Colorado Therapeutics earns FDA nod for biologic soft tissue repair implant


The FDA cleared Colorado Therapeutics’ xenograft implant for the surgical repair of damaged soft tissue membranes, including hernias. The company is now planning a financing round and prepping for a U.S. commercial launch.

The xenograft implant is designed to strengthen soft tissue where it is weak and for the surgical repair of damaged or ruptured membranes, according to a statement. The xenogenic biologic tissue matrix is derived from different mammalian species and can be stored dry, so it is ready for use straight off the shelf, the company said. The biocompatible tissue has “superior benefits” over existing biologic or synthetic products.

Colorado Therapeutics will open a Series A round to help it round up the funds it needs to drive the implant’s commercial launch. The company will also put the proceeds toward advancing its pipeline products based on its tissue-processing tech, according to the statement.

Its pipeline products include xenogenic tendons for tendon or ligament repair or replacement, implants for abdominal wall reconstruction and xenogenic veins for use in vascular repair or to create fistulas for dialysis.

“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,” said CEO Joseph Horn.