Fiscal 2026 Revenue Guidance
Company projects fiscal 2026 sales of at least $10.5M, representing a minimum 17% increase versus fiscal 2025.
Sequential Revenue Growth
Product revenue of $2.9M in Q1 FY2026 increased 5.5% sequentially from $2.7M in the prior quarter.
1RF Brain Ablation Adoption
Number of ablations performed in Q1 FY2026 was nearly half of all ablations since launch, indicating rapid penetration and adoption of the 1RF brain ablation system; positive clinical anecdotes shared (e.g., professional pianist resuming career). Registry planned with first patient enrollment target by end of Q3.
Trigeminal Nerve System Clinical Success
1RF trigeminal nerve ablation received FDA 510(k) clearance (Aug 2025). Limited commercial launch: 9 patients treated across 3 centers in 2026 with all reported pain free to date; first two patients at University Hospitals Cleveland reported pain relief. Limited launch expected to complete by 2026; in diligence discussions with strategics for potential licensing.
Accelerated Drug Delivery Program
Drug delivery program accelerated; devices expected to be available for investigational clinical studies or animals in Q3 FY2026 (~6 months ahead of prior schedule). Advisory board of oncology experts being organized and active discussions with pharma/biotech partners underway.
Back Pain Programs Progress
14‑gauge needle program: long-term animal study to start next month in preparation for first human implant; basivertebral nerve ablation program: multiple advisory board meetings held, product requirements validated, and strategic diligence ongoing.
Cost Discipline in SG&A
Selling, general & administrative expense decreased 7.7% year-over-year to $1.9M (from $2.0M), indicating some operating cost control.
No Debt and Strategic Board Addition
Company reported no outstanding debt as of 12/31/2025 and appointed Jason Mills (formerly EVP Strategy, Penumbra) to the board to support business development and strategic efforts.