Advanced Medical Isotope Corporation Announces
Collaboration with IsoTherapeutics Group, LLC
KENNEWICK, WA -- August 28, 2015 -- InvestorsHub NewsWire
-- Advanced Medical Isotope Corporation ("AMIC") (OTC:ADMD),
a late stage development company engaged in the development of
brachytherapy devices for therapeutic applications, today announced
its collaboration with IsoTherapeutics Group, LLC of Angleton, TX
on the preclinical development of Y-90 based brachytherapy products
including AMICs Y-90 RadioGel(TM) device.
After a comprehensive search of entities capable of supporting
the commercialization of its Y-90 brachytherapy products, AMIC has
selected IsoTherapeutics Group as its lead collaboration partner.
IsoTherapeutics Group provides research and development services,
including animal studies and early stage manufacturing, for the
purpose of aiding customers and collaborators in the development of
radionuclide-based drug and device products.
The first project that AMIC and IsoTherapeutics will focus on is
the evaluation of AMICs Y-90 RadioGel(TM) device. IsoTherapeutics
is developing and will execute studies, under AMIC guidance, in the
manner the FDA has requested, with the end goal of FDA clearance
for the Y-90 RadioGel(TM) device. This multiple phase group of
tasks has begun, with the first phase of tech transfer/development
underway with anticipated completion by November 1, 2015. The next
phase, which includes rigorous in vivo testing, will commence
immediately thereafter. In June 2015, AMIC was notified by the FDA
that the December 2014 de novo submission for the Y-90 RadioGel(TM)
device was declined. All studies conducted by IsoTherapeutics will
be designed with significant attention to data sets and endpoints
aimed at addressing comments and questions provided by the FDA in
the June 2015 de novo denial letter to support a new submission. A
de novo granted by the FDA allows a Class II medical device to be
marketed in the United States.
James C. Katzaroff, CEO of AMIC, stated We are delighted to be
working with IsoTherapeutics Group to support the ongoing
preclinical validation of the safety and efficacy of the Y-90
RadioGel(TM) device as a therapeutic agent. IsoTherapeutics
expertise and facilities make them an ideal partner for AMIC.
We are pleased to offer our services to AMIC and look forward to
a long and outstanding collaboration that will have a significant,
positive impact on the commercialization efforts of the AMIC Y-90
brachytherapy products, stated R. Keith Frank, Ph.D., President and
CEO of IsoTherapeutics Group.
AMICs primary focus continues to be obtaining regulatory
clearance by the FDA of the Y-90 RadioGel(TM) device. In addition,
AMIC is evaluating the requirements for regulatory approval for the
Y-90 RadioGel(TM) device in Europe, Canada and Asia as well as for
use in the veterinary market as additional paths toward commercial
use of the device.
As part of the Companys financial capitalization plan, AMIC
intends to raise the capital necessary to complete a new direct de
novo FDA filing for the Y-90 RadioGel(TM) device, which todays
announcement with IsoTherapeutics supports. The Company expects
that its known data from previous bench and animal studies in
combination with the collaboration with IsoTherapeutics on
additional preclinical studies to address the FDA comments and
questions will support a Class II designation and corresponding
marketing clearance. There can be no assurance regarding the
outcome of the Company's regulatory, financing or commercial
efforts.
About Advanced Medical Isotope Corporation
Advanced Medical Isotope Corporation (ADMD)
is a late stage development company engaged in the development of
brachytherapy devices for therapeutic applications. AMIC's focus is
on transitioning to full operations upon receipt of FDA clearance
for its patented brachytherapy cancer products. 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 website,
www.isotopeworld.com.
About IsoTherapeutics Group, LLC
IsoTherapeutics Group is a radiopharmaceutical company that
provides research and development services, including animal
studies and early stage manufacturing for the purpose of aiding
customers and collaborators in the development of
radionuclide-based drug and device products. Additionally,
IsoTherapeutics is developing its own technologies including
CycloSam Sm-153-DOTMP for the treatment of primary and metastatic
bone cancer. Current collaborators include Molecular Imaging,
PerkinElmer, MD Anderson Cancer Center, University of
Missouri-Columbia, Excel Diagnostics and Valco Instruments. The
Company scientists, while formerly employed at The Dow Chemical
Company, developed the commercial products QUADRAMET and
Iotrex.
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, AMIC'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.
CONTACT:
Advanced Medical Isotope Corporation
James C. Katzaroff, CEO
(509) 736-4000
1021 N. Kellogg St.
Kennewick, WA 99336