ISELIN, N.J., June 21 /PRNewswire-FirstCall/ -- SyntheMed, Inc. today announced results from the open label clinical study of REPEL-CV Bioresorbable Adhesion Barrier conducted at several European cardiac surgery centers. The primary endpoint of the study was the extent to which REPEL-CV reduced clinically-significant (severe) adhesions in patients who have had previous open heart surgical procedures. The study results indicated that 13 of the 15 patients treated with REPEL-CV were completely free of severe adhesions at the point of the second surgical procedure. Dr. Eli Pines, the company’s VP of Research and Chief Scientific Officer stated, “We are very pleased with the reduction in adhesions that we observed in the patients treated with REPEL-CV. Normally, these patients’ hearts and critical vessels would be covered with severe adhesions.”
SyntheMed has applied for CE Mark certification for the marketing of REPEL-CV outside the United States. A network of independent distributors is being established in preparation for the impending product launch. REPEL-CV is also being evaluated in a multi-center, controlled pivotal clinical trial involving 15 cardiac surgical centers in the United States. It is anticipated that this trial should be completed in the near future, at which time, the results will be submitted to the FDA as a basis for gaining approval to commercialize REPEL-CV in the United States. REPEL-CV could become the first adhesion barrier approved by the FDA and European Union regulatory authorities for use in cardiac surgery which could represent a $300 million annual worldwide market opportunity.
SyntheMed, Inc. is a biomaterials company engaged in the development and commercialization of anti-adhesion and drug delivery products.
Statements in this Press Release that are not statements of historical fact, including statements regarding indications of the potential outcome of the REPEL-CV US clinical trial, 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 progress, timing and results of the clinical trial, European study and the Company’s efforts to obtain required FDA and other approvals and that failure can occur at any stage of testing; (ii) potential inability to secure funding as and when needed to support the trial, European study and the Company’s other 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 for a description of these, as well as other, risks and uncertainties.
SyntheMed, Inc.
CONTACT: Robert P. Hickey of SyntheMed, Inc., +1-732-404-1117,rphickey@synthemed.com
