NeuroMetrix Announces Strategic Launch of Quell Fibromyalgia
November 03 2022 - 9:00AM
NeuroMetrix, Inc. (Nasdaq: NURO) today announced the
strategic launch of its Quell® Fibromyalgia device through the
Pathfinder Program. Quell Fibromyalgia is the first and only
medical device authorized by the U.S. Food and Drug Administration
(FDA) to help reduce the symptoms of fibromyalgia.
The Pathfinder Program is designed to validate and further
refine the commercial process for Quell Fibromyalgia in
anticipation of a full commercial launch in Q2 of 2023. Pathfinder
starts on December 1, 2022 and will be limited to 25 key-opinion
leaders in fibromyalgia practice across the United States. The
guidance of these key physicians will be significant to the
Company’s ability to effectively communicate the benefits of Quell
to patients and healthcare professionals.
“We are excited to initiate the Pathfinder Program,” said Shai
N. Gozani, M.D., Ph.D., Chief Executive Officer of NeuroMetrix. “By
partnering with these physicians, some of the most forward-thinking
clinicians on the front lines of fibromyalgia, we will clarify our
messaging and distribution process to increase market access and
ultimately give patients the best chance of success with our
technology.”
Quell Fibromyalgia
Quell Fibromyalgia is a transcutaneous electrical nerve
stimulation (TENS) device indicated as an aid for reducing the
symptoms of fibromyalgia in adults with high pain sensitivity. The
device may be used during sleep.
Limitations The sale, distribution, and use of Quell
Fibromyalgia is restricted to prescription use in accordance with
21 CFR 801.109.
The Product labeling should be reviewed for a complete list of
contraindications, precautions and warnings.
About Quell Technology
Quell is an advanced, non-invasive, neuromodulation technology
that is covered by 23 U.S. utility patents. It is the only wearable
neuromodulator that is enabled by a proprietary microchip to
provide 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 user experience
both day and night. The device supports Bluetooth® low energy (BLE)
to communicate with mobile apps for multiple smartphone and
smartwatch platforms.
About NeuroMetrix
NeuroMetrix is an innovation-driven company with a mission to
improve individual and population health through novel medical
devices and technology solutions for neurological disorders and
pain syndromes. 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® Fibromyalgia is a
wearable neuromodulator that is the first and only FDA-authorized
medical device to help reduce the symptoms of fibromyalgia. For
more information, visit www.neurometrix.com.
Source: NeuroMetrix, Inc.
Thomas T. Higgins SVP and Chief Financial Officer 781-314-2761
neurometrix.ir@neurometrix.com
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