Hadasit, Yissum license innovative regenerative membrane implant to RegeneCure

Yissum Research Development Company Ltd., the technology transfer company of the Hebrew University of Jerusalem, and Hadasit Medical Research Services & Development Ltd., the technology transfer company of the Hadassah University Medical Center, today announced that they have licensed innovative regenerative membrane implant technology to RegeneCure, which will further develop and commercialize the technology for bone tissue engineering for applications in trauma, spine, and reconstructive cranial and facial orthopedics. 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.

Under the terms of the agreement, RegeneCure has received the worldwide exclusive right to develop and commercialize the technology. In return, Yissum and Hadasit will receive license fees, milestones and royalty payments from future sales of the final product.

The membrane implant has a microporous surface that facilitates adherence of bone stem cells (MSCs) recruited to the injured site through a signaling mechanism known as chemotaxis. The membrane optimizes proliferation and differentiation of the MSCs into bone tissue in the area of need. In addition, the membrane implant serves as an effective barrier that does not allow scar tissue to infiltrate into the fracture and slow down the regenerative healing process. 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. In contrast, RegeneCure's MSC scaffolding method improves natural bone healing due to the ability of the tubular implant to attract bone stem cells, enhance their proliferation and rapidly form new bone tissue.

RegeneCure has successfully completed a preclinical study to determine the safety and efficacy of the implant in animal models that mimic bone loss that creates a gap in the bone as result of trauma or disease and cannot be repaired spontaneously. The study, which took place in Hadassah Medical Center in Jerusalem, compared between 3 groups: animals implanted with RegeneCure's implant, those implanted with an alternative implant and untreated animals. Eight weeks post implantation, results clearly demonstrate that the healing process of animals implanted with RegeneCure's implant is far better than the alternative implant in all healing parameters. Healing rate measured by quantity of new bone formed was higher and the bone gap was completely bridged and integrated in 100% of the cases.

The membrane implant is recognized as a medical device, enabling an expedited regulatory pathway. Pre-clinical studies in larger animals are expected to begin in May 2011, and results are expected in October 2011. This will be followed by FDA and CE submissions towards the end of 2011.

"This biocompatible and user friendly membrane implant is suited for a large range of acute and chronic spine and craniofacial conditions that are characterized by delayed or lack of bone healing due to bone deficit. The innovative membrane implant was shown to be safe and effective, resulting in a high rate of bone healing in critical size defect animal trials. Since the bone physiology of the studied animal model is highly similar to that of humans, we believe that RegeneCure's implant has an excellent potential to substitute the bone grafting treatment that is currently considered the gold standard. Our technology can thus eliminate the additional surgical procedures that are required in current treatments," said Moshe Tzabari, CEO of RegeneCure.