NeuroMetrix Announces Strategic Launch of Quell Fibromyalgia
NeuroMetrix (Nasdaq: NURO) has launched the Quell® Fibromyalgia device through its Pathfinder Program.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
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.
Negative
- None.
Details
News Market Reaction – NURO
The recorded move for NURO in the trading session of this news was -10.19%.
Data tracked by StockTitan Argus. Session date unavailable.
AI-generated analysis. How Rhea-AI works. Not financial advice.
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
AI-generated questions and answers. How Rhea-AI works. Not financial advice.