Colorado Therapeutics Receives 510(k) Clearance For A Novel Xenograft Implant For Soft Tissue Repairs
Broomfield, CO, Oct. 21, 2016 (GLOBE NEWSWIRE) -- 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.
Mr. Horn continued, “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.”
For more information on the Colorado Therapeutics differentiated innovative and proprietary cross-linked tissue processing technology and product pipeline, please visit the Colorado Therapeutics website at www.co-therapeutics.com.
About Hernia Repairs
A hernia occurs when an organ, intestine or fatty tissue is pushed through a hole or a weak spot in the surrounding muscle or connective tissue. More than one million hernia repairs are performed each year in the U.S. Hernias have a high rate of recurrence, and surgeons often use a biologic or synthetic tissue, or mesh, to strengthen the weakened or damaged tissue, and reduce the rate of recurrence.[1]
About Colorado Therapeutics
The Company’s proprietary platform produces extremely strong, durable, and biocompatible tissue from xenogenic sources using innovative cross-linked tissue processing technology. Resulting tissue products demonstrate superior benefits compared to currently available biologic or synthetic products. Colorado Therapeutics is developing products for multiple indications to target the $2.25 Billion U.S. soft tissue reinforcement and regeneration markets. Products in development include abdominal wall reconstruction, orthopedic, and other applications that can benefit from the company’s proprietary technology. Colorado Therapeutics corporate headquarters and pre-commercialization facilities are located in Broomfield, Colorado. For more information on Colorado Therapeutics technology and career opportunities, please visit the Colorado Therapeutics website at www.co-therapeutics.com.
[1] U.S. Food and Drug Administration (Updated 11/16/2012). Hernia Surgical Mesh Implants. http://goo.gl/Z9GgxK on 01/18/2016
