John-Knee
3年前
NeuroMetrix Reports that Quell(R) Wearable Neuromodulation Device has Received FDA De Novo Authorization as First Non-Pharmacological Treatment for Fibromyalgia
2022-05-19 09:00:03 AM ET (GlobeNewswire)
EQNX::TICKER_START (NASDAQ:NURO), EQNX::TICKER_END NeuroMetrix, Inc. (Nasdaq: NURO) today announced U.S. Food and Drug Administration (FDA) De Novo authorization to market the Quell neuromodulation device as an aid for reducing the symptoms of fibromyalgia in adults with high pain sensitivity. The Company received FDA Breakthrough Designation for the use of Quell to treat fibromyalgia in July 2021.
Fibromyalgia is a chronic condition characterized by generalized pain, fatigue, poor sleep, memory and concentration impairments, mood disorders and other disabling symptoms. These individuals experience low health-related quality of life and are twice as likely to be hospitalized as someone without fibromyalgia. The prevalence of fibromyalgia is estimated to be 2 to 6 percent of the U.S. adult population (5 to 15 million people). The cause of fibromyalgia remains unclear, but scientific studies point to abnormalities in the way the central nervous system processes normal sensations and pain. Although a number of drugs are used to treat fibromyalgia only pregabalin, duloxetine and milnacipran have been approved by the FDA. These drugs are associated with side effects and generally poor adherence. Prior to Quell, the FDA had not approved or cleared any medical devices for treatment of fibromyalgia.
The data submitted by NeuroMetrix in support of the De Novo request included results from a double-blind, randomized, sham-controlled trial (NCT03714425). A total of 119 subjects with fibromyalgia were enrolled and randomized to a standard (active) or modified (sham) Quell device for 3-months of at-home use. In a pre-specified subgroup analysis of subjects with high pain sensitivity (N=60), Patient Global Impression of Change (PGIC) was 1.25 (95% CI [0.25, 2.24]) points higher in the active arm compared to the sham arm (p=0.015). PGIC was the primary study outcome measure and represents a subject's overall belief about the efficacy of treatment on a 7-point categorical scale. The high pain sensitivity subgroup was defined based on Quantitative Sensory Testing and should represent the majority of fibromyalgia patients in real-world practice.
In the intention-to-treat (ITT) analysis of all randomized subjects (N=119), multiple secondary outcome measures were positive. For example, 57% of those on active treatment exhibited a clinically meaningful improvement in health-related quality-of-life (Fibromyalgia Impact Questionnaire, FIQR) compared to 34% that received sham treatment (p=0.014). Subjects in the active treatment arm reported statistically significant improvements in 19 of the 21 symptoms comprising the FIQR instrument, including pain, sleep, fatigue, balance and the ability to carry out typical daily activities. Some of the trial results were published in the Journal of Pain Research recently.
A total of 9 adverse events were reported during the study and deemed to be definitely or possibly related to device use (4 in active arm, 5 in sham arm). All events were minor and self-limited. The most common occurrence was a rash under the Quell electrodes.
"There is an unmet need for effective and safe fibromyalgia treatments. Receiving this De Novo authorization is a key milestone towards the Company's goal of making Quell available as a prescription treatment option for people living with fibromyalgia," said Shai N. Gozani, M.D., Ph.D., Chief Executive Officer, NeuroMetrix. "We believe physicians treating patients with fibromyalgia will be interested in Quell's potential clinical benefits and safety profile. Our initial commercialization efforts will focus on rheumatologists and pain medicine physicians. We anticipate launching in the fourth quarter, with initial prescriptions processed by an online pharmacy partner before the end of this year."
NeuroMetrix was advised by MCRA, LLC in this submission.
Indications
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. The device is labeled for use only with compatible NeuroMetrix electrodes.
Limitations
The sale, distribution, and use of Quell Fibromyalgia is restricted to prescription use in accordance with 21 CFR 801.109. Many participants in the clinical study were also taking medication for fibromyalgia and it was difficult to assess the effects of the device compared to medication.
