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

Filing Impact
(Neutral)
Filing Sentiment
(Neutral)
Form Type
8-K
Rhea-AI Filing Summary

Profound Medical Corp. reported under Regulation FD that it has regained exclusive distribution rights for its TULSA-PRO product in Canada from Knight Therapeutics Inc. The company announced the change in a press release dated November 10, 2025, which is furnished as Exhibit 99.1.

The Item 7.01 disclosure notes the press release is furnished, not filed, and is not incorporated by reference into other SEC filings.

Positive
  • None.
Negative
  • None.

Insights

Regaining Canada distribution rights centralizes control; impact neutral.

Profound Medical disclosed it regained exclusive distribution rights for TULSA-PRO in Canada from Knight Therapeutics via an Item 7.01 communication. Exclusive rights typically allow a manufacturer to directly manage sales channels and messaging within the territory.

The notice is a furnished Reg FD press release dated November 10, 2025, without accompanying financial metrics in this excerpt. Actual commercial effects, if any, would depend on subsequent execution and market uptake.

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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 10, 2025

_______________________________

PROFOUND MEDICAL CORP.

(Exact name of registrant as specified in its charter)

_______________________________

Ontario, Canada001-39032Not 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 classTrading Symbol(s)Name of each exchange on which registered
Common SharesPROFThe 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 10, 2025, Profound Medical Corp. (the “Company”) issued a press release announcing that it has regained exclusive distribution rights for TULSA-PRO® in Canada from Knight Therapeutics Inc. 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 10, 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 10, 2025By: /s/ Rashed Dewan        
  Rashed Dewan
  Chief Financial Officer
  

 

FAQ

What did PROF disclose in its 8-K?

Profound Medical said it regained exclusive distribution rights for TULSA-PRO in Canada from Knight Therapeutics, announced via a press release furnished as Exhibit 99.1.

Which product is affected for PROF?

The disclosure concerns TULSA-PRO, for which Profound Medical regained exclusive distribution rights in Canada.

When was the announcement made by PROF?

The company announced the change in a press release dated November 10, 2025.

Is the PROF press release filed or furnished?

It is furnished under Item 7.01 (Regulation FD) and is not deemed filed or incorporated by reference into other SEC filings.

Where can investors find more details on PROF’s update?

See Exhibit 99.1 to the 8-K, which contains the press release detailing the distribution rights change.

Does the PROF 8-K include financial statements?

No. The Item 7.01 disclosure furnishes a press release and does not include financial statements.
Profound Med Corp

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Medical Devices
Surgical & Medical Instruments & Apparatus
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