Healthcare Industry News: Hydroxyapatite
News Release - April 20, 2006
Biocoral, Inc. Presentation of Prospective Report of its Randomized Clinical Multi-Trial for Treatment of Hip Fracture Associated With Natural Bone DemineralizationNEW YORK, April 20 (HSMN NewsFeed) -- Biocoral, Inc. (OTCBB: BCRA ) announced that it has recently presented the prospective report of its clinical trial for treatment of hip fractures associated with bone demineralization.
Osteoporosis and its bone complications including hip fractures have been and will be in the future a public health problem for the major economies for the world. Because of the increased life expectancy of the population, each family had, has or will have a grandparent or close relative, fall victim to what the public health authorities do not hesitate to call as a plague.
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, multi-center trial with collaboration of the French government agency "National Agency for Valorization of Research" (l'ANVAR) 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 l'ANVAR. The prospective report was presented for review and comments in March 2006 at a symposium organized by the company at the Concorde Lafayette Hotel in Paris, which representatives from most hospitals which participated in this study attended. The prospective report provided the final results and conclusions produced by independent monitoring and an independently directed investigation.
This study has confirmed the therapeutic benefit of our product Biocoral® in the treatment of such fractures.
In addition, during this symposium, The Company presented its technology under patented application for the prevention of low bone mass and Osteoporotic fractures. The Company believe that for the first time, patients who already have osteoporosis or had already suffered from osteoporotic fracture will be able to be treated before either refracture or the occurrence of fractures in other locations. The Company's product in this application is intended to permit the regeneration of newly formed bone in the area which is susceptible to osteoporosis and has a low bone mass. The initial human clinical study has now demonstrated and confirmed the result of regeneration of newly formed bone in the bone mass area.
Dr Yves Cirotteau, the Scientific Advisory Board member of Biocoral, Inc. commented, "Biocoral® (Natural Coral) composed of Carbonate of calcium has demonstrated its efficacy in bone repairing surgery since more than two decades. The French scientists have been the first working on the use of natural coral (Biocoral®) composed of calcium carbonate in the treatment of bone disease associated with bone demineralization such a Osteoporotic fractures and their prevention. We have awaited the results of this particular clinical trial to confirm our preliminary clinical trials which will now allow us to share the benefit of this technology with the rest of the society.
Nasser Nassiri, the Chairman and Chief Executive Officer of Biocoral, Inc. commented that, "This patented application in most countries in the World put into evidence the superiorities of our technology in this area."
Nasser Nassiri, further commented that, "Our patent covering technology in this application in addition to protecting use of our Biocoral® product, also covers any other product based on calcium salts. Most of the bone substitutes in the market are based on calcium salts such as Hydroxyapatite (calcium phosphate). The Company believes that the range of clinical orthopedics applications for the new patented application (treatment of bone diseases associated with demineralization such as osteoporosis) and "Treatment and Prevention of Osteoporotic Fractures" is wide open as the Company technology underlying this application is protected by strong issued patent in many countries around the world. Our patents in this application have thus far been granted by the official government patent offices of various countries, including 17 European Community countries, Japan, Australia and Canada and in the United States by the US Department of Commerce Patent and Trademark Office.
About Biocoral, Inc.
Biocoral, Inc., a Delaware corporation, is an international biomaterials "tissue-engineering" company specializing in the research and development of proprietary health care patented high technologies and biomaterials.
Biocoral®, the Company's primary product, is a natural coral "carbonate Calcium" derived bone graft substitute and is used by surgeons and practitioners because of its biocompatibility, resorbability, osteo conduction and safety. Certain chemical, physical and structural characteristics of coral are very similar to that of human bone tissue. Biocoral® is derived from three particular species of coral naturally present in abundance. Biocoral® is primarily (more than 98%) comprised of calcium carbonate. Porous and resorbable, Biocoral® is prepared in microgranules as well as in engineered shapes according to specific indication. Due to its similarity to bone tissue, Biocoral® is compatible, resorbed by the body as new bone growth invades the Biocoral® and is replaced by neoformed invasion. It is highly porous with numerous interconnected channels which allow a total migration to the center of the implant free of contamination risk. Because Biocoral® is resorbed, it can be combined with antimicrobials, anticancer agents or other pharmaceuticals for slow release into bone tissue, resulting in an advantage over autologous bone grafts. The principal current alternative to Biocoral® is the utilization of autologous (from the patient's own body) bone grafts. The use of autologous bone grafts requires the patient to undergo one or more additional surgeries to harvest the bone graft material. This is not always feasible due to the condition of the patient or other contraindications, and must be shaped in a separate procedure to fit the graft area.
Through its subsidiaries, the Company researches, develops, manufactures and commercializes bone graft substitutes and other high tech patented biomaterials in a number of countries outside the United States. Biocoral, Inc. through its subsidiaries has developed the additional twelve titles of patents for various applications and uses of its products, such as a method of treating a disease associated with demineralization or mineralization bone defects ("osteoporosis remediation"), and combination with growth factor, among others. With these patents titles applications in various countries in the European Community, Canada, the United States, Japan, Australia, and Switzerland, the Company owns more than 219 patent applications around the world, and approximately 166 of these have thus far been granted by various countries' official government patent offices, including most European Community countries, Canada, Australia, Japan and in the United States by the US Department of Commerce Patent and Trademark Office.
The information contained in this press release, including any "forward looking" statements within the meaning of section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 contained herein, should be reviewed in conjunction with the Company's Annual Report on Form 10-K and other publicly available information regarding the Company, copies of which are available from the Company upon request. Such publicly available information sets forth many risks and uncertainties related to the Company's business and such statements, including risks and uncertainties related thereto that are unpredictable and outside of the influence and/or control of the Company.
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