In the 1970’s, the first synthetic, absorbable fibers for medical applications were developed. Although absorbable fibers have now been used for 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 recombinant system to produce Polyhydroxyalkanoates (PHAs) in microorganisms.
Researchers at Metabolix further developed recombinant systems for the industrial production of PHAs. In 1998, Tepha, Inc. was incorporated to pursue the medical applications of PHAs.
The first P4HB medical devices: TephaFLEX® Suture & Mesh received FDA clearance
Tepha partnered with B.Braun Medical who received the CE Mark for the P4HB device: MonoMax® Suture.
MonoMax Suture was the first commercial launch of a P4HB device in Europe and in the US.
TephaFLEX® Mesh received FDA clearance for soft tissue reinforcement in Plastic Surgery and was first used for Plastic Surgery. Tepha partnered with Tornier® and commercially launched: BioFiber™ for Soft Tissue Reinforcement in the US.
Tepha partnered with Bard/Davol® to commercially launch the P4HB device: Phasix™ mesh for Hernia Repair in the US.
Galatea Surgical, Inc. became a wholly owned subsidiary of Tepha, Inc. to focus on plastic and reconstructive surgery.
Tepha P4HB devices achieved milestone of treating 1 million patients globally, with over 1,000 aesthetic plastic surgery patients.
Galatea Surgical received CE Mark for use of GalaFLEX scaffold in breast surgery.
Galatea Surgical received FDA Clearance for the first and only 3-Dimensional scaffolds designed for plastic and reconstructive surgery: GalaFLEX 3D and GalaFLEX 3DR.
Global expansion of the Galatea scaffold product portfolio.
CE approval of GalaFLEX 3D and GalaFLEX 3DR.
Over 29 regulatory clearances on P4HB products and over 60 published clinical and scientific papers on P4HB.
More than 3 million patients worldwide have been implanted with P4HB devices.
Introduction of a lightweight, low-profile P4HB scaffold, GalaFLEX LITE, designed to complement the patient’s anatomy and the plastic surgeon’s technique.
Global expansion continues in 2020 with first country in APAC and EMEA and in 2021 with first country in Latin America.