Advanced Medical Isotope (AMIC) has filed pre-market notification to the US Food and Drug Administration (FDA) pursuant to Section 510(k) of the US Food, Drug and Cosmetic Act for its Yttrium-90 RadioGel brachytherapy cancer product.
In accordance with the FDA Section 510(k), the agency has to either approve the device for commercial distribution or to seek additional information within 90 days.
The FDA previously confirmed that it would review the product as a medical device.
The company plans 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.
According to AMIC, annual sales of brachytherapy products for prostate cancer in the US exceed $160m.
Once approved by the FDA, AMIC plans to begin marketing efforts in the US for its Y-90 RadioGel(TM) device with initial focus on prostate cancer.
AMIC also plans to seek opportunities to license its products for sales worldwide. It has developed three Y-90 brachytherapy devices, including Y-90 RadioGel, Y-90 Fast-Resorbable Polymer Seeds and Y-90 Polymer Topical Paste.
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.
Y-90 RadioGel is a combined insoluble Y-90 microspheres and a polymer carrier that is injected directly into the cancer. Y-90 Fast-Resorbable Polymer Seeds is intended as an alternative to existing metal and glass seeds used in other brachytherapy devices. While Y-90 Polymer Topical Paste is intended as a supplemental treatment to be applied into a surgical incision to kill residual tumour cells.
The AMIC Y-90 RadioGel device uses a biodegradable carrier with FDA approved components, which leaves no metal or glass in the patient.
AMIC CEO Jim Katzaroff said: "Once AMIC receives clearance from the FDA for its Y-90 RadioGel brachytherapy device, we will commence operations with a product that will help save lives and that we believe 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
AMIC will seek to outsource material aspects of manufacturing, distribution, sales and marketing initially in the US and later in the other countries.