News | January 08, 2016

Advanced Medical Isotope Corp. Progressing Toward FDA Y-90 RadioGel Device Clearance

Company will seek class II medical device classification from FDA pending additional in vitro testing

January 8, 2016 — In November, Advanced Medical Isotope Corp. (AMIC) announced its progress in seeking U.S. Food and Drug Administration (FDA) clearance for marketing of its lead product, the Y-90 RadioGel brachytherapy device.

CEO Jim Katzaroff and the lead scientific and medical advisory team from AMIC met at the FDA offices 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 research and development company, to provide commercialization support and conduct additional studies as requested by the FDA for the Y-90 RadioGel device. AMIC announced 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 shortly after.

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.

For more information: www.isotopeworld.com

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