CorMatrix Cardiovascular Inc. Receives 510(k) Clearance for its Tyke™ Implantable Device for Neonate and Infant Cardiac Tissue Repair

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ROSWELL, Ga.--(BUSINESS WIRE)--(Roswell, GA—February 9, 2016) – CorMatrix® Cardiovascular, Inc., (www.cormatrix.com) a leading developer of biomaterial compositions and medical devices for regenerative medicine, today announced that it has received 510(k) clearance from the Food and Drug Administration (FDA) for its CorMatrix® Tyke™, a biomaterial technology derived from the Company's ECM® technology platform. CorMatrix® Tyke™ is intended for use in neonates and infants for repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defects, septal defects and annulus repair, suture-line buttressing, and cardiac repair. Tyke™ is made of 2 layers of CorMatrix® ECM® as compared to the 4 layers of the current CorMatrix® ECM® for Cardiac Tissue Repair and therefore providing a thinner product for smaller repairs. Tyke™ was developed as an alternative to synthetic grafts or patches and to enable congenital cardiovascular surgeons to repair complex reconstructive surgeries, in neonates and infants with congenital heart defects (CHD), such as atrial-septal defects and small pulmonary vessels.

"FDA clearance further validates CorMatrix ECM technology for creating world class implantable cardiac devices. CorMatrix is proud of this clearance achievement and the potential impact it can have on reducing CHD in children"
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According to the American Academy of Pediatrics and the Congenital Heart Public Health Consortium (CHPHC), congenital heart defects are the most common birth defects. Nearly 1 of every 100 babies is born with a CHD and each year, approximately 40,000 babies are born in the United States with a congenital heart defect. [Source: CHPHC]. Most CHD-related surgical procedures require the use of prosthetic material for reconstruction of intracardiac and extra cardiac structures. Several different biological and prosthetic materials are commonly used in surgery for CHDs including autologous pericardium, preserved homograft, bovine pericardium, and polytetrafluoroethylene. None of these above-mentioned represents the ideal prosthetic tissue, which should be pliable and easy to handle, resistant to calcification or shrinkage, and most importantly should have growth potential and should not induce formation of scar tissue.¹

CorMatrix develops biomaterials that harness the body's ability to repair damaged cardiac and vascular tissues. In vivo tissue engineering represents a new approach to tissue and organ regeneration and replacement. Specifically, cardiac and vascular tissue engineering is an emerging field that may hold a great promise for advancement in the treatment of CHDs². CorMatrix® Tyke™ now creates a viable choice for pediatric patients with few surgical options that could affect their long term prognosis.

Dr. Robert Matheny, CorMatrix Scientific Director said, "The Tyke product was developed in response to congenital surgeon's directed needs. It is our stated goal to continue to develop the cardiovascular regenerative products as dictated by the needs of patients and physicians. One size doesn't fit all applications and the Tyke is a step in the direction of satisfying a particular surgical need. We are currently in clinical trials to apply the technology to Congestive Heart Failure and Heart Valves."

Dr. David Morales, Director of Congenital Heart Surgery, The Heart Institute, Cincinnati Children's Hospital Medical Center noted, "CorMatrix ECM has been useful in repairing children's hearts but there were a few areas where a thinner material would even be better. This is why we are excited about the Tyke—we now have an option to perhaps repair even the smallest structures more accurately."

"FDA clearance further validates CorMatrix ECM technology for creating world class implantable cardiac devices. CorMatrix is proud of this clearance achievement and the potential impact it can have on reducing CHD in children," said CEO and Co-Founder, David Camp. "This is but one small step in our ongoing quest to develop and deliver ideal materials for use in reconstructing damaged cardiac and vascular tissues. Tyke™ and other CorMatrix cardiac products will help us extend and improve the lives of those who receive our implants and move toward a global goal of making cardiovascular disease curable."

Early availability of CorMatrix Tyke™ will begin with up to 15 clinical sites across the United States that will take part in a post-market study. The study is targeted to include up to 150 patients undergoing pediatric cardiovascular procedures. Patients will be enrolled at the time of treatment and monitored at standard follow-up time points with routine collection of data. Based upon early collection of patient data, broadened commercial availability will be scheduled, and expansion of the product extended to additional centers under normal launch conditions.

About CorMatrix

CorMatrix® Cardiovascular, Inc. is a privately held medical device company dedicated to developing and delivering innovative biomaterial devices that harness the body's own innate ability to repair damaged cardiac and vascular tissues. CorMatrix ECM Technology allows surgeons to restore the native anatomy of cardiac and vascular tissue in need of repair, serving as a superior alternative to synthetic or cross-linked materials. Headquartered in Roswell, Georgia, the Company is currently researching, developing and commercializing a platform technology known as CorMatrix® ECM™ for a variety of cardiovascular and other indications, and has U.S. clearance and European registration (with a CE Mark) for its ECM® technology. Since its launch in 2006, CorMatrix® ECM™ Technology has been used at more than 975 hospitals across the U.S. and has been implanted in over 135,000 cardiovascular procedures. Visit cormatrix.com for additional information.

¹ Preliminary Experience with Cardiac Reconstruction Using Decellularized Porcine Extracellular Matrix Scaffold: Human Applications in Congenital Heart Disease
Frank G. Scholl, MD¹, Mark M. Boucek, MD¹, Kak-Chen Chan, MD, MBBS¹, Lilliam Valdes-Cruz, MD¹, and Richard Perryman, MD¹
World Journal for Pediatric and Congenital Heart Surgery
² Londono R, Badylak SF. Biologic scaffold for regenerative medicine. Mechanisms of in vivo remodeling.
Ann Biomed Eng. 2015; 43: 577–92.

Contacts
Cormatrix Cardiovascular, Inc.
Patricia Cuomo, 678-566-2628
Director of Marketing