---
schema_version: "secwatch.filing_event.v1"
accession: "0001171843-26-001553"
form_type: "8-K"
ticker: "PROF"
cik: "0001628808"
company_name: "Profound Medical Corp."
filed_at: "2026-03-13T23:59:59+00:00"
generated_at: "2026-05-15T12:36:52.250840+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# CAPTAIN trial meets primary safety endpoint: TULSA superior to robotic RP on function preservation

## Summary
- Primary composite endpoint met: 50% of TULSA patients preserved erectile function and continence at 6 months vs 24% for RP (p<0.05, risk ratio 2.1).
- TULSA preserved pad-free continence in 84% and erectile function in 56% of men at 6 months; RP: 49% and 47% respectively.
- Perioperative benefits: zero blood loss (0 mL vs 150 mL), median 0.3-day hospital stay vs 1.1 days, no ICU admissions versus 1.6% for RP.
- Serious complications requiring hospitalization within 90 days: 0.7% for TULSA vs 6.3% for RP (p<0.05).
- Secondary oncologic endpoints for TULSA arm (12-month biopsy and MRI) expected later in 2026.

## SEC filing metadata
- accession: 0001171843-26-001553
- form_type: 8-K
- ticker: PROF
- cik: 0001628808
- company_name: Profound Medical Corp.
- filed_at: 2026-03-13T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1628808/000117184326001553/0001171843-26-001553-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1628808/000117184326001553/f8k_031326.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001171843-26-001553
- JSON: https://secwatch.observer/filing/0001171843-26-001553.json
- Plain text: https://secwatch.observer/filing/0001171843-26-001553.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.