Colorado Therapeutics LLC, a privately held medical device company with a proprietary technology platform for the production of innovative cross-linked tissue products, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for a novel xenogenic biologic tissue matrix.
The Colorado Therapeutics xenograft implant is intended to be used for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. This unique xenograft product has been developed to combine the benefits of currently available biologic and synthetic products while being packaged in a dry state, making it a ready-for-use, off-the-shelf, biologic tissue matrix. Colorado Therapeutics, now with 510(k) FDA clearance, has the right to commence manufacturing, marketing and sales of the product in the United States and its possessions subject to FDA jurisdiction.
“Receiving 510(k) clearance from the U.S. FDA is very exciting and supports the safety profile and unique features of the Company’s proprietary tissue technology,” commented Joseph B. Horn, Colorado Therapeutics president and chief executive officer. “Over the coming months, the Company will be preparing for a U.S. commercial launch in the surgical repair of damaged or ruptured soft tissue membranes such as the repair of hernia defects.”
Colorado Therapeutics has also announced it will open a Series A financing to accelerate corporate activities for the U.S. commercial 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.
http://www.co-therapeutics.com/