Navigation Links
SyntheMed Receives Australian Regulatory Approval for REPEL-CV(R)
Date:5/28/2009

ISELIN, N.J., May 28 /PRNewswire-FirstCall/ -- SyntheMed, Inc. (OTC Bulletin Board: SYMD), a biomaterials company engaged in the development and commercialization of anti-adhesion products, announced today that REPEL-CV, the company's bioresorbable adhesion barrier film for the reduction of adhesions following cardiac surgery, has received approval from the Australian Therapeutic Goods Administration for use in all patients who undergo open heart surgery. REPEL-CV will be marketed throughout Australia by Tag Medical Pty Ltd., a distributor of cardiac surgery products. Marc Sportsman, SyntheMed's Vice President of Sales, stated, "We are pleased to receive the Australian regulatory approval which allows us to further expand the international distribution of REPEL-CV."

REPEL-CV is FDA approved for use in pediatric cardiac surgery patients and is marketed in the United States through a direct sales force. It also has CE Mark approval for use in all cardiac surgery patients and is marketed in the European Union and certain other international countries through a network of independent distributors.

About Adhesions

Adhesions, or scar tissue, occur after virtually all open-heart surgical procedures, often resulting in the heart becoming attached to the sternum and other surrounding tissue surfaces. The presence of adhesions represents a prevalent and serious complication in secondary surgical procedures, increasing the length, cost and risk of the surgical procedure.

About REPEL-CV

REPEL-CV is a bioresorbable adhesion barrier film designed to be placed over the surface of the heart at the conclusion of an open-heart surgical procedure to reduce the extent and severity of adhesions (scar tissue) that form between the surface of the heart and opposing tissue surfaces following the surgical procedure. It is designed to perform the therapeutic task and then degrade so that it is cleared from the body.

About SyntheMed, Inc.

SyntheMed, Inc. is a biomaterials company engaged in the development and commercialization of anti-adhesion products. The company is primarily focused on the advancement and expansion of product development programs based on its proprietary bioresorbable polymer technology.

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 FDA and other 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, 2008 for a description of these, as well as other, risks and uncertainties.


'/>"/>
SOURCE SyntheMed, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. FDA Approves SyntheMeds REPEL-CV(R) Adhesion Barrier for Use in Pediatric Cardiac Surgery
2. SyntheMed Announces FDA Clearance of SinusShield(TM)
3. SyntheMed Announces New Management Appointments
4. SyntheMed Completes $4.0 Million Equity Placement
5. SyntheMed To Present at the AdvaMed 2008 MedTech Conference
6. SyntheMed to Present at Canaccord Adams Small-Cap Orthopedics Conference
7. SyntheMed Files Universal Shelf Registration
8. SyntheMed to Present at the Acumen BioFin Conference
9. SyntheMed to Host Symposium on Adhesions in Cardiac Surgery
10. Astellas Receives FDA Approval for Use of Prograf(R) (Tacrolimus) in Conjunction With Mycophenolate Mofetil (MMF) in Kidney Transplant Recipients
11. Sanofi Pasteur Receives Seed Virus to Produce New Influenza A(H1N1) Vaccine
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/9/2016)... ... ... Aditya Humad, Acting CFO of AxioMed and Managing Partner of KICVentures, is ... is now gaining interest from Silicon Valley. “It was satisfying to complete the due ... say that, “We expect interest to continue to rise as AxioMed completes its cleanroom ...
(Date:12/9/2016)... Portage Biotech Inc. ("Portage" or "the Company") (OTC: PTGEF, ... Biohaven has issued today the following press release: ... Dec 9, 2016 - Biohaven Pharmaceutical Holding Company Ltd. ... Food and Drug Administration ("FDA") has granted the Company,s ... an orally dissolving tablet being developed for the treatment ...
(Date:12/8/2016)... La Jolla, CA (PRWEB) , ... December 08, 2016 , ... ... that 2016 was a banner year for team building events, new program offerings and ... focus, which it expanded earlier this year to include groups of over 30 people. ...
(Date:12/8/2016)... SAN DIEGO , Dec. 8, 2016 /PRNewswire/ ... presented demonstrating the role of the Breast Cancer ... stage, ER+ breast cancer are most at-risk for ... therapy. Data include results from three studies advancing ... provide information related to tumor biology and inform ...
Breaking Biology Technology:
(Date:11/17/2016)... -- Global Market Watch: Primarily supported by ownership ... and Academics) market is to witness a value of US$37.1 ... highest Compounded Annual Growth Rate (CAGR) of 10.75% is foreseen ... period 2014-2020. North America is not ... Europe at 9.56% respectively. Report Focus: ...
(Date:11/14/2016)... 2016  xG Technology, Inc. ("xG" or the "Company") ... communications for use in challenging operating environments, announced its ... Management will hold a conference call to discuss these ... Time (details below). Key Recent Accomplishments ... binding agreement to acquire Vislink Communication Systems. The purchase ...
(Date:6/22/2016)... 2016 On Monday, the Department of Homeland ... share solutions for the Biometric Exit Program. The Request ... Protection (CBP), explains that CBP intends to add biometrics ... the United States , in order to deter ... Logo - http://photos.prnewswire.com/prnh/20160622/382209LOGO ...
Breaking Biology News(10 mins):