Advanced Medical Isotopes CEO Releases Shareholder Letter
Detailing Launch of Veterinary Oncology Division with RadioGel
Commercial Launch Begins at 4 University Hospital Centers of
Excellence with the data generated to be used as a Springboard to
FDA Submission for Human use
Kennewick, WA -- March 7th, 2017 -- InvestorsHub NewsWire --
Advanced Medical Isotope Corporation (AMI) (OTC:
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 the fourth letter in a four-letter series
outlining AMIs push towards FDA submittal and commercialization
from its new President & CEO, Dr. Mike Korenko.
Dear Shareholders,
In my February letters, I described our progress on the medical
sector. With this letter, I will discuss the veterinary sector.
In my January 11th letter, I discussed my intent to evaluate
four major veterinary teaching hospitals to confirm veterinarian
interest and select the best places to introduce RadioGel for
treating cancer in animals. Since then, I have visited three
centers and have had discussions with a fourth. I am encouraged
that four of the countrys best veterinary medical centers have now
independently reviewed the RadioGel device as a therapy and have
agreed it would be an exciting new tool in their cancer-treatment
toolbox. Each center is an impressive and respected teaching
hospital, and each is anxious to use RadioGel as a cancer
treatment. Therefore, I have decided to move forward on four
fronts.
Each veterinary center of excellence will focus on a different
cancer type:
- Washington State University feline sarcoma, possibly followed
by canine sarcoma
(Dr. Janean Fidel and Dr. Megan Duffy)
- University of Missouri soft tissue carcinoma, followed by
localized prostate cancer
(Dr. Jimmy Lattimer and Dr. Jeffrey Bryan)
- University of Florida lymph nodes, followed by liver cancer -
(Dr. Beau Toskich, Dr. Brad Case and Dr. Sarah Boston)
Colorado State University oral squamous cancer - (Dr. Jac Nickloff
and Dr. Susan LaRue)
These tumors in animals serve as models for a variety of related
human cancers. Clear demonstration of therapeutic benefit in
animals would directly enhance our pending FDA application for
human use.
Together with Dr. Alice Villalobos, Chair of our Veterinary
Medicine Advisory Board, the specialists listed above are
accomplished leaders in U.S. veterinary oncology. Their engagement
will provide significant support to our plans to introduce RadioGel
throughout the entire field, including private veterinarian
clinics. As academics, these specialists are motivated to publish
their work with RadioGel in peer-reviewed scientific literature.
Scientific and medical journal articles would help to advance the
use of RadioGel as a treatment of choice.
Pre-clinical studies have already begun at Washington State
University. The others will begin by preparing animal welfare and
research protocols. Our medical physicist, Dr. Darrell Fisher, past
president of the Health Physics Society, will address any questions
from review committees on radiation safety and the characteristics
of RadioGel for the treatment of cancer.
Each of the selected veterinary centers will optimize a
treatment approach which we will incorporate into an FDA approved
Label format. We will then ask the FDA to review these Labels, as
recommended by their guidance. These Labels, together with clinical
research experience, will then be used as part of our supporting
data for our medical application to the FDA.
The Labels and clinical experience will translate to use by
veterinarians in smaller, private clinics. Dr. Villalobos believes
that her private clinic could be the first to capitalize on this
broad-based experience and she is reviewing this with the facility
owners. This schedule will give her ample time to put in place the
required radioactive material license. We will work with her to
expedite that application.
Since the FDA has classified RadioGel as a medical device rather
than a drug product, we can more easily implement any future
improvements in the product design and the application techniques
to benefit the animals and to strengthen our intellectual property
without requiring additional FDA approvals.
Next month we will begin interviewing candidates for a
veterinary oncologist to head the IsoPet subsidiary.
Dr. Mike Korenko
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.
CONTACTS:
Company Contact:
Advanced Medical Isotope
Dr. Mike Korenko, President & CEO
Investors:
Circadian Group IR
Tyler Troup, B. Comm
info@Circadian-group.com
866-950-8300