Profound Medical (NASDAQ: PROF) plans strong TULSA presence at SRS2026

Rhea-AI Filing Summary

Profound Medical Corp. announced that its MRI-guided, AI-powered, robotically driven and incisionless TULSA Procedure will be featured in multiple physician-led presentations at the Society of Robotic Surgery Annual Meeting in Fort Lauderdale, FL, scheduled for July 23-26, 2026.

Clinical talks will cover real-world outcomes, randomized trial primary safety data, single-center efficacy and safety, salvage treatment after prior therapies, and program adoption, with leading presenters from UT Southwestern and other centers. Profound will also be one of only eight companies spotlighted in the Society of Incisionless Surgery plenary session on imaging, AI and robotic autonomy.

Before the clinical program, management plans to participate in an SRS Investor Session on July 22, 2026, discussing innovative robotic technologies and TULSA-PRO. Profound describes itself as a commercial-stage medical device company focused on MRI-guided, incision-free therapies including TULSA-PRO and Sonalleve, which have clearances or approvals in multiple global markets.

8-K Event Classification

2 items: 7.01, 9.01

2 items

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.

Key Figures

SRS Annual Meeting dates: July 23-26, 2026 SIS spotlight companies: 8 companies UT Southwestern TULSA milestone: 100th procedure +3 more

6 metrics

SRS Annual Meeting dates July 23-26, 2026 Dates of the Society of Robotic Surgery Annual Meeting in Fort Lauderdale, FL

SIS spotlight companies 8 companies Profound is one of only eight companies to be spotlighted during the SIS plenary session at SRS2026

UT Southwestern TULSA milestone 100th procedure UT Southwestern reached the 100th TULSA Procedure milestone back in 2022

CPT Category 1 effective date January 2025 CPT Category 1 codes for the TULSA Procedure became effective in January 2025

Investor Session date July 22, 2026 Date of Profound’s participation in the SRS Investor Session before the clinical program

SIS plenary talk time 10:35-10:42 a.m. EDT Time slot for Profound Medical’s SIS plenary presentation on July 26, 2026

Key Terms

Transurethral Ultrasound Ablation (TULSA), interventional MRI (iMRI), CPT Category 1 codes, HDE, +1 more

5 terms

Transurethral Ultrasound Ablation (TULSA) medical

"MRI-guided Transurethral Ultrasound Ablation (TULSA) for Localized Prostate Cancer"

interventional MRI (iMRI) medical

"an innovator in interventional MRI (iMRI) procedures"

CPT Category 1 codes regulatory

"well before the CPT Category 1 codes became effective in January 2025"

CPT Category I codes are standardized medical procedure codes used in the United States to describe common clinical services and tests for billing and statistics. Like a menu item number that hospitals and insurers both recognize, these codes determine how services are documented and reimbursed, so changes in code use or coverage can affect healthcare providers’ and medical-device makers’ reported revenue and claims processing.

HDE regulatory

"Sonalleve is approved by the FDA as HDE in the United States"

hyperthermia-based cancer therapies medical

"including non-invasive ablation of abdominal cancers and hyperthermia-based cancer therapies"

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FAQ

What did Profound Medical (PROF) disclose about the Society of Robotic Surgery Annual Meeting?

Profound Medical disclosed that its TULSA Procedure will be highlighted in several physician-led presentations at the Society of Robotic Surgery Annual Meeting in Fort Lauderdale, taking place July 23-26, 2026, covering real-world outcomes, safety, efficacy, salvage use and program adoption.

How will the TULSA Procedure from Profound Medical (PROF) be featured at SRS2026?

The TULSA Procedure will be discussed in multiple main congress sessions, including real-world registry outcomes, the CAPTAIN randomized trial, localized prostate cancer results, extreme apical disease treatment, salvage therapy after focal or radiation treatment, and a lunch symposium on building a prostate ablation program.

What is the Society of Incisionless Surgery plenary spotlight involving Profound Medical (PROF)?

The Society of Incisionless Surgery will spotlight Profound as one of only eight companies during a plenary session at SRS2026, featuring a talk titled “Profound Medical: Incisionless Precision: Imaging, AI, and the Rise of Robotic Autonomy” on July 26, 2026, from 10:35-10:42 a.m. EDT.

