SyntheMed Receives CE Mark Approval for REPEL-GYN™
ISELIN, N.J., May 24 /PRNewswire-FirstCall/ -- SyntheMed, Inc. (OTC Bulletin Board: SYMD), a biomaterials company engaged in the development and commercialization of anti-adhesion products, today announced that REPEL-GYN™, the company's bioresorbable adhesion barrier film for the reduction of adhesions following gynecologic surgery, has received CE Mark approval in the European Union (EU). CE Mark approval signifies that REPEL-GYN has met the essential requirements of the European Union Medical Devices Directive and enables the company to begin marketing the product to reduce the incidence, severity and extent of post-operative adhesion formation in patients undergoing gynecologic surgery.
The formation of adhesions (scar tissue) between organs in the pelvic cavity is a frequent, undesirable result of gynecologic surgery. Pelvic adhesions can cause the patient to endure chronic pain, small bowel obstruction and infertility. The presence of adhesions is also a complicating factor in repeat caesarian sections. There are an estimated 2 million gynecologic procedures performed annually in the EU and other international markets in which the patients are at risk of developing adhesion-related complications.
Robert P. Hickey, President and CEO, SyntheMed, Inc., stated, "We are very pleased to have received regulatory approval to expand the use of our proprietary bioresorbable polymer film in the EU markets. REPEL-GYN is similar to REPEL-CV® Adhesion Barrier which is currently marketed internationally for use in all cardiac surgical procedures and in pediatric cardiac surgery in the United States. We are currently evaluating our options on the marketing of REPEL-GYN throughout the EU either through a corporate partner or an independent distribution network."
REPEL-GYN is a bioresorbable adhesion barrier film designed to be placed over traumatized tissue surfaces at the conclusion of a gynecologic surgical procedure to reduce the formation of adhesions between adjacent tissue surfaces in the pelvic cavity.
About SyntheMed, Inc.
SyntheMed, Inc. is a biomaterials company engaged in the development and commercialization of anti-adhesion products.
Statements in this press release that are not statements of historical fact 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 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, 2009 for a description of these, as well as other, risks and uncertainties.
SOURCE SyntheMed, Inc.