NeuroMetrix Receives FDA Breakthrough Device Designation for Treatment of Chronic Chemotherapy Induced Peripheral Neuropathy (CIPN) with its Wearable Neurostimulation Technology
January 18 2022 - 9:00AM
NeuroMetrix, Inc. (Nasdaq: NURO) today announced that its Quell®
technology has received Breakthrough Designation from the U.S. Food
and Drug Administration (FDA) for reducing moderate to severe
symptoms of chemotherapy induced peripheral neuropathy that have
persisted for at least 6-months following the end of chemotherapy.
About 650,000 cancer patients receive chemotherapy annually in
the United States. CIPN is a disabling complication that occurs in
many patients treated with common chemotherapeutic drugs such as
vincristine, paclitaxel and cisplatin. Symptoms include
burning/shooting pain, tingling, cramping, and numbness in the
hands and feet. CIPN is also associated with impaired balance,
walking, and sleep, decreased quality of life, and increased risk
of falls. Approximately 30% of patients experience chronic CIPN,
defined as symptoms lasting longer than 3-6 months after the last
chemotherapy treatment. There are no FDA approved treatments for
CIPN, and those that are used have limited effectiveness and have
side effects.
Quell is an advanced, non-invasive, neuromodulation technology
that is covered by 19 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. 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 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.
The data submitted by NeuroMetrix in support of the Breakthrough
Designation included results from a 6-week open label study that
evaluated the safety and effectiveness of Quell used at home for
treatment of patients diagnosed with CIPN (study publication
available here). The study enrolled 29 patients who had completed
chemotherapy with a neurotoxic agent at least 3-months earlier, had
a clinical diagnosis of CIPN, and reported lower extremity symptoms
of pain, tingling, numbness, or cramping. The primary outcome
measure was EORTC-CIPN20, which is a composite measure of CIPN
symptoms and functional impairments. There were statistically
significant group improvements in the EORTC-CIPN20 and other
outcome measures, with the relative improvements ranging from 13 to
52%. All adverse effects were mild and self-limited.
A National Cancer Institute (NCI) funded, multi-center, double
blind, randomized, sham-controlled trial of Quell in CIPN is
currently ongoing (see ClinicalTrials.gov for details). A total of
150 patients will be enrolled, with subjects randomized to an
active or sham Quell device for 6 weeks. The primary outcome
measure is the baseline to 6-week change in the EORTC-CIPN20. Other
outcomes include individual CIPN symptoms and objective measures of
central descending pain inhibition, lower limb sensation threshold,
and balance. The study is expected to complete by the end of
2022.
"This Breakthrough Device Designation is an important step in
our effort to make Quell technology available to patients suffering
from the debilitating effects of CIPN,” said Shai N. Gozani, M.D.,
Ph.D., CEO of NeuroMetrix. “We are looking forward to completion
and subsequent reporting of the results from the ongoing
multi-center RCT of Quell in CIPN. Depending on the outcome of the
trial, we hope to be positioned for an FDA filing in 2023.
Following on our first Breakthrough Designation for fibromyalgia,
this new designation for CIPN advances our effort to build a
portfolio of Quell based prescription wearable
neurotherapeutics."
Note: The use of Quell for chemotherapy induced
peripheral neuropathy is investigational and has not been cleared
or approved by the FDA. The safety and effectiveness for this
purpose 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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