rectal expulsion device (RED)

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NeurAxis Stock Gains Following Strong Q1 Earnings and FDA Milestones
ZACKS· 2025-05-15 17:11
Shares of NeurAxis, Inc. (NRXS) have gained 13.3% since the company reported its earnings for the quarter ended March 31, 2025. This compares to the S&P 500 Index’s 4.3% growth over the same time frame. Over the past month, the stock gained 39.9% compared with the S&P 500’s 11.6% rise.Revenue and Earnings PerformanceIn the first quarter of 2025, NeurAxis posted revenues of $0.9 million, a 38.5% increase from $0.6 million in the prior-year period. Unit sales grew 46% year over year, largely driven by higher ...
NeurAxis Reports Strong First Quarter 2025 Financial Results Driven by a 39% Growth in Revenues
Globenewswire· 2025-05-12 12:15
Core Viewpoint - NeurAxis, Inc. reported strong financial growth in Q1 2025, with a 39% year-over-year revenue increase, driven by expanding treatment access and positive payer coverage for its neuromodulation therapies [4][7]. Financial Highlights - Revenues for Q1 2025 reached $896 thousand, up from $647 thousand in Q1 2024, marking a 39% increase year-over-year and an 18% increase quarter-over-quarter [7][9]. - Operating loss improved by 9% when excluding a one-time legal settlement, with a reported operating loss of $2.3 million, an increase of 25% compared to $1.8 million in Q1 2024 [12][13]. - Cash balance as of March 31, 2025, was $2.0 million, with no long-term debt [14]. Operational Highlights - The company treated 300 patients in Q1 2025, indicating an annualized treatment rate of 1,200 patients, which is still a small fraction of the 600,000 children in the U.S. suffering from IBS [4][6]. - Positive coverage policies now encompass approximately 51 million lives, a significant increase from 4 million as of December 31, 2023 [5][7]. - NeurAxis received FDA clearance for expanding the IB-Stim label to include patients aged 8-21 and for its rectal expulsion device (RED), which is expected to generate meaningful revenues starting in Q2 2025 [7][8]. Management Commentary - The CEO highlighted that the growth is attributed to physicians becoming more comfortable with billing processes and increased awareness of treatment guidelines [5][6]. - The company anticipates that the upcoming publication of academic society guidelines and the implementation of a Category I CPT code on January 1, 2026, will be critical for expanding insurance coverage and driving national growth [6][9]. Market Position - NeurAxis is focused on expanding its pediatric addressable market and has submitted for FDA clearance to include pediatric Functional Dyspepsia, which could effectively double its market size [8]. - The company is committed to clinical research, with 16 peer-reviewed publications supporting its PENFS technology, enhancing its position for expanding payer coverage [7].