OSTEOPROSIS APPLICATION OF BIOCORAL®
Osteoporosis applicationsThe Company has developed several variants of its Biocoral® technology aimed at treatment of bone disease associated to bone demineralisation and or low bone masse (osteoporotic fractures and theirs prevention).
Osteoporosis is characterized by a decreased bone mass per unit volume, coupled with a structural weakening of the bone tissue. Biocoral® offers an ideal method of preventing bone fractures caused by osteoporosis. It has the ability to help the skeletal system, reinforcing it where it is weak and fragile.
Biocoral® can see to both the healing of bones that are already fractured and to the prevention of bone fractures from occurring. The number of individuals stricken with osteoporosis is growing steadily with the aging of the world's population.
Following the successful preliminary clinical trials (from 1994 to 1998) conducted by our French subsidiary (one of the pioneers in the bone substitute technology), it has put in place a randomized, double blind, multicenter trial with collaboration of the French government agency "National Agency for Valorization of Research" (l'ANVAR), known currently as (OSEO) in the 14 hospital Centers "Military and Civil" in Europe. Starting in 2000, it has been covering 123 elderly persons suffering from hip fractures associated with natural bone demineralization and principally originating from Osteoporotic fractures. The Company believes that the study was unique and first in the world covering this area.
The study was monitored by an independent organization called Biomatech located in France which has been chosen directly by OSEO. Following the presentation in March 2006 of the prospective report for review and comments to hospitals which participated in this study the Company received the final report produced by independent monitoring and an independently directed investigation. The final report confirms the therapeutic benefit of our product Biocoral in the treatment of such fractures which will permit better patient recovery, allowing patients faster mobility and return to a healthy state with a very low risk of refracture. The Company believes that the study is a unique and first in the world covering this area.
It is proved and confirmed that Biocoral® permits the body of even old persons to remake a new bone which consequently helps to quickly repair fractures caused by osteoporosis.
Summary of the study
Prevention of fracture
Biocoral® can also serve to prevent bone fractures caused by osteoporosis. It has the ability to help the skeletal system, reinforcing it where it is weak and fragil
Osteodensimetry of the femoral neck before Biocoral® graft
The osteodensimetry is normal for this range of age
1 week postoperative radiography.
The Biocoral® spheres are placed in the femoral neck
Osteodensimetry of the femoral neck 18 months after the Biocoral® graft
The Bone is regenerated and reinforced due