Over 3 Million Patients Have Been Implanted with P4HB Devices
In the 1970’s, the first synthetic, absorbable fibers for medical applications were developed. Although absorbable fibers have now been used for nearly 50 years in medical devices, most absorbable fiber-based products degrade too rapidly in the body for use as a transitory scaffold [1,23]. A macroporous, monofilament, fully absorbable scaffold with long term strength retention and predictable absorption profile, was elusive in the field of plastic and reconstructive surgery until the development of P4HB.
Researchers at MIT developed a biosynthetic system to produce Polyhydroxyalkanoates (PHAs), a naturally occurring biopolymer. This technology was licensed to Metabolix, Inc. in the early 1990’s. While at Metabolix, Inc, David Martin, Ph.D. and Simon Williams, Ph.D. developed PHAs for medical applications, specifically optimizing a new absorbable, high strength suture made from the polymer poly-4-hydroxybutyrate (P4HB). With these discoveries, Dr. Martin and Dr. Williams led the spinout of Tepha, Inc. to continue to enhance P4HB medical devices with controlled degradation which began the next generation in implantable medical devices. [1,23]
In 2007, the FDA cleared sutures made from P4HB for use in soft tissue approximation, and within a relatively short period of time, other applications of P4HB expanded rapidly due to its unique properties and proven biocompatibility.[1,23] In the same year, the FDA also cleared a P4HB scaffold for use in soft tissue support and as of 2019 there are 29 additional regulatory clearances for products made from P4HB, including the Galatea Collection of scaffolds, which offer a unique combination of properties that are designed for soft tissue reinforcement in plastic and reconstructive surgery procedures. Other members of the P4HB family include MonoMax® Suture for soft tissue approximation, BioFiber® Scaffold for tendon repair, and Phasix Mesh® for hernia repair. Each of these fully absorbable products provides prolonged strength retention, and facilitates remodeling in vivo to provide a strong, lasting repair.[1,23]
P4HB fibers are now used in a number of clinical products and over three million patients have been implanted with P4HB based devices.