The first human umbilical cord-derived medical device to be sold in sheet form, Theracor, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), according to StimLabs. This approval strengthens StimLabs’ leadership position in the wound care sector and is another important turning point. Theracor broadens StimLabs’ product line to accommodate the specific requirements of a wide range of patients, building on the approval of Corplex P®, the first FDA 510(k)-cleared human umbilical cord-derived medical device for wound treatment offered in a particle format.
“After 10 years, StimLabs continues to focus on innovating technologies and driving advancements that redefine standards and progress in healthcare,” stated John Daniel, Founder and Chief Executive Officer of StimLabs. “Getting 510(k) clearance for Theracor highlights our leadership and provides more choices for doctors and patients who use human tissue-based solutions to treat acute and chronic wounds.”
Theracor is a sheet device made from the extracellular matrix (ECM) of human umbilical cords that is designed to cover, shield, and create a moist environment for wounds. Theracor is meant for various types of wounds, including pressure ulcers, venous ulcers, diabetic ulcers, long-lasting vascular ulcers, wounds that are tunneled or undermined, surgical wounds (like donor sites, post-Mohs surgery, post-laser surgery, podiatric issues, and wound dehiscence), and trauma wounds (such as abrasions, cuts). By providing a sheet version, StimLabs can offer a completely FDA 510(k)-cleared human tissue-based medical device to doctors who need a continuous format (instead of a particle).
“We are thrilled to announce 510(k) clearance for 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.”
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