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Profound Medical (NASDAQ: PROF) to highlight TULSA and PSMA PET integration at AUA2026

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Rhea-AI Filing Summary

Profound Medical Corp. furnished a current report describing plans to spotlight its MRI-guided TULSA Procedure™ at the American Urological Association’s 2026 Annual Meeting in Washington, DC. Four oral presentations on MRI-guided transurethral ultrasound ablation for localized prostate cancer will be delivered by clinicians from Mayo Clinic, Turku University Hospital and Sapporo Hokuyu Hospital.

The company will also demonstrate TULSA-PRO® and a Siemens Free.Max MR system at Booth #413 and has launched an initiative to explore integrating PSMA PET molecular imaging with TULSA-PRO treatment planning. This effort aims to support intent-to-treat decisions and patient monitoring across focal, subtotal and whole-gland prostate ablation strategies.

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Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
AUA2026 TULSA session time May 16, 2026, 1:00–3:00 p.m. ET Prostate Cancer: Localized: Ablative Therapy II session
TULSA oral presentations 4 presentations TULSA-focused talks at AUA2026
Booth location Booth #413 Profound’s exhibit at AUA2026
Multifocal prostate cancer share Approximately 85% Portion of prostate cancer described as multifocal
interventional MRI (iMRI) medical
"a commercial-stage medical device company that develops and markets innovative interventional MRI (“iMRI”) procedures"
TULSA Procedure medical
"the TULSA Procedure™ will be highlighted in four oral presentations at the upcoming American Urological Association’s Annual Meeting"
The Tulsa procedure is a minimally invasive medical treatment for an enlarged prostate that uses targeted pulses of sterile water vapor to destroy excess tissue and relieve urinary blockage. For investors, its clinical adoption, reimbursement status, and ease of use influence demand for the devices, shift patient flow away from long‑term drugs or major surgery, and can materially affect revenue and growth for device manufacturers, hospitals and urology clinics — like a new tool that changes how often and where a condition gets treated.
PSMA PET molecular imaging medical
"explore the potential of integrating PSMA PET molecular imaging technologies with the TULSA Procedure to support intention-to-treat decisions and patient monitoring"
transurethral ultrasound ablation medical
"MRI-guided transurethral ultrasound ablation (TULSA): MRI characteristics associated with treatment outcome"
Humanitarian Device Exemption (HDE) regulatory
"Sonalleve is approved by the FDA as HDE in the United States for the treatment of osteoid osteomas in the extremities"
forward-looking statements regulatory
"This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, the expectations regarding the efficacy"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
Understanding 8-K Material Events →
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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):  May 14, 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 7.01. Regulation FD Disclosure.

 

On May 14, 2026, Profound Medical Corp. (the "Company") issued a press release announcing that the Company’s TULSA Procedure™ will be highlighted in four oral presentations at the upcoming American Urological Association’s Annual Meeting in Washington, DC on May 16, 2026. A copy of the press release is furnished herewith as Exhibit 99.1 and is incorporated herein by reference.

 

The information in this Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No. Description
   
99.1 Press Release dated May 14, 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: May 14, 2026By: /s/ Rashed Dewan        
  Rashed Dewan
  Chief Financial Officer
  

 

EXHIBIT 99.1

Profound to Showcase TULSA-PRO®, the TULSA Procedure™ and the Future of iMRI at AUA2026

Company to explore the potential of integrating TULSA-PRO with PSMA PET molecular imaging technologies to enhance ablation planning and monitoring

TORONTO, May 14, 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, is pleased to announce that the TULSA Procedure™ will be highlighted in four oral presentations at the upcoming American Urological Association’s (“AUA”) Annual Meeting in Washington, DC, in the session titled “Prostate Cancer: Localized: Ablative Therapy II” on May 16th from 1:00-3:00 p.m. ET.

TULSA Procedure Talks at AUA2026

  • Ram A. Pathak, M.D., Associate Professor in the Department of Urology at Mayo Clinic in Florida, will give a presentation titled "Multicenter registry of MRI-guided transurethral ultrasound ablation (TULSA): MRI characteristics associated with treatment outcome";
  • Mikael Anttinen, M.D., Ph.D., a Urologist at Turku University Hospital in Finland, will give a presentation titled "Morphologic and perfusion changes induced by short-term neoadjuvant and androgen deprivation therapy before MRI-guided transurethral ultrasound ablation for localized prostate cancer";
  • Dr. Anttinen will also give a presentation titled: “Lesion-targeted MRI-guided transurethral ultrasound ablation for localized prostate cancer: 12-month safety, efficacy, and functional outcomes from a phase 2 trial”; and
  • Masayoshi Miura, M.D., Ph.D., the Director of the Department of Urology and Renal Transplantation Surgery at Sapporo Hokuyu Hospital in Japan, will give a presentation titled “Transurethral ultrasound ablation of the prostate is effective for localized prostate cancer and functional preservation: Single-center real world data”.

