NeuroMetrix (Nasdaq: NURO) second-quarter results took a hit from challenges related to reimbursement changes at CMS, but Quell Fibromyalgia saw positive trends.
The Woburn, Massachusetts–based company’s Quell neuromodulation device won FDA de novo nod to treat fibromyalgia in May 2022. The company had 123 unique prescribers for the fibromyalgia therapy in Q2, versus 92 in Q1.
A new sales force expansion has the company focusing on the Texas, California and Florida markets, according to NeuroMetrix.
Meanwhile, the University of Rochester School of Medicine and Dentistry recently reported results of an NIH-funded multi-center randomized sham-controlled trial of Quell for chemotherapy-induced peripheral neuropathy (CIPN). According to NeuroMetrix, people with moderate to severe CIPN symptoms of hot/burning pain, sharp/shooting pain or muscle cramping experienced about a 50% reduction in symptoms for active Quell treatment compared to about 30% for sham Quell treatment.
The plan is to file for a 510(k) related to CIPN with the FDA in the fourth quarter of 2023.
NeuroMetrix says it continues to grapple with the disruption in the first quarter to the Medicare Advantage market, which the company says was caused by CMS changes to Risk Adjustment Data Validation (RADV) and to risk adjustment calculations.
Second-quarter revenue of $1.7 million was down 23% from Q2 2022, primarily due to reduced sales volume for DPNCheck in the Medicare Advantage market.
NURO shares were down more than 6% to 91¢ apiece by afternoon trading today.