NeuroMetrix has reported final regulatory approval in China for DPNCheck, a diagnostic test for peripheral neuropathy.
DPNCheck is registered as a Class II Medical Device with the China Food and Drug Administration (CFDA) and the Company’s facility in Woburn, MA is approved for DPNCheck production. This clears the final hurdle for DPNCheck to be marketed in China.
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 nearly 12% 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.
“We are pleased that we have completed the regulatory process in China and can now shift our focus to product launch,” said Shai N. Gozani, M.D., Ph.D., President and Chief Executive Officer of NeuroMetrix.
“Marketing and operational planning is underway with our Asia partner, Omron. Our goal is to launch in selected regions late in Q4. Longer-term we will work with Omron to expand product awareness among leading physicians, likely including clinical studies in China. We believe that DPNCheck addresses an important void in the care of persons with diabetes and that China offers us a significant market opportunity.”
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.
It 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