CorMatrix® Cardiovascular, Inc. Treats First Patients with New Tyke® Product for Neonates and Infants

Extracellular Matrix (ECM®) Now an Alternative for Congenital Heart
Defect Repairs in Smaller Structures

ROSWELL, Ga.–(BUSINESS WIRE)–CorMatrix Cardiovascular, Inc., a leading developer of biomaterials and
medical devices, today announced the treatment of the first patients
using its CorMatrix® Tyke®, a product specifically designed and cleared
for cardiac tissue repairs in neonates and infants. The product received
FDA 510(k) clearance in February 2016. 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, therefore providing a thinner
product for smaller repairs.

Dr. Frank Scholl, Chief, Pediatric & Congenital Heart Surgery and
Surgical Director, Pediatric Heart Transplant and Dr. Steven Bibevski,
Pediatric & Congenital Cardiac Surgeon, both at Joe DiMaggio Children’s
Hospital in Hollywood, FL were the first to implant the CorMatrix® Tyke®
ECM® device. The company is implementing a phased commercial launch of
the device involving approximately 20 pediatric centers who will be
trained and certified to receive the device. Tyke™ was developed as an
alternative to synthetic grafts or patches, and for complex
reconstructive surgeries in neonates and infants with congenital heart
defects (CHD).

Dr. Scholl noted, “The availability of Tyke and its 2 ply construction
will allow us the ability to repair the tiniest structures in the most
delicate and tiniest of newborn babies, and achieve a more accurate—and
hopefully—more durable repair. We are excited about the future Tyke
provides for our most fragile patients.”

The American Academy of Pediatrics and the Congenital Heart Public
Health Consortium (CHPHC) estimates 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 including autologous pericardium, preserved
homograft, bovine pericardium, and polytetrafluoroethylene. None of
these alternatives represents the ideal prosthetic tissue, which should
be pliable and easy to handle, resistant to calcification or shrinkage.
Most importantly, it should have growth potential and should not induce
formation of scar tissue.¹

Andrew Green, President and Chief Operating Officer commented, “We are
excited to partner with our pediatric cardiac surgeons to deliver Tyke
as product developed to address a specific need in the neonatal and
infant population. CorMatrix Tyke is one of the few products
commercially available that is specifically designed and labeled for the
treatment of neonate and infant cardiac tissue repair.”

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 145,000 cardiac procedures. Visit 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


CorMatrix Cardiovascular, Inc.
Patricia Cuomo, 470-514-4042