NeurAxis Inc. Announces FDA 510(k) Clearance of RED for Testing and Evaluation of Patients with Chronic Constipation [Yahoo! Finance]
Neuraxis, Inc. (NRXS)
Company Research
Source: Yahoo! Finance
NeurAxis Inc. will begin the process of commercially marketing RED and expects initial revenues in 1Q25 as there is a Category I CPT code assigned to the procedure and the procedure is covered by Medicare and most commercial insurance companies. CARMEL, Ind., Dec. 10, 2024 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (“NeurAxis,” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies addressing chronic and debilitating conditions in children and adults, today announced the US Food and Drug Administration (FDA) granted a 510(k) clearance for RED (Rectal Expulsion Device), allowing NeurAxis to commercially market the device for testing and evaluation of patients with chronic constipation due to pelvic floor dyssynergia and who are unlikely to improve with increased laxative use. NeurAxis will begin the process of commercially marketing RED and expects a soft launch in the first quarter of 2025 with a full launch expected in the second
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News
- NeurAxis Inc. Announces FDA 510(k) Clearance of RED for Testing and Evaluation of Patients with Chronic ConstipationGlobeNewswire
- NeurAxis Stock Surges After Strong Q3 Earnings and Expanded Coverage [Yahoo! Finance]Yahoo! Finance
- NeurAxis Reports Strong Third Quarter 2024 Financial Results Driven by a 40% Increase in Revenues [Yahoo! Finance]Yahoo! Finance
- NeurAxis Reports Strong Third Quarter 2024 Financial Results Driven by a 40% Increase in RevenuesGlobeNewswire
- NeurAxis to Host Third Quarter 2024 Results and Business Update Call on Tuesday, November 12, 2024GlobeNewswire
NRXS
Sec Filings
- 12/13/24 - Form S-3
- 12/2/24 - Form SC
- 12/2/24 - Form SC
- NRXS's page on the SEC website