ISELIN, N.J., July 14 /PRNewswire-FirstCall/ -- SyntheMed, Inc. (OTC Bulletin Board: SYMD), a biomaterials company engaged in the development and commercialization of anti-adhesion, drug delivery products and other surgical implants, announced today that REPEL-CV(R), the company's bioresorbable adhesion barrier film for the reduction of adhesions following cardiac surgery, has received Health Canada approval for use in pediatric patients who undergo open heart surgery. REPEL-CV will be marketed throughout Canada by Force3 Medicale, Inc., a Montreal-based distributor of cardiac surgery products. Marc Sportsman, SyntheMed's Vice President of Sales, stated, "We are pleased to receive the Health Canada approval which allows us to further expand the international distribution of REPEL-CV."
SyntheMed was previously granted CE Mark approval to market REPEL-CV in most international markets for use in all patients who undergo open heart surgery and is being sold through a network of independent distributors. In November 2007, SyntheMed received an Approval Letter from the US FDA stating the REPEL-CV would be approved for use in pediatric patients pending satisfactory completion of field inspections. This process is ongoing as are discussions with the FDA on the requirements for expansion of the indication for REPEL-CV from pediatric patients to all patients who undergo cardiac surgery.
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 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. 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, drug delivery products, and other surgical implants. 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, 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 FDA and other required 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.
|SOURCE SyntheMed, Inc.|
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