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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):  March 5, 2026

_______________________________

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 2.02. Results of Operations and Financial Condition.

 

On March 5, 2026, Profound Medical Corp. (the “Company”) issued a press release to announce its financial results for the quarter and year ended December 31, 2025 and provided a business update. A copy of the press release is furnished as Exhibit 99.1. 

 

The information in Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18, of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under that section, and shall not be deemed to be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No. Description
   
99.1 Press Release dated March 5, 2026
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: March 5, 2026By: /s/ Rashed Dewan        
  Rashed Dewan
  Chief Financial Officer
  

 

EXHIBIT 99.1

Profound Medical Reports Fourth Quarter and Full Year 2025 Financial Results

TORONTO, March 05, 2026 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets innovative interventional MRI (“iMRI”) procedures, today reported financial results for the fourth quarter and full year ended December 31, 2025. Unless specified otherwise, all amounts in this press release are expressed in U.S. dollars and are presented in accordance with U.S. generally accepted accounting principles (U.S. GAAP).  

Business Highlights

“We continued to execute well, delivering record revenues, an expanded TULSA-PRO installed base, and a stronger capital sales pipeline again in the fourth quarter — validating our belief that Q3-2025 marked an important inflection point in our business,” said Arun Menawat, Profound’s CEO and Chairman. “Moving forward, with the strengthening of our balance sheet via the completion of our financing in December, and based on several upcoming potential catalysts, including the clinical outcomes from the Level 1 post-market CAPTAIN study, we believe that we are on the right path toward driving high double digit to low triple digit revenue growth and, ultimately, positive cash flows and net profitability.”

Summary Fourth Quarter 2025 Results

For the quarter ended December 31, 2025, Profound recorded revenue of approximately $6.0 million, with $2.3 million from recurring - non-capital revenue, which consists of the sale of TULSA-PRO one-time use devices service revenue related to extended warranties, and $3.7 million from the one-time sale of capital equipment. Fourth quarter 2025 revenue was up 43% from $4.2 million for the same three-month period a year ago.

Gross margin for the fourth quarter of 2025 was 67%, compared to 71% in the prior year period. The lower than usual fourth quarter 2025 gross margin was primarily due to product mix and new market introductory prices with international distributors in Saudi Arabia and Australia.

Total operating expenses in the fourth quarter of 2025 were approximately $11.4 million, up marginally from $11.3 million in the prior year period. The increase in operating expenses was primarily due to increased headcount, increased sales force, commission payments, and increased travel and infrastructure costs to support the Company’s growth.

Fourth quarter 2025 net loss was approximately $8.2 million, or $0.27 per common share, compared to a net loss of approximately $4.9 million, or $0.20 per common share, in the three months ended December 31, 2024.

Summary Full Year 2025 Results

For the year ended December 31, 2025, Profound recorded revenue of approximately $16.1 million, with $9.7 million from recurring non-capital revenue and $6.4 million from the one-time sale of capital equipment. This compares to revenue of approximately $10.7 million in the year ended December 31, 2024.

Profound’s full year 2025 gross margin was 71%, compared to 66% in the prior year period. Gross margin expansion in 2025 was primarily due to increased selling prices coupled with the growth in the number of capital systems sold.

Total operating expenses in the year ended December 31, 2025 were approximately $52.6 million, compared with $40.1 million in 2024. The increase in operating expenses was primarily due to increased headcount, increased enrolment for the CAPTAIN trial and higher material expenditures and travel associated with the trial, increased testing and design modification, increased sales force and commission payments, and increased travel and infrastructure costs to support the Company’s growth. Partially offsetting these increases was a decrease to insurance due to lower premium rates and a reduction in trade receivable write-offs.

Profound recorded a net loss for the year ended December 31, 2025 of approximately $42.6 million, or $1.41 per common share, compared to approximately $27.8 million, or $1.12 per common share, for the year ended December 31, 2024.

Liquidity and Outstanding Share Capital

As at December 31, 2025, Profound had cash of approximately $59.7 million.

As at March 5, 2026, Profound had 36,293,640 common shares issued and outstanding.

For complete financial results, please see Profound’s filings, which will be made available under Profound’s profile at www.sedarplus.com, www.sec.gov and on Profound’s website under “SEC & SEDAR+ Filings.”

Changes to Board of Directors

Profound also announced today that Kris Shah has resigned from its Board of Directors and Frank Baylis has been appointed as Mr. Shah’s successor, effectively immediately.

