NeurAxis, a medical technology company commercializing neuromodulation therapies addressing chronic and debilitating conditions in children and adults, today 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.
A systematic literature review demonstrated that at least 9 published studies that used the IB-Stim technology in children with chronic abdominal pain used a total of four devices over 4 consecutive weeks. The systematic literature review also demonstrated that many patients as young as 8 years and up to 21 years, which is outside of the current indication age range, have been successfully treated with IB-Stim. No study reported serious adverse events. These data were submitted to the FDA through a 510k application to expand the current label.
“We are excited about our new submission to the FDA to expand the label for IB-Stim which would include ages 8-21, and 4 devices over 4 weeks. IB-Stim is currently indicated for ages 11-18 years of age, using 3 devices not to exceed 4. This potential label expansion could impact many children who would otherwise fall into an “off-label” category and allow for them to receive the proper care that is supported by the scientific literature. We are cautiously optimistic that the FDA will grant the request for a label expansion,” said Brian Carrico, President and Chief Executive Officer of NeurAxis. “We continue to make progress on our robust pipeline of indications, as we have positioned NeurAxis to become a leader in the treatment of disorders of the gut-brain interactions,” Mr. Carrico concluded.
Compliance with NYSE Guidelines on Audit Opinion
As previously disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, which was filed on April 16, 2024 with the Securities and Exchange Commission, 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. This announcement is being made solely to comply with Section 610(b) of the NYSE American LLC Company Guide, which requires public announcement of the receipt of an audit opinion containing a going concern paragraph. This announcement does not represent any change or amendment to the Company’s audited financial statements or to its Annual Report on Form 10-K for the year ended December 31, 2023.
Management continues to improve the Company’s financial position to achieve its objectives. In addition to securing $3.0 million in committed convertible note financing from affiliates of Inspire Health Alliance on November 8, 2023, the Company also closed an additional $3.1 million in committed financing from various investors, including affiliates of Inspire Health Alliance, with identical terms in the first quarter of 2024, with the financing scheduled to be paid in monthly amounts through the first quarter of 2025. The Company further strengthened its balance sheet and liquidity position on May 21, 2024 as it closed on an additional $3.0 million in convertible notes with a healthcare focused fund managed by institutional accredited investors.
