NeuroMetrix to review strategic options

NeuroMetrix said on Tuesday that it initiated a process to review strategic options to grow its neuromodulation and neurodiagnostic businesses.

The Woburn, Massachusetts-based company wants to promote the growth of its Quell and DPNCheck offerings and maximize shareholder value. It said it plans to consider a wide range of options. That could include marketing strategies, acquiring new assets, potentially selling company assets or other mergers or strategic transactions.

NeuroMetrix says it expects no changes in its commercial operations as it looks at new opportunities. The company enlisted Ladenburg Thalmann & Co. as its financial advisor. It offered no assurances of this process resulting in any particular transaction or strategic outcome. NeuroMetrix also declined to set a timetable for this process.

“There are attractive opportunities for both vertical and horizontal growth with our Quell neuromodulation technology,” said Dr. Shai N. Gozani, Neu…

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NeuroMetrix is expanding its salesforce

NeuroMetrix (Nasdaq: NURO) second-quarter results took a hit from challenges related to reimbursement changes at CMS, but Quell Fibromyalgia saw positive trends.

The Woburn, Massachusetts–based company’s Quell neuromodulation device won FDA de novo nod to treat fibromyalgia in May 2022. The company had 123 unique prescribers for the fibromyalgia therapy in Q2, versus 92 in Q1.

A new sales force expansion has the company focusing on the Texas, California and Florida markets, according to NeuroMetrix.

Meanwhile, the University of Rochester School of Medicine and Dentistry recently reported results of an NIH-funded multi-center randomized sham-controlled trial of Quell for chemotherapy-induced peripheral neuropathy  (CIPN). According to NeuroMetrix, people with moderate to severe CIPN symptoms of hot/burning pain, sharp/shooting pain or muscle cramping experienced about a 50% reduction in symptoms for active Quell treatment compared to about 30% for s…

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NeuroMetrix launches peripheral neuropathy test

[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…

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NeuroMetrix strategically launches Quell Fibromyalgia

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…

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NeuroMetrix’s Quell neuromodulation device wins FDA de novo nod to treat fibromyalgia

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…

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NeuroMetrix revenues rise in Q1

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…
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NeuroMetrix dips on Q4 losses

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…

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NeuroMetrix’s Quell wins FDA breakthrough designation to treat certain chemo side effects

[Image from NeuroMetrix]

NeuroMetrix (NSDQ:NURO) announced today that it received FDA breakthrough device designation for its Quell technology.

Woburn, Massachusetts-based NeuroMetrix’s Quell garnered the breakthrough nod for reducing moderate-to-severe symptoms of chemotherapy-induced peripheral neuropathy (CIPN) that have persisted for at least six months following the end of chemotherapy.

Get the full story at our sister site, MassDevice.

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NeuroMetrix’s Quell wins FDA breakthrough designation to treat certain chemo side effects

The Quell wearable pain relief device [Image courtesy of NeuroMetrix]NeuroMetrix (NSDQ:NURO) announced today that it received FDA breakthrough device designation for its Quell technology.

Woburn, Massachusetts-based NeuroMetrix’s Quell garnered the breakthrough nod for reducing moderate-to-severe symptoms of chemotherapy-induced peripheral neuropathy (CIPN) that have persisted for at least six months following the end of chemotherapy.

NeuroMetrix designed Quell 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 allow for control and personalization of the treatment.

The company earned the breakthrough designation through the submission of results from a six-week open-label study that evaluated Quell’s safety and effectiveness in 2…

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NeuroMetrix rises on Q3 results, projects Quell launch in 2022

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…

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NeuroMetrix stock slides on publication of Quell study

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 …

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MedTech 100 roundup: Return to normal after last week’s spike

After rising more than 31 points to heights never before reached, the medtech industry returned to normal this past week.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week (July 23) at 115.54 points, a total that, had it not been for last week, would be the index’s all-time high.

However, the index finished the previous week (July 16) at 145.88 points, a remarkable 27.1% rise week-over-week, registering by far the greatest increase the index has seen since its inception — and perhaps an anomaly. Although the index slid by -20.8%, it remains in a stronger position than ever before, last week notwithstanding.

Medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry has registered a 25.2% increase from the pre-pandemic high of 92.32 (set on Feb. 19, 2020). It remains well ahead of the mid-pandemic low…

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