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CorMatrix® Reports FDA Clearance of CorMatrix® ECM® for Vascular Repair

Companies mentioned in this article: CorMatrix Cardiovascular, Inc.

ROSWELL, Ga. -- (BUSINESS WIRE) -- CorMatrix Cardiovascular announced today that it has received U.S. Food and Drug Administration (FDA) clearance to market the CorMatrix® ECM® for Vascular Repair.

The CorMatrix ECM for Vascular Repair is intended for use as a patch material for repair and reconstruction of peripheral vasculature including the carotid, renal, iliac, femoral, and tibial blood vessels. The CorMatrix ECM for Vascular Repair may be used for patch closure of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels. It is constructed from a multi-laminate sheet of decellularized, non-crosslinked, lyophilized extracellular matrix (ECM) derived from porcine small intestinal submucosa (SIS).

According to Dr. Richard F. Neville, Professor of Surgery, Chief, Division of Vascular Surgery at George Washington University, “CorMatrix ECM for Vascular Repair is an innovative scaffold permitting the patient’s own stem cells to regenerate viable autogenous tissue improving the results of revascularization procedures that often fail due to myointimal hyperplasia and accelerated atherosclerosis.”

“The CorMatrix ECM for Vascular Repair is an expansion of the current indications for our CorMatrix ECM for Carotid Repair and was pursued due to requests by our physicians for a product that could be used to repair blood vessels throughout the vascular system. CorMatrix devices have now been used in over 100,000 patients worldwide to treat a growing number of cardiovascular indications. We are pleased that we can address these additional requests by physicians, providing a novel device to meet current clinical needs,” commented Andrew Green, CorMatrix Cardiovascular’s Executive Vice President of Operations. “Expansion of our current FDA-cleared devices to satisfy unmet indications further strengthens our leadership position in the field of ECM technologies and regenerative medicine, utilizing the patient’s own stem cells and their natural healing ability.”

About CorMatrix

CorMatrix® Cardiovascular, Inc. was founded in 2001 as 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 cardiovascular tissues. Headquartered in Atlanta, Georgia, the Company is currently researching, developing and commercializing a platform technology known as CorMatrix ECM® for a variety of cardiovascular indications, and has U.S. clearance and European approval (with a CE Mark) for its ECM® technology as an implant for pericardial closure, cardiac tissue repair, as well as clearance for carotid repair. With significant patent protection, CorMatrix is poised to successfully expand its current line of products. For more information, visit www.cormatrix.com.

Safe Harbor Statement

This report includes forward-looking statements covered by the Private Securities Litigation Reform Act of 1995. Because such statements deal with future events, they are subject to various risks and uncertainties and actual results for fiscal year 2014 and beyond could differ materially from the Company's current expectations. Forward-looking statements are identified by words such as "anticipates," "projects," "expects," "plans," "intends," "believes," "estimates," "targets," and other similar expressions that indicate trends and future events.

Factors that could cause the Company's results to differ materially from those expressed in forward-looking statements include, without limitation, variation in demand and acceptance of the Company's products and services, the frequency, magnitude and timing of raw-material-price changes, acceptance by FDA or other regulatory agencies, general business and economic conditions beyond the Company's control, the consequences of competitive factors in the marketplace including the ability to attract and retain customers, results of continuous improvement and other cost-containment strategies, and the Company's success in attracting and retaining key personnel. The Company undertakes no obligation to revise or update forward-looking statements as a result of new information, since these statements may no longer be accurate or timely.


Copyright © Business Wire 2014
Contact:

CorMatrix Cardiovascular, Inc.
Stephanie Beall, 470-514-4031
sbeall@cormatrix.com