Tepha, Inc. News
FDA Clears First of Its Kind Suture Made Using DNA Technology
The U.S. Food and Drug Administration (FDA) announced it has cleared for marketing in the U.S. the TephaFLEX Absorbable Suture—the first absorbable polymer suture made from material isolated from bacteria modified by recombinant DNA technology. (February 12, 2007)
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Tepha files DMF with FDA for new biomaterial with significant elastomeric properties.
Tepha, Inc of Cambridge Mass has taken major steps forward in addressing unmet medical needs by developing new products for regenerative medicine. Tepha's biomaterials are all thermoplastics and may be processed using conventional melt and solvent processing techniques into virtually any shape or form. The company has developed the expertise to produce fibres, foams, films, meshes and injection molded devices from its initial biomaterials. (August, 2003)
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U.S. Department of Commerce’s ATP awards Tepha $2 million for development of cardiovascular tissue engineered products.
More than 60 million Americans suffer from cardiovascular disease, which is the nation's number one cause of death and drains the economy of nearly $300 billion annually in treatment costs and lost productivity and future earnings. To provide better treatment options and reduce costs, Tepha Inc. plans a three-year project to develop and test novel elastic biomaterial scaffolds seeded with a patient's own cells and used to repair or restore defective cardiovascular tissues. (October, 2002)
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Tepha at forefront of U.S. Opportunities in Heart Valve Disease Management
Hundreds of thousands of patients in the U.S., including a large share with congestive heart failure, could potentially benefit from heart valve repair or replacement. However, because both are currently performed as open heart procedures requiring cardiopulmonary bypass, less than 94,000 individuals underwent heart valve surgery in 2001 due to its invasiveness, risks and cost. (March, 2002)
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