KENNEWICK, WA / ACCESSWIRE / February 14, 2017 / Advanced Medical Isotope Corporation ("AMI") (OTC PINK: ADMD), a cancer therapeutics company focused on the commercialization of their RadioGel™ device, a tumor-injectable and biodegradable radiation that remains focused at the treatment site, today released a letter from its new President and CEO, Dr. Mike Korenko:
With my first letter on January 11, I shared AMI's plans for our near-term future. With this letter, I will discuss the progress on that plan in the medical sector of our business over the last month.
PATH FORWARD WITH THE FOOD AND DRUG ADMINISTRATION (FDA)
In order to maximize our expertise in communicating with the FDA, I spent a lot of time locating the correct FDA expert to be at our side. We have engaged Hogan Lovells. They have 21 lawyers in the field of FDA devices and are very familiar with the personnel at the FDA.
We are thrilled to have the input of senior partner John Smith, M.D., J.D. As both a physician and a lawyer, John combines clinical and regulatory experience relating to the FDA with a practical approach to addressing the regulatory issues. He places a particular focus on bringing device-based technologies to market. John and his lawyers have just completed the review of all our previous FDA communications and our supporting data. Based on their recommendations with respect to interacting with the FDA, we intend to:
1. Introduce AMI's new leadership and let them know we have listened; we are narrowing our indication for use to secure our first approval and completing the test plans to answer their previous questions for their review.
2. Present our specific test plans and data in a Pre-Submission meeting to clarify the final application.
3. Submit an Investigation Device Exemption to begin clinical trials.
4. With the FDA's permission, submit a de novo application for approval (FDA.gov De Novo Application FAQs).
The FDA classification of RadioGel™ as a device increases our chances of a timely FDA approval exponentially. The critical path on the overall schedule to approval is, first, to complete laboratory testing concurrent with veterinary animal studies, then into human clinical trials. It is my intent to align the animal treatments in our veterinarian business division to support the animal testing required for the FDA to synergize the two divisions, and potentially create time and cost savings. In this parallel strategy, the company looks to move to first-in-man trials as soon as possible, while aggressively pursuing near-term revenues through the veterinary division, IsoPet, and through licensing.
PRIORITIZE THE SEQUENCE OF THERAPIES
Our Medical Advisory Board has been expanded. Under the Chairmanship of Dr. Barry Pressman (a neuroradiology expert at Cedars-Sinai Medical Center in Los Angeles and Past-President of the American College of Radiology), the Board now includes Dr. Albert Denittis (Chief of Radiation Oncology Lankenau Medical Center), and Dr. Howard Sandlin (Ronald H. Bloom Chair in Cancer Therapeutics, Professor and Chair, Department of Radiation Oncology, Cedars-Sinai Medical Center). Their combined medical experience adds up to over 125 years. We have also been harvesting advice from other doctors, including two from the Mayo Clinic.
The focus of the Advisory Boards is to prioritize our indications for use (which cancer types to treat first) in order to present them one at a time, in sequence to the FDA. The Board has selected 18 cancers that are good candidates for treatment with RadioGel™. To me, this large number is a confirmation of our belief that RadioGel has broad potential to treat a variety of tumors. From a business standpoint, it set the stage for incremental growth for many years into the future. In the near-term, we are prioritizing this list down to our top three therapy targets based on specific criteria.
These criteria are:
1. Potential for FDA approval and successful therapy:
a. Accessibility in the body, ease of application
b. Therapeutic effectiveness in response to radiation
c. Potential collateral risks from injection
d. FDA Testing requirements
2. Improvement over current treatments
3. Business considerations
a. Number of patients diagnosed yearly
b. Ease of acceptance by the medical community
c. Medical Insurance and Medicare reimbursement
To paraphrase: 1) It works; 2) Nobody has a better mousetrap; and 3) It has to be profitable to the medical business sector.
There have been other great products that made it through the FDA and failed, since the medical community did not see a profitable way to adapt the new technology. The medical community cares about saving lives, but they are in a business. We did not want to be surprised by that reality.
As of today, we are down to six near-term candidates. We hope to have our final selection before the end of February. This is an important decision, so we need to get it right.
I will send out another shareholder letter when we select our first indication for use. I will also discuss our veterinarian sector's business plan, as well as some updates in a near-term communication to you.
I hope this was not too much detail, but I am not a big fan of fluff.
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 cancer treatment. The IsoPet Solutions division is focused on utilizing RadioGel for a cancer therapy in animals. 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
Dr. Mike Korenko, President & CEO
Circadian Group IR
Tyler Troup, B. Comm
SOURCE: Advanced Medical Isotope Corporation