Omron Leading Local Initiatives
WALTHAM, Mass.--(BUSINESS WIRE)--
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160913005189/en/
NeuroMetrix, Inc.
Thomas T. Higgins, 781-314-2761
SVP and
Chief Financial Officer
neurometrix.ir@neurometrix.com
Source: NeuroMetrix, Inc.
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