KENNEWICK, Wash., Feb. 5, 2013 (GLOBE NEWSWIRE) — Advanced Medical Isotope Corporation (“AMIC”) (OTCBB:ADMD), a company engaged in the production and distribution of medical isotopes, has submitted data on its RadioGel device to the FDA and requested a collaborative meeting.
This represents the initial step in the FDA’s pre-market review process of the RadioGel.
Based on favorable results of animal studies recently concluded at the Pacific Northwest National Laboratory (PNNL), operated by Battelle, AMIC is also submitting to the Washington State Department of Health the information required for a Sealed Source and Device (SS&D) registration, which will allow the use of the Y-90 RadioGel in hospitals and clinics to be authorized in Nuclear Regulatory Commission Agreement States.
AMIC is preparing to manufacture RadioGel in Washington State and anticipates building a new facility in Richland, Washington to include a new state-of-the-art cyclotron which will produce enough Tc99m to adequately meet the clinical needs of large urban centers.
RadioGel products allow medical personnel to deliver higher doses of radiation exactly where needed when fighting cancerous tumors that cannot be surgically removed. The treatment minimizes exposure to surrounding healthy tissues and organs. The injectable RadioGels allow for the delivery of insoluble yttrium-90, a well established medical radioisotope with many applications in cancer treatment.
James C. Katzaroff, CEO of AMIC, stated, “RadioGel will provide doctors with greater flexibility to safely direct radiation therapy to the interior of tumors, as well as to tumor margins following surgical removal. We anticipate further development of RadioGel products that will eventually be used to treat cancers of the breast, liver, kidneys, and pancreas, as well as the brain and neck.”
About Advanced Medical Isotope Corporation
Advanced Medical Isotope Corporation (AMIC) (OTCBB:ADMD) is a U.S.-based public company engaged in the production and distribution of medical isotopes and in the development and identification of medical isotope technologies that are changing the practice of medicine and revolutionizing the standard of medical care.
The Advanced Medical Isotope Corporation logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5139
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934 and Section 27A of the Securities Act of 1933, including, but not limited to, statements related to AMIC’s beliefs and expectations regarding its licensed patents. These statements involve current expectations and beliefs as to future events and other statements that are not historical facts. Known and unknown risks and uncertainties can affect the accuracy of forward-looking statements and cause actual results to differ materially from those anticipated by these forward-looking statements. Factors that could affect actual future events or results include, but are not limited to, risks relating to product development, regulatory approval, sales and marketing, and competition, risks relating to patents, and such other risks as are defined in AMIC’s annual report filed by AMIC with the U.S. Securities and Exchange Commission.
James C. Katzaroff, Chairman and CEO
6208 W. Okanogan Ave.
Kennewick, Wa. 99336