Advanced Medical Isotope (AMIC), a developer of medical isotopes, has filed 510(k) pre-market notification to the US Food and Drug Administration (FDA) approval for its Yttrium-90 RadioGel brachytherapy cancer product.
In accordance to the Section 510(k), the FDA has a period of 90 days either to approve the device for commercial distribution or to seek additional information.
Earlier, the FDA confirmed that it would review the product as a medical device.
The company proposes to file FDA pre-market notifications for two related Yttrium-90 ‘Y-90’ brachytherapy products after receiving either approval or any comments from the FDA regarding the application.
After receiving the FDA approval, AMIC proposes to begin marketing efforts in the US for its Y-90 RadioGel(TM) device initially for prostate cancer and later other cancers.
The company also intends to seek opportunities to license its products for worldwide sales.
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-90 RadioGel, Y-90 Fast-Resorbable Polymer Seeds and Y-90 Polymer Topical Paste.
Y-90 RadioGel is a combined insoluble Y-90 microspheres and a polymer carrier that is injected directly into the tumor.
Y-90 Fast-Resorbable Polymer Seeds is intended as an alternative to existing metal and glass seeds used in other brachytherapy devices.
Y-90 Polymer Topical Paste is intended as a supplemental treatment to be applied into a surgical incision to kill residual tumor cells.
Using a biodegradable carrier and the FDA approved components, the AMIC Y-90 RadioGel device will not leave metal or glass in the patient.
AMIC CEO Jim Katzaroff noted once the company receives clearance from the FDA for its Y-90 RadioGel brachytherapy device, it will commence operations with a product that will help save lives and that the company believes offers therapeutic benefits, reduced risk of radiation exposure for healthy tissue and a lower cost of manufacturing.
"The introduction of these products would begin a new era for AMIC," Katzaroff added.
The company will seek to outsource material aspects of manufacturing, distribution, sales and marketing initially in the US and later in the other countries.