KENNEWICK, WA / ACCESSWIRE / April 23, 2015 / Advanced Medical Isotope Corporation ("AMIC") (ADMD), a late stage development company engaged in the development of brachytherapy devices for therapeutic applications, today 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.
CEO James C. Katzaroff stated, "We are very grateful for the continued support and commitment of the Cadwell family and associated entities. This important step, as the company moves to normalize its capital structure and balance sheet, is in anticipation of capitalizing the company to pursue commercial opportunities for our Y-90 product line."
The Company's primary focus continues to be obtaining regulatory clearance by the FDA of the Y-90 RadioGel(TM) device. The Company is awaiting feedback from the FDA on the de novo requesting regulatory clearance to market the Y-90 RadioGel(TM) device. Previously, the FDA found the same device under Section 510(k) of the Act not substantially equivalent, and concluded that the device is classified by statute as a Class III medical device, unless the device is reclassified. By filing the de novo, the Company is seeking reclassification of the product to Class II. If the de novo is granted, the device may be immediately marketed in the United States and the company will pursue funding toward the US commercialization effort. If the de novo is declined, the Company may elect to seek additional funding to secure approval for the device as a Class III medical device in the US. Alternatively, and based on the feedback from our existing and potential investors, the Company may seek funding to pursue marketing approval for the Y-90 RadioGel™ device in Europe, Canada or Asia which could present a faster path toward commercialization.
CEO James C. Katzaroff concluded, "AMIC remains focused on the commercialization of its Y-90 brachytherapy products that have been developed to offer new solutions for cancer treatment that improve on the safety, cost and efficacy of existing treatments. A cleaner, healthier balance sheet and simplified capital structure is an important element in the Company's financing plan in support of the commercialization goals. Today's announcement on debt conversion is an important initial step in executing our strategic plan."
About Advanced Medical Isotope Corporation
Advanced Medical Isotope Corporation (ADMD) is a late stage development company engaged in the development of brachytherapy devices for 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. 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 ofmarketing, 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.
CONTACT: Advanced Medical Isotope Corporation
James C. Katzaroff
1021 N. Kellogg St.
Kennewick, WA 99336
SOURCE: Advanced Medical Isotope Corporation