Tepha’s TephaFLEX® biopolymer (P4HB) is Poly (4-hydroxybutyric acid), a homopolymer of 4-hydroxybutyrate (4HB), and belongs to a diverse class of materials called polyhydroxyalkanoates (PHAs) that are produced naturally by microorganisms. The TephaFLEX® polymer is a thermoplastic linear polyester and is produced by means of a recombinant fermentation process. Following fermentation the polymer is isolated and purified to yield an extremely high purity material.
The purified polymer can be converted into a wide range of medical devices such as sutures, films, and textile products.
Once implanted, P4HB will degrade in the body primarily by hydrolysis to produce 4HB. This monomer is a normal constituent of the mammalian body and is found within a variety of tissues, including brain, heart, kidney, liver, lung, muscle and brown fat. The body quickly metabolizes 4HB, and its half-life is approximately 27 minutes. 4HB is eliminated from the body primarily by metabolism via the Krebs Cycle and secondarily by beta-oxidation ultimately to carbon dioxide and water. To ensure the safety of P4HB, the biological effects of the polymer and devices made from it have been extensively evaluated both in vitro and in vivo.