Brain tumor IORT — the Intrabeam and GammaTile systems delivering localized radiation during glioblastoma, meningioma, and metastasis resection creating the neurosurgical IORT segment in the global intraoperative radiation therapy market — creates the highest neuro-oncology segment, with the Intraoperative Radiation Therapy Market reflecting brain IORT as the premium neurosurgical commercial driver.

The glioblastoma resection challenge — the 90-95% local recurrence within 2 cm of resection cavity despite surgery, temozolomide, and external beam radiotherapy creating the dose escalation need. IORT delivering 10-15 Gy to the resection margin, with local control improved 15-20% and median survival extended 3-6 months in selected patients, demonstrating the local control benefit.

GammaTile brachytherapy — the Cs-131 collagen tile implants placed at resection margin providing 60-80 Gy over 30-60 days. FDA-cleared for recurrent brain tumors (2018), with 4x4 mm tiles containing Cs-131 sources embedded in absorbable collagen, and 50-60% local control at 1 year versus 20-30% with resection alone, representing approximately fifteen to twenty percent of current brain IORT and growing, with sustained release rather than single fraction characterizing the brachytherapy approach.

Meningioma and metastasis applications — the recurrent atypical/malignant meningiomas and limited brain metastases creating the IORT consideration. IORT for meningioma with Simpson grade 4-5 resection, and metastasis with single lesion and prior whole brain radiotherapy, representing approximately ten to twelve percent of current brain IORT and growing, with recurrence prevention rather than primary treatment characterizing the application.

Do you think brain IORT will become standard for glioblastoma, or will the modest survival benefit, neurotoxicity concerns, and technical complexity sustain it as specialized center practice for selected patients?

What brain IORT technologies exist, and what is the evidence for clinical benefit? Brain IORT technologies: Intrabeam (Zeiss) — 50 kV; X-ray; spherical; applicator; resection; cavity; 10-15 Gy; surface; 20-30 min; setup; 1-2M; GammaTile (GT Medical) — Cs-131; collagen; tile; 4x4 mm; implant; resection; margin; 60-80 Gy; 30-60 days; sustained; FDA; 2018; recurrent; other — linear accelerator: electron; 6-12 MeV; limited; brain; proton: IORT; research; early; evidence: glioblastoma — IORT: 10-15 Gy; local control: 40-50%; 1-year; vs. 20-30%; without; survival: 15-18 months; median; vs. 12-15; without; 3-6 months; improvement; meningioma — atypical/malignant: Simpson 4-5; recurrent; IORT: 10-15 Gy; local control: 60-70%; 5-year; vs. 30-40%; without; metastasis — single; prior; WBRT; IORT: 10-15 Gy; local control: 50-60%; 1-year; vs. 20-30%; without; toxicity: radionecrosis — 10-20%; symptomatic; steroid; responsive; 5-10% surgery; edema — 20-30%; asymptomatic; symptomatic; 10-15%; steroid; wound — 5-10%; infection; dehiscence; delayed; healing.

What is the brain IORT market, and what are the competitive and reimbursement dynamics? Brain IORT market: size — $30-50M annually; 10-15% of IORT; 2024; glioblastoma: $15-25M; 50-60% of brain; meningioma: $10-15M; 30-40% of brain; metastasis: $5-10M; 10-20% of brain; competitive landscape: GT Medical (GammaTile) — market leader; ~60%; Cs-131; collagen; FDA; 2018; recurrent; Zeiss (Intrabeam) — ~30%; 50 kV; X-ray; spherical; breast; brain; others: ~10%; LINAC; proton; research; reimbursement: US — CMS: GammaTile; Category I; CPT; 61798; $15,000-25,000; covered; Intrabeam: Category III; C-code; limited; MAC; commercial: GammaTile; 60-70%; covered; Intrabeam: 40-50%; limited; EU — national: variable; Germany: limited; research; France: limited; UK: NICE; not recommended; future outlook: 10-15% of recurrent glioblastoma; 2030; 20-30% of recurrent meningioma; GammaTile; standard; technology; combination; 5-aminolevulinic acid; fluorescence; guided; resection; IORT; precision; temozolomide; Gliadel; wafer; combination; local; control; survival; improvement; randomized; Phase III; needed; definitive; evidence; standard; of care.

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