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 that provides 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 innovative 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 is a wearable neuromodulation technology indicated for treatment of fibromyalgia symptoms and chronic lower extremity pain. 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
John-Knee
3年前
NeuroMetrix Receives FDA Breakthrough Device Designation for Treatment of Chronic Chemotherapy Induced Peripheral Neuropathy (CIPN) with its Wearable Neurostimulation Technology
2022-01-18 09:00:05 AM ET (GlobeNewswire)
NeuroMetrix, Inc. (Nasdaq: NURO) today announced that its Quell technology has received Breakthrough Designation from the U.S. Food and Drug Administration (FDA) for reducing moderate to severe symptoms of chemotherapy induced peripheral neuropathy that have persisted for at least 6-months following the end of chemotherapy.
About 650,000 cancer patients receive chemotherapy annually in the United States. CIPN is a disabling complication that occurs in many patients treated with common chemotherapeutic drugs such as vincristine, paclitaxel and cisplatin. Symptoms include burning/shooting pain, tingling, cramping, and numbness in the hands and feet. CIPN is also associated with impaired balance, walking, and sleep, decreased quality of life, and increased risk of falls. Approximately 30% of patients experience chronic CIPN, defined as symptoms lasting longer than 3-6 months after the last chemotherapy treatment. There are no FDA approved treatments for CIPN, and those that are used have limited effectiveness and have side effects.
Quell is an advanced, non-invasive, neuromodulation technology that is covered by 19 U.S. utility patents. It is the only wearable neuromodulator that is enabled by a proprietary microchip that provides precise, high-power nerve stimulation in a form factor the size of a credit card. The Quell device utilizes position and motion sensing to automatically adjust stimulation for an optimal patient experience both day and night. The device supports Bluetooth low energy (BLE) to communicate with smartphone and smartwatch apps that help the patient personalize and control their treatment.
The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide NeuroMetrix with priority review and interactive communication regarding device development, through to commercialization.
The data submitted by NeuroMetrix in support of the Breakthrough Designation included results from a 6-week open label study that evaluated the safety and effectiveness of Quell used at home for treatment of patients diagnosed with CIPN (study publication available here). The study enrolled 29 patients who had completed chemotherapy with a neurotoxic agent at least 3-months earlier, had a clinical diagnosis of CIPN, and reported lower extremity symptoms of pain, tingling, numbness, or cramping. The primary outcome measure was EORTC-CIPN20, which is a composite measure of CIPN symptoms and functional impairments. There were statistically significant group improvements in the EORTC-CIPN20 and other outcome measures, with the relative improvements ranging from 13 to 52%. All adverse effects were mild and self-limited.
A National Cancer Institute (NCI) funded, multi-center, double blind, randomized, sham-controlled trial of Quell in CIPN is currently ongoing (see ClinicalTrials.gov for details). A total of 150 patients will be enrolled, with subjects randomized to an active or sham Quell device for 6 weeks. The primary outcome measure is the baseline to 6-week change in the EORTC-CIPN20. Other outcomes include individual CIPN symptoms and objective measures of central descending pain inhibition, lower limb sensation threshold, and balance. The study is expected to complete by the end of 2022.
"This Breakthrough Device Designation is an important step in our effort to make Quell technology available to patients suffering from the debilitating effects of CIPN," said Shai N. Gozani, M.D., Ph.D., CEO of NeuroMetrix. "We are looking forward to completion and subsequent reporting of the results from the ongoing multi-center RCT of Quell in CIPN. Depending on the outcome of the trial, we hope to be positioned for an FDA filing in 2023. Following on our first Breakthrough Designation for fibromyalgia, this new designation for CIPN advances our effort to build a portfolio of Quell based prescription wearable neurotherapeutics."
Note: The use of Quell for chemotherapy induced peripheral neuropathy is investigational and has not been cleared or approved by the FDA. The safety and effectiveness for this purpose have not been reviewed by the FDA.
