|Over a month ago|
NeuroMetrix files $50M mixed securities shelf 16:0810/2210/22/21
NeuroMetrix reports Q3 EPS (12c) vs. (7c) last year » 07:4810/2110/21/21
Reports Q3 revenue $2.06M…
Reports Q3 revenue $2.06M vs. $2.04M last year. "We continued to successfully execute on our core initiatives this past quarter. We saw further adoption of DPNCheck testing within Medicare Advantage plans and are pleased that Sue Bell has joined the Company to lead and accelerate this effort," said Shai N. Gozani, M.D., Ph.D., President and Chief Executive Officer of NeuroMetrix. "Submission of the De Novo request was an important milestone in our effort to make Quell technology available as a prescription treatment for people living with fibromyalgia and we look forward to working with the FDA during their review process."
NeuroMetrix appoints Susan Bell as SVP, population health, value based care » 09:0610/2010/20/21
NeuroMetrix announced that it has appointed Susan M. Bell as Senior Vice President, Population Health & Value Based Care. Ms. Bell will be responsible for growing the Company's DPNCheck business with a primary focus on the Medicare Advantage population, and more broadly, expanding the Company's footprint in the value-based healthcare market. Ms. Bell was most recently at eHealth, Inc., where she was Senior Director, Value Based Provider Partnerships.
NeuroMetrix submits De Novo request to FDA for Quell in fibromyalgia » 18:4510/0610/06/21
NeuroMetrix has submitted…
NeuroMetrix has submitted a De Novo request to the FDA for Quell as a prescription treatment for the symptoms of fibromyalgia in adults. The company received FDA Breakthrough Designation for this indication in July. Fibromyalgia is a chronic pain condition that is accompanied by fatigue, sleep, cognitive and mood disturbances. It affects an estimated 2%-6% of the U.S. population. Although several drugs are FDA approved for managing fibromyalgia pain, there is an unmet need for safe and effective non-pharmacological treatments. There are currently no medical devices with FDA clearance or approval for treating fibromyalgia. The De Novo pathway for marketing authorization is available to low-to-moderate risk medical devices that do not have a cleared predicate device, and are therefore not eligible for the pre-market notification process.
NeuroMetrix joins Center to Stream Healthcare in Place as industry partner » 09:0710/0510/05/21
NeuroMetrix announced that it has joined the Center to Stream Healthcare In Place as an industry partner. C2SHIP is a U.S. National Science Foundation funded consortium of leading academic centers and industry partners with a mission to develop technologies and approaches for high-quality personalized healthcare that is delivered at-home. The initial four participating academic centers are the University of Arizona, Baylor College of Medicine, University of Southern California and the California Institute of Technology. In this collaboration, NeuroMetrix will focus on novel therapeutic applications of its Quell wearable neuromodulation technology and leveraging the information in the Quell Health Cloud chronic pain database using data science expertise at the participating academic centers.
|Over a quarter ago|
NeuroMetrix announces publication of trial of its neurostimulation technology » 09:0907/2607/26/21
NeuroMetrix announced a…
NeuroMetrix announced a publication titled "Effects of Wearable Transcutaneous Electrical Nerve Stimulation on Fibromyalgia: A Randomized Controlled Trial" in the Journal of Pain Research. The article reports an intention-to-treat analysis of a double-blind, randomized, sham-controlled trial that compared 3-months of at-home treatment with a standard or low dose Quell device in 119 subjects with fibromyalgia.
NeuroMetrix up another 32% in pre-market after Q2 results » 08:0307/2207/22/21
Shares of NeuroMetrix are…
Shares of NeuroMetrix are up another 32% in pre-market trading above $27 per share after yesterday's 107% gain. The company reported Q2 results earlier today and also remains in the top-three spots in terms of StockTwits message volume this morning.
NeuroMetrix reports Q2 EPS (13c) vs. (28c) last year » 07:2007/2207/22/21
Reports Q2 revenue $2.2M…
Reports Q2 revenue $2.2M vs. $1.4M last year. "We continued to make progress in both the DPNCheck and Quell business lines. We believe we are laying the groundwork for steady top-line growth going forward," said Shai N. Gozani, M.D., Ph.D., President and Chief Executive Officer of NeuroMetrix. "It was particularly rewarding to share the Quell fibromyalgia data with international pain medicine experts in June and to receive Breakthrough Device Designation from the FDA. We look forward to advancing this program towards a commercial launch in 2022."
NeuroMetrix extends yesterday's advance, up 52% in pre-market trading » 09:0007/2107/21/21
Shares of NeuroMetrix are…
Shares of NeuroMetrix are up another 52% in pre-market trading, extending yesterday's 208% spike after the company received an FDA breakthrough device designation for Quell device for treating the symptoms of fibromyalgia in adults. The stock is also the second highest trending ticker on StockTwits in terms of message volume this morning.
NeuroMetrix receives FDA breakthrough device designation for Quell device » 09:0307/2007/20/21
NeuroMetrix announced that its Quell device has received Breakthrough Designation from the U.S. Food and Drug Administration for treating the symptoms of fibromyalgia in adults. The data submitted by NeuroMetrix in support of the Breakthrough Designation included results from a double-blind, randomized, sham-controlled trial. A total of 119 subjects with fibromyalgia were enrolled and randomized to a standard or modified Quell device for 3-months of at-home use. In an intention-to-treat analysis of all subjects, 56% of those on active treatment exhibited a clinically meaningful improvement in health-related quality-of-life compared to 35% that received sham treatment. There were additional positive outcomes in both the ITT population and in a pre-specified subgroup analysis of subjects with elevated pain sensitivity based on Quantitative Sensory Testing.