8-K
Profound Medical Corp. (PROF)
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): May 7, 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 2.02. Results of Operations and Financial Condition.
On May 7, 2026, Profound Medical Corp. (the “Company”) issued a press release to announce its financial results for the quarter ended March 31, 2026 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 May 7, 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: May 7, 2026 | By: | /s/ Rashed Dewan |
| Rashed Dewan | ||
| Chief Financial Officer |
EdgarFiling EXHIBIT 99.1
Profound Medical Reports Strong First Quarter 2026 Financial Results
– Quarterly results marked by 104% revenue growth and improved operating performance –
– Company issues full-year 2026 revenue guidance –
– Announces Humana is now covering the TULSA Procedure™ –
TORONTO, May 07, 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 first quarter ended March 31, 2026. 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).
“We continued to execute well across our business in the first quarter, delivering triple-digit revenue growth combined with strong gross margin and lower operating expenses. We were also pleased to see statistically significant and clinically meaningful benefit from the TULSA Procedure beginning to readout from the randomized post-market CAPTAIN clinical trial comparing it to robotic radical prostatectomy, the current standard of care,” said Arun Menawat, Profound’s CEO and Chairman. “These and other anticipated tailwinds, including the expansion of payer coverage for the TULSA Procedure, give us confidence that we are moving closer to a pivotal inflection point in our growth trajectory. Nevertheless, it continues to be difficult for the investment community to accurately predict our revenues in the short-term. Accordingly, we are setting what we believe is a reasonable bar for our total annual revenue in 2026.”
Business Highlights
- Profound’s TULSA-PRO installed base stood at 80 at the end of Q1-2026, and the Company shipped an additional six (6) systems during the first quarter that had yet to be installed.
- In March 2026, Profound announced superiority on the prespecified, primary safety endpoint in the Level 1 post-market CAPTAIN randomized controlled trial comparing the TULSA Procedure with robotic radical prostatectomy in men with organ-confined, intermediate-risk, Gleason Score 7 (Grade Group 2 and 3) prostate cancer. The Company looks forward to announcing additional clinical outcomes from this unique, potentially paradigm-changing study when they become available later this year.
- Also in March, Texas Prostate achieved its 100^t^^h^ TULSA Procedure. Prior to that, in September 2025, Profound announced the launch of a first-of-its-kind ‘TULSA-PROgram’ under which Texas Prostate began performing TULSA Procedures for men with disease conditions requiring prostate tissue ablation in Dallas Medical Center’s state-of-the-art MRI suite. This model — bridging private-pay practices and Medicare-participating hospitals — is designed to allow more men to benefit from the TULSA Procedure’s versatility across several prostate conditions requiring medical intervention.
- In April 2026, the TULSA Procedure was highlighted in several presentations at the 2026 Society of Interventional Radiology (SIR) Annual Scientific Meeting, which was held in Toronto, ON.
- Today, Profound is pleased to announce that Humana has become the first national payor in the United States to cover the TULSA Procedure. Humana is one of the largest commercial payers in the U.S., and crucial for many health systems due to its large Medicare Advantage enrollment numbers. The addition of approximately 8.5 million covered lives in the first quarter (6.9 million covered lives with Humana alone) represents meaningful progress toward ensuring more patients have access to the TULSA Procedure. Profound will continue to work collaboratively with payers, providers, and health systems to expand coverage and streamline patient access pathways for the TULSA Procedure.
Q1-2026 Clinical Utilization Trends
Physicians continued to utilize the TULSA Procedure’s customizable prostate tissue ablation capabilities in the first quarter of 2026:
Prostate Condition
| Ablation of malignant prostate tissue | Ablation of malignant and benign enlarged prostate tissue | Ablation of recurrent malignant prostate tissue | Ablation of benign enlarged prostate tissue |
|---|---|---|---|
| 71%<br><br>(9% GG1, 61% GG2, 21% GG3, 9% GG4&5) | 16% | 9% | 4% |
Intention-to-Treat
| Whole-gland | Sub-total but more than half the gland | Hemi-ablation | Focal therapy |
|---|---|---|---|
| 42% | 26% | 23% | 9% |
Prostate Size
| < 20 cc | 20-40 cc | 40-60 cc | 60-100 cc | > 100 cc |
|---|---|---|---|---|
| 8% | 44% | 29% | 15% | 4% |
TULSA INDEX20
The following table sets out a supplemental ‘same-store’ TULSA Procedure volume analysis designed to assist investors in following the Company’s progress over time. As the name implies, this new TULSA INDEX20 is comprised of 20 active commercial sites that have been performing TULSA Procedures for at least 12-months. The index includes a representative variety of providers, including teaching hospitals and private-pay practices. Geographically, 80% of the index sites are in the U.S. and 20% are international.
