Washington-based Advanced Medical Isotope Corp. is evaluating its options for U.S. market approval of its proprietary brachytherapy cancer product, the company announced.
AMIC learned that the FDA plans to review the company’s product as a Class III device, the highest-risk category requiring the greatest extent of medical testing and review before allowed on the U.S. market. Depending on which path looks most promising, AMIC will either move forward with a Class III application or seek down-classification to a lower-risk category, according to a company statement.
AMIC is a late-stage medical device development company focused primary on brachytherapy products, which deliver radiotherapy from inside the body by placing a radioactive source directly into or beside a tumor. The technology represents a market of more than $1 billion per year worldwide, about half of that in the U.S.
The device maker is poised to launch "full operations" as soon as it lands FDA clearance. AMIC plans to outsource major parts of its manufacturing, distribution, sales and marketing in the U.S. and to license the product overseas.