FDA Clears NeuroMetrix Wearable Technology for Over-the-Counter Use in Treatment of Chronic Pain
Key Step Towards Entering Consumer Healthcare Market
WALTHAM, Mass.--(BUSINESS WIRE)--NeuroMetrix, Inc. (Nasdaq: NURO) today announced that its wearable technology for treatment of chronic pain received 510(k) clearance (K140333) from the U.S. Food and Drug Administration (FDA) for over-the-counter use.
“Patient response to SENSUS, our prescription wearable device for treatment of chronic pain, has been very positive since it was launched in early 2013. We believe that there is a substantial consumer market for an over-the-counter version of this technology”
The Company is in late stage development of a consumer oriented chronic pain treatment product. The device is based on wearable technology, presently deployed in the Company’s SENSUS® Pain Management System, that utilizes comfortable, non-invasive electrical stimulation of sensory nerves to induce safe and effective pain relief. It is lightweight and can be worn during the day while active, and at night while sleeping. This 510(k) clearance allows the Company to market the over-the-counter device through retail distribution channels without a prescription requirement.
“Patient response to SENSUS, our prescription wearable device for treatment of chronic pain, has been very positive since it was launched in early 2013. We believe that there is a substantial consumer market for an over-the-counter version of this technology,” said Shai N. Gozani, M.D., Ph.D., President and Chief Executive Officer of NeuroMetrix. “The ability to offer both prescription and over-the-counter products will give us maximal market exposure and allow us to reach more people with chronic pain. We anticipate a commercial launch in 2015.”
NeuroMetrix is an innovative health-care company that develops wearable medical technology and point-of-care tests that help patients and physicians better manage chronic pain, nerve diseases, and sleep disorders. The Company has a major focus on diabetic neuropathies, which affect over 50% of people with diabetes. If left untreated, diabetic neuropathies trigger foot ulcers that may require amputation and cause disabling chronic pain. The annual cost of diabetic neuropathies has been estimated at $14 billion in the United States. The Company markets the SENSUS device for treating chronic pain, focusing on physicians managing patients with neuropathic pain such as painful diabetic neuropathy. The Company also markets DPNCheck®, which is a rapid, accurate, and quantitative point-of-care test for peripheral neuropathies such as diabetic neuropathy. This product is used to detect neuropathies at an early stage and to guide treatment. For more information, please visit http://www.SENSUSRx.com or http://www.NeuroMetrix.com.