Over 3 Million Patients Have Been Implanted with P4HB Devices[1]

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.[1] 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. [1]

  • 1980s

    Researchers at MIT developed a recombinant system to produce Polyhydroxyalkanoates (PHAs) in microorganisms.

  • 1990s

    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.

  • 2007 / 2008

    The first P4HB medical devices: TephaFLEX® Suture & Mesh received FDA clearance.

  • 2009 / 2010

    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.

  • 2011

    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.

  • 2012 / 2013

    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.

  • 2014 / 2015

    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

  • 2016 / 2017

    Launch of GalaFLEX 3D and GalaFLEX 3DR

  • 2018 -2020

    Global expansion of the Galatea scaffold product portfolio.