Advanced Medical Isotope Corporation (AMIC),  a late stage development company engaged primarily in the development of brachytherapy devices and medical isotopes for diagnostic and therapeutic applications, has filed a de novo submission (Evaluation of Automatic Class III  Designation) with the Food and Drug Administration (FDA) for marketing clearance for its patented Y-90 RadioGel device pursuant to Section 513(f)(2) of the US Food, Drug and Cosmetic Act (the "Act").

In February 2014, the FDA rejected the company's request for marketing clearance for the same device under Section 510(k) of the Act.  The FDA determined that the device was not substantially equivalent, concluding that the device is classified by statute as a Class III medical device, unless the device is reclassified.

By filing the de novo submission, the company is seeking reclassification of the product to Class II.  The FDA has 120 days in which to make a decision, though the period will be extended for any time AMIC requires to respond to FDA requests for additional information.  If the de novo submission is granted, the device may be immediately marketed in the United States, though the company would have to secure funding and commercial arrangements before marketing could commence.  If the de novo submission is declined, the company will explore steps toward seeking approval for the device as a Class III medical device.  Generally, the time period and cost of seeking approval as a Class III medical device is materially greater than the time period and cost of seeking approval as a Class II medical device.

The company's ability to pursue regulatory approvals and ultimately to commercialize this device, or its other products, is dependent upon the company's securing additional funding.  The recent decline in the company's share price, the FDA's rejection of the company's request for marketing clearance through the 510(k) process for the Y-90 RadioGel device, a reduction of the company's level of activities arising from a lack of funds, the company's outstanding debt, payables and conversion features of its debt have made it more difficult for the company to secure capital.  Nonetheless, the company continues its efforts to address the foregoing weaknesses, to seek capital and to reduce its debt and payables.