---
schema_version: "secwatch.filing_event.v1"
accession: "0001171843-25-002561"
form_type: "8-K"
ticker: "PROF"
cik: "0001628808"
company_name: "Profound Medical Corp."
filed_at: "2025-04-29T23:59:59+00:00"
generated_at: "2026-05-23T03:50:56.354060+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Profound Medical presents CAPTAIN RCT: TULSA-PRO eliminates blood loss, overnight stay; launches TULSA-AI for BPH

## Summary
- CAPTAIN RCT peri-operative data: median blood loss 0 vs 100 mL and length of stay 0.29 vs 1.24 days for TULSA vs robotic prostatectomy (p<0.001).
- Patients reported significantly less pain and better overall health (EQ-5D-5L VAS) in first month after TULSA vs robotic prostatectomy (p<0.05).
- Real-world CARE registry (n=223): PSA decreased 90% at 1 year; 94% pad-free continence; 77% preserved erectile function; 6.3% retreatment rate.
- New TULSA-AI Volume Reduction module and Treatment ARC FDA cleared for BPH, expanding TULSA addressable market.
- CAPTAIN is first RCT in localized prostate cancer to reach target enrollment (201 patients randomized 2:1 TULSA vs radical prostatectomy).

## SEC filing metadata
- accession: 0001171843-25-002561
- form_type: 8-K
- ticker: PROF
- cik: 0001628808
- company_name: Profound Medical Corp.
- filed_at: 2025-04-29T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1628808/000117184325002561/0001171843-25-002561-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1628808/000117184325002561/f8k_042825.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001171843-25-002561
- JSON: https://secwatch.observer/filing/0001171843-25-002561.json
- Plain text: https://secwatch.observer/filing/0001171843-25-002561.txt

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