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 receipt of marketing certification from Technischer Überwachungs-Verein SÜD Japan Ltd. (TÜV SÜD Japan) for NC-stat DPNCheck as a Class II Designated Controlled Medical Device as defined in the technical standards of the Japan Ministry of Health, Labor, and Welfare.
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 regulatory process was managed by Omron Healthcare Co. Ltd. As the Company's exclusive distributor for Japan, Omron initiated a DPNCheck product awareness campaign at the recent Annual Meeting of the Japan Diabetes Society. TÜV SÜD Japan approval will allow Omron to shift from market education to direct sales promotion.
Diabetes is a major health issue in Japan affecting over 7 million people or 7.6% of its adult population. Japan is also a unique market. It has a combination of physician reimbursement for nerve conduction testing and an approved pharmacological agent (Epalrestat) for treating diabetic peripheral neuropathy. As the home market for Omron Healthcare, Omron has a strong presence through complimentary products and broad, established distribution.
"Omron skillfully guided DPNCheck through the Japan regulatory process," said Shai N. Gozani, M.D., Ph.D., President and Chief Executive Officer of NeuroMetrix. "TÜV SÜD Japan approval allows us to finalize product labeling and, within the next few weeks, initiate DPNCheck shipments to Japan. Working closely with Omron over the past year has also helped us develop a solid partnership foundation which should serve us well in this and other large Asian markets."