NeuroMetrix Announces Strategic Launch of Quell Fibromyalgia

Rhea-AI Summary

NeuroMetrix (Nasdaq: NURO) has launched the Quell^® Fibromyalgia device through its Pathfinder Program. This device is the first FDA-authorized medical device aimed at alleviating fibromyalgia symptoms. The Pathfinder Program, beginning December 1, 2022, will involve 25 key-opinion leaders in fibromyalgia to refine its commercial approach ahead of a full launch expected in Q2 2023. Quell Fibromyalgia utilizes TENS technology and is designed for adults with high pain sensitivity, offering a non-invasive treatment option.

Positive

• Launch of Quell Fibromyalgia, the first FDA-authorized device for fibromyalgia.
• Pathfinder Program involves key-opinion leaders to refine commercial strategies.
• Anticipated full commercial launch in Q2 2023.

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• None.

WOBURN, Mass., Nov. 03, 2022 (GLOBE NEWSWIRE) --  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 

FAQ

What is the Quell Fibromyalgia device?

Quell Fibromyalgia is a transcutaneous electrical nerve stimulation (TENS) device that helps reduce fibromyalgia symptoms in adults with high pain sensitivity.

When does the Pathfinder Program start for Quell Fibromyalgia?

The Pathfinder Program begins on December 1, 2022.

How many key-opinion leaders are involved in the Pathfinder Program?

The Pathfinder Program will involve 25 key-opinion leaders in fibromyalgia practice across the United States.

What is the significance of the Quell Fibromyalgia device launch?

It is the first and only FDA-authorized medical device to help reduce symptoms of fibromyalgia, representing a significant advancement in treatment options.

When is the full commercial launch of Quell Fibromyalgia expected?

The full commercial launch is anticipated in Q2 2023.