NeuroMetrix, Inc. (Nasdaq: NURO) today 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, MA 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% 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.
“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 Chief Executive Officer 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 leading 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 U.S. 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. For product information visit 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 a commercial stage, innovation driven 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, 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160913005189/en/Business Wire
Last updated on: 13/09/2016
PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.