| TULSA INDEX20 | Q1-2025 | Q2-2025 | Q3-2025 | Q4-2025 | Q1-2026 |
|---|---|---|---|---|---|
| # TULSA Sites | 20 | 20 | 20 | 20 | 20 |
| Average Procedures/Quarter | 7.1 | 8.2 | 8.6 | 10.3 | 11.3 |
| Average Procedures Annualized | 28.4 | 32.8 | 34.4 | 41.2 | 45.2 |
| Quarter-Over-Quarter Sequential Growth | 15% | 5% | 20% | 10% | |
| Year-Over-Year Growth | 59% |
Summary First Quarter 2026 Results
For the quarter ended March 31, 2026, Profound recorded revenue of approximately $5.3 million, with $2.5 million from recurring - non-capital revenue, which consists of the sale of one-time use devices and services associated with extended warranties, and $2.9 million from the one-time sale of capital equipment. First quarter 2026 revenue was up 104% from $2.6 million for the same three-month period a year ago.
Gross margin for the first quarter of 2026 was 72%, up marginally from 71% in the prior year period. The increase in first quarter 2026 gross margin was primarily due to product mix whereby more capital equipment was sold which contains a higher margin.
Total operating expenses in the first quarter of 2026 were approximately $11.8 million, down 9% from $13.0 million in the prior year period. The decrease in operating expenses was primarily due to decreases in salaries, sales force, travel expenses, insurance premiums, and clinical trial costs due to CAPTAIN trial enrollment completion, partially offset by increases in consulting expenditures due to spending on R&D initiatives to reduce design costs and improve quality and efficiencies with the Company’s products.
First quarter 2026 net loss was approximately $7.0 million, or $0.19 per common share, a 34% improvement from a net loss of approximately $10.7 million, or $0.36 per common share, in the three months ended March 31, 2025.
Liquidity and Outstanding Share Capital
As at March 31, 2026, Profound had cash of approximately $50.3 million.
As at May 7, 2026, Profound had 36,337,637 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.”
Full Year 2026 Financial Outlook
The Company projects total revenue for full-year 2026 to be approximately $25 million, which represents 56% growth compared to its prior year revenue. The Company also expects full year 2026 gross margin to be 70% or higher.
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 dial 1-800-717-1738 (North America) or 1-646-307-1865 (International). 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. The company’s flagship platform, TULSA-PRO^®^, enables MRI-guided, incision-free prostate ablation. Physicians use the TULSA Procedure™ to see, ablate, 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 using prostate tissue ablation, while minimizing the potential of the side effects that are 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 by the FDA in the United States for transurethral ultrasound ablation (TULSA) of prostate tissue. In addition, TULSA-PRO is cleared for use in various jurisdictions including Europe, Canada, Saudi Arabia, India, Australia/New Zealand, and the UAE. Sonalleve is approved by the FDA as HDE in the United States for the treatment of osteoid osteomas in the extremities. Sonalleve is also cleared or approved in the 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 technologies for disease conditions requiring MR-Guided ablation procedures for prostate, uterine fibroids, adenomyosis, palliative pain treatment, desmoid tumors, and osteoid osteoma; the extent and timing of Profound’s completion of TULSA-PRO^®^ and Sonalleve^®^ system sales; Profound’s expectations for future revenues/financial results; 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.
Financial Outlook
This press release contains a financial outlook within the meaning of applicable securities laws. The financial outlook has been prepared by management of the Company to provide an outlook for the Company’s forecasted revenue for the 12 months to be ended December 31, 2026, and may not be appropriate for any other purpose. The financial outlook has been prepared based on a number of assumptions, including the assumptions discussed under the heading “Forward-Looking Statements” herein. The actual results of the Company’s operations for any period may vary from the amounts set forth in these projections, and such variations may be material. The Company and its management believe that the financial outlook has been prepared on a reasonable basis. However, because this information is highly subjective and subject to numerous risks, including the risks discussed under the heading “Forward-Looking Statements” herein, it should not be relied on as necessarily indicative of future results.
