NeuroMetrix Announces Submission of FDA De Novo Request for Treatment of Fibromyalgia Symptoms with the Quell® Wearable Neuromodulation Device
07 Ottobre 2021 - 12:42AM
NeuroMetrix, Inc. (Nasdaq: NURO) today announced that it has
submitted a De Novo request to the U.S. Food and Drug
Administration (FDA) for Quell as a prescription treatment for the
symptoms of fibromyalgia in adults. The Company received FDA
Breakthrough Designation for this indication in July.
Fibromyalgia is a chronic pain condition that is 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). 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. There are currently no
medical devices with FDA clearance or approval for treating
fibromyalgia.
The De Novo pathway for marketing authorization is available to
low-to-moderate risk medical devices that do not have a cleared
predicate device, and are therefore not eligible for the pre-market
notification process (i.e., 510(k)). Unlike traditional TENS
devices that are narrowly cleared for pain relief, NeuroMetrix is
seeking a novel intended use for Quell to treat fibromyalgia
symptoms.
The data submitted by NeuroMetrix in support of the De Novo
request includes 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 randomized subjects, 57%
of those on active treatment exhibited a clinically meaningful
improvement in health-related quality-of-life (Fibromyalgia Impact
Questionnaire, FIQR) compared to 34% that received sham treatment
(p=0.014). Subjects in the active treatment arm reported
statistically significant improvements in 19 of the 21 symptoms
comprising the FIQR instrument, including pain, sleep, fatigue,
balance and the ability to carry out typical daily activities.
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). A
subset of the trial results were recently published in the Journal
of Pain Research.
“Submission of this De Novo request is an important milestone in
the Company's effort to make Quell technology available as a
prescription treatment for people living with fibromyalgia,” said
Shai N. Gozani, M.D., Ph.D., President and CEO of NeuroMetrix. “We
look forward to working with the FDA as they proceed through their
review, which we are optimistic will be facilitated by the device's
breakthrough status. Subject to a successful and timely process, we
hope to commercially launch Quell for this indication in the second
half of 2022.”
NeuroMetrix was advised by MCRA, LLC in this submission.
Note: The use of Quell for fibromyalgia is
investigational and has not been cleared or approved by the U.S.
Food and Drug Administration (FDA).
About Quell
Quell is an advanced, non-invasive, neuromodulation device that
is covered by 18 U.S. utility patents. It is the only wearable
neuromodulator that is enabled by a proprietary microchip that
provides 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. Quell is currently indicated
for symptomatic relief and management of chronic lower extremity
(knee, foot and leg) pain. It is available over-the-counter for
this use. 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 entrapment neuropathies. Quell® is a wearable
neurostimulation device indicated for treatment of lower extremity
chronic pain. For more information, visit NeuroMetrix.com.
Source: NeuroMetrix, Inc.Thomas T. HigginsSVP and Chief
Financial Officer781-314-2761neurometrix.ir@neurometrix.com
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