NEW YORK, January 12 /PRNewswire-FirstCall/ -- Biocoral, Inc. announced that it has received on January 5, 2007, the final report of its prospective randomised clinical multi-center trial for treatment of hip fractures associated with bone demineralization/or low bone mass.
Osteoporosis and its bone complications including hip fractures have been, are 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.
The company French subsidiary has been put in place a randomized, double blind, clinical 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 monitored by an independent organization (Biomatech) which has been chosen directly by l'ANVAR. 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 is a unique and first in the world covering this area.
Following the presentation of the prospective report in March 2006 to the representatives of the participating hospital and clinic centres for review and comments, the additional analysis have been conducted by Biomatech which confirm the prospective report.
The final report confirms the therapeutic benefit of our product Biocoral(r) in the treatment of such fractures.
Dr Yves Cirotteau, the Scientific Advisory Board member of Biocoral, Inc. commented, "The final report confirms that when using Biocoral(r) product the fractures healing is significantly more advanced in 3 to 6 months, there is a decrease of hospitalisation time of more then 15 days and the patients return faster into their home".
Dr Yves Cirotteau further commented that, "Biocoral(R) (Natural Coral) composed of Carbonate of calcium has demonstrated its efficacy in bone repairing surgery since more than two decades. Biocoral(R) is the only natural wholly mineral bone substitute which covers actually the treatment of the fractures and bone disease associated with bone demineralization such as Osteoporotic fractures and their prevention. The final report will 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, "The final report of our randomised clinical multi-center trial reinforce the company position where the company hold the strong patents in most countries in the world covering the application of treatments of the fractures and bone disease associated with bone demineralization and confirm the evidence of the superiorities of our technology in this area. Moreover the early return of the patients to their home environment brings very significant saving cost and resources to all local and government health authorities alike. "
Nasser Nassiri, further commented that, "Our patent covering technology in this application in addition to protecting use of our Biocoral(r) product, covers also the use of any other product composed from 40 to 100 % of calcium salts. Most of the bone substitutes in the market are composed of more then 50 % of calcium salts such as hydroxyapatite (Calcium Phosphate) or TCP (Tri-Calcium Phosphate) products. The Company believes that the range of clinical orthopedics applications for this 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 patents 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(r), 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(r) is derived from three particular species of coral naturally present in abundance. Biocoral(r) is primarily (more than 98%) comprised of calcium carbonate. Porous and resorbable, Biocoral(r) is prepared in microgranules as well as in engineered shapes according to specific indication. Due to its similarity to bone tissue, Biocoral(r) is compatible, resorbed by the body as new bone growth invades the Biocoral(r) 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(r) 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(r) 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, the Company owns approximately 166 patents which have thus far been granted by various countries by their official government patent office, including most European Community countries, Canada, Australia, Japan and in the United States by the US Department of Commerce Patent and Trademark Office. In addition, the Company owns more than 53 patents applications pending around the world.
The information contained in this press release contains certain statements that are "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, as amended. These forward looking statements include statements about Biocoral, Inc. managements' future expectations, beliefs, goals, plans or prospects that are based on current expectations, estimates, forecasts and projections about Biocoral, Inc., as well as Biocoral, Inc.'s future performance and the industries in which Biocoral, Inc. operates, in addition to managements' assumptions. Words such as "expects," "anticipates," "targets," "goals," "projects," "intends," "plans," "believes," "seeks," "estimates," variations of such words and similar expressions are intended to identify such forward-looking statements which are not statements of historical facts. These forward-looking statements are not guarantees of future performance and involve certain risks, uncertainties and assumptions that are difficult to assess. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in such forward-looking statements. The information contained in this press release, including any forward-looking statements, should be reviewed in conjunction with the Company's most recent Annual Report on Form 10-K and Company's quarterly reports on Form 10-Q 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. Except as required under the US federal securities laws and the rules and regulations of the US Securities and Exchange Commission, Biocoral, Inc., disclaims any intention or obligation to update any forward-looking statements.
Contact: Biocoral, Inc., Nasser Nassiri, +33-1-4757-9843
More info: www.osteoporosis-surgery.com