RICHLAND, WA / ACCESSWIRE / September 7, 2017 / Advanced Medical Isotope Corporation ("AMI") (OTC PINK: ADMD), a late stage radiation oncology focused medical device company, submitted a 233-page request to the Food and Drug Administration (FDA) for a pre-submission meeting to review the test plans for the remaining pre-clinical testing and to request a De Novo path for its pre-market application. A De Novo path is faster and less onerous than standard Premarket Approval pathway.
The FDA was very helpful, providing 14 pages of comments prior to the meeting with further insights and clarifications during the meeting from the 12 participants. Their observations and recommendations are being incorporated in the Company's test plans. The bench top (in vitro) testing will begin late September. The detailed animal study plans will be sent back to the FDA for a final review. It is important that the FDA agrees with the plans before they are conducted to increase the probability that the data will be accepted as adequate to allow the first clinical studies of Y-90 RadioGel™ in humans. The FDA also agreed to follow-up communications with their experts on specific topics. This is beneficial to ensure that we are totally aligned on the most complex subjects.
In previous written feedback to ADMD, the FDA recommended Premarket Approval (PMA) as a Class III device. In this meeting, we requested consideration for a De Novo reclassification as a Class II device based on the risks associated with the device. A De Novo path is faster and less onerous than a PMA. The FDA responded that they would need to first see the data from the pre-clinical testing so they could balance the therapeutic value versus the risks. We interpret this as encouraging since they did not refer to a PMA path and we expect the test data will demonstrate that RadioGel™ is a low to moderate risk device with clear therapeutic benefits.
About Advanced Medical Isotope Corporation (AMI)
Currently, the Company is engaged in the development of RadioGel™, a patent protected Yttrium-90 based device, for the treatment of tumors. RadioGel™ is a hydrogel liquid containing tiny Yttrium-90 phosphate particles to be injected directly into a tumor.
The company is seeking FDA approval to use RadioGel™ for the treatment of advanced basal and squamous 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.
The hydrogel in RadioGel™ 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.
Advanced Medical Isotope Corporation
Michael K. Korenko, President & CEO
Recent presentations and interviews may be viewed at: https://www.redchip.com/company/Biotech/ADMD/376/admd
SOURCE: Advanced Medical Isotope Corporation