Early Filing Achieved with Omron Healthcare China
WALTHAM, Mass.--(BUSINESS WIRE)--
NeuroMetrix, Inc. (Nasdaq: NURO), an innovative health care company that
develops wearable medical technology and point-of-care tests to help
patients and physicians manage chronic pain, nerve diseases, and sleep
disorders, today reported the regulatory submission for NC-stat®
DPNCheck® in China. NC-stat 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.
The submission was prepared in close collaboration with Omron
Healthcare, NeuroMetrix' partner for NC-stat DPNCheck in China and other
Asia markets. The submission seeks registration as a Class II Medical
Device as defined in the Regulations for the Supervision and
Administration of Medical Devices administered by the China Food and
Drug Administration (CFDA). Clearance of the submission will allow
NC-stat DPNCheck to be marketed within China.
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 2012 that over
ninety-two million people in China had diabetes. This represents nearly
25% of the IDF estimated worldwide population of 371 million people with
diabetes. The president of the IDF has described diabetes in China as a
"catastrophe".
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 has a major focus on diabetic neuropathies, which
affect over 50% of people with diabetes. If left untreated, diabetic
neuropathies trigger foot ulcers that may require amputation and cause
disabling chronic pain. The annual cost of diabetic neuropathies has
been estimated at $14 billion in the United States. The Company markets
the SENSUS™ device for treating chronic pain, focusing on physicians
managing patients with neuropathic pain such as painful diabetic
neuropathy. The Company also markets DPNCheck, which is a rapid,
accurate, and quantitative point-of-care test for peripheral
neuropathies such as diabetic neuropathy. This product is used to detect
neuropathies at an early stage and to guide treatment. For more
information, please visit http://www.DPNCheck.com.
NeuroMetrix, Inc.
Thomas T. Higgins, 781-314-2761
SVP and
Chief Financial Officer
neurometrix.ir@neurometrix.com
Source: NeuroMetrix, Inc.
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