Advanced Medical Isotope Corporation Files a "de novo" Submission for Y-90 RadioGel(TM) Device

KENNEWICK, Wash., Dec. 23, 2014 /PRNewswire/ -- Advanced Medical Isotope Corporation ("AMIC") (OTCQB: ADMD), a late stage development company engaged primarily in the development of brachytherapy devices and medical isotopes for diagnostic and therapeutic applications, today announced that it has filed a de novo submission with the Food and Drug Administration ("FDA") for marketing clearance for its patented Y-90 RadioGel(TM) device pursuant to Section 513(f)(2) of the U.S. 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(TM) 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.

About Advanced Medical Isotope Corporation
Advanced Medical Isotope Corporation (OTCBB: ADMD) is a late stage development company engaged primarily in the development of brachytherapy devices and medical isotopes for diagnostic and therapeutic applications.  AMIC's focus is on transitioning to full operations upon receipt of FDA clearance for its patented brachytherapy cancer products.  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.  The Company intends to outsource material aspects of manufacturing, distribution, sales and marketing for its products in the United States and to enter into licensing arrangements outside of the United States, though the Company will evaluate its alternatives before finalizing its plans.  For more information, please visit our website, www.isotopeworld.com.

Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions.  Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated.  These risks and uncertainties include, but are not limited to, AMIC's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control.

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SOURCE Advanced Medical Isotope Corporation

Related Links

http://www.isotopeworld.com