DPNCheck is a point-of-care-test designed to detect diabetic peripheral neuropathy at an early stage to allow for appropriate treatment. NeuroMetrix said that DPN is the most common complication of diabetes, and affects more than 50% of people with diabetes.
“Omron skillfully guided DPNCheck through an extended regulatory process. We are now collaborating on marketing plans leading to commercial launch. We believe that DPNCheck addresses an important void in the care of persons with diabetes in China, and have discussed this topic with leading Chinese physicians over the past several years. Working closely with Omron, we believe we can develop a significant market opportunity in China,” CEO Dr. Shai Gozani said in a press release.
NeuroMetrix worked with its exclusive Chinese distributor Omron Healthcare to win the regulatory nod, and said the device is now registered as a Class II medical device.
Waltham, Mass.-based NeuroMetrix said a study published in JAMA indicated that the prevalence of Diabetes has risen to 11.6% today, and the International Diabetes Federation estimated over 96 million people in the country had diabetes in 2014.
The Chinese approval has lifted NeuroMetrix in trading today, up 4.2% to trade at $1.74 as of 12:53 p.m. EST.
Earlier this month, NeuroMetrix saw shares jump as high as 37% after announcing it won FDA 510(k) clearance for an upgraded version of its Quell wearable over-the-counter chronic pain relief device, though stocks didn’t hold onto the inertia.
The new model is designed to be controlled through a company-developed smartphone app, and has an extended battery life and advanced sleep tracking, according to the company.