Operations to Center on Yttrium-90 Brachytherapy Products Following Anticipated Receipt of FDA Clearance of Y-90 RadioGel(TM) Brachytherapy Device
KENNEWICK, Wash., Dec. 2, 2013 (GLOBE NEWSWIRE) — Advanced Medical Isotope Corporation (“AMIC”) (ADMD), a company engaged in the development, production and distribution of medical isotopes, today announced that its Board of Directors has approved a three year business strategy focused on transitioning to full operations in 2014, following the anticipated receipt of FDA clearance for its patented brachytherapy cancer product, Yttrium-90 RadioGel(TM).
The business strategy results from the Company’s success in developing a family of three brachytherapy devices and the Company’s belief that there is: (1) strong market potential for these products in the United States and internationally, (2) the potential for attractive operating margins from the commercialization of such devices, (3) a considerably smaller capital requirement to complete the regulatory process and deploy these devices, as compared to the capital required for most of the other initiatives the Company is developing and (4) a material potential for the Company to receive advances and minimum guarantees from international licensees of these products.
The business strategy recognizes the advanced stage of development for certain other Company initiatives and prioritizes those initiatives based upon criteria, including: capital requirements and sources; market size and operating margin; competition and strength of AMIC’s intellectual property protection; probability of implementation; and support for the Company’s immediate goal of deploying its brachytherapy products upon receipt of regulatory approval and sufficient financing.
The Company’s financing efforts, allocation of resources, participation in industry events, web site and other activities will be modified to implement the priorities adopted by the Board.
AMIC To Focus on Launch of Yttrium-90 Brachytherapy Products
AMIC announced on November 3, 2013 that it filed a premarket notification with the U.S. Food and Drug Administration (FDA) pursuant to section 510(k) for a patented brachytherapy cancer treatment using the Yttrium-90 (Y-90) RadioGel(TM) device. On November 18, 2013, the FDA notified AMIC that an administrative acceptance review was conducted and the Company’s premarket notification was found to contain all of the necessary elements and information needed to proceed with the substantive review. Pursuant to Section 510(k), the FDA has until approximately February 2014 in which to clear AMIC’s Yttrium-90 RadioGelTM device for commercial distribution or to seek additional information. The FDA previously confirmed that it would review the product as a medical device. Following notification of FDA clearance, the Company would immediately have the right to commence manufacturing, marketing and sales of the product in the United States and its possessions.
The Company intends to file FDA premarket notifications for two related Yttrium-90 brachytherapy devices promptly after receiving either clearance from the FDA for the Y-90 RadioGel(TM) device, or any comments from the FDA to its application.
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. Among the cancers for which brachytherapy is often selected as a treatment are prostate, liver, breast, as well as head and neck tumors. AMIC’s products may also offer treatment options for certain pancreatic cancers. Once it receives FDA clearance, AMIC intends to begin marketing efforts in the United States for its Y-90 RadioGel(TM) device. In addition, AMIC intends to seek opportunities to license its products for worldwide sales, subject to the applicable local regulatory approvals.
The composition and uses of AMIC’s brachytherapy products are protected by a series of exclusive patent licenses from the Battelle Memorial Institute and the University of Utah.
The three Y-90 brachytherapy devices developed by AMIC are:
- Y-90 RadioGel(TM) Device — combines insoluble Y-90 microspheres and a polymer carrier that is injected directly into the tumor;
- Y-90 Fast-Resorbable Polymer Seeds — intended as a safer, more effective and less expensive alternative to existing metal and glass seeds used in other brachytherapy devices;
- Y-90 Polymer Topical Paste — intended as a supplemental treatment to be applied into a surgical incision to kill residual tumor cells.
As noted above, the 510(k) application filed by AMIC pertains only to the Y-90 RadioGel(TM) device.
AMIC’s analyses support an expectation that its brachytherapy products will achieve a higher therapeutic index than existing brachytherapy products, while reducing collateral damage to healthy tissue due to the shorter penetration distance, shorter half-life and other attributes of the device as compared to brachytherapy devices that use isotopes emitting gamma radiation. These features also reduce the risk of radiation exposure to the patient, family members and medical personnel involved in manufacturing and injecting the device. In addition, the AMIC Y-90 RadioGel(TM) device uses a biodegradable carrier with FDA approved components which leaves no metal or glass in the patient.
In the United States, the Company intends to outsource material aspects of manufacturing, distribution, sales and marketing. Outside of the United States, the Company intends generally to enter into licensing arrangements. The Company will evaluate its alternatives before finalizing its plans.
AMIC also to Expand Sales Capability and Consider Acquisition of German Company
The Board approved of two secondary priorities for 2014 and 2015:
- Expansion of the Company’s sales agency activities for isotopes and related equipment manufactured by third parties. This activity requires very little capital, facilitates the Company’s interaction with potential partners, customers and vendors and should be immediately cash positive. In the third quarter of 2013, the Company derived approximately $115,000 from such activities. By expanding this activity, the Company expects to be able to raise less capital through the sale of securities, thereby reducing dilution for shareholders. Profits from sales agency activities also could help create greater shareholder value, particularly if the Company is valued based upon its core brachytherapy business.
- Potential acquisition of a controlling interest in a specific company headquartered in Germany with which AMIC has been cooperating for the last few years. Acquisition of a controlling interest in this company could facilitate the Company’s business progress in Germany and other European markets. Germany accounts for the largest market share of the European nuclear medicine market, which is the world’s second-largest market for nuclear medicine, after the United States. The target company presently derives less than 1% of its sales in the United States. AMIC believes it could contribute to a significant increase in U.S. sales for this target company.
