NeuroMetrix Reports Final Approval to Market DPNCheck in China
September 13 2016 - 7:00AM
Business Wire
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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version on businesswire.com: http://www.businesswire.com/news/home/20160913005189/en/
NeuroMetrix, Inc.Thomas T. Higgins, 781-314-2761SVP and Chief
Financial Officerneurometrix.ir@neurometrix.com
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