NeurAxis ( NYSE: NRXS ) on Friday announced a submission to the FDA for expansion of its IB-Stim label. The new submission is significant as it would allow access to a larger patient population beyond 11-18 years of age and allow for marketing of 4 devices per prescription. As disclosed in the company’s Annual Report on Form 10-K for the year ended December 31, 2023, the audited financial statements contained an unqualified audit opinion from the company’s independent registered public accounting firm that included an explanatory paragraph related to the company’s ability to continue as a going concern.

The company said this announcement was made solely to comply with NYSE American LLC Company Guide, which requires public announcement of the receipt of an audit opinion containing a going concern paragraph. Source: Press Release More on NeurAxis Historical earnings data for NeurAxis Financial information for NeurAxis.