SyntheMed Announces FDA Clearance Of SinusShield(TM)

Main Category: Ear, Nose and Throat
Also Included In: Regulatory Affairs / Drug Approvals;  IT / Internet / E-mail
Article Date: 20 Nov 2008 - 0:00 PDT

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SyntheMed, Inc. (OTC Bulletin Board: SYMD) announced that it has received FDA 510(k) clearance to market SinusShield(TM), a bioresorbable membrane intended to prevent post-operative adhesions in nasal and sinus surgical procedures. There are approximately two million nasal and sinus procedures performed annually in the United States.

Robert P. Hickey, SyntheMed's President & CEO stated, "SinusShield represents an example of our strategy to capitalize on our proprietary polymer film technology in new surgical applications both in the United States and international markets." The company is in discussion with prospective partners with the distribution infrastructure to service the office-based and hospital outpatient sites where these procedures are performed.

About SinusShield(TM)

SinusShield is a bioresorbable polymer membrane indicated for use in patients undergoing nasal and sinus surgical procedures as a space-occupying stent to separate and prevent adhesions between mucosal surfaces. During surgical procedures involving the sinuses and sinus passages, it is common for surgeons to place silastic tubes or sheets in the sinus passages to prevent blockage caused by adhesion formation; however, these materials must often be removed in a second procedure. SinusShield is intended to prevent blockage and then biodegrade thereby eliminating the second procedure.

About SyntheMed, Inc.

SyntheMed, Inc. is a biomaterials company engaged in the development and commercialization of anti-adhesion products and other surgical implants based on its proprietary bioresorbable polymer technology. The company is developing a portfolio of anti-adhesion products led by REPEL-CV(R) Adhesion Barrier, an anti-adhesion product intended for use in open heart surgical procedures. REPEL-CV is currently marketed internationally and is awaiting FDA approval to market in the United States.

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 market potential, distribution strategies, 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, 2007 for a description of these, as well as other, risks and uncertainties.

SyntheMed, Inc.
http://www.synthemed.com