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Neuraxis, Inc. (NYSE American:NRXS), a medical device company with a market capitalization of $37.71 million, announced Friday that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its proprietary percutaneous electrical nerve field stimulation (PENFS) technology. The clearance allows the device to be used for the treatment of functional abdominal pain associated with functional dyspepsia and related nausea symptoms in patients aged 8 years and older. The company has shown impressive revenue growth of 42% in the last twelve months, though InvestingPro analysis indicates it’s currently trading above its Fair Value.
According to a statement based on the company’s SEC filing, the FDA reviewed clinical literature, including randomized controlled trials and real-world evidence, demonstrating the safety and effectiveness of the PENFS device in pediatric patients and individuals up to 21 years of age. The FDA then extrapolated this data to adults, supporting the expanded use of the device for patients aged 8 and above. The company stated this marks the first FDA clearance or approval for treatment specifically addressing functional dyspepsia in the adult patient population.
In a separate development, Neuraxis reported that it amended its existing At The Market Offering Agreement with Craig-Hallum Capital Group LLC. As of October 23, 2025, the company increased the aggregate offering price of its common stock that may be sold under the agreement from $3.3 million to $6.27 million. The shares will be offered from time to time at the company’s discretion through at-the-market transactions, as defined under SEC rules. No shares were sold under the agreement between August 29, 2025, and October 23, 2025.
The legal opinion related to the issuance and sale of the shares under this agreement was provided by Lucosky Brookman LLP and is included as an exhibit in the SEC filing. The company’s EBITDA stands at -$6.46 million for the last twelve months, reflecting its current investment phase in growth initiatives.
All information is based on a statement in the company’s Form 8-K filed with the Securities and Exchange Commission.
In other recent news, Neuraxis, Inc. reported preliminary financial results for the third quarter of 2025, indicating an estimated operating loss of approximately $2.1 million. The company expects net sales of about $0.8 million and gross profits of roughly $0.7 million for the same period. Additionally, Neuraxis has approximately $4.4 million in cash and cash equivalents as of September 30, 2025. In a strategic financial move, Neuraxis entered into an At The Market Offering Agreement with Craig-Hallum Capital Group LLC, allowing the company to offer and sell up to $3.3 million of its common stock. This agreement provides flexibility for Neuraxis to manage its capital needs effectively. Previously, Neuraxis reported a significant 46% revenue growth in the second quarter of 2025, attributed to strategic product expansion and market penetration. Despite experiencing operating losses, the company remains focused on its growth prospects, supported by new FDA indications. These developments highlight Neuraxis’s ongoing efforts to strengthen its financial position and market presence.
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