InnerScope Hearing Technologies Inc. & Erchonia Corporation to Conduct FDA Clinical Trial for the Treatment of Tinnitus
November 01 2018 - 8:00AM
InvestorsHub NewsWire
InnerScope Hearing Technologies Inc. &
Erchonia Corporation to
Conduct FDA Clinical
Trial for the Treatment
of Tinnitus
InnerScope and Erchonia
have entered
into Joint Development &
Exclusive Distribution
Agreements and
intend to obtain
a 510k
FDA-Clearance via
clinical trial to
study the effect on
using Erchonia's
Low-Level Laser
Therapy
Technology for
the relief of tinnitus
symptoms
Roseville, CA
-- November
01,
2018 -- InvestorsHub
NewsWire -- InnerScope Hearing
Technologies Inc.
(OTCQB: INND)
has
entered into a Joint Development Agreement (the "JD Agreement") and
an Exclusive Distribution Agreement (the "ED
Agreement")
with
Erchonia Corporation ("Erchonia"),
a world leader in the manufacturing and development of
Low-Level
Laser
Therapy
Technology ("3LT") and medical laser equipment using 3LT
technology. As part of
the JD
Agreement, InnerScope
and
Erchonia
will
conduct FDA Clinical
Research
and Trials for the purpose
of obtaining 510k
FDA-Clearances for devices, technologies, methods and
techniques ("Hearing
Products") used in the treatment
of hearing related conditions and disorders, including Tinnitus,
Sensorineural Hearing Loss, Central Auditory Processing Disorders,
Dizziness, Vertigo, Balance Disorders, and Meniere's Disease
("Hearing Disorders").
Both the
JD and ED
Agreements
gives
InnerScope the
exclusive worldwide rights for all designs and
any newly
developed
Erchonia
3LT lasers, related technologies
and methods to be used to
treat Hearing Disorders.
Additionally, the ED Agreement will
give InnerScope the
exclusive
rights
and
license
to commercially distribute such hearing
products
worldwide.
InnerScope and Erchonia have received
approval
under FDA
regulations from
a
Institutional Review Board
("IRB")
for
the initial
clinical
trial of the effect
of Erchonia's
low-level laser
therapy technology
on the
relief of tinnitus symptoms. The approved
initial
clinical
trial site
will
be InnerScope's Value
Audiology and Hearing Aid Center in Walnut Creek,
California. The IRB also
approved InnerScope's Director
of Audiology, Dr.
Kathy
L.
Amos,
Au.D.
Doctor of
Audiology, as the Principal
Investigator for the trial.
Tinnitus is the perception of sound when no
actual external noise is present. While it is commonly referred to
as "ringing in the ears," tinnitus can manifest many different
perceptions of sound, including buzzing, hissing, whistling,
swooshing, and clicking. Approximately
15% to 20% of the world's population suffers from tinnitus.
Tinnitus can be a severely debilitating
problem, and numerous risk factors have been associated with the
development of tinnitus. Those with a hearing impairment have a
higher risk for tinnitus, and the associated increase in risk is
dependent on the severity of hearing impairment. Furthermore, there is an
elevated risk of tinnitus in people with a history of head injury,
depressive symptoms, target shooting, arthritis, use of NSAID
medications, hypertension, and
smoking. In addition,
individuals with intolerable tinnitus often suffer from higher
rates of anxiety, depression, low self-esteem, and poor quality of
life compared to those without tinnitus.
According to the American
Tinnitus Association ("ATA")
estimates
nearly 50 million Americans experience some form of tinnitus and
roughly 20 million people struggle with burdensome chronic
tinnitus, while 2 million have extreme and debilitating
cases. Underlying hearing
loss occurs in 90% of all tinnitus sufferers.
Tinnitus is the number One Disability for
Veterans.
Tinnitus
is the most common service related disability among veterans, with
over 1.5 million American
veterans receiving disability payments for
intolerable tinnitus. 60% of veterans
returning from Iraq & Afghanistan come home with hearing loss
and tinnitus based on information
from www.hearinghealthfoundaton.org. With tinnitus
claims increasing
at
an
annual
rate of 15%, the total cost per year to
the U.S.
Department of
Veterans Affairs for tinnitus related compensation to veterans is
expected to have
exceeded
3 billion
dollars in 2017.
Currently,
other
than tinnitus maskers or tinnitus
management
devices
that
only
ease the
perceived burden of tinnitus,
there
is no
scientifically
validated cure
or any
FDA-Cleared treatments for temporary
relief for
most types of
tinnitus.
InnerScope and Erchonia Hearing
Products, when cleared, will be the first
FDA-Cleared treatment for relief of
tinnitus.
