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Sunday, September 25, 2022

What Do You Know About Advanced Medical Isotope Corp. (OTCMKTS:ADMD)

Advanced Medical Isotope Corp. (OTCMKTS:ADMD) continues to move steadily higher in recent weeks since reversing off $0.0001 lows. This is one sub penny that has been highly successful in attracting legions of shareholders who continue to bid up the price.

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.

Advanced Medical Isotope Corp. (OTCMKTS:ADMD) 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.

In December of last year ADMD announced 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.

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.

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In April the Company provided information on completion of the initial steps of the Company’s capital restructuring plan. AMIC is pleased to announce that it has reached an agreement with its primary lender, Carlton Cadwell, and his affiliated entities to convert $5 million of long term debt into a newly designated series of equity based convertible preferred stock. In addition, several other lenders have agreed to these debt conversion terms.

The Series A Convertible Preferred Stock will be convertible at a fixed price of $0.015 per share and will be treated as equity on the company’s balance sheet. The remaining debt held by the Cadwell family and associated entities totaling approximately $1 million will be exchanged for a new non-convertible 6% note that matures on December 31, 2017. These debt conversion agreements are subject to final documentation which is expected before the end of this quarter, and all will be deemed to be affiliates with appropriate lock-up agreements.

Under terms of the newly created Series A, upon completion of an up listing transaction to a national exchange, all shares of Series A stock will convert into common stock.

In addition to the elimination and exchange of the Cadwell debt referenced above, the company has also successfully eliminated approximately $500,000 of seasoned trade payables, without additional dilution of existing shareholders. It is anticipated that these items will be reflected in the company’s 2nd quarter 10-Q filing.

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Currently moving up steadily in sub penny land ADMD has minimal assets, rising short term debt and no revenues to date. But this is an exciting story developing in small caps; The Company is focused on obtaining regulatory clearance by the FDA of the Y-90 RadioGel(TM) device and working hard to restructure their debt. The Company also knows how to market itself and has quickly attracted a loyal shareholder base that believes this one goes much higher. We will be updating on ADMD when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with ADMD.

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Disclosure: we hold no position in ADMD either long or short and we have not been compensated for this article

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