NeuroMetrix Reports Final Approval to Market DPNCheck in China

NeuroMetrix Inc. has reported final regulatory approval in China for DPNCheck, a diagnostic test for peripheral neuropathy. DPNCheck is registered as a Class II medical device with the China Food and Drug Administration (CFDA) and the company’s facility in Woburn, Mass., is approved for DPNCheck production. This clears the final hurdle for DPNCheck to be marketed in China.
 
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 nearly 12 percent today. The International Diabetes Federation (IDF) estimated in 2014 that more than 96 million people in China had diabetes. This represents nearly 25 percent of the IDF estimated worldwide population of 387 million people with diabetes.
 
“We are pleased that we have completed the regulatory process in China and can now shift our focus to product launch,” said Shai N. Gozani, M.D., Ph.D., president and CEO of NeuroMetrix. “Marketing and operational planning is underway with our Asia partner, Omron. Our goal is to launch in selected regions late in Q4. Longer-term we will work with Omron to expand product awareness among physicians, likely including clinical studies in China. We believe that DPNCheck addresses an important void in the care of persons with diabetes and that China offers us a significant market opportunity.”
 
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. It 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. DPNCheck is marketed in the United States to Medicare Advantage providers for profiling their patient population as well as guiding treatment. It is marketed in Japan by Omron Healthcare and in Mexico by Scienta Pharma.
 
Omron Healthcare, headquartered in Kyoto, Japan, is a global leader in health care monitoring. The company offers a 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.
 
NeuroMetrix is a commercial stage 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, including a therapeutic device for restless leg syndrome. The company is located in Waltham, Mass., and was founded as a spinoff from the Harvard-MIT Division of Health Sciences and Technology in 1996.