Colorado Therapeutics 510(k) for Xenogenic Biologic Tissue Repair

Colorado Therapeutics has submitted a 510(k) for its xenogenic biologic tissue matrix, intended for use in reinforcing soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes, including hernia defects. The company says the product has been developed in a dry state requiring no preparation or rehydration, making it ready for use off the shelf.

The product relies on the company’s proprietary cross-linked tissue processing technology that “produces extremely strong, durable, and biocompatible tissue from xenogenic sources that demonstrate superior benefits compared to currently available biologic or synthetic products,” it says. Colorado Therapeutics says it is developing products for multiple indications to target soft tissue reinforcement and regeneration markets. Products in development include abdominal wall reconstruction, and orthopedic applications.