NeuroMetrix gets FDA clearance for wearable pain management system for OTC use

8 July 2014 (Last Updated July 8th, 2014 18:30)

NeuroMetrix has received US Food and Drug Administration (FDA) 510(k) clearance for its wearable technology for over-the-counter (OTC) use in treatment of chronic pain.

NeuroMetrix has received US Food and Drug Administration (FDA) 510(k) clearance for its wearable technology for over-the-counter (OTC) use in treatment of chronic pain.

NeuroMetrix is currently at its late-stage development of a new consumer oriented chronic pain treatment product, based on its wearable technology.

At present, the company's wearable technology is deployed in its SENSUS Pain Management System that uses comfortable, non-invasive electrical stimulation of sensory nerves to induce safe and effective pain relief.

The lightweight device can be worn during the day and also is active at night while sleeping.

"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."

FDA 510(k) clearance allows the company to market the OTC device through retail distribution channels without a prescription requirement.

NeuroMetrix president and chief executive officer Shai Gozani said: "We believe that there is a substantial consumer market for an over-the-counter version of this technology.

"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."

The company develops wearable medical technology and point-of-care tests that help patients and physicians better manage chronic pain, nerve diseases and sleep disorders.

Mainly, the company is focused on diabetic neuropathies, which affect more than 50% of people with diabetes and if left untreated, diabetic neuropathies trigger foot ulcers that may require amputation and cause disabling chronic pain.

NeuroMetrix markets the SENSUS device to treat chronic pain, focusing on physicians managing patients with neuropathic pain such as painful diabetic neuropathy.

The company also markets DPNCheck, a rapid, accurate, and quantitative point-of-care test for peripheral neuropathies such as diabetic neuropathy and it is used to detect neuropathies at an early stage and to guide treatment.