ISELIN, N.J., March 28 /PRNewswire-FirstCall/ -- SyntheMed, Inc. , a biomaterials company engaged in the development and commercialization of anti-adhesion and drug delivery products, today announced that the US Food and Drug Administration (FDA) has accepted for 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).
“Adhesions pose serious health risks to patients who have cardiac reoperations as well as result in higher costs for the hospitals where these procedures are performed,” stated Robert P. Hickey, President and Chief Executive Officer, SyntheMed, Inc. “Our clinical trial results have demonstrated that REPEL-CV has the potential to reduce OR time, patient exposure to anesthesia and other complications associated with cardiac adhesions. The FDA acceptance of our PMA filing marks another important step toward our goal of making REPEL-CV available to patients in the US who may require secondary open heart surgery.”
In September 2006, SyntheMed announced positive efficacy results from the Company’s multi-center, randomized, masked pivotal clinical trial of REPEL-CV in neonatal patients who underwent staged, open-heart surgical procedures. The trial was conducted at 15 pediatric cardiac surgery centers throughout the United States, and enrolled 144 neonatal patients. In the trial, surgeons used a four-point grading system to determine the extent and severity of adhesions in the patients. 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, with a p value < 0.0001. 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 patients, with a p value = 0.0005.
REPEL-CV is currently marketed through a network of independent distributors in the European Union and in several Southeast Asian countries.
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 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 an estimated 500,000 open heart surgeries performed annually in the United States, and another 350,000 estimated in the European Union. In both markets, approximately 15-20 percent of these surgeries are secondary procedures.
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 the 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 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.
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.
SyntheMed, Inc.
CONTACT: Tara Spiess of TS Communications Group, LLC for SyntheMed, Inc.,+1-914-921-5900, Spiess@biotechirpr.com
