NeuroMetrix Receives FDA Breakthrough Device Designation for Treatment of Fibromyalgia with its Wearable Neurostimulation Tec...
July 20 2021 - 9:00AM
NeuroMetrix, Inc. (Nasdaq: NURO) today announced that its Quell®
device has received Breakthrough Designation from the U.S. Food and
Drug Administration (FDA) for treating the symptoms of fibromyalgia
in adults.
Fibromyalgia is a common form of chronic pain that is also
accompanied by fatigue, sleep, cognitive and mood disturbances. It
affects an estimated 2 to 6 percent of the U.S. population (5 to 15
million people) and is most often diagnosed between the ages of 30
and 50. The cause of fibromyalgia remains unclear, but scientific
studies point to abnormalities in the way the brain processes
normal sensations and pain. Although several drugs are FDA approved
for managing fibromyalgia pain, there is an unmet need for safe and
effective non-pharmacological treatments.
Quell is an advanced, non-invasive, nerve stimulation device
that is covered by 18 U.S. utility patents. It is the only wearable
neurostimulator that is enabled by a custom designed microchip that
provides flexible, precise, high-power nerve stimulation in a form
factor the size of a credit card. Quell utilizes position and
motion sensing to automatically adjust stimulation for an optimal
patient experience both day and night. The device supports
Bluetooth® low energy (BLE) to communicate with the Quell app,
which is available for iOS and Android mobile devices.
The FDA Breakthrough Device Program is intended to help patients
receive more timely access to breakthrough technologies that have
the potential to provide more effective treatment or diagnosis for
life-threatening or irreversibly debilitating diseases or
conditions. Under the program, the FDA will provide NeuroMetrix
with priority review and interactive communication regarding device
development, through to commercialization. In addition, there are
government policies and programs under consideration that, if
eventually adopted, may facilitate Medicare reimbursement for FDA
Breakthrough Devices following marketing authorization.
The data submitted by NeuroMetrix in support of the Breakthrough
Designation included results from a double-blind, randomized,
sham-controlled trial (NCT03714425). A total of 119 subjects with
fibromyalgia were enrolled and randomized to a standard (active) or
modified (sham) Quell device for 3-months of at-home use. In an
intention-to-treat (ITT) analysis of all subjects, 56% of those on
active treatment exhibited a clinically meaningful improvement in
health-related quality-of-life (Fibromyalgia Impact Questionnaire,
FIQR) compared to 35% that received sham treatment (p=0.029). There
were additional positive outcomes in both the ITT population and in
a pre-specified subgroup analysis of subjects with elevated pain
sensitivity based on Quantitative Sensory Testing (QST).
“The Breakthrough Device Designation is an important milestone
in the Company's effort to make Quell technology available to
people living with fibromyalgia,” said Shai N. Gozani, M.D., Ph.D.,
President and CEO of NeuroMetrix. “We are moving forward with a
regulatory filing that could position us to launch Quell for this
indication in the second half of next year.”
Note: The use of Quell for fibromyalgia is
investigational and has not been cleared or approved by the U.S.
FDA. The safety and effectiveness for this purpose have not been
reviewed by the FDA.
About Quell
Quell is a novel transcutaneous electrical nerve stimulator
(TENS) that is indicated for symptomatic relief and management of
chronic lower extremity (knee, foot and leg) pain and is available
over-the-counter. It is a wearable device that can be used during
the day while active and at night while sleeping. Quell users can
personalize and manage therapy discreetly via the Quell app. Quell
also offers health tracking metrics relevant to chronic pain
sufferers. Quell users can synchronize their data with the Quell
Health Cloud®, which provides customized feedback and powers a
large chronic pain outcomes database. Visit QuellRelief.com for
more information.
About NeuroMetrix
NeuroMetrix is an innovation-driven company focused on the
development and global commercialization of non-invasive medical
devices for the diagnosis and treatment of pain and neurological
disorders. The Company has three commercial products. DPNCheck® is
a diagnostic device that provides rapid, point-of-care detection of
peripheral neuropathies. ADVANCE® is a diagnostic device that
provides automated, in-office nerve conduction studies for the
evaluation of focal neuropathies. Quell® is a wearable
neurostimulation device indicated for treatment of lower extremity
chronic pain. For more information, visit www.NeuroMetrix.com.
Source: NeuroMetrix, Inc.
Thomas T. HigginsSVP and Chief Financial
Officer781-314-2761neurometrix.ir@neurometrix.com
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