WALTHAM, Mass.--(BUSINESS WIRE)--NeuroMetrix, Inc. (Nasdaq: NURO) today provided an update on its Quell® clinical program. Quell is a wearable non-invasive neurostimulator that provides widespread analgesia for chronic pain. In addition to delivery of therapy, the device and its associated smartphone app track utilization and health metrics including pain, sleep, activity and gait.
The objective of the clinical program is to build clinical credibility for Quell technology, further scientific understanding of its mechanism of action, and better identify Quell therapy responders. In a study published last year in the Journal of Pain Research, 81% of subjects reported a general improvement in their chronic pain and 67% reported a reduction in pain medication use after 60 days of use. Additional study findings included decreased pain interference with sleep and walking ability. There are currently 4 studies underway.
Quell TENS band for Chemotherapy-Induced
Peripheral Neuropathy (CIPN). A Feasibility Study. University of
Rochester Medical Center, University of Rochester, Rochester, NY.
This open label study is evaluating Quell efficacy, assessed by pain relief and continued device use, in subjects with CIPN. Preliminary results were presented at the recent American Pain Society meeting May 17-20 in Pittsburgh, PA. Among subjects completing the first 6 weeks of the study, 73% decided to continue using their Quell device. In addition, statistically significant reductions in pain, tingling, cramping and numbness were observed.
Quell Opioid Reduction and Pain Relief in
Patients with Cancer. Scripps Translational Science Institute, Scripps
Health, San Diego, CA.
This randomized sham-controlled study is evaluating opioid use reduction in patients with various forms of cancer pain. The study is fully enrolled. Preliminary results are expected in Q4 ’17.
Efficacy of the Quell Wearable Device for
Chronic Low Back Pain. Brigham and Women’s Hospital, Harvard Medical
School, Boston, MA.
This randomized controlled study is evaluating pain relief and quality of life improvements in subjects with low back pain using Quell compared to control subjects on standard therapy. The study is 75% enrolled. Preliminary results are expected in Q4 ’17.
Prospective Validation of Quell Sleep/Wake
Classification and Periodic Leg Movement Detection. Massachusetts
General Hospital, Harvard Medical School, Boston, MA.
This study is comparing Quell sleep tracking to gold standard polysomnography. The study is 25% enrolled. Preliminary results are expected in Q4 ’17.
"We believe that the conduct of clinical studies evaluating various aspects of Quell technology is essential to continued evolution of the platform for both treatment of chronic pain and development of additional indications," said Shai N. Gozani, M.D., Ph.D., President and CEO of NeuroMetrix. "We are honored to work with outstanding academic medical centers in this effort, and look forward to learning from these initial studies and expanding our clinical program in the near future.”
Quell is designed for millions of people suffering from chronic pain. The advanced wearable device is lightweight and can be worn during the day while active, and at night while sleeping. It has been cleared by the FDA for treatment of chronic pain without a prescription. In a recent study, 81% of Quell users reported an improvement in their chronic pain. Quell users can personalize and manage therapy discreetly via the Quell Relief app. Quell also offers advanced health tracking relevant to chronic pain sufferers including pain, sleep, activity, and gait. Quell was the winner of the 2016 SXSW (South by Southwest) Innovation Award for Best Wearable Technology. Quell is available at select healthcare professionals and retailers. Visit QuellRelief.com for more information.
NeuroMetrix is a commercial stage, innovation driven healthcare company combining bioelectrical and digital medicine to address chronic health conditions including chronic pain, sleep disorders, and diabetes. The company's lead product is Quell, an over-the-counter wearable therapeutic device for chronic pain. Quell is integrated into a digital health platform that helps patients optimize their therapy and decrease the impact of chronic pain on their quality of life. The company also markets DPNCheck®, a rapid point-of-care test for diabetic neuropathy, which is the most common long-term complication of Type 2 diabetes. The company maintains an active research effort and has several pipeline programs. The company is located in Waltham, Massachusetts and was founded as a spinoff from the Harvard-MIT Division of Health Sciences and Technology in 1996. For more information, please visit NeuroMetrix.com.