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TULSA-PRO showcased at SIR 2026 for Profound Medical (NASDAQ: PROF)

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Rhea-AI Filing Summary

Profound Medical Corp. furnished information that its incision-free, MRI-guided TULSA Procedure™ for prostate disease will be featured in multiple physician presentations at the 2026 Society of Interventional Radiology Annual Scientific Meeting in Toronto from April 11-15, 2026.

The TULSA Procedure, performed with the company’s TULSA-PRO® system, uses robotically controlled ultrasound inside the urethra and real-time MRI thermography to ablate prostate tissue at 55-57°C while protecting surrounding structures. Presentations will cover clinical use in prostate cancer and benign prostatic hyperplasia, outcomes data, automated prostate segmentation, and initial perioperative results from the Level 1 post-market CAPTAIN trial.

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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.
SIR 2026 meeting dates April 11-15, 2026 Society of Interventional Radiology Annual Scientific Meeting in Toronto
Men's Health 1 session time April 12, 3:00-4:30 p.m. EDT Session where five TULSA-related oral presentations occur
Prostate tissue ablation temperature 55-57°C Target ‘kill temperature’ for TULSA Procedure using TULSA-PRO
Prostate interventions course time April 13, 8:30-9:45 a.m. EDT Categorical course ‘Prostate Interventions: TULSA and Beyond’ featuring TULSA
Regulation FD regulatory
"Item 7.01. Regulation FD Disclosure."
Regulation FD is a rule that prevents company insiders, like executives, from sharing important information with some people before others get it. It matters because it helps ensure all investors have equal access to key news, making the stock market fairer and reducing chances of insider trading.
interventional MRI medical
"the Company’s interventional MRI TULSA Procedure™ will be highlighted"
Interventional MRI is the use of magnetic resonance imaging machines during medical procedures to guide needles, catheters or surgical tools in real time, like using a live GPS map inside the body instead of relying on static pictures. For investors, it matters because hospitals and device makers adopting this technology can change procedure costs, reduce complications and open new markets for specialized scanners, instruments and software, affecting revenue, reimbursement and competitive positioning.
benign prostatic hyperplasia medical
"used by physicians to treat men with prostate cancer and/or benign prostatic hyperplasia"
Benign prostatic hyperplasia is a noncancerous enlargement of the prostate gland that can squeeze the urethra and cause urinary symptoms like weak stream, urgency, and incomplete emptying; think of it as a garden hose being pinched so water flow slows. It matters to investors because it creates steady demand for medications, medical devices and procedures, regulatory approvals, and insurance coverage decisions—factors that can drive revenue and growth in healthcare companies serving an aging population.
post-market CAPTAIN trial medical
"will give a presentation on the Level 1 post-market CAPTAIN trial"
forward-looking statements regulatory
"This release includes forward-looking statements regarding Profound and its business"
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):  April 1, 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 April 1, 2026, Profound Medical Corp. (the “Company” or “Profound”) issued a press release announcing that the Company’s interventional MRI TULSA Procedure™ will be highlighted in several presentations at the 2026 Society of Interventional Radiology Annual Scientific Meeting held in Toronto, ON, April 11-15, 2026. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.           

 

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 April 1, 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: April 1, 2026By: /s/ Rashed Dewan        
  Rashed Dewan
  Chief Financial Officer
  

 

EXHIBIT 99.1

Incision-Free, MRI-Guided Prostate Treatment with Profound’s TULSA-PRO® to be Featured in Multiple Presentations at the Upcoming 2026 Society of Interventional Radiology Scientific Meeting

TORONTO, April 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 AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue, is pleased to announce that the interventional MRI (“iMRI”) TULSA Procedure™ will be highlighted in several presentations at the 2026 Society of Interventional Radiology (“SIR”) Annual Scientific Meeting, to be held in Toronto, ON, April 11-15.

The TULSA Procedure, performed using the TULSA-PRO® system, represents a major advancement in prostate care, and is used by physicians to treat men with prostate cancer and/or benign prostatic hyperplasia (“BPH”, also known as an enlarged prostate). Robotically controlled directional ultrasound is delivered from inside the urethra to precisely and gently heat prostate tissue to ‘kill temperature’ (55-57°C), while protecting surrounding nerves and anatomy. Real-time MRI thermography enables continuous visualization and autonomous temperature adjustment throughout the procedure. This level of precision allows physicians to tailor therapy to each patient, resulting in no procedural blood loss, no overnight hospital stay, and a quicker return to everyday life, while minimizing side effects typically associated with surgery or radiation, such as urinary incontinence and/or erectile dysfunction.

