Broomfield-based startup applies to FDA for first product

BROOMFIELD — Medical-device startup Colorado Therapeutics LLC in Broomfield has filed an application with the Food and Drug Administration for its first product.

The product, a sheathlike membrane, will reinforce and regenerate 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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Colorado Therapeutics is working on other uses, including dental applications used for periodontal and oral surgery, vein grafting, and tendon/ligament repair or replacement.

The company raised an angel round of funding to cover the cost of preparing the application, and it is planning to launch a Series A funding round.

The company was launched in April 2015 by Broomfield-based Colibri Heart Valve, a medical-device company that is developing products for structural heart repairs, to use Colibri’s technology to develop and market products that can be used to repair soft tissue outside the heart.

Joseph B. Horn, Colibri’s president and chief executive, said the formation of Colorado Therapeutics is allowing Colibri to monetize the company’s proprietary technology in applications outside of the heart and focus on the development of structural heart products such as the Colibri TAVI System, which is preparing to enter a CE Mark clinical program.

The system delivers a heart valve that can be implanted without requiring full open heart surgery. The valve that is implanted via a needle-puncture rather than an opening created by a scalpel.

The TAVI System has been successfully tested in a first-in-human study in patients with severe aortic valve stenosis who are deemed very high risk for open-heart valve-replacement surgery.

To support the CE Mark clinical program, Colibri will convert all outstanding senior secured notes and open a Series C financing round.