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”.
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/.
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.
Thomas T. Higgins, 781-314-2761
SVP and Chief Financial Officer
Source: NeuroMetrix, Inc.