StimLabs announces that the U.S. Food & Drug Administration (FDA) has granted 510(k) clearance for Theracor, the first human umbilical cord-derived medical device to be offered in sheet form. This clearance marks another significant milestone for the wound care industry and reinforces StimLabs' position at its forefront. Predicated on the clearance of Corplex P^®, the first FDA 510(k) cleared human umbilical cord-derived medical device for wound management provided in a particulate format, Theracor expands StimLabs' offerings to meet the unique needs of a diverse patient population.

"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 a sheet device derived from human umbilical cord extracellular matrix (ECM) intended to cover, protect, and provide a moist wound environment. Theracor is designed for the same indications as Corplex P, including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, partial-thickness burns, and skin tears) and draining wounds. By offering a sheet version, StimLabs can provide clinicians who require a continuous format (rather than a particulate) with a fully FDA 510(k) cleared, comparable human tissue-based medical device. 

"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," stated John Daniel. "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."