Navigation Links
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.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. SyntheMed Receives Brazilian Regulatory Approval for REPEL-CV(TM)
2. SyntheMed Receives Russian Regulatory Approval for REPEL-CV(TM)
3. SyntheMed Receives US Patent on Novel Polymer Technology
4. SyntheMed Receives Frost & Sullivan Health Innovation Award Nomination
5. SyntheMed Receives Australian Regulatory Approval for REPEL-CV(R)
6. FDA Approves SyntheMeds REPEL-CV(R) Adhesion Barrier for Use in Pediatric Cardiac Surgery
7. SyntheMed Announces FDA Clearance of SinusShield(TM)
8. SyntheMed Announces New Management Appointments
9. SyntheMed Completes $4.0 Million Equity Placement
10. SyntheMed To Present at the AdvaMed 2008 MedTech Conference
11. SyntheMed to Present at Canaccord Adams Small-Cap Orthopedics Conference
Post Your Comments:
(Date:6/23/2016)... , June 23, 2016   Boston Biomedical ... novel compounds designed to target cancer stemness pathways, ... been granted Orphan Drug Designation from the U.S. ... of gastric cancer, including gastroesophageal junction (GEJ) cancer. ... designed to inhibit cancer stemness pathways by targeting ...
(Date:6/23/2016)... ... 2016 , ... Charm Sciences, Inc. is pleased to announce ... Research Institute approval 061601. , “This is another AOAC-RI approval of the Peel ... President of Regulatory and Industrial Affairs. “The Peel Plate methods perform comparably to ...
(Date:6/23/2016)... ... June 23, 2016 , ... ... launch of the Supplyframe Design Lab . Located in Pasadena, Calif., the ... future of how hardware projects are designed, built and brought to market. , ...
(Date:6/23/2016)... Calif. , June 23, 2016  Blueprint Bio, ... biological discoveries to the medical community, has closed its ... Matthew Nunez . "We have received ... with the capital we need to meet our current ... essentially provide us the runway to complete validation on ...
Breaking Biology Technology:
(Date:6/2/2016)... 2016 The Department of Transport Management ... 44 million US Dollar project, for the , ... Personalization, Enrolment, and IT Infrastructure , to ... and implementation of Identity Management Solutions. Numerous renowned international vendors ... Decatur was selected for the most compliant and ...
(Date:5/20/2016)... , May 20, 2016  VoiceIt is ... partnership with VoicePass. By working together, ... experience.  Because VoiceIt and VoicePass take slightly different ... engines increases both security and usability. ... excitement about this new partnership. "This ...
(Date:4/28/2016)... , April 28, 2016 Infosys ... (NYSE: INFY ), and Samsung SDS, a global ... that will provide end customers with a more secure, fast ...      (Logo: ) , ... but it also plays a fundamental part in enabling and ...
Breaking Biology News(10 mins):