RICHLAND, WA, Nov. 17, 2017 — Advanced Medical Isotope Corporation (OTC PINK: ADMD), a late-stage radiation oncology-focused medical device company, is initially focusing its animal therapy development efforts on canine soft-tissue sarcomas and feline sarcomas; which the Company believes will establish a short-term pathway to market for its RadioGel™ product in the veterinary services industry. Once these therapies are effectively commercialized, the Company plans to expand its efforts into the treatment of other animal cancers.
Mike Korenko, CEO of ADMD, stated, “Our focused strategy will optimize the use of our precious investor dollars and allow us to enter the private clinical market prior to completing the animal testing on the wider variety of cancers. As an added benefit, this same data we generate from our initial animal studies will also be used to fulfill part of the requirement for our human pre-clinical testing.”In September 2017, the Company filed a request for device product classification from the Center for Veterinary Medicine (CVM), a division of the US Food and Drug Administration (FDA). The Company’s legal team at Hogan Lovells, a top multi-national law firm, is helping to respond to comments received from the CVM, and management believes ultimately RadioGel will receive device classification.Animal testing of RadioGel is underway at the University of Missouri. RadioGel therapy has completed the university’s Internal Safety Review and the detailed test plan is being reviewed by the Principal Investigator. Because this testing will be used for the pre-clinical testing for application in humans, the test package will also be sent for final review by the human side of the FDA. Therapy treatment on animals will begin as soon as final comments are received from the FDA. This testing now has a dual benefit and is a critical path for both the veterinary and human markets.After canine therapy testing is complete, the University of Missouri will shift its focus to equine sarcoids as the next animal indication for use. In addition, the University of California at Davis will use RadioGel to demonstrate advanced therapies, such as treating prostate cancer.“We previously announced our efforts to develop relationships with consortiums of private clinics as the most effective way to expedite our roll-out,” commented Korenko. “Through these discussions, it was clear that publishing our results with the Veterinary Cancer Society (VCS) would provide significant benefit. To that end, the first poster on RadioGel was presented at the VCS annual meeting in late October.”At the meeting, held in Portland on October 26-28, Tomoko Takahashi of Nihon University in Japan delivered the first presentation on RadioGel. Takahashi also expressed interest in using RadioGel upon her return to Japan next year, which should benefit the Company’s strategy to obtain international licensing.During the VCS annual meeting, ADMD personnel met with Phillip Bergman, DVM, MS, PhD., the Director of Clinical Trials for VCA. Dr. Bergman expressed enthusiasm for RadioGel as a novel product that could be used to improve access to radiation therapy beyond the 12 veterinary centers that currently provide traditional radiation therapy treatments. He also emphasized the benefit to patients, owners, and vets of the “once and done” aspect of a RadioGel treatment versus the typical courses of radiation therapy or chemotherapy that require several weeks and multiple exams by the veterinarian.Dr. Bergman is a former President of VCS and observed several new product launches over the years. He understands the pitfalls that new products may experience and emphasized the importance of garnering the support of key opinion leaders to drive the adoption of a new product in the marketplace. His support will be key to gaining inroads within the veterinary market for a variety of indications for use.“We believe we’re in a strong position to execute,” concluded Korenko. “As we move forward with this focused strategy, multiple milestones can be achieved in the near-term, setting the stage for sustainable, long-term growth.”About Advanced Medical Isotope Corporation (OTC: ADMD)The strategic market sector of ADMD is isotope applications. Currently, the Company is engaged in the development of RadioGel™, an Yttrium-90 based brachytherapy device, for the treatment of tumors. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside the treatment area.The company is engaging the FDA for permission to use RadioGel™ for the treatment of advanced basal and squamous cell skin cancers. The IsoPet Solutions division of ADMD is focused on demonstrating the safety and therapeutic effectiveness for different animal cancers in four different university veterinary hospitals. ADMD is positioning itself so that after this demonstration phase, The Company can begin to generate revenues through the sale of RadioGel™ to private animal clinics.The Company currently is outsourcing material aspects of manufacturing of its product in the United States and intends to enter into licensing arrangements outside of the United States for the manufacturing and distribution of RadioGelTM in other countries.About RadioGel™ RadioGel™ is a hydrogel liquid containing tiny Yttrium-90 phosphate particles to be injected into a tumor. This hydrogel is a liquid at temperatures below body temperature but begins to gel, harden, upon injection as the temperature increases to normal body temperature, thereby locking the particles in place. The particles emit a very high concentrated and contained beta irradiation to kill the tumor. The beta radiation has a short penetration distance so there is minimal collateral damage to healthy tissues outside of the injected area.RadioGel™ also has a short half-life – delivering more than 90% of its therapeutic radiation within 10 days. This compares favorably to other available treatment options requiring up to 6 weeks or more to deliver a full course of radiation therapy. This is an outpatient treatment much safer to the personnel treating the patient than competing brands and the patient can go home immediately with no risk to family members.Safe Harbor StatementThis 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, the Company'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
Michael K. Korenko, President & CEO
We have changed our email and website to reflect our focus on RadioGelTM.
Please visit our website: www.radiogel.com and a direct link to recent presentations and interviews at https://www.redchip.com/company/Biotech/ADMD/376/admd.
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