Navigation Links
SyntheMed Receives Canadian Approval for REPEL-CV(R)
Date:7/14/2008

ISELIN, N.J., July 14 /PRNewswire-FirstCall/ -- SyntheMed, Inc. (OTC Bulletin Board: SYMD), a biomaterials company engaged in the development and commercialization of anti-adhesion, drug delivery products and other surgical implants, announced today that REPEL-CV(R), the company's bioresorbable adhesion barrier film for the reduction of adhesions following cardiac surgery, has received Health Canada approval for use in pediatric patients who undergo open heart surgery. REPEL-CV will be marketed throughout Canada by Force3 Medicale, Inc., a Montreal-based distributor of cardiac surgery products. Marc Sportsman, SyntheMed's Vice President of Sales, stated, "We are pleased to receive the Health Canada approval which allows us to further expand the international distribution of REPEL-CV."

SyntheMed was previously granted CE Mark approval to market REPEL-CV in most international markets for use in all patients who undergo open heart surgery and is being sold through a network of independent distributors. In November 2007, SyntheMed received an Approval Letter from the US FDA stating the REPEL-CV would be approved for use in pediatric patients pending satisfactory completion of field inspections. This process is ongoing as are discussions with the FDA on the requirements for expansion of the indication for REPEL-CV from pediatric patients to all patients who undergo cardiac surgery.

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. REPEL-CV is designed to provide the therapeutic benefit and then degrade so that it is cleared from the body. REPEL-CV represents the first in a series of anti-adhesion products under development that are based on the Company's proprietary polymer technology.

About SyntheMed, Inc.

SyntheMed, Inc. is a biomaterials company engaged in the development and commercialization of anti-adhesion, drug delivery products, and other surgical implants. 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, 2007 for a description of these, as well as other, risks and uncertainties.


'/>"/>
SOURCE SyntheMed, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
2. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
3. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
4. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
5. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
6. CryoCor Receives FDA Approval for Right Atrial Flutter
7. Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP
8. Dimericine(R) Receives FDA Fast Track Designation for Treatment Of Photosensitivity in XP Patients
9. Poniard Pharmaceuticals Receives FDA Fast Track Designation for Picoplatin for Treatment of Small Cell Lung Cancer
10. Kosan Receives Completed Special Protocol Assessment for TIME-1 Pivotal Phase 3 Trial of Tanespimycin in Multiple Myeloma
11. The Female Health Company Receives USAID DELIVER PROJECT Order for 5 Million Units
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/27/2016)... , May 27, 2016 ... the Dario™ Diabetes Management Tool, today announced that the Company,s ... the Marcum MicroCap Conference being held June 1-2 in ... Invitational, being held June 7-9 in Los Angeles, ... will discuss recent corporate and operational milestones, including the U.S. ...
(Date:5/27/2016)... Amarantus BioScience Holdings, Inc. (OTCQX: AMBS), ... Neurology and Orphan Diseases, today announced that President & CEO ... conferences: SeeThru Equity MicroCap Conference   ... City , NY When: Tuesday, May 31 st ... Where: Grand Hyatt Hotel, 109 East 42 nd ...
(Date:5/26/2016)... TARE (Transarterial Radio-embolization) Using ... and Overall Decreased Use of Hospital Resource ... specialist healthcare company, has today announced the publication ... of ISPOR (International Society for Pharmacoeconomics and Outcomes ... using yttrium-90 glass microspheres is associated with cost ...
Breaking Medicine Technology:
(Date:5/26/2016)... ... May 26, 2016 , ... Georgia State University ... specialty academic programs. , Answering to the increasing demand for curricular specializations, the ... law, and environmental and land use law. ,  , “The demand for lawyers ...
(Date:5/26/2016)... ... May 26, 2016 , ... The Woodlands at John Knox ... new model of care for living and healing, celebrated its grand opening, today. The ... a Real Home provided by Empowered Staff. , “This is an incredibly fulfilling time ...
(Date:5/26/2016)... ... May 26, 2016 , ... MadgeTech will be showcasing its line of ... Warner, New Hampshire at the MadgeTech headquarters. With products sold in more than 100 ... government agencies, including NASA. , In 2012, NASA strategically set up 17 RHTemp101A ...
(Date:5/26/2016)... ... ... An April Gallup survey found rising health care costs to be the top ... Living (SHSL) may not share those same worries thanks to a new bundled ... while holding the line on increasing their contributions, including premiums, deductibles and the portions ...
(Date:5/26/2016)... ... May 26, 2016 , ... Leadership ... solutions, today announced the organization has earned its ISO 13485 certification, indicating the ... compliant with all rules and policies associated with ISO quality standard 13485. ...
Breaking Medicine News(10 mins):