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Poly-4-hydroxybutyrate (P4HB): A new generation of resorbable medical devices for tissue repair and regeneration.

Simon F. Williams, PhD; Said Rizik, MS; and David P. Martin, PhD

Biomedical Engineering 58(5):1-14.2013

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Poly-4-hydroxybutyrate (P4HB) is a thermoplastic, linear polyester, produced by recombinant fermentation, that can be converted into a wide range of resorbable medical devices. P4HB fibers are exceptionally strong, and can be designed to provide prolonged strength retention in vivo. In 2007, the FDA cleared a monofilament suture made from P4HB for general soft tissue approximation and/or ligation. Subsequently, surgical mesh devices for hernia repair, tendon and ligament repair, and plastic and reconstructive surgery have been introduced for clinical use. This review describes the unique properties of P4HB, its clinical applications, and potential uses that are under development.


Tepha, Inc., the parent company of Galatea Surgical, Inc., provided the funding for this article. Dr. Simon Williams is a Consultant to Tepha, Inc. and a member of the Tepha Board of Directors. Dr. David Martin is the Chief Scientific Officer of Tepha, Inc. Said Rizik is an employee of Tepha, Inc.