Although the parties have reached an agreement in principle on a path forward, any transaction would be subject to reaching definitive agreements, AMIC obtaining sufficient financing and any required regulatory approvals. Because the target company is fully-operational and profitable, a business combination likely would be immediately accretive for AMIC shareholders.
The Board’s business strategy also contemplates that the Company will continue operation of its linear accelerator located in Kennewick, consider building a larger cyclotron production facility in Southern California in partnership with a major medical facility and continue its research and development activities for other isotopes and technologies, though the pace of all activities will be subject to the needs and performance of the Company’s strategic priorities, particularly the successful launch and growth of the brachytherapy products.
AMIC’s Financial Requirements and Prospects
Over the next year, the Company anticipates a requirement of about $1.5 million to maintain current operating activities and from approximately $2 million to $5 million to fund: (1) the FDA approval process and initial deployment of the brachytherapy products, and (2) a sales capability for third party isotopes and equipment. The continued deployment of the brachytherapy products would require additional spending. The principal variable in the amount of near-term spending for the brachytherapy products will be the nature of the Company’s arrangements with third parties for manufacturing, sales, distribution and licensing of those products.
The acquisition of a controlling interest in the German company likely would require up to approximately $3 million of cash and stock. Following its acquisition, the target company should operate on a cash positive basis. In allocating its capital between the brachytherapy products and the potential acquisition, the Company’s first priority is the FDA clearance for, and successful roll-out of, the brachytherapy products. The Company believes that its acquisition of a controlling interest in the German target company would help achieve that goal in Europe and Russia.
The Company anticipates funding the initial six months of its requirements for brachytherapy, sales agency activities and potentially the acquisition of a controlling interest in the German company through the sale of equity or equity-linked securities. In support of these efforts, the Company has reached an agreement in principle with the Company’s largest creditors to convert most of their debt into equity concurrent with the Company’s receipt of funds on pricing comparable to that obtained in any such financings.
Thereafter, the Company anticipates that funding also would be provided by the Company’s business activities, including, potentially, advances from foreign licensees for the brachytherapy products and proceeds from the sales agency activities and the Company’s linear accelerator in Kennewick.
There can be no assurance regarding the outcome of the Company’s regulatory, financing or commercial efforts. If some of the anticipated results are delayed or do not occur, the Company’s anticipated spending and capability to fund that spending would decline. Conversely, if the Company has the financial capacity to do so, the Company could spend additional sums to grow its businesses more rapidly and to maintain or accelerate research and development activities for future products and technologies.
Though there are many uncertainties, if the FDA provides clearance for the RadioGel(TM) device during the first half of 2014, the Company believes that its operations could turn cash-positive within four to nine months thereafter and could turn profitable on a GAAP-basis within six to 12 months after clearance is obtained, in each instance despite increased spending to support the deployment.
To bolster its capability to seek funding and to structure and negotiate outsourcing and licensing agreements, in October 2013, the Board elected Kenin M. Spivak to be a Director and Vice-Chairman. Mr. Spivak has extensive experience securing, structuring and negotiating complex transactions, including financings, manufacturing, sales, marketing, distribution, licensing, joint ventures and business combinations and directing roll-outs for a range of technologies, products and services. Though Mr. Spivak will not be a full-time Company officer or direct the Company’s roll-out of its brachytherapy products, the Company believes that Mr. Spivak’s advice and support will materially benefit the Company’s effort.
If the Company obtains the financing it seeks, the Company anticipates that it will be able to employ more of its part-time scientists on a full-time basis and that it will be able to engage marketing professionals with experience directly pertinent to its brachytherapy products.
AMIC’s Longer-Term Business Strategy
The business strategy adopted by the Board mandates that the Company’s first priority after 2015 would continue to be the deployment of its brachytherapy devices. Second, the Company would continue to nurture and grow the other business activities undertaken in 2014 and 2015. Subject to the success of the Company’s business and the availability of sufficient resources, by 2016, the Board has directed that the Company take steps toward the commercialization of other isotopes, businesses and technologies intended to help improve the diagnosis and treatment of cancer and other illnesses.
Among those longer-term projects being considered by the Company are potential solutions for the impending severe shortages of Molybendum-99 and its derivative product Technetium-99m, the most widely used isotopes for diagnostic purposes.
AMIC Founder, Chairman and CEO James C. Katzaroff commented: “The business strategy mandated by the Board is intended to focus AMIC on smoothly and profitably transitioning from a development-stage company into an operating company with a series of products that will help improve lives, can be commercially introduced with limited capital requirements and can reach positive cash flow and profits within a reasonable period after we receive clearance from the FDA.”
Mr. Katzaroff added: “Though AMIC will continue to progress our growth as a sales agency and will continue discussions for a possible acquisition in Europe, we will do so in support of our core mission to obtain FDA clearance and funding for our RadioGel(TM) device and other brachytherapy products so that we can commercially roll out these products commencing in 2014. We also will continue discussions for a cyclotron production facility and development of other products and technologies. However, the resources allocated to all AMIC activities will now be assessed against the impact on a successful deployment of our brachytherapy products and using that deployment to deliver therapeutic value to patients and financial value for our shareholders.”
About Advanced Medical Isotope Corporation
Advanced Medical Isotope Corporation (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 expected FDA clearance for its patented brachytherapy cancer product, Yttrium-90 RadioGel(TM). AMIC intends to file FDA premarket notifications for two related Yttrium-90 brachytherapy 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.
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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.
Advanced Medical Isotope Corporation
James C. Katzaroff
6208 W. Okanogan Ave.
Kennewick, WA 99336