BROOMFIELD — Colorado Therapeutics LLC in Broomfield on Friday said it has received clearance from the FDA for its first product, a sheathlike membrane that reinforces and regenerates soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft-tissue membranes, including the repair of hernia defects.
The membrane combines biologic and synthetic products and will be packaged in a dry state, requiring no preparation or rehydration.
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The 510(k) clearance gives Colorado Therapeutics, a spinoff of Colibri Heart Valve LLC, the right to start manufacturing, marketing and selling the product in the United States.
Joe Horn, Colorado Therapeutics’ president and chief executive, said the company is preparing for a U.S. commercial launch.
Colorado Therapeutics also said it will open a Series A financing to accelerate corporate activities for the launch. The proceeds of the Series A financing will also advance further development of the Colorado Therapeutics product pipeline that utilizes the company’s innovative and proprietary tissue-processing technology.
“The receipt of this 510(k) clearance is a significant milestone for Colorado Therapeutics and will be a spring board for advancing the company’s product pipeline, which includes other soft tissue repair opportunities such as dura repair, skin substitutes, covered stents for peripheral vascular disease and vascular grafts, Horn said.
Colorado Therapeutics is working on other uses, including dental applications used for periodontal and oral surgery, vein grafting, and tendon/ligament repair or replacement.