January 9, 2004. Tepha, Inc. Submits Device Master File for its elastomeric TephELAST™ biomaterial to the Food and Drug Administration.
Cambridge, MA – Tepha, Inc., a privately-held Boston-area medical device company, announces the accomplishment of submission of a Device Master File (DMF) to the United States Food and Drug Administration (FDA) in December 2003 for its polyhydroxyalkanoate (PHA) copolymer, TephELAST™ biomaterial, a.k.a. PHA 3444. This novel, biologically-produced polymer can be processed to devise a range of absorbable, elastomeric medical devices. Such products include, but are not limited to, devices for minimally invasive delivery, vascular sealants, device coatings, and products for the regeneration and reinforcement of elastomeric tissues.
Building upon the success of its TephaFLEX™ biomaterial, another absorbable PHA polymer, from which multiple medical device progress in various stages of development, the company is expanding its range of absorbable, polymer-based medical products. Both the TephELAST™ biomaterial and the TephaFLEX™ biomaterial are thermoplastics which can be processed via conventional melt and solvent processing techniques into virtually any shape or form. Tepha continues to develop products internally as well as partner with a number of medical device firms in collaborative arrangements.
“This DMF further extends the range of products that we can offer to our customers as well as our corporate partners,” claims Dr. David Martin, Ph.D., Director of Biomaterials, “as this allows Tepha to develop entirely novel class of absorbable, elastomeric medical devices.”
Tepha controls over 30 United States patents regarding the production and the medical applications of its PHA polymers, and many future patents are expected to make reference to this DMF. Company President and C.E.O. Dr. Simon Williams, Ph.D. states, “Tepha continues to build on its successes, and this filing continues to pave the way for a very bright future of the company as we continue to develop our products.”
For information on TephELAST™ biomaterial or on TephaFLEX™ biomaterial, please contact: Dr. David Martin, Ph.D., Director of Biomaterials, Tepha, Inc., 840 Memorial Drive, Cambridge, MA 02139, tel: 617-995-5400, fax: 617-995-5401. Email: firstname.lastname@example.org Or visit www.tepha.com.
About Tepha, Inc.
Tepha is a medical device firm engaged in the development of a new range of absorbable devices for therapeutic applications. The Company is applying a patented core technology which allows it to produce absorbable polymers suitable for use in a wide range of implantable products in the areas of surgical repair, regenerative medicine, and drug delivery.
The Company’s proprietary technology uses genetic engineering to produce a new class of biomaterials that can be converted into a wide range of products that restore, maintain, or improve tissue function. Potential products range from relatively simple medical devices such as surgical patches, sutures, and mesh, to more complex products that include cardiovascular stents, vascular grafts, and tissue engineered heart valves- as well as drug delivery products.
For further information, please visit our website: http://www.tepha.com