RegeneCure's Membrane Implant Shows 40% Accelerated Healing Time of Severe Bone Fractures in Pet Clinical Study
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|Tuesday, 12 March 2013 09:00 (UTC + 1)|
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.
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.
Dr. Harry Langbeheim