Advanced Medical Isotope Corporation Provides Commercialization and Strategic Plan Update
June 24 2015 - 8:19PM
InvestorsHub NewsWire

Advanced Medical Isotope Corporation Provides
Commercialization and
Strategic Plan Update
KENNEWICK, WA -- June 24, 2015 --
InvestorsHub NewsWire -- Advanced Medical Isotope Corporation
("AMIC") (ADMD),
a late stage development company engaged in the development of
brachytherapy devices for therapeutic applications, today provided
an update on the Y-90 RadioGel(TM) device de novo
submission to the FDA (United States Food and Drug Administration)
as well as an update on financial matters.
In late December 2014, the Company
provided the FDA with a de novo submission for the Y-90
RadioGel(TM) device requesting reclassification as a Class II
device and marketing clearance. The Company has been notified by
the FDA that it has declined the de novo request for Class
II designation for the AMIC Y-90 RadioGel(TM) device and that it
remains in Class III (Premarket Approval).
In the correspondence from the FDA,
the FDA requested additional data be generated to evaluate the
safety and effectiveness of the Y-90 RadioGel(TM) device and
provided a framework for submission of a new direct de
novo. As part of this process, AMIC is working with its
partners to establish protocols for preclinical animal studies as
suggested by the FDA. AMIC anticipates using the Pre-Submission
process to meet with the FDA in the 4th quarter to
review the draft protocols for the preclinical studies and to
generate additional feedback in support of a new direct de
novo filing seeking reclassification as a Class II device and
accordingly, marketing clearance.
The Company's 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.
AMIC intends to pursue an uplisting
transaction as part of its financial recapitalization plan to raise
the capital necessary to complete the direct de novo FDA
filing for the Y-90 RadioGel(TM) device and to pursue
commercialization and partnering efforts. The Company believes that
its known data from previous bench and animal studies in
combination with the preclinical studies that the FDA is requesting
will support a Class II designation and therefore, marketing
clearance. There can be no assurance regarding the outcome of the
Company's regulatory, financing or commercial efforts.
CEO James C. Katzaroff stated, "We are
committed to generating the data requested by the FDA to support
further regulatory review as we believe that the Y-90 RadioGel(TM)
device offers an innovative treatment option with a high
therapeutic index to physicians and patients for certain
non-resectable cancerous tumors.”
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.
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
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