For further information, please contact:
Stephen Kilmer Investor Relations skilmer@profoundmedical.com T: 647.872.4849
| Profound Medical Corp.<br>CONDENSED CONSOLIDATED BALANCE SHEETS <br>(USD in thousands, except per share data) <br>(unaudited) | ||
|---|---|---|
| March 31,2026 | December 31,2025 | |
| --- | --- | --- |
| Assets | ||
| Current assets: | ||
| Cash | 50,295 | 59,723 |
| Trade and other receivables, net | 9,423 | 7,200 |
| Inventory | 9,001 | 8,238 |
| Prepaid expenses and deposits | 811 | 928 |
| Total current assets | 69,530 | 76,089 |
| Trade and other receivables, net | 150 | 300 |
| Property and equipment, net | 682 | 698 |
| Intangible assets, net | 129 | 138 |
| Right-of-use assets, net | 2,897 | 184 |
| Deferred tax assets, net | 68 | 66 |
| Total assets | 73,456 | 77,475 |
| Liabilities | ||
| Current liabilities: | ||
| Accounts payable | 2,142 | 1,563 |
| Accrued expenses and other current liabilities | 3,389 | 3,815 |
| Deferred revenue | 464 | 445 |
| Long-term debt | 4,503 | - |
| Lease liabilities | 68 | 213 |
| Income tax payable | 41 | 39 |
| Total current liabilities | 10,607 | 6,075 |
| Deferred revenue | 441 | 388 |
| Long-term debt | - | 4,499 |
| Lease liabilities | 2,892 | - |
| Other non-current liabilities | 92 | 79 |
| Total liabilities | 14,032 | 11,041 |
| Shareholders’ equity | ||
| Common shares, no par value, unlimited shares authorized, 36,337,637 and 36,293,640 issued and outstanding at March 31, 2026 and December 31, 2025, respectively | 324,163 | 323,839 |
| Additional paid-in capital | 26,034 | 25,310 |
| Accumulated other comprehensive income | 4,020 | 5,025 |
| Accumulated deficit | (294,793 | (287,740 |
| Total shareholders’ equity | 59,424 | 66,434 |
| Total liabilities and shareholders’ equity | 73,456 | 77,475 |
All values are in US Dollars.
| Profound Medical Corp.<br>CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS <br>(USD in thousands, except per share data) <br>(unaudited) | ||
|---|---|---|
| Three Months Ended March 31, | ||
| --- | --- | --- |
| 2026 | 2025 | |
| Revenue | ||
| Recurring - non-capital | 2,474 | 1,801 |
| Capital equipment | 2,863 | 820 |
| 5,337 | 2,621 | |
| Cost of sales | 1,505 | 768 |
| Gross profit | 3,832 | 1,853 |
| Operating expenses | ||
| Research and development | 5,262 | 4,808 |
| Selling, general and administrative | 6,591 | 8,211 |
| Total operating expenses | 11,853 | 13,019 |
| Operating loss | 8,021 | 11,166 |
| Other (income) expenses | ||
| Net finance (income) expense | (377 | (445 |
| Net foreign exchange (gain) loss | (616 | (38 |
| Total other (income) expenses | (993 | (483 |
| Net loss before income taxes | 7,028 | 10,683 |
| Income tax expense | 27 | 41 |
| Deferred tax expense | (2 | - |
| Total income tax expense | 25 | 41 |
| Net loss attributed to shareholders for the period | 7,053 | 10,724 |
| Other comprehensive (income) loss | ||
| Item that may be reclassified to (income) loss | ||
| Foreign currency translation adjustment | 1,005 | (103 |
| Net loss and other comprehensive loss for the period | 8,058 | 10,621 |
| Loss per share | ||
| Basic and diluted net loss per common share | 0.19 | 0.36 |
| Basic and diluted weighted average common shares outstanding | 36,297,684 | 30,041,735 |
All values are in US Dollars.
| Profound Medical Corp.<br>CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS<br>(USD in thousands, except per share data) <br>(unaudited) | ||
|---|---|---|
| Three Months Ended March 31, | ||
| --- | --- | --- |
| 2026 | 2025 | |
| Cash flows from operating activities | ||
| Net loss for the period | (7,054 | (10,724 |
| Adjustments to reconcile net loss to net cash provided by operating activities: | ||
| Depreciation of property and equipment | 93 | 116 |
| Amortization of intangible assets | 7 | 47 |
| Non-cash lease expense adjustment | 50 | (9 |
| Share-based compensation | 1,048 | 989 |
| Interest and accretion expense | 5 | 48 |
| Changes in operating assets and liabilities: | ||
| Trade and other receivables | (2,240 | 1,090 |
| Inventory | (996 | (984 |
| Prepaid expenses and deposits | 105 | 592 |
| Accounts payable, accrued expenses and other liabilities | 311 | 300 |
| Deferred revenue | 88 | 252 |
| Income taxes payable | 2 | - |
| Deferred tax asset | (3 | - |
| Net cash used in operating activities | (8,584 | (8,283 |
| Cash flows from financing activities | ||
| Repayments of long-term debt | - | (290 |
| Net cash provided by (used in) financing activities | - | (290 |
| Net increase (decrease) in cash | (8,584 | (8,573 |
| Effect of exchange rate changes on cash | (844 | 94 |
| Cash, beginning of period | 59,723 | 54,912 |
| Cash, end of period | 50,295 | 46,433 |
All values are in US Dollars.