OCEANPORT, N.J., March 21 /PRNewswire-FirstCall/ -- Robert P. Hickey, President & CEO of Life Medical Sciences, Inc. (BULLETIN BOARD: CHAI) , announced that the Company has initiated a multi-center clinical study for REPEL-CV involving a number of leading cardiac surgery centers in Europe. Mr. Hickey stated, "In preparation for the commercial launch of REPEL-CV Adhesion Barrier in the major European markets during the first half of 2006, we are conducting this study involving prominent European cardiac surgeons so that they will gain experience with the surgical and patient benefits associated with the use of this product."
Mr. Hickey also reported that the US Food and Drug Administration (FDA) has approved the Company's request to increase, from 15 to 20, the number of surgical sites participating in the REPEL-CV pivotal clinical trial. The Company has already recruited the additional sites which should facilitate the completion of this trial by 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.
Life Medical Sciences, 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 clinical trial and 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 clinical trial and the Company's efforts to obtain required FDA approval, including that the DSMB recommendation described in this Press Release is not indicative of the results of the trial and that failure can occur at any stage of testing and (ii) potential inability to secure funding as and when needed to support the trial 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.
Life Medical Sciences, Inc.