InnerScope
and
Erchonia expect to be the
first to
receive a 510k FDA-Clearance for their Hearing
Products that
are
not
considered tinnitus "maskers"
and/or
tinnitus management devices, but
offers
a
treatment protocol for relief of
tinnitus symptoms.
Both
companies anticipate receiving the FDA-Clearance by the end of the
third quarter of 2019.
InnerScope plans to introduce
(depending upon
when the 510k
FDA-Clearance happens) and
commercially
market
and distribute the tinnitus
hearing
products
to
the audiological
global
market as early
as
December 2019. In addition,
InnerScope plans on working with U.S. Department of
Veterans Affairs for
using
its hearing
products
for
treating
the millions of U.S. veterans that suffer
from tinnitus.
"Erchonia
is the
world leader furthering
research
and
development
of
its Low-Level Laser
Technology for multiple medical laser
applications" said Steve Shanks,
President of Erchonia Corporation. "I would like
to
thank Mark Moore, InnerScope's
Chairman, for contacting
us a few
years back
introducing
Erchonia
to new
medical
applications
using Erchonia's 3LT
Technology for
treating hearing
disorders.
Erchonia
has
had
the
pleasure working with Mark and Matthew
Moore in
developing
treatment protocols using Erchonia's 3LT
Technology for treating
multiple
hearing
disorders.
We
look forward to many
Erchonia and InnerScope FDA-Cleared
devices
for treating hearing
disorders in the near
future.
"Our long-term partnership
with the Erchonia, the
world
leader in 3LT research and technology, has resulted in the
first of many opportunities to serve the hearing
impaired", said Matthew Moore,
CEO of InnerScope Hearing
Technologies. "We are
confident in a
successful
clinical
outcome
using
Erchonia's 3LT
technology to
treat
Hearing Disorders. Our Chairman, Mark
Moore, has invested critical resources in assisting Erchonia in the
development of these Hearing
Products, and
has
witnessed the possibilities with resolute
optimism. Once our tinnitus
treatment receives the 510k FDA Market Clearance, we plan to market
and distribute this worldwide to help the hundreds of millions of
people who suffer from tinnitus. InnerScope and
Erchonia also
intends
to obtain more 510k FDA-Clearances by developing more treatment
applications for other Hearing Disorders using Erchonia's 3LT
technology", Mr. Moore
concluded.
About InnerScope Hearing Technologies
("INND")
InnerScope Hearing
Technologies (INND) is a rapidly expanding
consolidator of the hearing aid industry. Management is applying
decades of profitable
industry experience and
technology to an antiquated and disjointed industry, unlocking
scale and efficiency,
which will serve all
of InnerScope's
stakeholders. Its
direct-to-consumer
model is revolutionizing the industry with its Walmart.com
relationship representing a paramount shift in the consumption of
hearing aids by
the
hearing impaired.
In
addition InnerScope
plans
to continue
to
open,
acquire,
and operate
a
physical
chain
of audiological and
retail hearing device clinics. InnerScope's
mission
is to serve approximately
1.2 billion people around the globe that are suffering with 25 db
or greater hearing loss across the entire
hearing impaired vertical from R&D and manufacturing through
direct consumer sales and services. For more information,
please visit: www.innd.com
About Erchonia Corporation
LLC.
A small
family company located in
Melbourne,
Florida,
is
changing the world with the most advanced non-invasive lasers on
the market. Erchonia went from starting in a small garage in 1996
to selling their product in over 50 different countries around the
world in 2018. Erchonia has been passionate about researching and
developing low level lasers since the beginning with over (15) FDA
clearances for treating chronic pain and promoting fat loss. As
this family has grown so has the world of non-invasive drug-free
healthcare solutions. For more information,
please visit: www.erchonia.com
Safe Harbor
This
presentation contains forward-looking statements,
which relate to future
events or InnerScope Hearing Technologies future performance or
financial condition. Any statements that are not statements of
historical fact (including statements containing the words
"believes," "should," "plans," "anticipates," "expects,"
"estimates" and similar expressions) should also be considered to
be forward-looking statements. These forward-looking statements are
not guarantees of future performance, condition or results and
involve a number of risks and uncertainties. Actual results may
differ materially from those in the forward-looking statements as
result of a number of factors, including those described from time
to time in InnerScope Hearing Technologies filings with the
Securities and Exchange Commission. InnerScope Hearing Technologies
undertakes no duty to update any forward-looking statements made
herein.
Contact
InnerScope Hearing
Technologies,
Inc.
Investor
Relations
Info@innd.com
916-218-4100
www.innd.com
Institutional Review
Boards (IRB)
American Tinnitus Association
www.hearinghealthfoundaton.org
www.erchonia.com
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