Jerusalem, Israel, March 12, 2013 / B3C newswire / - RegeneCure announced today the successful results of a clinical study in pets using the company's regenerative membrane implant technology for the treatment of bone fractures. The study showed that the healing time was about 40 percent quicker than normally observed using current Standard of Care therapies. The product was also demonstrated to be safe in all of the study participants.
"The healing time for animals treated in the participating clinical study sites with injuries that normally take from five to twelve months was in many cases reduced to just eight weeks," said Dr. Michal Limor, VP Medical Affairs of RegeneCure.
The multi-center trial was conducted at leading veterinary clinics in England, Germany and Israel. The study included 35 mature dogs and cats with different bone fractures including delayed healing and non-union conditions.
"The outstanding safety and efficacy results and additional data collected from pre-clinical studies, will enable us to proceed with a human clinical study in the near future," said Moshe Tzabari, CEO of RegeneCure.
When applied to humans, RegeneCure's membrane is expected to reduce healing time in current treatment and eliminate the need of secondary surgical intervention due to failure.
Due to the membrane capabilities, it can reduce the use of bone grafting and bone graft substitutes currently used in standard procedures. RegeneCure's membrane implant is suited for a large range of fresh or delayed long bone fractures, large bone defects and craniofacial conditions that are characterized by delayed or lack of bone healing due to bone deficit. The existing US orthopedic biomaterial market used in these human conditions is over $500 million.
About RegeneCure's Technology
RegeneCure's regenerative AMCA membrane Implant is cationic and has a microporous surface that facilitates adherence of mesenchymal stem cells (MSCs) recruited to the injured site through a signaling mechanism known as chemotaxis. Due to its osteoconductive stimulation, the membrane optimizes proliferation and differentiation of the MSCs into bone tissue in the area of need. In addition, the AMCA Membrane Implant enables concentration of growth factors, cytokins and MSCs, where needed by functioning as a barrier to prevent diffusion into adjacent soft tissue.This helps promote rapid bone healing by Guided Bone Regeneration. Current methods that facilitate bone regeneration and healing of non-union fractures are based on autografts, bone transplantation from the patient's body, or else by adding bone graft substitutes that help fill the fractured gap. RegeneCure’s membrane improves natural bone healing due to the cationic characteristic of the membrane to attract stem cells, enhance their proliferation and rapidly form new bone tissue.
The AMCA membrane is thin and flexible, drill-able, and easily sutured in the treated area. It is easy to use in orthopedic surgery and requires no special surgical knowledge or special preparation prior to use.
The technology was invented by Professor Michael Friedman from the Institute of Drug Research at the Hebrew University of Jerusalem and Prof. Rami Mosheiff. M.D., Head of Orthopedic Trauma Center, Hadassah Medical Center, Jerusalem and Chairperson of AOTrauma Europe, which oversees the development of new orthopedic products and technologies in Europe.
RegeneCure Ltd. was founded in July 2010 to develop, produce and market synthetic implants for bone reconstruction and fracture fusion for the orthopedic, dental and aesthetic fields. AMCA Membrane Implant technology is protected by worldwide patents. The company submitted a 510(k) application to the FDA in April 2012 for an initial trauma indication. The privately owned company has manufacturing facilities capable of meeting the high production standards required by European and United States authorities. In 2012, the company received ISO 13485:2003 certification. RegeneCure is currently initiating a clinical study at the Academic Department Of Trauma and Orthopedic Surgery, School of Medicine, University of Leeds, UK (Prof. Peter Giannoudis) and Hadassah Medical Organization Orthopedic Surgery Department, Jerusalem Israel. Prof. Peter Giannoudis is the Chairperson of RegeneCure’s Scientific Advisory Board. For more information visit www.regenecure.co.il or www.bonecure.co.il
Dr. Harry Langbeheim
VP Business Development