OCEANPORT, N.J., Feb. 8 /PRNewswire-FirstCall/ -- SyntheMed, Inc. today announced the completion of patient enrollment for the multi-center pivotal clinical trial for REPEL-CV Adhesion Barrier. The clinical trial, which was initiated approximately two years ago, is being conducted at approximately 15 pediatric cardiac surgery centers in compliance with a surgical protocol approved by the US Food and Drug Administration (FDA). According to Eli Pines, PhD, the Company’s Chief Scientific Officer, “We are very pleased to have achieved this milestone and now look forward to completing the pivotal trial in mid-2006. Assuming a favorable outcome, the trial results will be submitted to the FDA as a basis for securing approval to market REPEL-CV in the US for use in all cardiac surgical procedures.”
The Company is also conducting a multi-center clinical study for REPEL-CV involving several leading cardiac surgery centers in Europe. This open label study is distinct from the US pivotal trial and is intended to support the anticipated market launch of REPEL-CV in Europe and other international markets beginning in mid-2006.
Post-operative adhesion formation is a prevalent and serious complication experienced in the approximately 1 million open heart surgical procedures performed worldwide on an annual basis. REPEL-CV could become the first adhesion barrier approved by the FDA for use in cardiac surgery which could represent a $250 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 and European clinical study, 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, 2004 for a description of these, as well as other, risks and uncertainties.
SyntheMed, Inc.
CONTACT: Robert P. Hickey of SyntheMed, Inc., +1-732-728-1769,rphickey@synthemed.com
