WALTHAM, Mass.--(BUSINESS WIRE)--NeuroMetrix, Inc. (Nasdaq: NURO), a medical device company focused on the treatment and management of the neurological complications of diabetes, reported the regulatory submission for NC-stat DPNCheck® in Japan. 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 Co., Ltd, NeuroMetrix’ partner for NC-stat DPNCheck in Japan and other Asia markets. The submission seeks marketing certification for a Class II Designated Controlled Medical Device as defined in the technical standards of the Japan Ministry of Health, Labor, and Welfare. Clearance of the submission will allow NC-stat DPNCheck to be marketed within Japan.
NeuroMetrix is a medical device company that develops and markets home use and point-of-care devices for the treatment and management of chronic pain, peripheral neuropathies, and associated neurological disorders. The Company is presently focused 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™ Pain Management System for treating chronic pain, focusing on physicians managing patients with painful diabetic neuropathy. The company also markets the DPNCheck® device, which is a rapid, accurate, and quantitative point-of-care test for diabetic neuropathy. This product is used to detect diabetic neuropathy at an early stage and to guide treatment. For more information, please visit http://www.DPNCheck.com.