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:  0001171843-25-002572
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

CAPTAIN trial: TULSA shows zero blood loss, shorter stay vs robotic prostatectomy (p<0.001)
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- Median blood loss 0 mL (TULSA) vs 100 mL (RP); length of stay 0.29 vs 1.24 days (p<0.001).
- Significantly lower post-operative pain (NRS) through day 6 and higher overall health (EQ-5D-5L VAS) for 30 days (p<0.05).
- Fewer TULSA patients reported extreme problems in mobility (0% vs 12%), self-care (3% vs 17%), usual activities (17% vs 40%) in first month.
- First Level 1 RCT comparing TULSA to radical prostatectomy; 201 patients randomized across 23 sites.
- CEO notes data supports insurance coverage decisions; company expects further follow-up reporting.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1628808/000117184325002572/0001171843-25-002572-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1628808/000117184325002572/f8k_042825.htm
  HTML page:      https://secwatch.observer/filing/0001171843-25-002572

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