Current Report · Items 7.01, 9.01 · 8-K

Profound Medical Corp.

Regulation FD Disclosure

Filed Sep 4, 2026Accepted Sep 3, 2026, 9:00 PM EDTCIK 1628808Accession 0001171843-26-005884

Company context

Profound is a commercial-stage medical device company that develops and markets AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue. Profound is commercializing TULSA-PRO ®, a technology that combines real-time MRI, AI-enhanced planning, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. The TULSA Procedure™, performed using the TULSA-PRO system, has the potential of becoming a mainstream treatment modality across the entire prostate disease spectrum; ranging from low-, intermediate-, or high-risk prostate cancer; to hybrid patients suffering from both prostate cancer and benign prostatic hyperplasia (“BPH”); to men with BPH only; and also, to patients requiring salvage therapy for radio-recurrent localized prostate cancer. The TULSA Procedure employs real-time MR guidance for precision to preserve patients’ urinary continence and sexual function, while killing the targeted prostate tissue via precise sound absorption technology that gently heats it to 55-57°C. TULSA is an incision- and radiation-free “one-and-done” procedure performed in a single session that takes a few hours. Virtually all prostate shapes and sizes can be safely, effectively, and efficiently treated with TULSA. There is no bleeding associated with the procedure; no hospital stay is required; and most TULSA patients report quick recovery to their normal routine. TULSA-PRO is CE marked, Health Canada approved, and 510(k) cleared by the U.

Current securities

PRNTSX · EQUITY · Current PROFNASDAQ · EQUITY · Current

Recent company filings

Disclosure sections

Items 7.01, 9.01

Select an item to read the extracted section. The as-filed document remains the primary evidence.

Item 7.01Item 7.01 - Regulation FD Disclosure

Item 7.01. Regulation FD Disclosure. On September 3, 2026, Profound Medical Corp. (the “Company” or “Profound”) issued a press release announcing that the Company’s management will participate in the Lake Street Capital Markets “BIG10” Conference on September 10, 2026 in New York City. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information furnished under this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, or the Exchange Act, or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, or the Securities Act. The information in this Item 7.01, including Exhibit 99.1, shall not be deemed incorporated by reference into any other filing with the U.S. Securities Exchange Commission, or the SEC, made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

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