Tepha files DMF with FDA for new biomaterial with significant elastomeric properties.
From Waterfalls Institute of Technology Transfer (WITT)
Biomaterials for Regenerative Medicine
The medical community has long sought biomaterials with properties such as elasticity, flexibility, tailored absorption rates and strength retention.
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.
Recently, Tepha has been awarded three US Patents: US 6,514,515; US 6,555,123 and US 6,548,569 (the latter is licensed from Metabolix, Inc) bringing Tepha’s US patent portfolio to a total of 23.
These three new patents represent significant progress in elastomeric and flexible absorbable biomaterials. In May 2002, Tepha filed a Device Master File with the US Food & Drug Administration for its lead biomaterial, PHA4400, which has been used successfully, in preclinical studies, in cardiovascular tissue engineering to regenerate complex tissue structures closely resembling native tissue. PHA4400 is also being used to develop medical devices that require flexible, absorbable biomaterials with prolonged strength retention. Currently, elastomeric absorbable biomaterial (PHA3444) is being developed that offers the promise of even greater medical advances through development of devices for minimally invasive delivery, sealants, coatings, membranes, cosmetic implants and devices for regeneration and reinforcement of elastomeric tissues.