NeuroMetrix Reports Final Approval to Market DPNCheck in China
Omron Leading Local Initiatives
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.”
About DPNCheck
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/.
About Omron
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/.
About NeuroMetrix
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.
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NeuroMetrix, Inc.
Thomas T. Higgins, 781-314-2761
SVP and Chief Financial Officer
neurometrix.ir@neurometrix.com
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