The RegenCure product, the company says, consists of a strong, flexible membrane that can be shaped into any geometrical shape to provide complete containment of the damaged bone, preventing cells and soft tissue from penetrating but allowing fluids in, a process that the company says is crucial to the healing process.
RegenCure’s membrane implants have a microporous surface that facilitates adherence of bone stem cells (MSCs) to injuries. The stem cells help the healing process along, while the membrane keeps out material that can interfere with the process. In contrast to current methods of bone repair that require grafts, said RegenCure, its solution enhances the natural healing process without the need for any outside material for many injuries.
In 2011, RegeneCure 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.
For its first commercial application, the company is developing a dental implant system that will stimulate bone development in the mouth.
A common problem for patients having a tooth replaced with a dental implant is the lack of sufficient bone volume to house the implant. As a result, there is often a need to support the implant with a bone substitute until the natural bone regenerates. The bone substitute material, in turn, needs to be held in place by a membrane, usually collagen-based, which needs to be removed afterwards, or the patient risks infection, as collagen is organic material. RegenCare’s membrane, the company said, is entirely synthetic, eliminating risk of contamination by pathogens present in animal-tissue-derived membranes.
“Pre-clinical trials have shown excellent healing, including complete restoration of the bone,” said Moshe Tzabari, CEO of RegeneCure, adding “Our technology is designed to improve and accelerate healing in a large variety of medical procedures.” The company expects to have its product ready for the dental market by the end of 2014, and hopes to enter the market of human fractures in mid-2015.