RICHLAND, WA / ACCESSWIRE / July 6, 2017 / Advanced Medical Isotope Corporation ("AMI") (the "Company) (OTC PINK: ADMD), a late stage radiation oncology focused medical device company, today announced that they have filed a request for a pre-submission meeting with the FDA.
The Company has been working for the last four months with John Smith and his team at Hogan Lovells on this important request. They are considered one of the best FDA consultants in the country.
The FDA expects a disciplined professional communication. Our meeting request document is over two hundred pages. It informs the FDA of our focused indication for use of treating basal and squamous cell skin cancers. It summarizes our production processes, the RadioGel™ therapy protocols, the relevant literature, the data from our past testing, the detailed plans for the future bench top and animal testing, and the rationale for a denovo for this device. It also addresses all the questions that arose from previous submissions. The expectation from this meeting is that the past and proposed testing is adequate to ensure the FDA views the product as safe and that they indicate that the denovo is an appropriate pre-market submission.
The most cost-effective approach is to obtain FDA feedback on our planned tests prior to initiating those tests. We have decided that the pre-clinical animal testing will be performed at Colorado State Veterinary Hospital.
"This is a significant step forward in the Company's plan that was described in the June letter submitted to the shareholders. We are executing our path forward with all sense of urgency," added President & CEO, Dr. Mike Korenko.
About Advanced Medical Isotope Corporation
The strategic market sector of Advanced Medical Isotope Corporation (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 skin cancers. The IsoPet Solutions division is focused on demonstrating the safety and therapeutic effectiveness for different animal cancers in four different university veterinary hospitals. After this demonstration phase, the plan is to sell RadioGel™ to the 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. For more information, please visit our websites: www.isopetsolutions.com and www.isotopeworld.com.
AMI is developing a brachytherapy and topical cancer treatment product called RadioGel™. It can be best described as a gel embedded with radioactive infused particles of Yttrium-90.
RadioGel™ is a hydrogel liquid containing tiny Yttrium-90 phosphate particles which may be injected into a tumor. This hydrogel liquid is maintained at a temperature below body temperature but begins to gel, harden, once it is injected into the body and as the temperature increases up to body temperature, thereby locking the particles in place. The particles emit a very high concentrated and contained beta irradiation to kill the tumor. RadioGel™ has a short penetration distance so there is minimal collateral damage outside of the injected area.
RadioGel™ also has a short half-life - after 10 days only about 5% of the radiation remains; as opposed to other available options that would 50% after 10 days. This is an outpatient treatment much safer to the personnel treating the patient than competing brands and the patient can go home immediately after with no risk to any 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.