SyntheMed Receives Russian Regulatory Approval For REPEL-CV(TM)

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 19 Aug 2009 - 2:00 PDT

email to a friend   printer friendly   opinions  

SyntheMed, Inc. (OTC Bulletin Board: SYMD), a biomaterials company engaged in the development and commercialization of anti-adhesion products, announced that REPEL-CV, the company's bioresorbable adhesion barrier film for the reduction of adhesions following cardiac surgery, has received approval from the Ministry of Health of the Russian Federation for use in all patients who undergo open heart surgery. REPEL-CV will be marketed throughout Russia by Cardiomedics, Ltd., a distributor of cardiac surgery products. Marc Sportsman, SyntheMed's Vice President of Sales, stated, "We are pleased that this regulatory and clinical evaluation process has been successfully completed and we can proceed with the launch of REPEL-CV in this important market."

REPEL-CV is FDA approved for use in pediatric cardiac surgery patients and is marketed in the United States through a direct sales force. It also has CE Mark approval for use in all cardiac surgery patients and is marketed in the European Union and certain other international countries through a network of independent distributors.

About 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.

About REPEL-CV

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. It is designed to perform the therapeutic task and then degrade so that it is cleared from the body.

About SyntheMed, Inc.

SyntheMed, Inc. is a biomaterials company engaged in the development and commercialization of anti-adhesion products 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, 2008 for a description of these, as well as other, risks and uncertainties.

Source: SyntheMed, Inc

• Additional
• References
• Citations