secwatch.observer — SEC 8-K summary
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Issuer:     Profound Medical Corp. (PROF)
CIK:        0001628808
Form:       8-K
Filed at:   2025-04-29T23:59:59+00:00
Accession:  0001171843-25-002561
Event type: other_material
Sentiment:  positive
Materiality: 0.60
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1628808/000117184325002561/0001171843-25-002561-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1628808/000117184325002561/f8k_042825.htm
  HTML page:      https://secwatch.observer/filing/0001171843-25-002561

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer