BOSTON, April 10 /PRNewswire/ -- TEI Biosciences Inc. (TEI) announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for TissueMend(TM) Soft Tissue Repair Matrix (TissueMend), a biomembrane to be used as a general surgical mesh for the reinforcement or repair of soft tissues.
TissueMend is a high-strength, fully remodelable collagen membrane that exhibits superior characteristics when compared to both synthetic and competing biologic materials. Unlike synthetic polymer implants, TissueMend remodels into the body's native tissues, thereby avoiding long-term complications that may arise from the use of permanent products. When compared to competing biologic products, TissueMend has a high tensile and suture pullout strength without requiring a crosslinking step, thereby retaining the intrinsic biological information needed for remodeling by native cells. In contrast, synthetic polymers and crosslinked biopolymers remain in the patient as foreign bodies and are not remodeled. Biodegradable poly-L- lactic and polyglycolic acid-based products, on the other hand, lack the biological information for specific cell attachment and for the binding of cell-secreted products needed for tissue reconstitution.
TissueMend is intended for use as a patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured tissue membranes. It is specifically indicated for the repair of hernias and urogynecological conditions such as incontinence, prolapse, and pelvic floor reconstruction.
"We're very pleased to have received clearance from the FDA for TissueMend, which we're preparing to launch immediately following cGMP compliance of our manufacturing facilities, anticipated this summer," said Dr. Yiannis Monovoukas, TEI's President and Chief Executive Officer. "This clearance is a key milestone for TEI as it brings us closer to the launch of our first products and closer to our first commercial revenues. We are presently in discussions with several US companies interested in obtaining exclusive worldwide marketing rights to TissueMend products, and we expect to select a partner for pelvic reconstruction applications within the next few months."
TEI Biosciences Inc. is a development-stage biomedical company that develops and manufactures medical implants and biopharmaceutical agents to repair or replace tissues and organs of the body that have failed due to aging, injury, or disease. The Company's core technologies include collagen- based remodelable biomembranes, such as TissueMend(TM) and Durepair(TM), with broad applications for the repair and regeneration of human tissues; and Signal-plexes(TM), tissue-specific signaling complexes shown in pre-clinical studies to predictably direct the differentiation of stem cells into a broad range of phenotypes.
This news release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements, including statements about product development status and clinical trials, represent the company's judgment as of the time of this release. The company disclaims any intent or obligation to update these forward-looking statements.