About NeuroMetrix
NeuroMetrix is an innovation-driven company focused on the development and global commercialization of non-invasive medical devices for the diagnosis and treatment of pain and neurological disorders. 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 entrapment neuropathies. Quell is a wearable neurostimulation device currently indicated for treatment of lower extremity chronic pain. For more information, visit NeuroMetrix.com.
John-Knee
3年前
----NeuroMetrix Reports Q3 2021 Financial Results
2021-10-21 07:00:02 AM ET (GlobeNewswire)
NeuroMetrix, Inc. (Nasdaq: NURO) today reported financial and business highlights for the quarter ended September 30, 2021. The Company is a leader in proprietary non-invasive medical devices for the diagnosis and treatment of pain and neurological disorders.
Highlights:
-- Revenue of $2.1 million was up slightly from Q3 2020. Gross margin on revenue was $1.4 million, a 70.0% gross margin rate. This was a decrease of 3.6 percentage points from $1.5 million, a 73.6% gross margin rate, in Q3 2020. The margin rate contraction reflected cost increases for component parts.
-- The DPNCheckMedicare Advantage business continued to be the primary contributor to revenue during the quarter. Subsequent to the end of the quarter, Susan Bell, RN was appointed as SVP, Population Health & Value Based Care and will lead the Company's Medicare Advantage and value based health care business.
-- Operating expenses increased $0.4 million over Q3 2020 reflecting regulatory activities and personal costs.
-- Net loss for the quarter was $0.7 million in comparison to a net loss of $0.3 million in Q3 2020.
-- In July the Company's Quell technology received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the treatment of fibromyalgia symptoms in adults. Subsequent to the end of the quarter, a De Novo request was filed. The Company indicated that a successful and timely review process could result in commercial launch of Quell for fibromyalgia in the second half of 2022.
-- The Company joined the Center to Stream Healthcare in Place (C2SHIP) as an industry partner. Quell was cited by C2SHIP as being well suited to its mission for the in-place management of chronic pain, remote monitoring, and personalization of pain management.
-- The Company utilized its at-the-market (ATM) facility to raise $15.8 million in net proceeds from the sale of common stock. It ended the quarter with $23.2 million cash on the balance sheet.
"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."
Financials:
Q3 2021 revenue of $2.1 million exceeded revenue of Q3 2020 by $28 thousand. The gross margin rate of 70.0% in Q3 2021 declined from 73.6% in Q3 2020 due to cost increases to secure electronic parts essential to the Company's products. Operating expenses of $2.1 million increased from $1.8 million in Q3 2020. The increase was attributable to regulatory costs, higher R&D parts costs, sales & marketing staffing, and non-cash stock compensation expenses. The Q3 2021 net loss of $687 thousand, or $0.12 per share, exceeded the net loss in Q3 2020 of $257 thousand, or $0.07 per share by $430 thousand.
Company to Host Live Conference Call and Webcast
NeuroMetrix will host a conference call at 8:00 a.m. Eastern today, October 21, 2021. The call may be accessed in the United States at 844-787-0799, international at 661-378-9630 using confirmation code 7683407. A replay will be available starting two hours after the call at 855-859-2056 United States and 404-537-3406 international using confirmation code 7683407. It will remain available for one week. The call will also be webcast and accessible at www.NeuroMetrix.com under "Investor Relations".
About NeuroMetrix
NeuroMetrix is an innovation-driven company focused on the development and global commercialization of non-invasive medical devices for the diagnosis and treatment of pain and neurological disorders. 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 is a wearable neurostimulation device indicated for treatment of lower extremity chronic pain. For more information, visit www.NeuroMetrix.com.
John-Knee
3年前
---- NeuroMetrix, Inc. Announces Date for Third Quarter 2021 Financial Results Conference Call
2021-10-14 09:00:02 AM ET (GlobeNewswire)
NeuroMetrix, Inc. (Nasdaq: NURO) announced today that it plans to issue its 2021 third quarter financial results before the opening of the market on October 21, 2021. The Company will host a conference call at 8:00 a.m., Eastern Time on October 21, 2021 to discuss its financial results as well as business developments affecting the Company.
