OCEANPORT, N.J., June 8 /PRNewswire-FirstCall/ -- SyntheMed, Inc. is pleased to announce the enrollment of the first patient in its multi-center European Clinical Study for REPEL-CV Adhesion Barrier. The initial patient was enrolled at the Clinic for Heart and Vascular Surgery of the German Heart Center in Munich under the direction of Prof. Dr. Rudiger Lange. Dr. Christian Schreiber, the Principal Investigator and a pediatric cardiovascular surgeon at the Clinic who performed the first procedure, stated, "Post operative adhesions are a significant complication in our surgical practice and we are eager to determine the potential benefit that REPEL-CV may provide."
The open label study will be conducted at several prominent cardiac surgery centers in Europe during which the efficacy and safety of REPEL-CV will be evaluated in open heart surgical procedures performed on neonatal patients undergoing a series of staged reconstructive procedures. The objective of the study is to provide an opportunity for leading European cardiac surgeons to gain experience with the surgical and patient benefits associated with the use of REPEL-CV. SyntheMed is planning to initiate the sale of REPEL-CV in European markets during the first half of 2006.
SyntheMed is also in the midst of a multi-center pivotal clinical trial for REPEL-CV in the United States, the results of which are intended to be submitted to the FDA as a basis for securing approval to market the product in the United States. REPEL-CV previously demonstrated positive results in two FDA-sanctioned clinical trials, one in adults undergoing open heart surgery and the other in neonatal patients requiring staged reconstructive open heart procedures.
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 the European clinical study, the timing or ability to achieve regulatory approval in respect of 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 US clinical trial, the European clinical study and the Company's efforts to obtain required FDA approval and that failure can occur at any stage of testing and (ii) potential inability to secure funding as and when needed to support the US clinical trial, the European clinical study and the Company's other 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