secwatch.observer — SEC 8-K summary
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Issuer:     Profound Medical Corp. (PROF)
CIK:        0001628808
Form:       8-K
Filed at:   2026-03-13T23:59:59+00:00
Accession:  0001171843-26-001553
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1628808/000117184326001553/0001171843-26-001553-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1628808/000117184326001553/f8k_031326.htm
  HTML page:      https://secwatch.observer/filing/0001171843-26-001553

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