LEXINGTON, Mass., Nov. 8, 2017 /PRNewswire/ — Tepha Inc., a developer and marketer of implantable medical devices based on its proprietary P4HB™ resorbable polymer technology, announced today recent developments and R & D initiatives in the field of regenerative medicine scaffolds for the repair or replacement of compromised human tissue. Tepha is an established developer and supplier of P4HB-based resorbable mesh and suture products for plastic surgery and hernia repair. The Company’s expanded regenerative scaffold programs, all based on Tepha’s P4HB polymer technology, are targeting unmet clinical needs in such areas as structural heart disease, urogynecology, orthopedics, and plastic surgery.
Tepha has been engaged in the field of structural heart disease for its entire 20 year history. This research, in collaboration with both commercial and academic partners, has been focused on regenerative scaffolds for heart valve replacement, vascular grafts and patches, and PFO (patent foramen ovalae) occlusion. Academic research at the prestigious Boston Children’s Hospital and the Wyss Institute of Biologically Inspired Engineering, both affiliated with Harvard University, has resulted in more than 20 publications involving P4HB scaffolds for regenerative cardiovascular applications. Recent publications include: “JetValve: Rapid Manufacturing of Biohybrid Scaffolds for Biomimetic Heart Valve Replacement,” based on research at the Wyss Institute and published in the journal, Biomaterials; and “Elastomeric Fibrous Hybrid Scaffolds Supports In Vitro and In Vivo Tissue Formation“, based on research at Boston Children’s Hospital and published in the journal, Advanced Functional Materials. Participating authors of these publications include two of the original scientists exploring the potential of P4HB as a scaffold for regenerative cardiovascular devices: John E. Mayer, Jr. MD, Senior Associate in Cardiac Surgery at Boston Children’s Hospital; and Simon P. Hoerstrup, MD, Ph.D., Associate Professor at the Wyss Institute and Chair of the Institute of Regenerative Medicine, University of Zurich.
Over the past two years Tepha has also developed and implemented an integrated R&D program targeting clinical needs in the field of urogynecology, including prolapse and incontinence. The objective of the program is 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 materials. In partnership with leading academic research centers in both the United States and Europe, this program has involved benchtop and small animal screening and evaluation of several new P4HB mesh designs. One of these new mesh designs is now being tested in a large animal, functional model.
Tepha continues to be active in the field of orthopedic soft tissue repair and replacement, including tendons, ligaments, meniscus, and cartilage. The company is collaborating with a development stage company focused on a synthetic device that is designed to regenerate a functioning ligament for ACL reconstruction. This device, utilizing P4HB monofilament and multifilament fibers, is now being evaluated in a large animal, functional model. Tepha also has initiated a program to design a non-woven, regenerative scaffold for complex rhinoplasty and other reconstructive plastic surgery applications. These scaffolds are being designed to deliver bioactive agents in order to stimulate healing and regenerative processes. Tepha is conducting benchtop and small animal research with the University of Illinois at Chicago (UIC).
ABOUT TEPHA INC:
Tepha Inc., founded in 1998 and headquartered in Lexington, MA, is a supplier of medical devices focused on its proprietary P4HB polymer technology. Tepha’s products are designed and developed to elevate, support and reinforce areas of soft tissue weakness as well as to stimulate tissue healing and regenerative processes. Commercial mesh and suture products based on Tepha’s resorbable P4HB polymer technology are currently utilized in the fields of hernia repair; orthopedic soft tissue repair; general wound repair; and plastic and reconstructive surgery through Tepha’s wholly owned subsidiary, Galatea Inc. Tepha and its partners have received 23 FDA 510(k) and 5 CE Mark clearances in the United States in Europe, respectively. To date, products made from P4HB have been successfully used in more than 2,000,000 surgical procedures worldwide, and have been the subject of over 30 published clinical and scientific papers.
SOURCE Tepha Inc.