The conference call may be accessed in the United States by dialing 844-787-0799 and using the confirmation code 7683407. Internationally, the conference call may be accessed by dialing 661-378-9630 and using the same confirmation code. The earnings press release and accompanying condensed financial statements will be accessible from the Company's website at www.NeuroMetrix.com under the "Investor Relations" tab.
A replay of the conference call will be available starting two hours after the call by dialing 855-859-2056, domestically and 404-537-3406, internationally. The confirmation code to access the replay is 7683407. The replay will be available for one week after the conference call.
About NeuroMetrix
NeuroMetrix is an innovation-driven company focused on the development and global commercialization of non-invasive medical devices for the diagnosis and treatment of pain and neurological disorders. 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 entrapment neuropathies. Quell is a wearable neurostimulation device indicated for treatment of lower extremity chronic pain. For more information, visit www.NeuroMetrix.com.
NeuroMetrix, Inc.
Thomas T. Higgins, 781-314-2761
SVP and Chief Financial Officer
neurometrix.ir@neurometrix.com
Source: NeuroMetrix, Inc.
Dell_Griffith
3年前
Yes, I saw that and they’re not messing around, as they’re using MCRA to help them get it approved. MCRA has huge FDA connections and it’s a big part of what they do, and succeed at. Check out just this one senior executive’s background (they all have backgrounds like this) and let’s speculate if MCRA won’t get them the approval -
February 2006, Mr. Stiegman served as the Chief of the Orthopedic Devices Branch for US Food and Drug Administration.
It almost sounds like it shouldn’t be allowed, huh? But then that’s like saying someone from the U.S. Atty’s Office shouldn’t be allowed to become a criminal defense atty - they can’t stop that either.
MCRA is also noteworthy for assisting biotech and medical small caps with selling off to the larger biotechs and med/pharmas.
I saw the results were 57% improvement in quality of life - sleep, fatigue, pain - for patients in the study. That’s impressive. Looks positive. Hopefully, the upcoming Q looks good. I’m sensing they’re going to sell off, at some point, although that might take a while.
John-Knee
3年前
---- News: NeuroMetrix Announces Submission of FDA De Novo Request for Treatment of Fibromyalgia Symptoms with the Quell® Wearable Neuromodulation Device
Press Releases
2021-10-06 06:42:26 PM ET (GlobeNewswire)
NeuroMetrix Announces Submission of FDA De Novo Request for Treatment of Fibromyalgia Symptoms with the Quell® Wearable Neuromodulation Device
WOBURN, Mass., Oct. 06, 2021 (GLOBE NEWSWIRE) -- NeuroMetrix, Inc. (Nasdaq: NURO) today announced that it has submitted a De Novo request to the U.S. Food and Drug Administration (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 to 6 percent of the U.S. population (5 to 15 million people). 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 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 (i.e., 510(k)). Unlike traditional TENS devices that are narrowly cleared for pain relief, NeuroMetrix is seeking a novel intended use for Quell to treat fibromyalgia symptoms.
The data submitted by NeuroMetrix in support of the De Novo request includes results from a double-blind, randomized, sham-controlled trial (NCT03714425). A total of 119 subjects with fibromyalgia were enrolled and randomized to a standard (active) or modified (sham) Quell device for 3-months of at-home use. In an intention-to-treat (ITT) analysis of all randomized subjects, 57% of those on active treatment exhibited a clinically meaningful improvement in health-related quality-of-life (Fibromyalgia Impact Questionnaire, FIQR) compared to 34% that received sham treatment (p=0.014). Subjects in the active treatment arm reported statistically significant improvements in 19 of the 21 symptoms comprising the FIQR instrument, including pain, sleep, fatigue, balance and the ability to carry out typical daily activities. 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 (QST). A subset of the trial results were recently published in the Journal of Pain Research.
