Profound Medical (NASDAQ: PROF) details first TULSA-PRO use at Mount Sinai

Rhea-AI Filing Summary

Profound Medical Corp. reported that Mount Sinai Hospital has treated its first prostate cancer patient using the company’s TULSA-PRO® system. This update was shared through a press release dated January 15, 2026, which is included as an exhibit to the report. The disclosure is made under Regulation FD, meaning the company is sharing this operational milestone to keep all investors informed at the same time.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

_________________

FORM 8-K

_________________

CURRENT REPORT

Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):  January 13, 2026

_______________________________

PROFOUND MEDICAL CORP.

(Exact name of registrant as specified in its charter)

_______________________________

Ontario, Canada	001-39032	Not Applicable
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

2400 Skymark Avenue, Unit 6

Mississauga, Ontario, Canada L4W 5K5

(Address of Principal Executive Offices) (Zip Code)

Registrant's Telephone Number, Including Area Code: 647-476-1350

(Former name or former address, if changed since last report)

_______________________________

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Shares	PROF	The Nasdaq Stock Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01. Regulation FD Disclosure.

On January 15, 2026, Profound Medical Corp. (the “Company”) issued a press release announcing that Mount Sinai Hospital treated its first prostate cancer patient with the Company’s TULSA-PRO® system. 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.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		Press Release, dated January 15, 2026
104		Cover Page Interactive Data File (embedded within Inline XBRL document)

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	PROFOUND MEDICAL CORP.
Date: January 15, 2026	By:	/s/ Rashed Dewan
		Rashed Dewan
		Chief Financial Officer

FAQ

What did Profound Medical Corp. (PROF) disclose in this 8-K filing?

Profound Medical Corp. disclosed that Mount Sinai Hospital treated its first prostate cancer patient with the company’s TULSA-PRO® system, as announced in a January 15, 2026 press release furnished with the report.

Which hospital used Profound Medical Corp.’s TULSA-PRO system for prostate cancer?

The filing states that Mount Sinai Hospital treated its first prostate cancer patient using Profound Medical Corp.’s TULSA-PRO® system.

How did Profound Medical Corp. communicate the TULSA-PRO patient treatment milestone?

The company issued a press release dated January 15, 2026, furnished as Exhibit 99.1 to the report under Regulation FD Disclosure (Item 7.01).

Is the Mount Sinai TULSA-PRO press release considered filed with the SEC?

No. The company states that the information under Item 7.01, including Exhibit 99.1, is furnished and not deemed “filed” for purposes of Section 18 of the Exchange Act or Sections 11 and 12(a)(2) of the Securities Act.

Who signed the Profound Medical Corp. 8-K related to the TULSA-PRO update?

The report was signed on behalf of Profound Medical Corp. by Rashed Dewan, who is identified as the Chief Financial Officer.

What exhibits are included with Profound Medical Corp.’s 8-K about TULSA-PRO?

The report lists Exhibit 99.1, a press release dated January 15, 2026, and Exhibit 104, the cover page interactive data file embedded within the Inline XBRL document.