Mr. Baylis joined Baylis Medical Company in 1989, serving as its President until 2015. During his tenure, the company grew into an internationally recognized developer of medical devices used in cardiac electrophysiology, structural heart disease, and spine procedures. He returned to Baylis Medical Company in 2019 after serving as Liberal Member of Canada’s Parliament for the federal riding of Pierrefonds-Dollard from 2015 to 2019. During his time at Baylis Medical Company, his leadership and vision helped build the company from a small start-up into a global leader, ultimately leading to its acquisition by Boston Scientific in 2022 for $1.75 billion. Mr. Baylis also co-founded the consulting business OME Group in 1991, which was sold to Ernst and Young in 2011. Currently, Mr. Baylis is the Executive Chairman of Baylis Medical Technologies, a leader in the development and commercialization of innovative medical devices in the fields of interventional radiology and spine procedures. Headquartered in Canada, the company also provides contract manufacturing services to some of the world’s leading medical device companies.

Mr. Baylis is an active board member for Epineuron Technologies, a clinical-stage company developing a novel class of bioelectronic therapy that offers a transformative approach to aid in the treatment of injured peripheral nerves. In the past he has served on the boards of MEDEC, Campus de Technologie de Sante (CTS), and the Business Advisory Committee of HTX. His list of accomplishments includes several patents, the Ernst and Young Entrepreneur Award for Healthcare in Quebec (2011) and the University of Waterloo Alumni Achievement Award (2014). Mr. Baylis holds a Bachelor of Science in Electrical Engineering from the University of Waterloo, and while attending, he met Mr. Shah, and together they founded Baylis Medical Technologies.

“On behalf of the Board and staff of Profound, I would like to take this opportunity to thank Kris for his many contributions to the Company and wish him all the best in his future endeavours,” said Dr. Menawat. “I am also very pleased to welcome Kris’ long-time business partner, Frank, to our team. He is not only a successful entrepreneur and experienced executive, but also has a breadth of relevant business and Board experience that should be invaluable as Profound executes the next stages of its growth strategy.”

Conference Call Details

Profound Medical is pleased to invite all interested parties to participate in a conference call today at 4:30 pm ET during which time the results will be discussed.

To participate in the conference call by telephone, please pre-register via this link to receive the dial-in number and your unique PIN.

The call will also be broadcast live and archived on Profound's website in the Investors section here.

About Profound Medical Corp.

Profound is a commercial-stage medical device company and an innovator in interventional MRI (iMRI) procedures, enabling precise, incision-free therapies that improve clinical confidence, procedural control, and patient outcomes. By leveraging real-time MRI guidance, Profound’s technologies are designed to replace uncertainty with clarity across treatment planning, delivery, and confirmation.

The company’s flagship platform, TULSA-PRO®, enables MRI-guided, incision-free prostate therapy designed for precision and flexibility. The TULSA Procedure™ allows physicians to see, treat, and confirm therapy in real time, supporting personalized treatment strategies across the continuum of prostate care—from whole-gland to subtotal, hemi, multifocal, and focal treatment. This approach enables individualized care for the full spectrum of prostate disease, including prostate cancer and/or benign prostatic hyperplasia (BPH), while minimizing side effects typically associated with surgery or radiation, such as urinary incontinence and/or erectile dysfunction.

Profound also commercializes Sonalleve®, an MRI-guided therapy that provides a non-surgical treatment option for pain palliation of bone metastases, desmoid tumors, and osteoid osteoma, as well as for common gynecologic conditions including uterine fibroids and adenomyosis. Sonalleve delivers targeted therapy with no incisions, no blood loss during the procedure, no overnight hospital stay, and faster recovery — and, in gynecologic applications, enables uterine-sparing treatment that may help preserve fertility. Profound is also exploring additional clinical applications for Sonalleve, including non-invasive ablation of abdominal cancers and hyperthermia-based cancer therapies.

Profound Medical’s technologies are approved across major global markets. TULSA-PRO is cleared or approved in the United States, Europe, Canada, Saudi Arabia, India, Australia/New Zealand, and the UAE, while Sonalleve is cleared or approved in the United States (HDE), Europe, Canada, China, and Saudi Arabia.

Through real-time MRI guidance and data-driven innovation, Profound is advancing the future of MRI-guided therapy — expanding access to precise, personalized, and incision-free treatment options worldwide.

Forward-Looking Statements

This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer, BPH, uterine fibroids, adenomyosis, palliative pain treatment, desmoid tumors, and osteoid osteoma; the extent and timing of Profound’s completion of TULSA-PRO® system sales from its qualified sales pipeline; Profound’s expectations for future revenues; and the success of Profound’s commercialization strategy and activities for TULSA-PRO and Sonalleve. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "is expected", "expects", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks regarding the medical device industry, regulatory approvals, reimbursement, economic factors, the equity markets generally and risks associated with growth and competition. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Other factors and risks that may cause actual results to differ materially from those set out in the forward-looking statements are described in Profound's Annual Report on Form 10-K and other filings made with U.S. and Canadian securities regulators, available at www.sedarplus.com and www.sec.gov. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law.

