September 14, 2017 07:22 ET | Source: Advanced Medical Isotope Corporation RICHLAND, Wash., Sept. 14, 2017 (GLOBE NEWSWIRE) -- Advanced Medical Isotope Corporation ("AMI") (OTC PINK:ADMD), a late stage radiation oncology focused medical device company’s business plan is to generate initial revenues from animal therapy while pursuing FDA approval to use RadioGel™ for skin cancer in humans. The strategy is to prove the safety and effectiveness of the product via testing at four university veterinary hospitals.
Consolidation in the private veterinary clinic space enables the Company to cost-effectively form business arrangements with the large consortiums of private clinics. We met and had discussions with the Veterinary Cancer Group (VCG) and with VCA Inc. to gain firsthand information on the steps required to market RadioGel™ in the commercial sector. VCG has 55 veterinary centers feeding into three specialty clinics. VCA has 820 clinics in the US and Canada feeding into approximately 25 specialty treatment centers.
Both consortiums confirmed the importance of learning from the testing that we are sponsoring at the university veterinary centers. They encouraged us to publish the results in a scientific journal. VCG was interested in teaming with the universities by conducting some of the testing in their own facilities. They both emphasized the importance of obtaining a written confirmation from the veterinary side of the FDA that RadioGel™ is a device. After the data collection is completed the results will be sent to their internal review boards for approval. The final stage is a business contract to purchase RadioGel™ for use in their clinics.
Cancer is the leading cause of death for 32% of cats and 50% of dogs over age ten. Treating just 10% of pet cancers at an average treatment cost of $5,000 could generate $40 million in annual revenue for the Company. RadioGelTM will provide a more effective therapy that will benefit both the pets and their owners.
Getting into the field is the best way to start building the relationships and to determine precisely the steps required for implementation. We requested confirmation from the FDA Center for Veterinary Medicine (CVM) that RadioGelTM is also designated as a device for use in animals since we have been confirmed since 2013 as a device for use in humans. We anticipate completing the majority of the university testing in the 1st quarter of 2018.
About Advanced Medical Isotope Corporation (“AMI”) (OTC:ADMD)
The strategic market sector of Advanced Medical Isotope Corporation (AMI) 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 AMI is focused on demonstrating the safety and therapeutic effectiveness for different animal cancers in four different university veterinary hospitals. AMI 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 RadioGel™ 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 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, 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.
CONTACT:
Company Contact:
Advanced Medical Isotope Corporation Michael K. Korenko, President & CEO MKorenko@isotopeworld.com 509-736-4000
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