Tepha Inc. Announces the Presentation of Pre-Clinical and Clinical Data on the Use of P4HB™ Regenerative Scaffolds In Urogynecology

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Tepha Inc., announced today that four abstracts will be presented at the upcoming combined meeting of the American Urogynecology Association (AUGS) and the International Urogynecology Association (IUGA) in Nashville, TN on September 24th-28th, which evaluate the use of the company’s proprietary fully resorbable poly-4-hydroxybutyrate (P4HB) polymer scaffold for Female Pelvic Health applications. Fully resorbable scaffolds manufactured from Tepha’s P4HB polymer were first introduced in 2012 and have now been safely used in more than 200,000 surgical procedures around the world in both complex abdominal wall reconstruction as well as plastic and reconstructive surgery applications.

In 2016 Tepha initiated an integrated bench, pre-clinical and clinical testing program in collaboration with urogynecological thought leaders on three continents, in an effort to design and develop P4HB scaffolds for the surgical treatment of Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP). P4HB scaffolds are designed to reinforce, resorb, and support the regeneration of a new functional tissue plane, thereby potentially reducing the development of chronic complications such as pain, erosion and infection that have been associated with permanent non-resorbable mesh devices.

The Tepha urogynecolgical program has been led by: Professor Jan Paul Roovers, Medical Director of the Bergman Clinic and Head of the Department of Gynaecology at the Academic Medical Center in Amsterdam;  Dr. Stephen Jeffery, Head of the Department of Urogynaecology and Pelvic Floor Reconstruction at the University of Cape Town, South Africa; and Dr. Harvey Winkler, System Chief of the Division of Female Pelvic Medicine and Reconstructive Surgery at Northwell Health and Professor in the Department of Obstetrics and Gynecology at the Zucker School of Medicine at Hofstra/Northwell.  The joint research program initially focused on the evaluation and comparison of the histological and biomechanical properties of various P4HB scaffold designs for SUI and POP as compared to existing commercially available polypropylene mesh devices following implantation in both large and small animal models. In both the short (six months) and long term (up to 18 month) studies, P4HB scaffolds were demonstrated to be biocompatible, successfully encouraged the regeneration of connective tissue, provided mechanical support to the vaginal wall during the resorption period, and showed promise as an alternative graft material to polypropylene.

Dr. Harvey Winkler commented, “With the FDA’s recent directive removing transvaginal mesh for the surgical management of pelvic organ prolapse in the United States, urogynecologists and patients alike are in need of a safe and effective alternative to native tissue repair.  After working with P4HB designs for the past two years I am very encouraged by the pre-clinical results we have evidenced and am optimistic that the P4HB resorbable polymer technology may eliminate the long term complications associated with non resorbable grafts and may lead to a new generation of safe and effective treatments for our patients.”

After more than two years of pre-clinical research, co-investigators Dr. Stephen Jeffery and Professor Jan Paul Roovers, in conjunction with the Pelvic Floor Foundation of South Africa, initiated the first clinical application of Tepha’s P4HB fully resorbable polymer scaffold for the surgical treatment of female SUI. The clinical abstract being presented at the combined AUGS/IUGA meeting this week, shows promise that a retropubically placed sling manufactured from P4HB could be a viable alternative to non-resorbable slings currently in use.

Dr. Stephen Jeffery commented, “We are in our second year of patient enrolment, and with our first patients out more than one year at this point, I have been very pleased with the results evidenced by our team to date. All surgically treated patients are currently continent, with no evidence of device-related pain or erosion, which has previously been associated with non-resorbable scaffold designs.”

Tepha’s P4HB fully resorbable scaffolds are designed to resorb and remodel forming a new, natural tissue plane that provides support and long term strength to the repair site. The benefit of complete resorption of scaffolds engineered from P4HB may serve to reduce patients’ concerns relative to complications associated with non resorbable materials.

Professor Jan Paul Roovers summarized, “Hundreds of thousands of women suffering from stress urinary incontinence and pelvic organ prolapse are currently being deprived of an optimal treatment for their serious clinical challenges. Our commitment and confidence in this technology is the result of the hard work of this multi-institutional collaboration, and we are very encouraged that P4HB scaffolds could be the technology that best serves this patient population.”



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