|Over a month ago|
NeuroMetrix reports Q1 revenue $2.2M vs. $3.1M last year » 07:4204/2304/23/20
"Despite the commercial slow down attributable to COVID-19 in March, we were encouraged by Q1 sales activity coupled with a 70%+ gross margin and an improving operating margin. While there is more work to be done to achieve operating profitability, we believe these financial results demonstrate the potential of our core businesses," said Shai N. Gozani, M.D., Ph.D., President and Chief Executive Officer of NeuroMetrix. "We are uncertain when the sales drop-off we saw in March will abate and start to return to normal. However, we hope that revenue lost in Q1 and Q2 will be recovered in the second half of the year. In the meantime, we are focused on employee safety, serving our customers and continuing our R&D programs."
NeuroMetrix says Quell technology selected for use in 'large' NIH-funded study » 13:3404/1604/16/20
NeuroMetrix announced that Quell technology has been selected for use in a large, NIH-funded, randomized, pragmatic clinical trial of TENS for fibromyalgia. Fibromyalgia is a disorder characterized by widespread musculoskeletal pain accompanied by fatigue, sleep and mood disturbances. It affects an estimated 2 to 4 percent of the US population, or as many as 6 to 12 million people, and is most often diagnosed between the ages of 30 and 50. The cause of fibromyalgia remains unclear, but scientific studies point to abnormalities in the way the brain processes normal sensations and pain. Although several drugs are approved for treating fibromyalgia pain, there is an unmet need for safe, non-pharmacological options.
NeuroMetrix plans to offer consumer, prescription versions of Quell technology » 11:0503/1103/11/20
NeuroMetrix (NURO) provided an update on its Quell technology commercial strategy and pipeline. Quell technology is an advanced TENS platform designed for the symptomatic relief and management of chronic pain. It is enabled by a proprietary neurostimulation microchip that provides precise, high-power nerve stimulation in a small wearable device. Quell technology includes sensors and algorithms to automatically regulate nerve stimulation and track objective health metrics such as sleep and gait. It supports Bluetooth low energy to communicate with mobile applications that enhance functionality and connect to the Quell Health Cloud. The Company plans to offer consumer and prescription versions of Quell technology. Quell technology is marketed OTC as Quell 2.0, which has FDA clearance and is indicated for symptomatic relief and management of chronic pain. Over the past year, the Company has succeeded in making its consumer health business profitable. This necessitated changes in advertising and distribution, as well as headcount reductions. Quell 2.0 is now only available on QuellRelief.com and Amazon.com. Promotional spending has been reduced to achieve an attractive customer acquisition cost. The objective going forward is to grow this business while maintaining profitability. Starting in 2Q20, Quell marketing will focus on lower extremity chronic pain, a common issue for our customers. The Company will continue to innovate, with new Quell 2.0 features planned for 1H21. The Company is collaborating with GSK Consumer Healthcare (GSK) through a strategic agreement that began in 2018. It is supporting GSK in their launch of Quell technology outside the US. It is also partnering with GSK on clinical research that resulted in several scientific reports at pain medicine conferences in 2019, with additional presentations expected in 2020. GSK is partially funding Quell R&D. The Company currently has two investigational clinical targets in its prescription Quell pipeline: fibromyalgia and chemotherapy-induced peripheral neuropathy. A double-blind, sham-controlled randomized controlled trial of Quell efficacy in patients with primary fibromyalgia pain is currently ongoing and should read-out in 2H20. If the trial is positive, based on its results and the results of other studies, the Company plans to submit a 510(k) for a prescription Quell indicated for treatment of fibromyalgia pain in 2H20, with a goal of a commercial launch in 4Q21. A RCT of Quell efficacy in patients with CIPN is expected to start this year, which will build on encouraging pilot data published last year. If the trial is positive, we anticipate submitting a 510(k) in H1 2022 with the goal of a commercial launch in late 2022. The commercialization strategy for the prescription products is expected to include direct sales and distributors. The Company also plans to explore strategic partnerships. These products will likely launch as self-pay, but with the goal of obtaining third-party reimbursement with additional clinical and real-world outcomes data.
NeuroMetrix reports clinical studies recently published on DPNCheck » 12:1603/0503/05/20
NeuroMetrix reported the…
NeuroMetrix reported the recent publication of three additional DPNCheck clinical studies. DPNCheck is a point-of-care test that provides accurate and cost-effective screening, diagnosis and monitoring of peripheral neuropathies such as diabetic peripheral neuropathy. "These three recently published studies contribute to the growing body of research that validates the technical and diagnostic accuracy of DPNCheck and adds to its credibility as a primary outcome measure in clinical trials and epidemiological studies," said Shai Gozani, President and CEO of NeuroMetrix.
