- Regulatory Progress. The FDA cleared the Company’s 510(k) submission for the SENSUS pain management device in August 2012. A second 510(k) submission in June 2012 for the Company’s proprietary SENSUS electrode is under FDA review. Following FDA clearance for the electrode, the Company plans to launch SENSUS before the end of 2012.
- Managed Care Expansion. The WellMed Medical Group of San Antonio, TX adopted NC-stat DPNCheck in the second quarter of 2012 to test its Medicare Advantage patients. WellMed accelerated patient testing during the third quarter with continued product support from the Company. The Company has added other managed care accounts and initiated pilots with additional Medicare Advantage provider networks. The managed care market sector represents the most compelling near term market opportunity for NC-stat DPNCheck.
- Endocrinology/Podiatry Sales. The Company’s direct sales force recorded orders for 102 NC-stat DPNCheck devices during the third quarter which reflects a consistent quarterly pace since product launch.
- Installed Base Growth. The installed base of NC-stat DPNCheck devices reached 778 by the end of the third quarter. This places the Company on track toward achieving its goal of 1,000 devices by the end of 2012.
NeuroMetrix, Inc. (Nasdaq: NURO), a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes, today reported business and financial highlights for the quarter and nine months ended September 30, 2012. The Company is working to develop a high growth, profitable diabetes franchise focused on diabetic peripheral neuropathy, or DPN, the most common complication of diabetes. DPN affects over 50% of people with diabetes and 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 Company’s emerging business currently has two products: a diagnostic test, NC-stat ® DPNCheck™, which was launched into the market at the end of 2011, and the SENSUS™ pain management device which is in late stage product development. The Company also sells the ADVANCE™ general purpose nerve testing system. Recent highlights include: