Omron Healthcare Leads Local Initiatives
WALTHAM, Mass.--(BUSINESS WIRE)--
NeuroMetrix, Inc. (Nasdaq: NURO) today reported regulatory approval in
China for DPNCheck®, a diagnostic test for peripheral
neuropathy. DPNCheck is now registered as a Class II Medical Device
under the Regulations for the Supervision and Administration of Medical
Devices of the China Food and Drug Administration (CFDA). Regulatory
approval allows DPNCheck to be marketed in China. The regulatory process
was managed by Omron Healthcare (China) Co. Ltd, the Company's exclusive
local distributor.
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. DPN 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.
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 11.6% 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.
"Omron skillfully guided DPNCheck through an extended regulatory
process," said Shai N. Gozani, M.D., Ph.D., President and Chief
Executive Officer of NeuroMetrix. "We are now collaborating on marketing
plans leading to commercial launch. We believe that DPNCheck addresses
an important void in the care of persons with diabetes in China, and
have discussed this topic with leading Chinese physicians over the past
several years. Working closely with Omron, we believe we can develop a
significant market opportunity in China."
Product information on DPNCheck is available at 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 an innovative health-care company that develops wearable
medical technology and point-of-care tests that help patients and
physicians better manage chronic pain, nerve diseases, and sleep
disorders. 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/20160121005233/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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