Navigation Links
SyntheMed Receives Russian Regulatory Approval for REPEL-CV(TM)
Date:8/18/2009

ISELIN, N.J., Aug. 18 /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 Ministry of Health of the Russian Federation for use in all patients who undergo open heart surgery. REPEL-CV will be marketed throughout Russia by Cardiomedics, Ltd., a distributor of cardiac surgery products. Marc Sportsman, SyntheMed's Vice President of Sales, stated, "We are pleased that this regulatory and clinical evaluation process has been successfully completed and we can proceed with the launch of REPEL-CV in this important market."

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 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. SyntheMed Receives US Patent on Novel Polymer Technology
2. SyntheMed Receives Frost & Sullivan Health Innovation Award Nomination
3. SyntheMed Receives Australian Regulatory Approval for REPEL-CV(R)
4. FDA Approves SyntheMeds REPEL-CV(R) Adhesion Barrier for Use in Pediatric Cardiac Surgery
5. SyntheMed Announces FDA Clearance of SinusShield(TM)
6. SyntheMed Announces New Management Appointments
7. SyntheMed Completes $4.0 Million Equity Placement
8. SyntheMed To Present at the AdvaMed 2008 MedTech Conference
9. SyntheMed to Present at Canaccord Adams Small-Cap Orthopedics Conference
10. SyntheMed Files Universal Shelf Registration
11. SyntheMed to Present at the Acumen BioFin Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , ... June 23, 2016 , ... ... release of its second eBook, “Clinical Trials Patient Recruitment and Retention Tips.” Partnering ... retention in this eBook by providing practical tips, tools, and strategies for clinical ...
(Date:6/23/2016)... June 23, 2016 /PRNewswire/ - FACIT has announced ... biotechnology company, Propellon Therapeutics Inc. ("Propellon" ... commercialization of a portfolio of first-in-class WDR5 inhibitors ... such as WDR5 represent an exciting class of ... precision medicine for cancer patients. Substantial advances have ...
(Date:6/23/2016)... , ... June 23, 2016 , ... ... YM (Yeast and Mold) microbial test has received AOAC Research Institute approval 061601. ... microbial tests introduced last year,” stated Bob Salter, Vice President of Regulatory and ...
(Date:6/23/2016)... 23, 2016   EpiBiome , a precision microbiome ... in debt financing from Silicon Valley Bank (SVB). The ... to advance its drug development efforts, as well as ... "SVB has been an incredible strategic partner to ... traditional bank would provide," said Dr. Aeron Tynes ...
Breaking Biology Technology:
(Date:4/13/2016)... , April 13, 2016  IMPOWER physicians supporting ... are setting a new clinical standard in telehealth thanks ... By leveraging the higi platform, IMPOWER patients can routinely ... pulse and body mass index, and, when they opt ... and convenient visit to a local retail location at ...
(Date:3/29/2016)... 2016 LegacyXChange, Inc. (OTC: ... SelectaDNA/CSI Protect are pleased to announce our successful effort ... variety of writing instruments, ensuring athletes signatures against counterfeiting ... from athletes on LegacyXChange will be assured of ongoing ... Bill Bollander , CEO states, "By ...
(Date:3/22/2016)... and SANDY, Utah , March ... operates the highest sample volume laboratory in ... and UNIConnect, leaders in clinical sequencing informatics and molecular ... of a project to establish the informatics infrastructure for ... NSO has been contracted by the Ontario Ministry ...
Breaking Biology News(10 mins):