Form 8-K

8-K — Profound Medical Corp.

Accession: 0001171843-26-005868

Filed: 2026-09-03

Period: 2026-09-01

CIK: 0001628808

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — f8k_090326.htm (Primary)

EX-99.1 — PRESS RELEASE (exh_991.htm)

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8-K — FORM 8-K

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Filename: f8k_090326.htm · Sequence: 1

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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): September 1, 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, No Par Value Per Share 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 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

Appointment of President

On September 1, 2026, Profound Medical Corp. (the “Company” or “Profound Medical”) announced that Richard R. Fabian has been appointed by the Board of Directors of the Company (the “Board”) to serve as the President of the Company, effective as of the same date (the “Appointment Date”). Mr. Fabian succeeds Mathieu Burtnyk, PhD, who has shifted to the newly created position of Chief Technology Officer, effective as of September 1, 2026.

Richard R. Fabian, age 59, served as President and CEO of FUJIFILM Sonosite, Inc. from 2017 to June 2026, where he oversaw the global Point of Care Ultrasound (POCUS) business. From 2002 to 2016, he held various executive leadership roles in marketing, sales, and global general management for the imaging and imaging guided therapy businesses at Philips Healthcare. Earlier in his career, he held positions in finance where he was a group controller at STERIS Corporation before he pivoted into operations and served as Vice President of Operations. Mr. Fabian holds a Bachelor of Arts degree in Economics from the University of Michigan and an MBA from the University of Pittsburgh Katz Graduate School of Business.

The selection of Mr. Fabian to serve as the Company’s President was not pursuant to any arrangement or understanding between Mr. Fabian and any other person. There are no family relationships between Mr. Fabian and any director or executive officer of the Company, and there are no transactions between Mr. Fabian and the Company that would be required to be reported under Item 404(a) of Regulation S-K.

In connection with his appointment, the Company entered into an Employment Agreement with Mr. Fabian, dated as of September 1, 2026 (the “Employment Agreement”). Under the Employment Agreement, Mr. Fabian will receive an annualized base salary of $550,000. Mr. Fabian is eligible to receive an annual discretionary bonus of up to 100% of his base salary. During Mr. Fabian’s initial 12-month period of employment, the Company will lease a residence in Toronto, Canada for Mr. Fabian’s use while he spends approximately 50% of his time at the Company’s Toronto office. The Company will also provide Mr. Fabian with a monthly car allowance of $1,000. Pursuant to the Employment Agreement, Mr. Fabian will be granted (i) 200,000 restricted share units under the Company’s 2020 Amended and Restated Long Term Incentive Plan, vesting in three equal annual installments over three years, and (ii) options to purchase 475,000 common shares of the Company under the Company’s Second Amended and Restated Share Option Plan, vesting over four years, with one-quarter vesting on the first anniversary of the grant date and the remainder vesting in 36 equal monthly installments thereafter.

The foregoing description of the Employment Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Employment Agreement, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q.

Item 7.01. Regulation FD Disclosure.

On September 1, 2026, the Company issued a press release announcing the appointment of Mr. Fabian as President of the Company, as described in Item 5.02 above. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

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 September 1, 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: September 3, 2026 By: /s/ Arun Menawat

Arun Menawat

Chief Executive Officer and Chairman

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EXHIBIT 99.1

Profound Medical Further Strengthens Executive Leadership Team with Appointment of Richard Fabian as President

TORONTO, Sept. 01, 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 announced the appointment of Richard Fabian as its new President, effective immediately. Mr. Fabian succeeds Mathieu Burtnyk, PhD, who has shifted to the newly created position of Chief Technology Officer.

Mr. Fabian has an accomplished history of sales, marketing, operations, general and executive management success within the global healthcare industry, specifically in the medical imaging and medical device spaces. In a career spanning more than 29 years, he most recently served as Chief Executive Officer of FUJIFILM Sonosite, Inc. (“Sonosite”), an innovator and leader in point-of-care ultrasound. Before joining Sonosite in 2017, Mr. Fabian served in a variety of roles with Philips Healthcare (“Philips”), the primary healthcare and medical technology business segment and division of NYSE/AEX-listed Royal Philips. Starting in 2002 as a Senior Director in the Cardiovascular X-ray Business Unit, North America, he progressed to lead in several executive roles in sales, marketing, and global general management. Earlier in his career, Mr. Fabian was VP, Sales at Noetix Corporation (now Magnitude Angles) and VP, Operations at STERIS Corporation. Mr. Fabian received a Bachelor of Economics degree from the University of Michigan, where he was a two-time letterman on the varsity swim team, and a Master of Business Administration from the University of Pittsburgh Joseph M. Katz Graduate School of Business.

“I am excited that we were able to recruit a medical device executive of Rich’s caliber to this key position,” said Arun Menawat, Profound’s CEO and Chairman. “Rich is a seasoned leader with a strong track record of delivering profitable growth to both established and emerging healthcare businesses. I have tremendous confidence in his ability to help us sharpen our overall execution. At the same time, I am pleased that our continuing clinical innovation and development will be in the capable hands of Mathieu, the inventor of the patented closed-loop temperature feedback control algorithm used by TULSA-PRO®, as well as the executive who has led the scientific design and execution of all of our clinical studies for the technology, including the ongoing Level 1 post-market CAPTAIN randomized controlled trial.”

“I am incredibly energized to join Profound at such a transformative time in the evolutions of both robotic and incisionless surgeries,” commented Mr. Fabian. “By combining the unrivalled precision and patient-centered customization enabled by real-time MRI guidance and thermometry, artificial intelligence, and supervised autonomous robotics, Profound is truly changing the paradigm for patients facing prostate disease and other conditions - proving that effective treatment no longer requires compromising a patient's quality of life. I am honored to be part of a team that is actively replacing uncertainty with clarity and expanding the boundaries of modern medicine."

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; 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.

For further information, please contact:

Stephen Kilmer

Investor Relations

skilmer@profoundmedical.com

T: 647.872.4849

Susan Thomas

Public Relations

sthomas@profoundmedical.com

T: 619.540.9195

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