SyntheMed, Inc.
HCID Member | Medical Devices & Tech
200 Middlesex Essex Turnpike, Suite 210
Iselin, NJ 08830 USA
phone: 732- 404-1117
fax: 732-404-1118
Symbol SYMD
Exchange .OB
Founded 1990
Employees 6
www.synthemed.com
Research Sector Medical Devices & Tech
Summary Description
Products to Reduce the Formation of Surgical Scar Tissue
Management
ROBERT P. HICKEY, President & CEO, Chief Financial Officer; ELI PINES, Ph.D., Vice President of Research & Development, Chief Scientific Officer; MARC R. SPORTSMAN, Vice President of Sales
Ownership
Financials


* numbers in thousands

 
Keywords
Cardiovascular, anti-adhesion, cardiology, Surgery Products, surgery, bioresorbable polymer, cardiac, heart surgery, scar tissues, adhesion, adhesions, orthopedic, spinal surgery, gynecologic surgery, general surgery, adv2007, j2008a, advamed

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Description
SyntheMed is a biomaterials company engaged in the development and commercialization of anti-adhesion and drug delivery products. The company is primarily focused on the advancement and expansion of product development programs based on its proprietary bioresorbable polymer technology.
Products / Services
REPEL-CV Bioresorbable Adhesion Barrier is a thin film designed to be placed over the surface of the heart at the conclusion of an open heart surgical procedure to reduce the formation of post-operative adhesions. Due to the trauma and bleeding associated with open heart surgery, dense, vascular adhesions typically form between the heart and surrounding tissue surfaces. At the point of reoperation, these adhesions represent a significant complication in that they make it very difficult for the surgeon to visualize the heart and other critical vessels. The tedious, delicate process of cutting away the adhesions can add 30 to 60 minutes to the operation and increase the risk of mortality and morbidity. Other products under development focus on preventing or reducing post-operative adhesions subsequent to gynecologic, orthopedic and general surgical procedures and are in various stages of clinical trials and preclinical studies. Also in preclinical development is a drug delivery product intended to reduce the onset of atrial fibrillation after open heart surgery.
Technology / Differentiation
Bioresorbable polymers are polymers that serve a temporary function in the body and then safely degrade into fragments which are either metabolized or eliminated via normal excretory routes. The company's proprietary line includes water soluble polymers, solid and injectable polymeric materials and thermal gels. The polymers can be reconstituted into forms of various viscosities depending on the temperature.
Market / Customers
Adhesions are unavoidable byproducts of the trauma and bleeding that are associated with virtually all internal surgeries. They may cause such complications as infertility, bowel obstruction, chronic pain and restriction on joint mobility, in addition to the previously mentioned complications in cardiac surgery. The estimated annual market potential for anti-adhesion products ranges from $2-3 billion.
Competitors / Substitutes / Alternatives
There are several anti-adhesion products which have been approved for use in the US and EU, principally for use in gynecologic and general surgery. REPEL-CV could become the first anti-adhesion product with regulatory approval in the US and the EU for use in open heart surgical procedures.
Strategy
Development programs and collaborative relationships are being pursued which should result in the broadening of the proprietary polymer technology portfolio and the application of this technology in a number of new product categories.
Status
Synthemed announced in July 2008 that REPEL-CV received Health Canada approval for use in pediatric patients undergoing open heart surgery. REPEL-CV will be marketed throughout Canada by Force3 Medicale, Inc., a Montreal-based distributor of cardiac surgery products. In September 2007, the Advisory Panel of the FDA recommended approval of the REPEL-CV Adhesion Barrier for use in pediatric patients (21 and younger) likely to need secondary open heart surgery. The FDA approved the companys PMA application for the pediatric indication.


2008-11-23-5622