ISELIN, N.J., March 9 /PRNewswire-FirstCall/ -- SyntheMed, Inc. (OTC Bulletin Board: SYMD - News), a biomaterials company engaged in the development and commercialization of anti-adhesion products, today announced that the U.S. Food and Drug Administration (FDA) has approved the Pre-market Approval (PMA) application for REPEL-CV® Adhesion Barrier for use in pediatric cardiac surgery patients. REPEL-CV is a bioresorbable film designed to be placed over the surface of the heart at the conclusion of an open-heart surgical procedure to reduce the formation of post-operative adhesions (scar tissue).
"The FDA approval of REPEL-CV as the first anti-adhesion product for use in cardiac surgery marks a major milestone for our company," stated Robert P. Hickey, President and Chief Executive Officer, SyntheMed, Inc. "We now look forward to providing US-based cardiac surgeons with a means of reducing the risks to which their pediatric patients are routinely exposed during secondary open-heart surgical procedures. We are engaged in discussions with FDA personnel to define the clinical data required to expand the use of REPEL-CV to include adult cardiac surgery patients."
REPEL-CV will be marketed in the United States through a direct sales force comprised of both company and independent sales representatives. REPEL-CV has CE Mark approval for use in all cardiac surgical patients and is currently marketed through a network of independent distributors in the European Union and in several Southeast Asian countries.
About Cardiac Adhesions
Adhesions, or scar tissue, occur after virtually all open-heart surgical procedures, often resulting in the heart becoming attached to the sternum and other surrounding tissue surfaces. The presence of adhesions represents a prevalent and serious complication in secondary surgical procedures, increasing the length, cost and risk of the surgical procedure.
REPEL-CV is a bioresorbable adhesion barrier film designed to be placed over the surface of the heart at the conclusion of an open-heart surgical procedure to reduce the severity of adhesions that form between the surface of the heart and adjacent tissue surfaces following the surgical procedure. REPEL-CV is designed to provide the therapeutic benefit and then degrade so that it is cleared from the surgical site. REPEL-CV represents the first in a series of anti-adhesion products under development that are based on the company's proprietary polymer technology.
In a randomized, controlled clinical trial conducted at 15 pediatric cardiac surgery centers throughout the United States, over 70% of the REPEL-CV treated patients were completely free of clinically-significant adhesions, the most severe grade of adhesions measured, as compared to less than 30% in the control patients. In the primary clinical endpoint assessment, the mean extent of clinically-significant adhesions in the control patients was 2.5 times greater than in the REPEL-CV treated patients.
About SyntheMed, Inc.
SyntheMed, Inc. is a biomaterials company engaged in the development and commercialization of anti-adhesion products. The company is primarily focused on the advancement and expansion of product development programs based on its proprietary bioresorbable polymer technology.
Statements in this Press Release that are not statements of historical fact, including statements regarding indications of the timing or ability to achieve regulatory approval and market launch for REPEL-CV constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the company, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include but are not limited to (i) potential adverse developments regarding the company's efforts to obtain and maintain required FDA and other regulatory approvals; (ii) potential inability to secure funding as and when needed to support the company's future activities and (iii) unanticipated delays associated with manufacturing and marketing activities. Reference is made to the company's Annual Report on Form 10-KSB for the year ended December 31, 2007 for a description of these, as well as other, risks and uncertainties.