PROF

EX-99.1

2 exh_991.htm

PRESS RELEASE

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 100th 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 tissueAblation of malignant and benign enlarged prostate tissueAblation of recurrent malignant prostate tissueAblation of benign enlarged prostate tissue

71%

(9% GG1, 61% GG2, 21% GG3, 9% GG4&5)16%

9% 4%

Intention-to-Treat

Whole-glandSub-total but more than half the glandHemi-ablationFocal therapy

42% 26% 23% 9%

Prostate Size

< 20 cc20-40 cc40-60 cc60-100 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

Form 8-KFalse000162880800016288082026-03-052026-03-05iso4217:USDxbrli:sharesiso4217:USDxbrli:shares

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

Form 8-KFalse000162880800016288082025-10-072025-10-07iso4217:USDxbrli:sharesiso4217:USDxbrli:shares

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):  October 7, 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 2.02. Results of Operations and Financial Condition.

On October 7, 2025, Profound Medical Corp. (the “Company”) issued a press release to announce certain of its preliminary unaudited financial results for the three months ended September 30, 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 October 7, 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: October 7, 2025By: /s/ Rashed Dewan Rashed Dewan Chief Financial Officer