TULSA-PRO will be front-and-center in the session titled "Men's Health 1" on April 12th from 3:00-4:30 p.m. EDT with five oral presentations:

  • Joseph J. Busch, Jr., M.D., a board-certified radiologist and Founder of the Busch Center in Alpharetta, GA, will give a presentation titled "Robotic Assisted MRI-Guided Transurethral Ultrasound Ablation (TULSA) for MRI-visible Prostate Cancer at the Extreme Apex";
  • Dr. Joseph Busch will also give a presentation titled "Robotic Assisted MRI-Guided Transurethral Ultrasound Ablation in Recurrent Prostate Cancer: A Retrospective Analysis";
  • Arsalan Nadeem, MBBS, a Postdoctoral Research Fellow in the Department of Radiology, Section of Interventional Radiology at the Northwestern University Feinberg School of Medicine in Chicago, IL, will present a literature review on the TULSA Procedure titled "Oncologic and Functional Outcomes Following MRI-Guided Transurethral Ultrasound Ablation for Localized Prostate Cancer: A Systematic Review and Meta-Analysis";
  • Steven S. Raman, M.D., FASR, FSIR, Professor of Radiology, Urology and Surgery at the David Geffen School of Medicine at UCLA in Los Angeles, CA, will present an abstract that was selected as a "2026 Featured Abstract" at SIR, titled "Automated Prostate Segmentation for MRI-guided Transurethral Ultrasound Ablation: Validation and Real-world Experience"; and
  • David A. Woodrum, M.D., Ph.D., an interventional radiologist at Mayo Clinic in Rochester, MN, will give a presentation on the Level 1 post-market CAPTAIN trial, titled "Randomized Controlled Trial of MRI-Guided Transurethral Ultrasound Ablation (TULSA) vs Robotic Prostatectomy for Intermediate-Risk Prostate Cancer: Ablation Parameters and Initial Perioperative Outcomes".

In addition, on April 13th from 8:30-9:45 a.m. EDT, the TULSA Procedure will be highlighted in two presentations during a categorical course titled "Prostate Interventions: TULSA and Beyond", coordinated by Christopher Ingraham, M.D., a board-certified diagnostic and interventional radiologist and Associate Professor of Radiology, and Juan Javier-Desloges, M.D., a urologic oncologist and Assistant Professor of Urology, at the UCSD School of Medicine in San Diego, CA.

“Our significant presence at SIR 2026 comes at an opportune time as leading iMRI procedures, including MRI-guided biopsy and TULSA, are poised to transform how unmet medical needs across the prostate disease spectrum are being addressed,” said Arun Menawat, Profound’s CEO and Chairman. “Awareness and acceptance of the TULSA Procedure’s strong clinical profile, as well as its potential to become the next mainstream treatment modality for most men with prostate disease, is growing. And we look forward to building on that progress by highlighting CAPTAIN trial data and showcasing real-world physician experience throughout 2026.”

About Profound Medical Corp.

Profound is a commercial-stage medical device company and an innovator in interventional MRI 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 safety and efficacy of Profound’s technology in the treatment of prostate cancer, BPH, pain palliation of bone metastases, desmoid tumors, osteoid osteoma, uterine fibroids and adenomyosis. 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 about SIR 2026?

Profound Medical announced that its MRI-guided TULSA Procedure™ will be highlighted in multiple presentations at the 2026 Society of Interventional Radiology meeting in Toronto, April 11-15. Talks will feature clinical outcomes, automated prostate segmentation, and CAPTAIN trial perioperative data.

What is Profound Medical’s TULSA Procedure and what conditions does it treat?

The TULSA Procedure is an incision-free, MRI-guided prostate therapy using the TULSA-PRO® system. Robotically controlled ultrasound ablates tissue at 55-57°C, treating prostate cancer and benign prostatic hyperplasia while aiming to reduce side effects like urinary incontinence and erectile dysfunction versus surgery or radiation.

How does Profound Medical’s TULSA-PRO system work during the prostate procedure?

TULSA-PRO delivers directional ultrasound from inside the urethra to heat prostate tissue to 55-57°C while real-time MRI thermography tracks temperatures. This enables tailored ablation, no procedural blood loss, no overnight hospital stay, faster recovery, and potentially fewer urinary and sexual side effects.

What other technologies does Profound Medical (PROF) commercialize besides TULSA-PRO?

Profound also markets Sonalleve®, an MRI-guided, incision-free therapy for pain palliation of bone metastases, desmoid tumors, osteoid osteoma, and gynecologic conditions like uterine fibroids and adenomyosis. Sonalleve aims to provide non-surgical treatment with no blood loss, no overnight stay, and faster recovery.

In which regions are Profound Medical’s TULSA-PRO and Sonalleve systems approved?

TULSA-PRO is cleared or approved in the United States, Europe, Canada, Saudi Arabia, India, Australia/New Zealand, and the UAE. Sonalleve holds clearances or approvals in the United States (HDE), Europe, Canada, China, and Saudi Arabia, supporting global use of MRI-guided, incision-free therapies.

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