StimLabs Receives FDA Approval for First Umbilical Cord-Derived Wound Sheet, Theracor

Key findings

• StimLabs has received FDA 510(k) clearance for Theracor, an umbilical cord-derived wound care device in sheet form.
• The product uses human umbilical cord extracellular matrix (ECM) and is intended to cover and protect wounds while maintaining a moist wound environment.
• Theracor is cleared for the same wound indications as StimLabs’ previously cleared Corplex P, which is provided in particulate form.

StimLabs says it has received FDA 510(k) clearance for Theracor, the first human umbilical cord-derived medical device offered in sheet form. The company positions the clearance as an expansion of its wound care portfolio alongside Corplex P, a human umbilical cord-derived device for wound management provided in particulate format.

What Theracor is cleared for
StimLabs says Theracor is cleared 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)
• draining wounds

Why a sheet format matters
According to the company, the sheet version is aimed at clinicians who want a continuous format rather than a particulate, while still using a 510(k)-cleared human tissue-based medical device.

StimLabs says Theracor will be available soon for use in medical settings. More information: www.StimLabs.com/About-Us/

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