For further information, please contact:

Stephen Kilmer
Investor Relations
skilmer@profoundmedical.com
T: 647.872.4849


Profound Medical Corp.
Consolidated Balance Sheet
As at December 31, 2025 and 2024
In USD (000s)

 2025
$
 2024
$
 
   
Assets  
   
Current assets:  
Cash59,723 54,912 
Trade and other receivables, net7,200 7,045 
Inventory8,238 5,801 
Prepaid expenses and deposits928 1,307 
Total current assets76,089 69,065 
   
Trade and other receivables, net300 - 
Property and equipment, net698 425 
Intangible assets, net138 261 
Right-of-use assets, net184 396 
Deferred tax assets, net66 87 
Total assets77,475 70,234 
   
Liabilities  
   
Current liabilities:  
Accounts payable1,563 1,317 
Accrued expenses and other current liabilities3,815 2,835 
Deferred revenue445 419 
Long-term debt- 1,737 
Lease liabilities213 257 
Income tax payable39 - 
Total current liabilities6,075 6,565 
   
Deferred revenue388 49 
Long-term debt4,499 2,924 
Lease liabilities- 203 
Other non-current liabilities79 71 
Total liabilities11,041 9,812 
   
Commitments and contingencies  
   
Shareholders’ equity  
   
Common shares, no par value, unlimited shares authorized, 36,293,640 and 30,039,809 issued and outstanding at December 31, 2025 and 2024, respectively323,839 281,552 
Additional paid-in capital25,310 21,298 
Accumulated other comprehensive income5,025 2,742 
Accumulated deficit(287,740) (245,170) 
Total shareholders’ equity66,434 60,422 
   
Total liabilities and shareholders’ equity77,475 70,234 


Profound Medical Corp.
Consolidated Statements of Operations and Comprehensive Loss
In USD (000s)

 Three months ended
December 31, 2025

$
Three months ended
December 31, 2024

$
Year ended
December 31, 2025

$
Year ended
December 31, 2024

$
 
      
Revenue     
Recurring - non-capital2,3022,6799,7308,240 
Capital equipment3,6751,4986,3682,440 
 5,9774,17716,09810,680 
Cost of sales1,9861,2144,7053,643 
Gross profit3,9912,96311,3937,037 
      
Operating expenses     
Research and development4,2724,64920,59616,965 
Selling, general and administrative7,0886,65832,05123,134 
Total operating expenses11,36011,30752,64740,099 
      
Operating loss7,3698,34441,25433,062 
      
Other (income) expenses     
Net finance (income) expense(160)(332)(1,070)(1,436) 
Net foreign exchange (gain) loss940(2,828)2,134(3,808) 
Total other (income) expenses780(3,160)1,064(5,244) 
      
Net loss before income taxes8,1495,18442,31827,818 
      
Income tax expense12(92)231144 
Deferred tax (recovery) expense14(146)21(146) 
Total income tax (recovery) expense26(238)252(2) 
      
Net loss attributed to shareholders for the year8,1754,94642,57027,816 
      
Other comprehensive (income) loss     
Item that may be reclassified to (income) loss     
Foreign currency translation adjustment(275)(1,968)(2,283)2,823 
      
Net loss and other comprehensive loss for the year7,9006,91440,28730,639 
      
Loss per share     
Basic and diluted net loss per common share0.270.201.411.12 
Basic and diluted weighted average common shares outstanding30,726,38225,770,80030,232,96624,765,503 


Profound Medical Corp.
Consolidated Statements of Cash Flows
For the years ended December 31, 2025 and 2024
In USD (000s)

 2025
$
 2024
$
 
   
Cash flows from operating activities  
Net loss for the year(42,570) (27,816) 
Adjustments to reconcile net loss to net cash provided by operating activities:  
Depreciation of property and equipment373 707 
Amortization of intangible assets187 229 
Non-cash lease expense adjustment(37) (38) 
Share-based compensation5,490 2,581 
Interest and accretion expense63 600 
Change in amortized cost of trade and other receivables- (307) 
Changes in operating assets and liabilities:  
Trade and other receivables(172) 186 
Inventory(2,822) 656 
Prepaid expenses and deposits464 31 
Accounts payable, accrued expenses and other liabilities378 815 
Deferred revenue371 (948) 
Income taxes payable42 - 
Deferred tax liabilities- (58) 
Deferred tax assets26 (91) 
Net cash used in operating activities(38,207) (23,453) 
   
Cash flows from investing activities  
Purchase of property and equipment(176) - 
Purchase of intangible assets(66) - 
Net cash used in investing activities(242) - 
   
Cash flows from financing activities  
Issuance of commons shares42,436 62,106 
Payments of financing costs(1,016) (4,895) 
Repayments of long-term debt(290) (2,560) 
Proceeds from the exercise of stock options8 45 
Net cash provided by financing activities41,138 54,696 
   
Net increase in cash and cash equivalents2,689 31,243 
Effect of exchange rate changes on cash2,122 (2,544) 
Cash, beginning of year54,912 26,213 
Cash, end of year59,723 54,912