secwatch.observer — SEC 8-K summary
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Issuer:     Profound Medical Corp. (PROF)
CIK:        0001628808
Form:       8-K
Filed at:   2026-10-14T12:00:36+00:00
Accession:  0001171843-26-006615
Event type: other_material
Sentiment:  positive
Materiality: 0.50
Item codes: 7.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

Profound Medical touts TULSA data at iMRI Symposium; CAPTAIN shows 2.1x functional preservation vs robotic RP
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- CAPTAIN randomized trial: whole-gland TULSA patients 2.1x more likely to preserve erectile function and pad-free continence vs robotic prostatectomy (p=0.004); hospitalizations 0.7% vs 6.3%.
- CARE Registry (197 patients, 5 centers, median 24-mo follow-up): median PSA nadir 0.23 ng/mL whole-gland vs 0.60 subtotal vs 1.10 focal; catheterization 13.5 days vs 7 days.
- Mayo Clinic Florida: 58 patients up to 4.5 years; 100% pad-free and 94% leak-free continence, 87.5% potency beyond 12 months; median PSA nadir 0.9 ng/mL; 12% needed secondary treatment.
- Mayo Clinic Rochester: 41 patients, mean PSA fell roughly 62-66% from 7.7 ng/mL through one year; biopsy-confirmed recurrence in 22% (12% in-field, 10% out-of-field).
- Siemens 0.55T Free.Max platform validated: 3D thermometry precision up 40%, targeting accuracy 1.0±0.9 mm; no FDA clearance or commercial availability claimed.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1628808/000117184326006615/0001171843-26-006615-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1628808/000117184326006615/f8k_101426.htm
  HTML page:      https://secwatch.observer/filing/0001171843-26-006615

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