A Complete Interventional MRI (“iMRI”) Solution for Prostate Ablation

To see the future of iMRI prostate ablation first-hand, Profound is pleased to invite AUA2026 attendees to visit Booth #413, where it will host demonstrations of TULSA-PRO® and display an actual Siemens MAGNETOM Free.Max MR.1

The Potential Role of PSMA Pet Imaging in iMRI Prostate Ablation

Profound also announced that it is launching an initiative to explore the potential of integrating PSMA PET molecular imaging technologies with the TULSA Procedure to support intention-to-treat decisions and patient monitoring.

“Approximately 85% of prostate cancer is multifocal, meaning that there are two or more distinct index lesions and/or satellite lesions present in different areas of the organ2,” said Preston C. Sprenkle, M.D., an Associate Professor of Urology at Yale University School of Medicine, and Chair of the NCCN Early Detection of Prostate Cancer Guidelines Committee. “As diagnostic imaging like MRI and PSMA PET have advanced, enabling urologists to ‘see it before they plan how to treat it’, so too have treatment options expanded. The TULSA Procedure, in particular, allows urologists to take advantage of its unique coverage and precision to deliver precise, anatomy-driven, and patient-tailored ablation that is really ‘pan-prostate’- ranging from whole-gland, to focal, to everything in between. At the same time, TULSA answers the call of patients who are increasingly demanding more targeted approaches that have the potential to minimize side effects, such as erectile disfunction and/or urinary incontinence, while providing similar cancer control as standard mainstream therapies. I am excited to see Profound explore the potential of combining the flexible and customizable ablation advantages of MRI-guided TULSA-PRO with the treatment planning and monitoring power of molecular imaging to further advance targeted therapy.”

“From a product development perspective, we are exploring the integration of PSMA PET imaging into the TULSA-PRO treatment planning software,” said Mathieu Burtnyk, Ph.D., Profound’s President. “We are already seeing urologists use PSMA to complement MRI to better define treatment extent, with appropriate margins extending to the prostate capsule.3 For TULSA, this isn’t about patient selection for focal therapy. It’s about empowering physicians to plan and deliver the best possible intent-to-treat — focal, subtotal or whole-gland — with confidence and precision tailored to every patient.”

Note and Sources

1 TULSA-PRO compatibility with 0.55T MRI's such as the Siemens Free.Max is not commercially available in all markets, including in the United States. Its future availability cannot be ensured.

2 Mazzucchelli R, Scarpelli M, Cheng L, Lopez-Beltran A, Galosi AB, Kirkali Z, Montironi R: Pathology of prostate cancer and focal therapy (‘male lumpectomy’). Anticancer Res 29: 5155-5161, 2009.

3 Anttinen M, Mäkelä P, Nurminen P, Pärssinen H, Malaspina S, Sainio T, Högerman M, Taimen P, Blanco Sequeiros R, Boström P: Salvage Magnetic Resonance Imaging–guided Transurethral Ultrasound Ablation for Localized Radiorecurrent Prostate Cancer. European Urology Open Science 71: 69-77, 2025.

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

Source: View Original Filing on SEC EDGAR

FAQ

What did Profound Medical Corp. (PROF) announce in its latest 8-K filing?

Profound Medical announced that its TULSA Procedure will be featured in four oral presentations at the AUA2026 meeting and that it is starting an initiative to explore integrating PSMA PET molecular imaging with TULSA-PRO treatment planning and patient monitoring.

When and where will Profound Medical’s TULSA presentations occur at AUA2026?

The TULSA presentations are scheduled for May 16, 2026, in Washington, DC, during the American Urological Association’s Annual Meeting session titled “Prostate Cancer: Localized: Ablative Therapy II,” which runs from 1:00 to 3:00 p.m. Eastern Time.

What new initiative involving PSMA PET did Profound Medical describe?

Profound Medical described an initiative to explore integrating PSMA PET molecular imaging with its MRI-guided TULSA-PRO system, aiming to enhance treatment planning, define ablation extent with appropriate margins, and support ongoing monitoring of patients undergoing prostate tissue ablation.

Where can attendees see Profound Medical’s TULSA-PRO system at AUA2026?

Attendees can visit Profound Medical at Booth #413, where the company plans to host hands-on demonstrations of the TULSA-PRO platform and display an actual Siemens Free.Max MRI system as part of its interventional MRI prostate ablation showcase.

What other products and indications does Profound Medical highlight in this disclosure?

Profound Medical also highlights Sonalleve, its MRI-guided therapy platform for pain palliation of bone metastases, desmoid tumors, osteoid osteoma, and gynecologic conditions like uterine fibroids and adenomyosis, noting regulatory clearances in the United States, Europe, Canada, China, and Saudi Arabia.

Filing Exhibits & Attachments

5 documents

Press Releases

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