PROF announces exclusive Saudi Arabia distribution with Al Faisaliah

Rhea-AI Filing Summary

Profound Medical Corp. (PROF) announced it entered into an exclusive distribution and supply agreement in Saudi Arabia with Al Faisaliah Medical Systems Co. covering its TULSA-PRO and Sonalleve technologies. The company disclosed the news via a press release furnished under Item 7.01 (Regulation FD).

The agreement designates a single distributor for these systems in Saudi Arabia, signaling a focused commercial pathway for Profound Medical’s prostate ablation (TULSA-PRO) and MR-guided therapeutic ultrasound (Sonalleve) platforms in that market. The press release was furnished as Exhibit 99.1.

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):  November 11, 2025

_______________________________

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 November 11, 2025, Profound Medical Corp. (the “Company”) issued a press release announcing that it has entered into an exclusive distribution and supply agreement for its TULSA-PRO® and Sonalleve® technologies in Saudi Arabia with Al Faisaliah Medical Systems Co. 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 November 11, 2025
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: November 11, 2025	By:	/s/ Rashed Dewan
		Rashed Dewan
		Chief Financial Officer

FAQ

What did Profound Medical (PROF) announce in its 8-K?

The company entered into an exclusive distribution and supply agreement in Saudi Arabia with Al Faisaliah Medical Systems for TULSA-PRO and Sonalleve.

Which technologies are covered by the agreement for PROF?

The agreement covers Profound Medical’s TULSA-PRO and Sonalleve technologies.

Who is Profound Medical’s partner in Saudi Arabia?

Al Faisaliah Medical Systems Co.

Is the disclosure part of a filed or furnished item?

It was furnished under Item 7.01 (Regulation FD).

When was the press release issued?

November 11, 2025.

Where can I find the detailed announcement?

See Exhibit 99.1, the press release dated November 11, 2025.