[8-K] Profound Medical Corp. Reports Material Event

Rhea-AI Filing Summary

Profound Medical Corp. (PROF) announced it has entered into an exclusive distribution and supply agreement with Getz Healthcare for its TULSA-PRO system in Australia and New Zealand. The company disclosed the news under Regulation FD, indicating a commercial channel partner will handle market distribution in these regions.

The announcement was provided via a press release furnished as Exhibit 99.1. As furnished information under Item 7.01, it is not deemed filed under Section 18 of the Exchange Act and is not incorporated by reference into other SEC filings.

Insights

Medical Technology Commercialization Analyst

Exclusive ANZ distribution announced; positive signal, but no terms—impact depends on execution and later disclosures.

Profound Medical Corp. disclosed an exclusive distribution and supply agreement with Getz Healthcare for the TULSA-PRO system in Australia and New Zealand, furnished under Item 7.01 on November 12, 2025. In simple terms, an exclusive distributor becomes the single authorized channel for sales and supply in those markets, which can streamline logistics and provide focused commercial coverage.

The filing does not include commercial terms, duration, performance obligations, or financial commitments. Exclusivity concentrates market access through one partner, which can aid coordination but reduces flexibility if performance lags. Because the disclosure is furnished (not filed), it carries different liability treatment and omits contract details that would clarify materiality.

What matters next: look for any subsequent Item 1.01 filing or future reports that specify contract length, territory scope details, purchase obligations, or sales milestones. Also watch for operational indicators the company typically reports that might reflect ANZ activity over the next few reporting periods. Without stated amounts or targets, the near-term financial impact remains unclear.

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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 12, 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 12, 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® system in Australia and New Zealand with Getz Healthcare. 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 12, 2025
104		Cover Page Interactive Data File (embedded within the 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 12, 2025	By:	/s/ Rashed Dewan
		Rashed Dewan
		Chief Financial Officer

FAQ

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

The company announced an exclusive distribution and supply agreement with Getz Healthcare for its TULSA-PRO system in Australia and New Zealand.

Which product is covered by the agreement for PROF?

The agreement covers Profound Medical’s TULSA-PRO system.

Which regions are included in the new distribution agreement?

Australia and New Zealand are included under the exclusive agreement.

How was the announcement disclosed by PROF?

It was disclosed under Item 7.01 (Regulation FD) and a press release was furnished as Exhibit 99.1.

Is the information considered 'filed' with the SEC?

No. The Item 7.01 information, including Exhibit 99.1, is furnished, not deemed filed, and is not incorporated by reference into other filings.