KENNEWICK, WA / ACCESSWIRE / January 11, 2017 / Advanced Medical Isotope Corporation ("AMI") (ADMD), a late stage radiation oncology focused medical device company, would like to release a letter from Its CEO to its shareholders.
As the new AMI President and CEO, it is important to have regular information sharing with our owners. With this first letter, I would like to share our plan for our near-term future.
During the past month, I have been assessing the company's baseline status. Based on this due diligence, my assessment is that the company must fine-tune its direction and become more action oriented and implement a well-defined plan.
FDA STATUS AND SUBMISSION STRATEGY:
AMI has tried unsuccessfully to obtain regulatory approval for its products for over five years without a specific indication for use. It is my intent to listen to the Food and Drug Administration's previous guidance and narrow our indications for use (This is FDA lingo for the specific cancers that we want to target for treatment). We believe that RadioGel™ has broad potential to treat a variety of non-resectable (non-operable) tumors; however, gaining approval on such a wide range of therapies requires an unrealistic amount of testing. In order to secure approval in a timely manner, AMI will submit our next FDA application for a single type of cancer therapy. When successful, we will then apply for approval for the next therapy, and the next, in sequence over a period of three or four years.
We are in active discussion with external medical experts and our Medical Advisory Board under the Chairmanship of Dr. Barry Pressman, a neuroradiology expert at Cedars-Sinai Medical Center, Past-President of the American College of Radiology to select the optimum first indication for use. It is important to get this right by assessing all the therapy options in detail for both clinical and commercial reasons.
Since the FDA-required-testing is the longest activity on the critical-path timeline, we will determine and then start performing the required testing as a priority after we select our cancer target. We intend to formally engage the FDA during this process to ensure that they agree with our proposed testing protocols.
ISOPET, OUR VETRINARY ONCOLGY DIVISION:
Our household pet cancer therapy path forward under the IsoPet component of our company is also in the process of refocusing. We are pleased that Dr. Alice Villalobos, a founding member of the Veterinary Cancer Society, has agreed to remain as the Chair of our Veterinary Medicine Advisory Board. She has already given us expert advice during my discussions with her in December, which we have just started implementing. With her guidance, we have selected the first cut of three potential cancer types for pet therapy at up to three university centers. These will be assessed for a final selection in the relatively short term and will require a visit to those facilities.
We do plan to continue our effort treating feline sarcoma at Washington State University Veterinary center. As we have previously announced, our initial test at Washington State University to treat a feline sarcoma (cancer of the connective tissues in cats), was initiated to verify our procedures and to confirm there were no toxicity effects. There is an obvious synergy between the human and household pet markets, and these animal therapies will build the confidence of the medical community.
I will be communicating to you, the AMI owners, on a regular basis as we proceed along our plan. We have to earn your confidence that we have a sound plan and we are delivering on implementing that plan.
I took this job only because I believe that RadioGel™ has the potential to save lives. I feel I have a responsibility to bring this promising product to those people and those pets with a sense of urgency.
President and CEO (acting), Advanced Medical Isotope and IsoPet
About Advanced Medical Isotope Corporation
Advanced Medical Isotope Corporation (ADMD) is a late stage radiation oncology focused medical device company engaged in the development of yttrium-90 based brachytherapy devices for the treatment of non resectable tumors. The IsoPet Solutions division is focused on establishing the infrastructure necessary to provide product to veterinary clinics including regulatory clearances and compliance as well as providing product awareness and education to veterinary oncologists. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area. 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 websites: www.isopetsolutions.com and www.isotopeworld.com.
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 Korenko, CEO
1021 N Kellogg
Kennewick WA 99336
Circadian Group IR
Tyler Troup, B. Comm
SOURCE: Advanced Medical Isotope Corporation