WALTHAM, Mass.--(BUSINESS WIRE)--NeuroMetrix, Inc. (Nasdaq: NURO) today reported regulatory approval in China for DPNCheck®, a diagnostic test for peripheral neuropathy. DPNCheck is now registered as a Class II Medical Device under the Regulations for the Supervision and Administration of Medical Devices of the China Food and Drug Administration (CFDA). Regulatory approval allows DPNCheck to be marketed in China. The regulatory process was managed by Omron Healthcare (China) Co. Ltd, the Company’s exclusive local distributor.
DPNCheck is a rapid, accurate and quantitative point-of-care test to detect diabetic peripheral neuropathy, or DPN, at an early stage allowing physicians to select appropriate treatment. DPN is the most common complication of diabetes, affecting over half of people with diabetes. DPN causes significant morbidity including pain, increased risk of falling in the elderly, and is the primary trigger for diabetic foot ulcers which may require lower extremity amputations.
China is dealing with an epidemic of diabetes. According to a recently published study in the Journal of the American Medical Association (JAMA), the prevalence of diabetes in the Chinese population has risen dramatically over the past decades to 11.6% today. The International Diabetes Federation (IDF) estimated in 2014 that over 96 million people in China had diabetes. This represents nearly 25% of the IDF estimated worldwide population of 387 million people with diabetes.
“Omron skillfully guided DPNCheck through an extended regulatory process,” said Shai N. Gozani, M.D., Ph.D., President and Chief Executive Officer of NeuroMetrix. “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.”
Product information on DPNCheck is available at http://www.DPNCheck.com/
Omron Healthcare, headquartered in Kyoto, Japan, is a global leader in health care monitoring. The company offers a wide range of devices and services that help prevent and manage lifestyle diseases such as blood pressure monitors, body composition monitors and activity counters as well as medical devices such as vascular screening devices and visceral fat monitors in more than 100 countries. For more information on Omron Healthcare, visit www.healthcare.omron.co.jp/english/.
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 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 www.NeuroMetrix.com.