ISELIN, N.J., Sept. 20 /PRNewswire-FirstCall/ -- SyntheMed, Inc. (OTC Bulletin Board: SYMD), a biomaterials company engaged in the development and commercialization of anti-adhesion and drug delivery products, announced today that the Circulatory System Devices Advisory Panel of the US Food and Drug Administration (FDA) recommended approval of REPEL-CV(R) Adhesion Barrier for use in pediatric patients (21 and younger) who are likely to need secondary open heart surgery. The panel also recommended the development of additional safety data as a basis for expanding the indicated use to include adult patients. Dr. Eli Pines, the Company's Vice President of Research stated, "We are pleased with the panel's recommendation to approve REPEL-CV and we look forward to discussions with the FDA on securing approval to market REPEL-CV for the initial indication. We will also immediately seek FDA approval to initiate the adult clinical study."
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 (scar tissue) that form between the surface of the heart and opposing 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 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.
|SOURCE SyntheMed, Inc.|
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