Colorado Therapeutics Submits 510(k) for a Novel Xenograft Implant for Soft Tissue Repairs

BROOMFIELD, CO , Jan. 28, 2016 -- Colorado Therapeutics LLC, a privately held medical device company that is leveraging over 15 years of innovative and proprietary cross-linked tissue processing technology, announced today that it has submitted a 510(k) application requesting clearance of a novel xenogenic biologic tissue matrix, with the U.S. Food and Drug Administration (“FDA”) to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes including the repair of hernia defects.  This unique product has been developed to combine the benefits of currently available biologic and synthetic products while being packaged in a dry state requiring no preparation or rehydration, making it a ready-for-use, off-the-shelf, biologic tissue matrix.  

Pursuant to Section 510(k), the FDA has 90 days in which to clear a Class II medical device for commercial distribution or to seek additional information. Following notification of FDA clearance, Colorado Therapeutics would immediately have the right to commence manufacturing, marketing and sales of the product in the United States and its possessions subject to FDA jurisdiction. 

Colorado Therapeutics has also announced the closing of an Angel Financing, proceeds from which have been used to prepare the 510(k) filling. Colorado Therapeutics will be opening a Series A financing round shortly to prepare the Company for commercial launch of this novel and unique xenograft implant for soft tissue repair, should it be cleared by the FDA.

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.

About Colorado Therapeutics

The Company’s proprietary cross linked tissue processing technology produces extremely strong, durable, and biocompatible tissue from xenogenic sources that 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.

Note for editors: the Colorado Therapeutics xenograft implant has not been cleared by the FDA and is not currently available for commercial sale in any jurisdiction.

Corporate and Media Contacts:

Eric Schauble, Vice President                                                      
Colorado Therapeutics LLC                                                           
Telephone: (303) 469-9459                                                          
[email protected]                                             

Aline Sherwood
Scienta Communications
(312) 238-8957
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