Core Insights - NeurAxis, Inc. has received FDA 510(k) clearance for its percutaneous electrical nerve field stimulation (PENFS) technology to treat functional abdominal pain (FAP) associated with functional dyspepsia (FD) and related nausea in patients aged 8 years and older, marking a historic milestone as the first FDA clearance for a treatment specifically addressing functional dyspepsia in adults [1][2] Company Overview - NeurAxis is a medical technology company focused on neuromodulation therapies for chronic and debilitating conditions in both children and adults, with a commitment to advancing science and evidence-based medicine [3] Market Expansion - The FDA clearance significantly expands NeurAxis's total addressable market by including patients aged 8 years and older, which is expected to drive substantial revenue growth in the gastrointestinal (GI) space [2][5] - The upcoming January 1, 2026, Category I CPT Code for PENFS procedures will apply to this new adult indication, facilitating broader clinical impact [2][5] Clinical Significance - Functional dyspepsia can lead to severe abdominal pain and nausea, significantly impacting quality of life, and the approval of PENFS technology provides a new treatment option for adult patients who previously had limited options [2]