What investor-focused events involving Profound Medical (PROF) are planned around SRS2026?

Profound’s management will join an SRS Investor Session on July 22, 2026, before the clinical program, in panels titled “Innovative Robotic Technologies” and “Profound Medical: TULSA-PRO,” moderated by medtech equity research analysts from Stifel Financial and Wells Fargo.

Which products and indications does Profound Medical (PROF) describe in this disclosure?

Profound highlights TULSA-PRO, enabling MRI-guided, incision-free prostate tissue ablation across whole-gland to focal treatments, and Sonalleve, an MRI-guided therapy for pain palliation of bone metastases, desmoid tumors, osteoid osteoma, and gynecologic conditions such as uterine fibroids and adenomyosis.

What regulatory clearances for Profound Medical (PROF) technologies are referenced?

Profound notes that TULSA-PRO is FDA-cleared for transurethral ultrasound ablation of prostate tissue and cleared in Europe, Canada, Saudi Arabia, India, Australia/New Zealand and the UAE, while Sonalleve has an FDA HDE and approvals or clearances in Europe, Canada, China and Saudi Arabia.

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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):  July 15, 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 7.01. Regulation FD Disclosure.

On July 15, 2026, Profound Medical Corp. (the “Company”) issued a press release announcing that the Company’s TULSA Procedure™ will be highlighted in several presentations at the upcoming Society of Robotic Surgery Annual Meeting in Fort Lauderdale, FL on July 23-26, 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 July 15, 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: July 15, 2026	By:	/s/ Rashed Dewan
		Rashed Dewan
		Chief Financial Officer

EXHIBIT 99.1

Profound Medical: Autonomous Robotics and Incisionless Surgery to Have Exceptional Presence at SRS2026

TORONTO, July 15, 2026 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”) is pleased to announce that its MRI-guided, AI-powered, Robotically-Driven and Incisionless TULSA Procedure™ will be highlighted in several presentations by leading physicians at the upcoming Society of Robotic Surgery (“SRS”) Annual Meeting to be held in Fort Lauderdale, FL, July 23-26, 2026.*

MAIN CONGRESS SESSIONS

• Real-world Outcomes after MRI-guided Transurethral Ultrasound Ablation of the Prostate in a Multicenter Post-market Registry
  Xiaosong Meng, MD, PhD; UT Southwestern Medical Center, Dallas, TX
  July 24, 2026; 9:55:10:00 a.m. EDT

• CAPTAIN Randomized Controlled Trial of MRI-guided Transurethral Ultrasound Ablation (TULSA) vs. Radical Prostatectomy: Primary Safety Outcomes
  Xiaosong Meng, MD, PhD; UT Southwestern Medical Center, Dallas, TX
  July 24, 2026; 10:00-10:04 a.m. EDT

• MRI-Guided Transurethral Ultrasound Ablation (TULSA) for Localized Prostate Cancer: Single-Center Efficacy and Safety Outcomes
  Xiaosong Meng, MD, PhD; UT Southwestern Medical Center, Dallas, TX
  July 24, 2026; 10:30-10:34 a.m. EDT

• Intermediate Term Oncologic and Functional Outcomes of Incisionless Robotic Prostatectomy (Whole-Gland TULSA) for Extreme Apical Prostate Cancer
  Victoria Y. Bird, MD; National Medical Association and Research Group, Gainesville, FL
  July 24, 2026; 10:46-10:50 a.m. EDT

• Salvage MRI-Guided Transurethral Ultrasound Ablation (TULSA) for Locally Recurrent Prostate Cancer Following Focal Therapy or Radiation: Oncologic and Functional Outcomes from a Single-Center Cohort
  Victoria Y. Bird, MD; National Medical Association and Research Group, Gainesville, FL
  July 24, 2026; 10:50-10:55 a.m. EDT

• Building a Prostate Ablation Program - Lessons from Adopting TULSA at a High-Volume Academic Medical Center (Lunch Symposium)
  Xiaosong Meng, MD, PhD; UT Southwestern Medical Center, Dallas, TX
  July 24, 2026; 12:30-1:30 p.m. EDT

