With over 1 million procedures with P4HB medical products, the next generation of Soft Tissue Reinforcement is here![33]

In the 1970’s, the first synthetic, resorbable fibers for medical applications were developed.  Although resorbable fibers have now been used for nearly 50 years in medical devices, most resorbable fiber-based products degrade too rapidly in the body for use as a transitory scaffold. A resorbable polymer that can be used to produce a long-lasting transitory scaffold, but which will resorb and leave a strong repair has been elusive until relatively recently. 

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 resorbable, 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. 

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 on account of its unique properties and excellent biocompatibility.[33] In the same year, the FDA also cleared a P4HB scaffold for use in soft tissue support and by the end of 2015 there were 22 additional regulatory clearances for products made from P4HB, including Galatea scaffold which was cleared for use in the repair, elevation and reinforcement of soft tissue deficiencies, including use in plastic and reconstructive surgeries.[20] 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 resorbable products provides prolonged strength retention, and facilitates remodeling in vivo designed for a strong, lasting repair.

P4HB fibers are now used in a number of clinical products and over one million patients have been implanted with P4HB based devices in the past 7 years. [21]

  • 1980s

    Researchers at MIT isolated a biosynthetic pathway to produce Polyhydroxyalkanoates (PHAs) in microorganisms.

  • 1990s

    Researchers at Metabolix further developed biosynthetic systems for the industrial production of PHAs.

  • 1998

    Tepha, Inc. was incorporated to pursue the medical applications of PHAs.

  • 2003

    Tepha began commercial development of P4HB in Cambridge, Massachusetts.

  • 2007

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

  • 2008

    TephaFLEX Suture was used clinically for the first time.

  • 2009

    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.

  • 2010

    TephaFLEX Mesh was first used in Hernia Repair.

    P4HB Mesh received FDA clearance for use in Orthopedic Surgery.

    B.Braun Medical’s MonoMax Suture received FDA clearance and was launched commercially in the US.

  • 2011

    TephaFLEX Mesh received FDA clearance for Plastic Surgery.

    Tepha partnered with Tornier and commercially launched the P4HB device: BioFiber™ for Soft Tissue Reinforcement in the US.

    TephaFLEX scaffold was first used for Plastic Surgery.

  • 2012

    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.

  • 2014

    Tepha P4HB devices achieved milestone of treating 1,000,000 patients worldwide.

    Galatea scaffold received FDA clearance of varying shapes and sizes for use in general plastic surgery and commercially launched in the US.

  • 2015

    Galatea scaffold achieved milestone of use in 1,000 aesthetic Plastic Surgery patients in the US (cumulative).

    Galatea received CE Mark for use of Galatea scaffold in breast surgery.

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