Vivos Receives FDA Confirmation of RadioGel Device Classification for Animal Skin Cancer Therapy
January 30 2018 - 9:00AM
Richland, WA, Jan. 30, 2018 (GLOBE NEWSWIRE) --
Vivos Inc (OTC: RDGL) announced today that it has
been notified by the FDA that RadioGel™ is classified
as a device for animal therapy.
After four months of dialog with the Center for Veterinary
Medicine Product Classification Group we received a ruling that
RadioGel is classified as a device for animal therapy of feline
sarcomas and canine soft tissue sarcomas.
The FDA also reviewed and approved our label, which is a
requirement for any device used in animals. Based on the FDA
recommendation, RadioGel™ will be marketed as IsoPet™ for use by
veterinarians to avoid any confusion between animal and human
therapy. Vivos already has trademark protection for the IsoPet
name.
The Company’s feline sarcoma therapy series at Washington State
University was completed in January. Those tests were designed to
optimize our procedures and to determine the optimum dose. The
tests demonstrated that RadioGel™ is safe and effective
in killing cancer cells.
In February, we plan to start recruiting canine skin cancer
patients to be treated at the University of Missouri, incorporating
lessons learned at WSU.
The animal therapy data generated from these studies will also
be used in the pre-clinical data required by the FDA as part of the
testing required for treating skin cancer in humans. After all the
pre-clinical testing is completed we will submit an Investigational
Device Exemption to obtain permission to initiate human clinical
trials.
In April we plan to begin therapy at University of California
Davis on canine prostate and liver cancers. Later, we will continue
our testing at the University of Missouri to treat equine sarcoids.
As we expand the indications for use of IsoPet™ we intend to
communicate with the FDA to confirm the device designation applies.
Having established a precedent for classification of skin
cancer therapy as a device makes it highly likely that subsequent
cancers will also be ruled similarly. Obtaining FDA approval
in stages should increase the probability of success and provide
the fastest path to commercializing our product in the animal
sector.
We continue to communicate our progress with potential strategic
partners. In the future, we anticipate interacting with their
technical review teams to assess the results of our animal
therapies and endorse our product. We will then determine the
optimum business relationship to sell IsoPet™, with the goal of
leveraging the broad national presence of our strategic
partner.
Dr. Mike Korenko stated “Obtaining this approval is an important
step to set the stage for selling IsoPet to the private clinics for
animal therapy. By being labeled a device there are no other
regulatory approvals necessary for treating skin cancer, the most
common cancer in animals. We chose a conservative path of obtaining
FDA classification early with full and open communication on our
intent in order to remove any future uncertainty in the regulatory
space.”
About Vivos Inc. (OTC: RDGL)
The strategic market sector of RDGL is isotope
applications. Currently, the Company is engaged in the
development of RadioGelTM, an Yttrium-90 based
brachytherapy device, for the treatment of tumors. Brachytherapy
uses radiation to destroy cancerous tumors by placing a radioactive
isotope inside the treatment area.
The Company is engaging the FDA for permission to use
RadioGelTM for the treatment of advanced basal and
squamous cell skin cancers. The IsoPet Solutions division of RDGL
is focused on demonstrating the safety and therapeutic
effectiveness for different animal cancers in four different
university veterinary hospitals. RDGL is positioning itself so that
after this demonstration phase, The Company can begin to generate
revenues through the sale of RadioGelTM to private
animal clinics.
The Company currently is outsourcing material aspects of
manufacturing of its product in the United States and intends to
enter into licensing arrangements outside of the United States for
the manufacturing and distribution of RadioGelTM in
other countries.
About RadioGel™
RadioGelTM is a hydrogel liquid containing tiny
Yttrium-90 phosphate particles to be injected into a tumor.
This hydrogel is a liquid at temperatures below body temperature
but begins to gel, harden, upon injection as the temperature
increases to normal body temperature, thereby locking the particles
in place. The particles emit a very high concentrated and contained
beta irradiation to kill the tumor. The beta radiation has a short
penetration distance so there is minimal collateral damage to
healthy tissues outside of the injected area.
http://www.globenewswire.com/NewsRoom/AttachmentNg/33e87c6b-ef60-4dff-8618-d5dabd088184
RadioGelTM also has a short half-life – delivering
more than 90% of its therapeutic radiation within 10 days.
This compares favorably to other available treatment options
requiring up to 6 weeks or more to deliver a full course of
radiation therapy. This is an outpatient treatment much safer to
the personnel treating the patient than competing brands and the
patient can go home immediately with no risk to family members.
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.
We have changed our email and website to reflect our focus on
RadioGelTM. Please visit our website located
at www.radiogel.com, which contains a direct link to recent
presentations and interviews at
https://www.redchip.com/company/Biotech/ADMD/376/admd.
CONTACT:
Vivos Inc.
Michael K. Korenko, President & CEO
MKorenko@RadioGel.com
509-736-4000
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