News | January 24, 2019

CorMatrix® Cardiovascular, Inc. Receives FDA IDE Approval To Conduct The Safety And Feasibility Clinical Trial Of The Cor™ TRICUSPID ECM® Valve For Pediatric And Adult Patients

Atlanta, GA /PRNewswire/ - CorMatrix® Cardiovascular, Inc. www.cormatrix.com, a leading developer of regenerative cardiovascular medical devices, today announced FDA approval of an early feasibility study IDE to evaluate the safety and feasibility of the Cor™ TRICUSPID ECM® cardiac valve for adults with endocarditis and for pediatric patients with congenital heart valve disease. The Cor™ TRICUSPID is the first cardiac valve of its kind composed of extracellular matrix or ECM®. The CorMatrix ECM® has been utilized extensively and successfully in other cardiovascular applications in 220,000 plus implants. The Cor™ TRICUSPID ECM® valve IDE study will be conducted in up to 8 clinical centers performing pediatric and adult cardiac surgery. The Cor™ TRICUSPID joins a series of ECM® products that will address clinical challenges in the cardiovascular disease market, which will eventually include regenerative solutions for congestive heart failure and pediatric and adult cardiac valve patients.*

"This important step for our patients and CorMatrix to create a valve that will mimic in all respects a normal valve is no easy task, but the technology and our ability to harness the regenerative potential continues to improve," said Robert G Matheny, MD Chief Medical & Scientific Officer.*

"The Cor™ TRICUSPID ECM® valve is the first seamless ECM® cardiac valve approved by the FDA for an IDE safety and feasibility clinical trial for adult and pediatric patient applications. The Cor™ TRICUSPID ECM® valve joins a rapidly developing CorMatrix® pipeline of next generation ECM® products and patient solutions," said Edgar Rey, President & CEO, CorMatrix® Cardiovascular Inc.*

CorMatrix® Cardiovascular, Inc. is a regenerative biotechnology company based in metro Atlanta, Georgia. A pioneer and leader in regenerative science and technology, the company was founded to address congestive heart failure, the largest global disease management challenge and unmet cardiovascular clinical need. CorMatrix® provides regenerative, technological innovations, and patient solutions for the treatment of congestive heart failure and other cardiovascular diseases. The company is committed to developing innovative future non-synthetic, regenerative devices for the cardiovascular system through continued research and improvements to the CorMatrix® ECM® technology.

For more information, please contact Edgar Rey, President & CEO at erey@cormatrix.com or visit www.cormatrix.com

*Cor™ TRICUSPID ECM® valve is an investigational device and not commercially available.

SOURCE: CorMatrix® Cardiovascular, Inc.

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