NeuroMetrix Reports that Quell® Wearable Neuromodulator to be Evaluated in Post-Acute COVID-19 Syndrome
February 24 2022 - 9:00AM
NeuroMetrix, Inc. (Nasdaq: NURO) today announced that its Quell
wearable neuromodulation technology will be evaluated for treatment
of a fibromyalgia-like syndrome in individuals with post-acute
COVID-19 syndrome (PACS, or "long COVID"). The trial will be
conducted at the Baylor College of Medicine in collaboration with
the National Science Foundation (NSF) funded Center to Stream
Healthcare In Place (C2SHIP). The principal investigator is Dr.
Bijan Najafi, Professor of Surgery, and clinical director at the
Division of Vascular Surgery and Endovascular Therapy, Baylor
College of Medicine.
Over 10 million Americans are estimated to be
living with PACS. This condition is defined as persistent symptoms
following an acute COVID-19 infection. It may affect over one-third
of individuals who had COVID-19, even those whose initial disease
was mild or asymptomatic. PACS is characterized by a constellation
of symptoms that include fatigue, joint pain, muscle pain, memory
and concentration issues, sleep problems, shortness of breath,
cough, and heart rate abnormalities. Many of these symptoms are
also characteristic of fibromyalgia. In a recently published study,
31% of individuals who experienced an acute COVID-19 infection met
the American College of Rheumatology (ACR) criteria for
fibromyalgia when surveyed an average of 6-months following
infection. PACS treatment is challenging and there is an unmet need
for effective therapies.
Quell is an advanced, non-invasive, neuromodulation
technology that is covered by 22 U.S. utility patents and numerous
international 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. The Quell device 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 smartphone and smartwatch apps that help the
patient personalize and control their treatment. The U.S. Food and
Drug Administration (FDA) is currently reviewing Quell under a De
Novo request for treatment of fibromyalgia symptoms. NeuroMetrix
received an FDA Breakthrough Designation for this indication in
July 2021.
The PACS study is a double blinded, randomized,
sham-controlled trial (RCT). A total of 40 patients with persistent
symptoms of pain, fatigue, weakness, or poor gait and balance
following COVID-19 infection will be enrolled. The subjects will be
randomized to an active or sham Quell device for 4-weeks. Subjects
in both arms will be instructed to use their device for at least
3-hours of nerve stimulation each day. The primary outcome measures
are baseline to 4-week changes in pain, sleep and fatigue.
Secondary outcomes measures include patient global impression of
change, quality of life and objective assessments of gait, lower
extremity muscle function and sural nerve conduction using the
DPNCheck® device. Complete study details are
available at clinicaltrials.gov.
“This project will test the potential effectiveness
of Quell, which is a practical neuromodulation wearable technology,
shown to be effective to manage pain and lower extremities
symptoms, for clinical management of patients with PACS," said
Professor Najafi, Co-Director of C2SHIP. "This wireless tool has
the potential, not only to revolutionize PACS management, but also
to significantly reduce the burden on the healthcare industry by
reducing clinic visits while performing home-based therapy. This is
aligned with the mission of C2SHIP to promote in-place care
technologies that enable a patient engagement ecosystem.”
"The impact of COVID-19 appears to linger long
after the acute infection, which may lead to a profound surge of
chronic illness in the coming years. One of the likely
manifestations will be an increase in a fibromyalgia-like syndrome.
Unfortunately, like traditional fibromyalgia, the COVID-19 version
is expected to be debilitating and difficult to treat," said Shai
N. Gozani, M.D., Ph.D., CEO of NeuroMetrix. "We appreciate the
opportunity to work with Professor Najafi and his colleagues at the
Baylor College of Medicine to evaluate whether Quell has a
therapeutic role in patients with PACS. Moreover, this project is a
demonstration of the goals and potential of C2SHIP to address some
of the most difficult healthcare challenges facing the country, and
we are honored to be an industrial member. Another novel aspect of
this study is that our DPNCheck device will be used to objectively
detect and stage peripheral neuropathy. There have been several
early reports that peripheral neuropathy is a neurological
complication of long COVID.”
Note: The use of Quell for post-acute
COVID-19 syndrome and fibromyalgia is investigational and neither
indication has been cleared or approved by the FDA. The safety and
effectiveness for these purposes have not been reviewed by the
FDA.
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 currently 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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