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AMIC files de novo submission with US FDA for Y-90 RadioGel device

Kennewick, Washington
Monday, December 29, 2014, 12:00 Hrs [IST]


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.

Some more good info:
https://seekingalpha.com/filing/3843389[url]

https://seekingalpha.com/filing/3761789

Advanced Medical Isotope Corporation Provides Commercialization and Strategic Plan Update

KENNEWICK, WA / Investors Hub / June 24, 2015 / Advanced Medical Isotope Corporation ("AMIC") (ADMD), a late stage development company engaged in the development of brachytherapy devices for therapeutic applications, today provided an update on the Y-90 RadioGel(TM) device de novo submission to the FDA (United States Food and Drug Administration) as well as an update on financial matters.



In late December 2014, the Company provided the FDA with a de novo submission for the Y-90 RadioGel(TM) device requesting reclassification as a Class II device and marketing clearance. The Company has been notified by the FDA that it has declined the de novo request for Class II designation for the AMIC Y-90 RadioGel(TM) device and that it remains in Class III (Premarket Approval).



In the correspondence from the FDA, the FDA requested additional data be generated to evaluate the safety and effectiveness of the Y-90 RadioGel(TM) device and provided a framework for submission of a new direct de novo. As part of this process, AMIC is working with its partners to establish protocols for preclinical animal studies as suggested by the FDA. AMIC anticipates using the Pre-Submission process to meet with the FDA in the 4th quarter to review the draft protocols for the preclinical studies and to generate additional feedback in support of a new direct de novo filing seeking reclassification as a Class II device and accordingly, marketing clearance.



The Company's primary focus continues to be obtaining regulatory clearance by the FDA of the Y-90 RadioGel(TM) device. In addition, AMIC is evaluating the requirements for regulatory approval for the Y-90 RadioGel(TM) device in Europe, Canada and Asia as well as for use in the veterinary market as additional paths toward commercial use of the device.



AMIC intends to pursue an uplisting transaction as part of its financial recapitalization plan to raise the capital necessary to complete the direct de novo FDA filing for the Y-90 RadioGel(TM) device and to pursue commercialization and partnering efforts. The Company believes that its known data from previous bench and animal studies in combination with the preclinical studies that the FDA is requesting will support a Class II designation and therefore, marketing clearance. There can be no assurance regarding the outcome of the Company's regulatory, financing or commercial efforts.



CEO James C. Katzaroff stated, "We are committed to generating the data requested by the FDA to support further regulatory review as we believe that the Y-90 RadioGel(TM) device offers an innovative treatment option with a high therapeutic index to physicians and patients for certain non-resectable cancerous tumors.”