Neurometrix

[Image courtesy of NeuroMetrix]NeuroMetrix (Nasdaq:NURO) announced today that it commercially launched its DPNCheck 2.0 point-of-care device.

Woburn, Massachusetts–based NeuroMetrix designed DPNCheck 2.0 to use nerve conduction technology to detect peripheral neuropathy.

DPNCheck 2.0 provides rapid patient screening with quantitative measurement of peripheral nerve function. It features an easy-to-use touchscreen, step-by-step onboarding instructions and improved temperature compensation. Additionally, it offers real-time nerve response display and other enhancements, with companion software for facilitating clinical documentation of test results.

The company plans to add cloud-based aggregation of population-health data and integration with provider EHR systems this year.

NeuroMetrix said that its nerve conduction technology allows for the potential uncovering of an elevated risk for complications from peripheral neuropathy. It said it aims to catch…

The Quell wearable pain relief device [Image courtesy of NeuroMetrix]NeuroMetrix (Nasdaq: NURO) announced the strategic launch of its Quell Fibromyalgia device through its Pathfinder Program.

The move — announced yesterday — comes nearly 6 months after NeuroMetrix said it had received an FDA de novo authorization to use its Quell neuromodulation device to treat fibromyalgia symptoms.

The Pathfinder Program starts Dec. 1. NeuroMetrix limited the program to 25 key-opinion leaders in fibromyalgia practice across the United States. The key physicians’ guidance will inform NeuroMetrix officials on how to effectively communicate the benefits of Quell to patients and healthcare professionals.

“We are excited to initiate the Pathfinder Program,” said NeuroMetrix CEO Dr. Shai N. Gozani. “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…

The Quell wearable pain relief device [Image courtesy of NeuroMetrix]NeuroMetrix (Nasdaq:NURO) announced today that it received FDA de novo authorization for its Quell neuromodulation device.

Quell received the authorization as an aid for reducing the symptoms of fibromyalgia in adults with high pain sensitivity. Quell garnered FDA breakthrough device designation to treat fibromyalgia in July 2021.

Much like when it received the breakthrough nod, NeuroMetrix’s stock is on the rise today, with shares currently up 38% at $4.31 per share in early-morning trading.

Data supporting the de novo request for Quell came from a double-blind, randomized, sham-controlled trial of 119 subjects with fibromyalgia. The subjects were randomized to a standard (active) or modified (sham) Quell device for three months of at-home use.

For 60 subjects with high pain sensitivity, Patient Global Impression of Change (PGIC), which stood as the primary study outcome meas…

The Quell wearable pain relief device [Image courtesy of NeuroMetrix]NeuroMetrix (Nasdaq:NURO) shares dipped today on first-quarter results that saw losses despite year-over-year revenue growth.

The Woburn, Massachusetts-based company posted losses of $958,562, or 14¢ per share, on sales of $2.3 million for the three months ended March 31, 2022, for a bottom-line slide deeper into the red on sales growth of 6.8%.

NeuroMetrix’s biggest step forward during the first quarter of 2022 came in January when its Quell technology received FDA breakthrough device designation for the treatment of chronic chemotherapy-induced peripheral neuropathy (CIPN).

The company said in a news release that it also grew its value-based healthcare commercial team to four experienced sales, marketing and clinical leaders.

“Our value-based care commercial team is now fully trained and focused on building our DPNCheck Medicare Advantage business. Although the sales cycl…

The Quell wearable pain relief device [Image courtesy of NeuroMetrix]NeuroMetrix (NSDQ:NURO) shares dipped slightly before hours today on fourth-quarter results that included a bottom-line slide.

The Woburn, Massachusetts-based neurostimulation technology developer posted losses of $1 million, or 15¢ per share, on sales of $1.8 million for the three months ended Dec. 31, 2021, for a bottom-line dip deeper into the red on sales growth of 0.6%.

NeuroMetrix develops the Quell system, which it designed as a wearable, non-invasive neuromodulation technology enabled by a proprietary microchip. The device automatically adjusts stimulation through position and motion sensing while supporting Bluetooth low energy (BLE) to communicate with smartphone and smartwatch apps to control and personalize the treatment.

“We accomplished a great deal in 2021 and are now positioned to focus on our growth strategy,” NeuroMetrix CEO Dr. Shai N. Gozani said in a news r…

The Quell wearable pain relief device [Image courtesy of NeuroMetrix]NeuroMetrix (NSDQ:NURO) shares are on the rise today after the company released third-quarter financial results last week.

NURO shares were up 7.9% at $7.92 per share in mid-morning trading. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up 0.2%.

The Woburn, Massachusetts-based company posted losses of -$687,089, or -12¢ per share, on sales of $2.1 million for the three months ended Sept. 30, 2021, for a bottom-line slide from losses of -$257,113 last year despite sales growth of 1.4%.

NeuroMetrix’s quarter was filled with ups and downs as the company’s stock shot up upon the news of FDA breakthrough device designation for its Quell non-invasive nerve stimulation device for pain relief, followed by the company’s reporting of its second-quarter financial results.

However, just one week later, NeuroM…

The Quell wearable pain relief device [Image courtesy of NeuroMetrix]NeuroMetrix (NSDQ:NURO) stock hit a massive skid today after the publication of a study on its Quell non-invasive nerve stimulation device for pain relief.

Shares of NURO were down -12.2% at $18.41 in late-afternoon trading today. Its stock price still remains about twice as a week ago, when it began to quickly climb upon the news of Quell’s FDA breakthrough device designation, followed by the company’s reporting of its second-quarter financial results.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was down 0.6% on the day.

The study observed Woburn, Mass.-based NeuroMetrix’s Quell, a transcutaneous electrical nerve stimulation (TENS) system, in treating fibromyalgia, for which the device has not been FDA approved at this point. The double-blind, randomized, sham-controlled trial compared three months …

The Quell wearable pain relief device [Image courtesy of NeuroMetrix]NeuroMetrix (NSDQ:NURO) shares saw a huge boost this afternoon on strong second-quarter revenues and an increased bottom line.

NURO shares were up 19.1% at $24.77 per share in mid-afternoon trading. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up 0.4%.

The Woburn, Mass.-based company posted losses of -$531,584 on sales of $2.2 million for the three months ended June 30, 2021, for a 37.6% bottom-line gain on sales growth of 62.8%.

NeuroMetrix’s Quell non-invasive nerve stimulation device for pain relief, which earlier this week earned FDA breakthrough device designation — leading to the company’s stock skyrocketing — delivered positive operating margins during the quarter.

“We continued to make progress in both the DPNCheck and Quell business lines. We believe we are laying the groundwork fo…

The Quell wearable pain relief device [Image courtesy of NeuroMetrix]NeuroMetrix (NSDQ:NURO) today announced that its Quell device has received FDA breakthrough designation for treating fibromyalgia symptoms in adults.

The news saw NURO shares nearly triple in value to $9.72 apiece near the close of trading. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was up 1.5%.

Fibromyalgia involves the widespread perception of pain and affects roughly 4 million Americans, according to the CDC. NeuroMetrix officials think their company’s Quell non-invasive nerve stimulation device could prove a useful alternative to the drugs FDA has approved to treat the condition.

The breakthrough designation means priority review and interactive communication with FDA over NeuroMetrix’s application for Quell. The designation could also facilitate Medicare reimbursement after authorization.

“The b…