• Robotic Assisted/AI Precision Prostate Cancer Treatment
  Arun Menawat, PhD; Profound Medical
  Masayoshi Miura, MD, PhD; Sapporo Hokuyu Hospital, Sapporo, Japan
  July 26, 2026; 9:05-9:25 a.m. EDT

• TULSA: Patient Selection and Outcomes (CAPTAIN Trial)
  Xiaosong Meng, MD, PhD; UT Southwestern Medical Center, Dallas, TX 
  July 26, 2026; 1:25-1:45 p.m. EDT

Dr. Meng commented, “UT Southwestern has helped pioneer the TULSA Procedure for prostate cancer, having reached the 100^th procedure milestone back in 2022, well before the CPT Category 1 codes became effective in January 2025. I am honored by this opportunity to share my experience, both as a surgeon and a researcher, at SRS2026.”

SOCIETY OF INCISIONLESS SURGERY (“SIS”) PLENARY SESSION

The SIS, which held its inaugural board meeting in March 2026, will also begin its activities as a chapter of SRS by spotlighting a select group of companies helping shape the future of surgery, procedural medicine, and intelligent operating rooms. According to SIS, its upcoming plenary session is designed not only to showcase technology, but also to highlight a broader vision for the future of surgery: one in which energy-based treatment, image guidance, robotics, artificial intelligence, and surgical data platforms work together to improve outcomes and expand what is possible for patients and clinicians alike.

Profound is honored to have been selected as one of only eight companies to be spotlighted during the SIS plenary session at SRS2026:

• Profound Medical: Incisionless Precision: Imaging, AI, and the Rise of Robotic Autonomy
  Y. Mark Hong, MD; Integrative Urology, Phoenix, AZ
  July 26, 2026; 10:35-10:42 a.m. EDT

Dr. Y. Mark Hong, Medical Director of Integrative Urology in Phoenix, Arizona, is a pioneer in MRI-guided, incisionless treatment of prostate disease and world-recognized for his focus on precision, anatomy-driven therapy and individualized patient care.

"Profound's TULSA-PRO^® represents a fundamentally different approach to traditional robotic surgery," said Dr. Hong. "By combining real-time MRI guidance, artificial intelligence, and supervised robotic autonomy, the platform enables surgeons to deliver highly personalized treatment based on each patient's unique anatomy and disease.

TULSA enables physicians to tailor treatment across a continuum of prostate disease, from whole-gland ablation to highly targeted focal therapy and everything in between. That flexibility allows us to personalize care while preserving quality of life whenever clinically appropriate. TULSA's AI empowers a smoother learning curve and wider adoption while maintaining excellent outcomes with increasing autonomy.

I believe this represents the future of prostate disease treatment, and I am honored to share that vision with the distinguished researchers and clinicians attending SRS2026. I also thank the Society of Incisionless Surgery for the opportunity to participate in this important discussion on the future of robotic and image-guided surgery."

SRS INVESTOR SESSION

In addition, prior to the start of the official SRS2025 clinical program, on July 22, 2026, Profound’s management team will participate in an Investor Session moderated by well-regarded medtech equity research analysts, Rick Wise, Managing Director at Stifel Financial, and Larry Biegelsen, Managing Director at Wells Fargo:

• Innovative Robotic Technologies
  Arun Menawat, PhD; Profound Medical
  July 22, 2026; 10:45-11:15 a.m. EDT

• Profound Medical: TULSA-PRO
  Tom Tamberrino; Profound Medical
  July 22, 2026; 1:05-1:10 p.m. EDT

Commenting on Profound’s first-time participation in the Investor Session, Dr. Menawat said, “SRS2026 is a unique global industry event that encompasses all surgical specialties and robotic systems, linking top surgeons, researchers, engineers, and financial investors to accelerate robotic-assisted surgery. We are looking forward to sharing our story there.”

* Sessions subject to change, please visit SRS website for the most up to date schedule.

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

Filing Exhibits & Attachments

5 documents

Press Releases

• EX-99.1 PRESS RELEASE 13.2 KB

Other Documents

• EX-101 XBRL SCHEMA FILE 3.3 KB
• EX-101 XBRL DEFINITION FILE 25.5 KB
• EX-101 XBRL LABEL FILE 35.1 KB
• EX-101 XBRL PRESENTATION FILE 24.1 KB