce 510(k) clearance of Theracor. By expanding our product portfolio, we empower clinicians with choice and strengthen our commitment to innovating around unmet clinical needs while meeting the highest standards," Daniel added. 

 

"With Corplex P already FDA cleared and available nationwide, Theracor rounds out our offering, arming wound care providers with an expanded suite of human umbilical-cord derived devices."