KENNEWICK, Wash.--(BUSINESS WIRE)--Advanced Medical Isotope Corporation ("AMIC") (OTC: ADMD), a late stage development company engaged in the development of brachytherapy devices for therapeutic applications, today announced its progress in seeking FDA clearance for marketing of its lead product, the Y-90 RadioGel™ device.
CEO Jim Katzaroff and the lead scientific and medical advisory team from AMIC met at the FDA offices last week to discuss next steps, expectations and required testing to progress towards obtaining marketing clearance for the Y-90 RadioGel™ device. The FDA and AMIC team are working closely in order to obtain all appropriate data and benchmarks the FDA requires in order to proceed with providing final clearance for marketing the device in the United States. AMIC intends to seek classification and clearance as a class II medical device through a de novo application.
In August, AMIC announced a partnership with IsoTherapeutics Group, a third-party radiopharmaceutical R&D company, to provide commercialization support and conduct additional studies as requested by the FDA for the Y-90 RadioGel™ device. AMIC is pleased to announce that IsoTherapeutics has completed the first stage of the project, comprised of tech transfer, manufacturing and in vitro testing. The next stage, comprised of additional in vitro and in vivo testing, commenced last Friday.
James C. Katzaroff, CEO of AMIC, stated: “We are pleased by the progress made thus far with both the FDA and our ongoing product development with IsoTherapeutics. After completing the first stage of product development with IsoTherapeutics ahead of schedule, we met with the FDA along with Dr. Darrell Fisher from our Medical Advisory Board, and we’re confident that we have clarity on the FDA expectations which are critical to generating a complete data package for our next FDA submission.”
The Y-90 RadioGel™ device is one of several Y-90 brachytherapy products in development by AMIC that may provide a safer, quicker and less expensive treatment to certain cancers, including tumors deemed inoperable. According to Global Industry Analysts, by 2016 the U.S. brachytherapy market will reach $2 billion. It is estimated that the U.S. market represents approximately half of the global market. AMIC believes there are significant opportunities in prostate, breast, liver, pancreatic, head and neck cancers with its Y-90 product suite. A new study published in the British Journal of Cancer claims 1 in 2 men and women will be diagnosed with a cancer at some point in their lives. AMIC's mission employs in vivo delivery systems to aid medical practitioners and medical researchers in the treatment of diseases such as cancer, and the Y-90 brachytherapy products show excellent promise for this purpose.
About Advanced Medical Isotope Corporation
Advanced Medical Isotope Corporation (ADMD) is a late stage development company engaged in the development of brachytherapy devices for therapeutic applications. AMIC's focus is on transitioning to full operations upon receipt of FDA clearance for its patented brachytherapy cancer products. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area. The Company intends to outsource material aspects of manufacturing, distribution, sales and marketing for its products in the United States and to enter into licensing arrangements outside of the United States, though the Company will evaluate its alternatives before finalizing its plans. For more information, please visit our website, www.isotopeworld.com.
About IsoTherapeutics Group, LLC
IsoTherapeutics Group is a radiopharmaceutical company that provides research and development services, including animal studies and early stage manufacturing for the purpose of aiding customers and collaborators in the development of radionuclide-based drug and device products. Additionally, IsoTherapeutics is developing its own technologies, including CycloSam® Sm-153-DOTMP for the treatment of primary and metastatic bone cancer. Current collaborators include Molecular Imaging, PerkinElmer, MD Anderson Cancer Center, University of Missouri-Columbia, Excel Diagnostics and Valco Instruments. The Company scientists, while formerly employed at The Dow Chemical Company, developed the commercial products QUADRAMET® and Iotrex®.
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, AMIC's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners and customers; general economic and business conditions; effects of continued geopolitical unrest and regional conflicts; competition; changes in technology and methods of marketing; delays in completing various engineering and manufacturing programs; changes in customer order patterns; changes in product mix; continued success in technical advances and delivering technological innovations; shortages in components; production delays due to performance quality issues with outsourced components; regulatory requirements and the ability to meet them; government agency rules and changes; and various other factors beyond the Company's control.
