NEW YORK, January 31 /PRNewswire-FirstCall/ -- Biocoral, Inc. (OTCBB: BCRA) announced today that recently the European Patent Office (EPO) approved and granted a company patent called process for preparing a fibrin glue capable of coagulating by addition of calcium ions.
The EPO, after almost seven years of examining of the company's application, granted the patent innovation to Bio Holdings International Ltd., the Company's wholly owned subsidiary, under the patent number 0850650. The Patent will expire in 2017.
The European Patent Office is a European official agency which grants European patents for the contracting states to the European Patent Convention (EPC), which was signed in Munich on 5 October 1973 and entered into force on 7 October 1977. It is the executive arm of the European Patent Organisation, an intergovernmental body set up under the EPC, whose members are the EPC contracting states. The activities of the EPO are supervised by the Organisation's Administrative Council, composed of delegates from the contracting states. France, United Kingdom, Germany, Austria, Switzerland, Italy and Belgium are already part of thirty contracting states with EPO. A number of other countries are expected to become members of EPO in due course.
The present invention provides a method for preparing a fibrin glue, comprising fibrinogen and at least one coagulation factor, which in aqueous solution, does not coagulate spontaneously for at least one hour at a temperature of 20 degrees C., and which is able to coagulate in less than 5 minutes by adding calcium ions. The method of preparation is providing the separating a liquid phase from a suspended solid phase in a biological fluid, for example, in the separation of a blood plasma cryoprecipitate "Filtration of Cryoprecipitate". The cryoprecipitate includes substances which are of therapeutic interest, such as clotting factor VIII or the proteins and in particular fibrinogen, fibronectin and factor VIII. Factor VIII is used in the treatment of haemophilia type A.
The method of preparation Company's fibrin glue "biological autologous surgical glue" is using a proprietary single use device which is also patented by the company that assures the purity of the product, further protecting the patient from any complications. The method of preparation Company's biological autologous surgical glue is by using the patient's own blood, in a closed system, eliminating immunologic problems and the risk of blood-borne disease transmission such as, for example, HIV and hepatitis. In contrast, all surgical glues currently on the market (whether autologous or homologous) require foreign proteins such as thrombin or antifibrinolitic agents. The Company's biological autologous surgical glue has more complete clotting and platelet factors than large plasma pools derived surgical glues, and by closely reconstituting naturally occurring events during repair, the adhesive yields superior treatment of tissue defects.
The Company's biological autologous surgical glue's superiority is further enhanced by its growth factors. These biological agents have been shown to speed tissue regeneration, thereby decreasing the recovery period after surgery. These advantages include enhanced plastic surgery results and improved graft take, notably in connection with the use of Biocoral(R) implants.
Nasser Nassiri, the Chairman and Chief Executive Officer of Biocoral, Inc. commented that, "The European Patent was filed in 1997 and was in examination for almost seven years before being granted and as no opposition was formulated against our patent, it is thus now definitively granted and protects the company technology in 17 European countries including France, Germany, United Kingdom, Italy, Switzerland and others. In addition our patent applications have already been granted and issued by the official government patent offices in, Australia, Mexico and in the United States by the US Department of Commerce Patent and Trademark Office." The grant of this Patent will complete the protection of Company's biological autologous glue technology in Europe where the European patent protecting the device allowing this preparation is also granted.
Nasser Nassiri further commented that, "Clinical trials have been done especially for skin replacement and skin grafts eliminating the need for protein based skin grafts. In its use to date in European trials, the Biological autologous surgical glue has been shown to be clinically safe and effective. The Company plans to continue with its clinical trials to examine the use of the biological autologous surgical glue for cosmetic applications, utilizing respected plastic surgeons in Europe and the United States."
Biocoral, Inc., a Delaware corporation, is an international biomaterials "tissue-engineering" company specializing in the research and development of proprietary health care patented high technology and biomaterials. 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 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"), coral block-bone cells, 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 185 patent applications around the world, and approximately 160 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-KSB 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.