KENNEWICK, Wash., Nov. 3, 2013 (GLOBE NEWSWIRE) -- Advanced Medical Isotope Corporation ("AMIC") (OTCBB:ADMD), a company engaged in the development, production and distribution of medical isotopes, today announced that it has filed pre-market notification to the FDA pursuant to Section 510(k) of the U.S. Food, Drug and Cosmetic Act for its Yttrium-90 RadioGel™ patented brachytherapy cancer product.
Pursuant to Section 510(k), the FDA has 90 days in which to clear the device for commercial distribution or to seek additional information. The FDA previously confirmed that it would review the product as a medical device. Following notification of FDA clearance, the Company would immediately have the right to commence manufacturing, marketing and sales of the product in the United States and its possessions subject to FDA jurisdiction.
The Company intends to file FDA pre-market notifications for two related Yttrium-90 "Y-90" brachytherapy products promptly after receiving either clearance from the FDA for the Y-90 RadioGel™ device, or any comments from the FDA to its application.
Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area. Annual sales of brachytherapy products exceed $1 billion, about half of which are in the United States. Among the cancers for which brachytherapy is often selected as a treatment are prostate, liver, breast, head and neck cancerous tumors. AMIC's products may also offer treatment options for certain pancreatic cancers.
In the United States, annual sales of brachytherapy products for prostate cancer exceed $160 million. Once it receives FDA clearance, AMIC intends to begin marketing efforts in the United States for its Y-90 RadioGel™ device with a focus on prostate cancer. Thereafter, AMIC intends to offer the device for other cancers. In addition, AMIC intends to seek opportunities to license its products for worldwide sales. Sales outside of the United States will be subject to the applicable local regulatory approvals.
Based on comparisons of the indications for use, design, materials, and functionality, AMIC believes the Y-90 RadioGel™ brachytherapy device is substantially equivalent to predicate devices previously granted clearance by the FDA, as referenced in the 510(k) application. The discussion in this press release is subject to the more complete disclosures and analyses set forth in its 510(k) application.
The composition and uses of AMIC's brachytherapy products are protected by a series of exclusive patent licenses from the Battelle Memorial Institute and the University of Utah.
The three Y-90 brachytherapy devices developed by AMIC are:
•Y-90RadioGel™ – combined insoluble Y-90 microspheres and a polymer carrier that is injected directly into the tumor;•Y-90 Fast-Resorbable Polymer Seeds – intended as a safer, more effective and less expensive alternative to existing metal and glass seeds used in other brachytherapy devices;•Y-90 Polymer Topical Paste – intended as a supplemental treatment to be applied into a surgical incision to kill residual tumor cells.