“Submission of this De Novo request is an important milestone in the Company's effort to make Quell technology available as a prescription treatment for people living with fibromyalgia,” said Shai N. Gozani, M.D., Ph.D., President and CEO of NeuroMetrix. “We look forward to working with the FDA as they proceed through their review, which we are optimistic will be facilitated by the device's breakthrough status. Subject to a successful and timely process, we hope to commercially launch Quell for this indication in the second half of 2022.”
NeuroMetrix was advised by MCRA, LLC in this submission.
Note: The use of Quell for fibromyalgia is investigational and has not been cleared or approved by the U.S. Food and Drug Administration (FDA).
About Quell
Quell is an advanced, non-invasive, neuromodulation device that is covered by 18 U.S. utility patents. It is the only wearable neuromodulator that is enabled by a proprietary microchip that provides 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 patient experience both day and night. The device supports Bluetooth® low energy (BLE) to communicate with the Quell app, which is available for iOS and Android mobile devices. Quell is currently indicated for symptomatic relief and management of chronic lower extremity (knee, foot and leg) pain. It is available over-the-counter for this use. Visit QuellRelief.com for more information.
About NeuroMetrix
NeuroMetrix is an innovation-driven company focused on the development and global commercialization of non-invasive medical devices for the diagnosis and treatment of pain and neurological disorders. 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 entrapment neuropathies. Quell® is a wearable neurostimulation device indicated for treatment of lower extremity chronic pain. For more information, visit NeuroMetrix.com.
John-Knee
3年前
NeuroMetrix Announces Participation in the Center to Stream Healthcare In Place (C2SHIP) as an Industry Partner
2021-10-05 09:00:07 AM ET (GlobeNewswire)
NeuroMetrix, Inc. (Nasdaq: NURO) today announced that it has joined the Center to Stream Healthcare In Place (C2SHIP) as an industry partner.
C2SHIP is a U.S. National Science Foundation (NSF) 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.
"One of the key goals of C2SHIP is accelerating translation of cutting-edge technologies to patients' care in-place, while training students and fellows in remote patient care," said Bijan Najafi, Ph.D., Professor of Surgery, Director of Clinical Research at the Division of Vascular Surgery and Director of C2SHIP at the Baylor College of Medicine. "We are pleased to welcome NeuroMetrix to C2SHIP as one of our industrial members. NeuroMetrix's innovative product called Quell is well suited to the mission of C2SHIP. We are hoping with the support of C2SHIP that we will accelerate its integration for the in-place management of chronic pain, remote monitoring of pain and its impact on mobility, and to empower patients to select personalized pain management regimes to better move through the world."
"We are honored to join C2SHIP and look forward to a productive partnership with the participating academic centers, which are among the top biomedical research institutions in the country. Through these collaborations we hope to advance Quell technology to further benefit patients," said Shai N. Gozani, M.D., Ph.D., President and CEO of NeuroMetrix."
About C2SHIP
The mission of the Center to Stream Healthcare In Place (C2SHIP) is to engage academic and industrial partners in joint efforts that develop healthcare technologies for in-place care and accelerate innovation through multi-specialty collaborations. The Center's strategy is to emphasize fundamental investigations that provide an in-depth understanding of the core disciplines needed for personalized technology that promotes in-place care, to establish effective interactions with Center members to promote innovation capacity and accelerate technology transfer, and to promote collaborations with other existing centers to create multi-center innovative technology for the involved core disciplines. C2SHIP is part of the U.S. National Science Foundation (NSF) Industry/University Cooperative Research Centers (I/UCRC) program. For more information visit C2SHIP.org.
About NeuroMetrix
NeuroMetrix is an innovation-driven company focused on the development and global commercialization of non-invasive medical devices for the diagnosis and treatment of pain and neurological disorders. 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 entrapment neuropathies. Quell is a wearable neurostimulation device indicated for treatment of lower extremity chronic pain. For more information, visit NeuroMetrix.com.
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