Strong Q2 Product Revenue Growth
Product revenue for OneRF brain ablation system grew 72% year-over-year to $2.4M in Q2 FY2026 (from $1.4M in Q2 FY2025); product revenue for the six months ended March 31, 2026 was $5.3M, up 13% year-over-year (from $4.7M).
Clinical and Publication Milestones
Peer-reviewed case series published validating real-time temperature monitoring in SEEG-guided RF ablation; OneRF highlighted at AANS; OneRF trigeminal nerve ablation system completed 16 cases under limited market release with all patients reportedly pain-free.
Regulatory / Quality Progress for International Expansion
Completed Stage 2 ISO 13485 audit for the Minnesota facility and remain bullish on certification in the latter part of 2026 — a key step toward enabling international distribution.
Strategic Partnerships and Commercial Progress
Ongoing partnership with Zimmer Biomet for domestic and international commercialization; collaboration announced with University of Minnesota Neurology Division to advance drug delivery studies; drug delivery system on track for availability in H2 FY2026 for investigational/animal studies.
Corporate and Governance Improvements
Regained NASDAQ compliance following a 1-for-6 reverse split; appointed David Wambeke as Chief Business Officer (purchased 1M pre-split shares); new high-net-worth investor acquired ~7.4% of outstanding common stock.
Positive Product Gross Profit and Expense Discipline
Product gross profit was $1.3M (53.8% of product revenue) in Q2 FY2026; total operating expenses were largely flat year-over-year at $3.4M in Q2, with SG&A flat at $1.9M and R&D stable at $1.5M.
No Debt and Receivables Near-Term Conversion
NeuroOne reported no debt as of March 31, 2026 and had $2.4M in accounts receivable expected to convert to cash in Q3 based on normal collection patterns.