Implant Sciences Corporation Receives Radioactive Sealed Source Registration Certificate for the I-Plant Iodine-125 Brachytherapy Seed.WAKEFIELD, Mass.--(BUSINESS WIRE)--Aug. 3, 1999-- Implant Sciences Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :IMPLU)(BSE See Bombay Stock Exchange. BSE See Boston Stock Exchange (BSE). :IMXU) announced today that its I-Plant(TM) radioactive Iodine-125 brachytherapy seed has been granted a sealed source registration certificate from the Commonwealth of Massachusetts, Department of Public Health, Radiation Control Program. The I-Plant seed (small encapsulated radiation sources approximately half the size of a grain of rice) is used for the primary treatment of early stage prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. and other cancers that are treated with radioactive seeds placed directly into the tumor, a procedure know as brachytherapy. The Nuclear Regulatory Commission Nuclear Regulatory Commission (NRC), an independent U.S. government commission, created by the Energy Reorganization Act of 1974 and charged with licensing and regulating civilian use of nuclear energy to protect the public and the environment. (NRC NRC abbr. 1. National Research Council 2. Nuclear Regulatory Commission Noun 1. NRC - an independent federal agency created in 1974 to license and regulate nuclear power plants ) requires all radioactive sealed sources meet required classification tests. This process is administered under the jurisdiction of the Commonwealth of Massachusetts as a NRC Agreement State. "Our I-Plant seed has met or exceeded the American National Standards Institute See ANSI. (body, standard) American National Standards Institute - (ANSI) The private, non-profit organisation (501(c)3) responsible for approving US standards in many areas, including computers and communications. ANSI is a member of ISO. (ANSI (American National Standards Institute, New York, www.ansi.org) A membership organization founded in 1918 that coordinates the development of U.S. voluntary national standards in both the private and public sectors. It is the U.S. member body to ISO and IEC. ) tests for brachytherapy devices," stated Clara Bajgar, Manager Nuclear Applications of Implant Sciences Corporation. "The State of Massachusetts has certified that the I-Plant radioactive seed is a sealed source that will maintain its containment integrity under normal conditions of use and accidental conditions that might occur." "Achieving our brachytherapy sealed source license is a historic event for our company," stated Dr. Anthony J. Armini, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Implant Sciences Corporation. "This major regulatory testing hurdle for the I-Plant seed combined with the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) granting of a 510(k) clearance in June brings us another step closer to scale up of our manufacturing facility and distribution of Implant Sciences I-Plant seed." Permanent implant of radioactive seeds for the primary treatment of prostate cancer is a relatively new technique that is rapidly gaining acceptance as a method of treating early stage tumors. The procedure involves placement of approximately 100 radioactive seeds directly into the prostate using ultrasound guidance and is usually performed on an outpatient basis with a rapid recovery. Implant Sciences Corporation, using ion implantation has developed propriety dry manufacturing process that allows radioactive seeds to be manufactured by a less hazardous method and allows distribution opportunities and economies that conventional methods of manufacturing would not allow. Implant Sciences Corporation develops products and processes for the medical device industry using ion implantation and thin film coatings of radioactive and non-radioactive materials. The company recently received FDA 510(k) clearance to market its I-PlantTM Iodine-125 radioactive seed for the treatment of prostate cancer. In addition to the I-Plant radioactive seed, the company also has under development radioactive coronary stents and interventional cardiology devices for the prevention of restenosis (reclosure of the artery after balloon angioplasty. The company currently uses its technology to apply radiopaque ra·di·o·paque adj. Relatively impenetrable by x-rays or other forms of radiation. radiopaque (rā´dēōpāk´), adj (visible by x-ray) coatings on stents, guidewires, catheters and other devices used in interventional cardiology procedures. In addition, the company modifies the surface characteristics of orthopedic joint implants to reduce polyethylene wear and thereby increasing the life of the implant. Visit our web site at www.implantsciences.com. Statements included here that are not historical facts may constitute forward-looking statements and are subject to a variety of risks and uncertainties. There are a number of factors that could cause actual results to differ materially from those expressed on any forward looking statements by the Company. |
|
||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion