Sell what is cleared now. Seed what comes next.
The robot's reach grows one indication at a time. Each hole below fills as the evidence and the label catch up.
The indication roadmap.
FDA cleared with CT. The core of the NeuWave base.
Small renal masses fit today's CT workflow. Label scope to confirm.
CE marked. EPIOS has treated US patients since April 2026.
Under study in Europe. Build thoracic champions early.
Needs new imaging, a new clearance and clinical data.
333,830 new prostate cancer cases in the US this year.Source
Two trends pull in opposite directions. More men are diagnosed every year: incidence has risen about 3% a year since 2014. Fewer of them get brachytherapy: its share of treatment halved between 2002 and 2010, partly because fewer physicians were trained to place the seeds. That is a placement problem, and placement is what a robot does.
Share of men with localized prostate cancer treated with brachytherapy
Each grid is 100 patients with localized disease. Filled holes received brachytherapy. 2010 is the latest year in this national study.
American Cancer Society estimate for 2026. Brachytherapy share: National Cancer Data Base, Martin et al.Source The other drivers were robotic prostatectomy, IMRT and SBRT, and reimbursement.
Focal ablation is the way in. Brachytherapy is the bridge.
Focal prostate therapy is already ablation. NanoKnife IRE is cleared for prostate tissue, and HIFU and focal laser are cleared too. My brachytherapy years give me the radiation oncology and urology relationships to start the conversation.
| What it takes | Epione today | Prostate needs |
|---|---|---|
| Imaging | CT and cone beam CT | Transrectal ultrasound or MRI fusion |
| Clearance | Abdominal ablation in the US | A new indication, backed by clinical data |
| Buyer | Interventional radiology | Urology and radiation oncology |
| Payment | Established ablation codes | Coverage for focal therapy is still uneven |
My role: convene KOLs, capture the procedure workflow step by step, and feed it to R&D and clinical affairs. I won't claim outcomes we haven't proven.