Tepha Inc. reported today the initiation of a pilot clinical evaluation of the Company’s P4HB regenerative polymer scaffold for the surgical treatment of stress urinary incontinence (SUI). The study was initiated in Cape Town, South Africa in partnership with the Pelvic Floor Foundation of South Africa (“PFFSA”) and the University of Cape Town. The first procedures were performed by co-principal investigators, Dr. Stephen Jeffery of the University of Cape Town and Professor Jan-Paul Roovers of the Academic Medical Center, Amsterdam, The Netherlands. The Cape Town SUI study represents the first clinical application of Tepha’s P4HB polymer technology in the field of urogynecology. Based in Lexington, MA, Tepha is the pioneer developer and exclusive supplier of the P4HB polymer for medical applications that include hernia repair, plastic surgery, tendon & ligament repair, and wound closure.
Patients in the Cape Town Stress Urinary Incontinence clinical study are being treated with a “mid-urethral sling” device based on Tepha’s resorbable P4HB polymer. Unlike most currently available non-resorbable mid-urethral sling devices made from polypropylene, the Tepha P4HB regenerative scaffold has been designed to resorb and remodel to form a new natural tissue plane that will maintain continence and potentially minimize long term complications. The Cape Town pilot SUI study with the P4HB regenerative scaffold is primarily a safety and feasibility study that will include certain efficacy endpoints. The patients will be followed for two years during which time the P4HB scaffold is expected to completely resorb and remodel. Tepha is planning to initiate further clinical evaluation of its P4HB regenerative scaffold in Europe in 2019 and the United States in 2020.
Dr. Stephen Jeffery M.D., a leading urogynecologist and Director of the University of Cape Town Urogynecology Department, commented, “We are pleased to have the opportunity to lead the first clinical evaluation of a P4HB regenerative scaffold for SUI. Our commitment and confidence in this technology is reinforced by Tepha’s extensive pre-clinical testing and the impressive long term safety profile of P4HB devices currently in use for multiple clinical applications. Our first six procedures have been successful as the P4HB regenerative scaffold deployed effortlessly in the sub-urethral plane and near-term follow-up has been uneventful.”
The initiation of the Cape Town SUI clinical trial is an important milestone for Tepha’s R&D program to develop P4HB regenerative scaffolds focused on clinical needs in the field of urogynecology, including both stress urinary incontinence and pelvic organ prolapse. Starting almost 3 years ago and collaborating with global thought leaders in the field of urogynecology, the objective of the program has been to develop mesh scaffolds that will resorb and regenerate a functional and supportive new tissue plane, thereby reducing complications such as pain and infection sometimes associated with currently available non-resorbable polypropylene mesh devices. The program has included bench top screening and animal studies that have been conducted in partnership with academic research centers in both the US and Europe. In addition to its pilot SUI clinical study, Tepha’s partnership with the PFFSA and University of Cape Town also is conducting a long term functional animal study in a well established sheep model for pelvic organ prolapse.
Professor Jan-Paul Roovers, of the Academic Medical Center in Amsterdam, The Netherlands, summarized, “The real and perceived problems associated with non-resorbable polypropylene devices have set back the surgical treatment of female pelvic floor disorders by 20 years. As a result, many hundreds of thousands of women are being deprived of the optimal treatment of their challenging clinical problems such as stress urinary incontinence and pelvic organ prolapse. Speaking for both myself and Tepha’s global team of academic research collaborators, we are impressed and gratified that Tepha is taking on this challenge and we share the company’s optimism that the unique profile of the P4HB polymer technology can lead to a new generation of devices for our patients.”