The pivotal trial was conducted at 15 pediatric cardiac surgery centers throughout the United States, and enrolled 144 neonatal patients who had undergone staged, open-heart surgical procedures. In this 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.
Carl Backer, MD, A. C. Buehler Professor of Surgery, Children's Memorial Hospital, Feinberg School of Medicine, Northwestern University and an investigator in the pivotal trial commented, "Post-operative adhesion formation is a significant clinical complication that surgeons routinely encounter in secondary cardiac surgical procedures. I have been pleased with the handling characteristics of REPEL-CV and am impressed by the results of this randomized study. I believe that REPEL-CV may offer a significant advance in the treatment of patients undergoing cardiac surgery."
"We are very pleased with the performance of REPEL-CV in this clinical trial and we will now focus on the completion of the data analysis in preparation for the Pre-Market Approval submission to the FDA. We look forward to REPEL-CV becoming the first FDA-approved anti-adhesion product to address this unmet need in cardiac surgery," stated Robert P. Hickey, President and Chief Executive Officer of SyntheMed.
In August 2006, SyntheMed received CE Mark clearance to market REPEL-CV in the European Union and other international markets. The Company plans to launch REPEL-CV this month at the European Association for Cardio-Thoracic Surgery Convention in Stockholm.
About Adhesions
Adhesions, or scar tissue, occur in virtually all open-heart surgical procedures, often resulting in the heart becoming attached to the sternum. 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 conducted 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 the Trial
The pivotal clinical trial was designed as a comparative, evaluator-masked, randomized, parallel, multi-center study to determine the safety and effectiveness of REPEL-CV for reducing post-operative adhesions following open-heart surgery. The trial was performed at 15 clinical sites in the US and involved pediatric patients requiring staged cardiovascular sternotomy procedures where it was anticipated that the second procedure would be performed two to eight months subsequent to the initial procedure. There were two treatment groups: one group received REPEL-CV and the second represented the untreated control group. SyntheMed intends to present complete results of this study at a peer-reviewed forum in the near future.
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. After a period of approximately four weeks, REPEL-CV is absorbed through exposure to moisture and body temperature. 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, 2005 and Registration Statement on SB-2 declared effective on August 1, 2006 (No. 333-134746) for a description of these, as well as other, risks and uncertainties.
Media Contact: Investor Contact: Francesca T. DeVellis Tara Spiess Senior Vice President TS Communications Group, LLC Feinstein Kean Healthcare 914-921-5900 617-577-8110 Spiess@biotechirpr.com Francesca.devellis@fkhealth.com
Source: SyntheMed, Inc.