|Over a quarter ago|
NeuroMetrix reports Q4 revenue $1.7M, one estimate $4.28M » 07:0501/2701/27/20
"Although we were…
"Although we were disappointed by the overall drop in revenue from the year-ago period, we expected this outcome given our large reduction in operating expenses, attention to improved gross margins and overall focus on long term growth and profitability. We believe we made important progress against these objectives. We experienced strong demand for DPNCheck during the fourth quarter which is typically our slowest period. This momentum should carry into 2020 as new Medicare Advantage accounts come on board and we expect a rebound in international sales. Our enthusiasm for the DPNCheck business is reflected in our investment in the next generation device to be launched in late 2020," said Shai N. Gozani, M.D., Ph.D., President and CEO of NeuroMetrix. "Our Quell business is focused on cost-efficient advertising combined with an exclusively direct-to-consumer model via our QuellRelief.com website and exploration of new markets. We believe this technology is unique and represents an attractive long term opportunity for the Company. Finally, we are actively engaged with the Federal Trade Commission to resolve the previously disclosed matter which is centered on earlier Quell advertising."
NeuroMetrix announces one-for-ten reverse split of common stock » 11:5211/1811/18/19
NeuroMetrix announced the…
NeuroMetrix announced the effectiveness of a one-for-ten reverse split of its common stock. The shares underlying the Company's outstanding options and warrants will also be adjusted accordingly. The reverse stock split is intended to increase the per share trading price of the Company's common stock to satisfy the $1.00 minimum bid price requirement for continued listing on the Nasdaq Capital Market. As a result of the reverse stock split, every ten shares of the Company's common stock issued and outstanding at 5:00 pm on November 18, 2019 will be consolidated into one issued and outstanding share, with no change in the nominal par value per share of $0.0001. No fractional shares will be issued as a result of the reverse stock split. Shareholders who otherwise would be entitled to receive a fractional share in connection with the reverse stock split will receive a cash payment in lieu thereof. Trading of the Company's common stock on the Nasdaq Capital Market will continue, on a split-adjusted basis, with the opening of the markets on Tuesday, November 19, 2019, under new CUSIP number 641255807. Trading of the Company's listed warrants to purchase common stock on the Nasdaq Capital Market will also continue, on a split-adjusted basis, with the opening of the markets on Tuesday, November 19, 2019 under new CUSIP number 641255211. Shares of the Company's common stock and the Company's listed warrants to purchase common stock will continue to trade under the symbols "NURO" and "NUROW". Immediately subsequent to the reverse stock split, there will be approximately 978,175 shares of the Company's common shares issued and outstanding.
NeuroMetrix reports Q3 revenue $2.1M, one estimate $3.93M » 07:1510/1710/17/19
"A new commercial…
"A new commercial model was necessary to make Quell widely accessable to people struggling with chronic pain," said CEO Shai Gozani. "Quell performance under the new approach will be closely monitored in Q4 2019, with modifications as necessary. DPNCheck continues to meet growth expectations in the domestic market, offset by delayed timing of international orders. Finally, we continue to seek resolution of the previously disclosed Federal Trade Commission matter which is centered on earlier Quell advertising."
NeuroMetrix shifting to exclusively direct-to-consumer model for Quell 2.0 » 11:0210/1510/15/19
NeuroMetrix announced updates to its Quell 2.0 commercial strategy. The company is shifting to an exclusively direct-to-consumer model delivered via the QuellRelief.com website, which is said "will allow it to offer the innovative Quell 2.0 system at accessible price points. This streamlined distribution model will allow more people with chronic pain to benefit from the advanced Quell pain relief technology. The new approach will also open the door for more people to take advantage of electrode savings through a subscription service." Shai Gozani, President, and CEO of NeuroMetrix, said, "We believe that everyone living with chronic pain should have the opportunity to experience Quell and determine if it is beneficial to their particular form of chronic pain. Therefore, we have worked over the past several quarters to refine our business model and distribution system to position us to deliver Quell 2.0 at widely attainable price points."
NeuroMetrix initiates process to evaluate potential divestiture of DPNCheck line » 07:2107/1807/18/19
The company said in Q2 it…
The company said in Q2 it "initiated a process to evaluate a potential divestiture of its DPNCheck product line. Back Bay Life Science Advisors, Inc. has been retained as its advisor to lead the process."
NeuroMetrix reports Q2 revenue $2.4M, one estimate $3.28M » 07:1907/1807/18/19
"We have engaged…
"We have engaged outside expertise to help optimize the value of our business. The restructuring that we initiated in June was a difficult but essential step to better align our operating structure with current revenues," said CEO Shai Gozani. "We are pleased with the DPNCheck performance, particularly in our domestic market, which offset variable timing of international sales, particularly in Mexico. With Quell, we are working to find the optimal commercial approach to deliver profitable sales with a modest investment in digital advertising. We continue to believe in the effectiveness and unique benefits of the Quell technology. Finally, we continue to seek resolution of the previously disclosed Federal Trade Commission matter which is centered on Quell advertising."