ISELIN, N.J., June 21 /PRNewswire-FirstCall/ -- SyntheMed, Inc. , a biomaterials company engaged in the development and commercialization of anti-adhesion and drug delivery products, announced today that it has been informed by the US Food and Drug Administration (FDA), that a meeting of the Circulatory System Devices Advisory Panel has been scheduled for September 19, 2007 to review the Company's Pre-market Approval (PMA) application for REPEL-CV(R) Adhesion Barrier. 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 Advisory Panel will be comprised of healthcare professionals including cardiac surgeons who will review the clinical merits of REPEL-CV and provide their recommendation regarding approval for sale in the US market.
Robert P. Hickey, President and Chief Executive Officer, SyntheMed, Inc. commented, "We are very pleased with the FDA's decision to convene an Advisory Panel meeting to review our PMA filing. We believe that our clinical data demonstrates sufficient safety and effectiveness to warrant marketing approval. We have assembled a team including clinical investigators and other prominent cardiac surgeons to join us in presenting our data to the panel."
Adhesions, or scar tissue, occur after virtually all open-heart surgical procedures, often resulting in the heart becoming attached to the sternum and other surround 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. There are approximately 500,000 open heart surgeries performed annually in the United States, and another 350,000 procedures estimated throughout the European Union. In both markets, approximately 15-20 percent of these surgeries are secondary procedures.
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 extent and severity of adhesions that form between the surface of the heart and the inner surface of the sternum following the surgical procedure. REPEL-CV is designed to provide the therapeutic benefit and then degrade so that it is cleared from the body. A CE Mark was granted in August 2006 and REPEL-CV is marketed through a network of independent distributors in international markets. REPEL-CV represents the first in a series of anti-adhesion products under development that are based on the Company's proprietary polymer technology.
About SyntheMed, Inc.
SyntheMed, Inc. is a biomaterials company engaged in the development and commercialization of anti-adhesion and drug delivery 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 or the potential market size 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, 2006 for a description of these, as well as other, risks and uncertainties.