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Stanford Medicine’s Dr. Pejman Ghanouni Receives RSNA’s Cum Laude Award for CAPTAIN Perioperative Data Presentation

(Moderate)
(Positive)
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Profound Medical (NASDAQ:PROF) highlighted RSNA recognition for perioperative data from the CAPTAIN randomized controlled trial comparing MRI-guided TULSA versus robotic radical prostatectomy, presented Dec 4, 2025.

Key points: CAPTAIN successfully recruited to target as a randomized trial; the presentation received an RSNA Cum Laude award (one of six awards, top 5% of posters); reported perioperative data show robotic RP patients take ~three weeks to recover to the same state TULSA patients reach the next day; TULSA has no blood loss and no overnight stay.

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Positive

  • CAPTAIN randomized trial successfully recruited to target
  • Perioperative recovery: robotic RP ~3 weeks vs TULSA next day
  • No blood loss reported for TULSA procedures
  • No overnight stay required after TULSA procedures

Negative

  • None.

News Market Reaction – PROF

-2.22%
-2.22% Session close to close

In the Dec 5 session, PROF declined 2.22%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights RSNA Cum Laude recognition for CAPTAIN perioperative data, reinforcing ...
Analysis

This announcement highlights RSNA Cum Laude recognition for CAPTAIN perioperative data, reinforcing TULSA-PRO’s positioning as an AI-powered, MRI-guided alternative to robotic prostatectomy. It builds on recent distribution agreements and clinical milestones that expanded access and demonstrated real-world use. At the same time, SEC filings note a shelf for up to $150,000,000 of securities and going-concern disclosures, so investors may track capital-raising activity, liquidity, and further clinical adoption data alongside such accolades.

Key Figures

Shelf size: $150,000,000 Shares outstanding: 30,193,592 shares Nasdaq close: $6.47 +5 more
8 metrics
Shelf size $150,000,000 Form S-3 shelf registration filed 2025-11-13
Shares outstanding 30,193,592 shares As of S-3 prospectus date
Nasdaq close $6.47 PROF closing price on 2025-11-12
TSX close C$9.05 PRN closing price on 2025-11-12
Short interest 2.28% Of float; days to cover 2.83
Days to cover 2.83 days Based on current short interest
Current price $6.6974 Prior to RSNA Cum Laude news
1-day move 10.14% Price change over prior 24 hours

Historical Context

5 past events · Latest: Nov 28 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Nov 28 Clinical/AI update Positive +2.2% Launch of TULSA-AI BPH module and new TULSA-PRO clinical data at RSNA/SUO.
Nov 18 Clinical utilization Positive -2.6% Announcement of 200th independent TULSA procedure milestone at The Hong Center.
Nov 13 Earnings results Positive -1.9% Record Q3 2025 revenue, margin expansion, and growing installed base and pipeline.
Nov 12 Distribution deal Positive +0.7% Exclusive distribution agreement with Getz Healthcare for TULSA-PRO in ANZ.
Nov 11 Distribution deal Positive +7.3% Exclusive Saudi Arabia distribution agreement for TULSA-PRO and Sonalleve platforms.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent news often produced modest price reactions, with a mix of aligned moves and occasional sell-the-news divergences on positive updates.

Recent Company History

Over the past month, Profound Medical reported record Q3 2025 revenue, expanded TULSA-PRO distribution into Saudi Arabia and Australasia, and highlighted over 4,000 men treated plus a milestone of 200 independent TULSA procedures. Clinical and AI advances, including new TULSA-PRO data and a BPH module, were showcased at RSNA and SUO. Today’s RSNA Cum Laude recognition for CAPTAIN perioperative data builds on this momentum in clinical validation and commercial expansion for TULSA-PRO.

Key Terms

randomized controlled trial, perioperative data, MRI-guided transurethral ultrasound ablation (TULSA), Radiological Society of North America, +3 more
7 terms
randomized controlled trial medical
"CAPTAIN is the first randomized controlled trial ever comparing a new technology"
A randomized controlled trial is a research method that tests the effects of a new idea or treatment by randomly dividing participants into two groups: one that receives the treatment and one that does not. This approach helps ensure that the results are fair and unbiased, providing clear evidence about whether the treatment actually works. Investors value such trials because they offer reliable information that can influence decision-making and reduce uncertainty.
perioperative data medical
"To put the perioperative data that Dr. Ghanouni presented into context"
Perioperative data includes information collected before, during, and after a medical procedure or surgery. It often covers patient health details, treatment steps, and recovery progress, providing a comprehensive view of the process. For investors, this data can indicate the quality and safety of healthcare providers, influencing their reputation and financial performance.
MRI-guided transurethral ultrasound ablation (TULSA) medical
"CAPTAIN Randomized Controlled Trial of MRI-Guided Transurethral Ultrasound Ablation (TULSA)"
MRI-guided transurethral ultrasound ablation (TULSA) is a minimally invasive medical procedure that uses focused ultrasound energy, guided by magnetic resonance imaging (MRI), to precisely destroy cancerous or diseased tissue in the prostate. For investors, it represents a potential advancement in medical technology that could improve treatment outcomes and reduce recovery times, influencing the competitiveness and growth prospects of healthcare companies specializing in innovative therapies.
Radiological Society of North America technical
"at the 2025 Radiological Society of North America (“RSNA”) Annual Meeting"
The Radiological Society of North America (RSNA) is a professional organization for medical imaging experts, such as radiologists, who use technology to diagnose and treat health conditions. It hosts conferences and publishes research that advances medical imaging techniques, which can influence healthcare innovation and costs. While primarily focused on medicine, developments in medical imaging can impact related industries and investment opportunities.
focal therapy spectrum medical
"an Emerging Alternative in the Focal Therapy Spectrum.” The TULSA Procedure"
The "focal therapy spectrum" refers to the range of treatment options that target specific areas of a disease, often aiming to minimize overall impact while effectively addressing the problem. For investors, understanding this concept highlights how innovative approaches can influence the success and adoption of new technologies or treatments in healthcare. It underscores the importance of precision and tailored strategies in improving outcomes and potentially reducing costs.
MRI thermography technical
"enabling real-time MRI thermography and autonomous temperature control."
MRI thermography is a technique that uses advanced imaging technology to measure temperature changes within the body. It creates detailed pictures showing how heat varies in tissues, which can help diagnose medical conditions or monitor treatments. For investors, understanding this technology highlights the growing importance of medical innovations and their potential impact on healthcare markets.
autonomous temperature control technical
"real-time MRI thermography and autonomous temperature control. This allows physicians"
Autonomous temperature control is a system that automatically adjusts and manages temperature settings without human intervention, much like a thermostat that learns and responds to changing conditions. For investors, it signifies advances in smart technology that can improve efficiency and reduce costs, potentially increasing the value and competitiveness of related products or industries.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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– CAPTAIN is the first randomized controlled trial ever comparing a new technology to the standard of care of robotic radical prostatectomy to successfully recruit to target –

TORONTO, Dec. 04, 2025 (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 Pejman Ghanouni, MD, PhD, Associate Professor in the Department of Radiology, Division of Body MRI at Stanford University School of Medicine, has received the Cum Laude award for his presentation titled “CAPTAIN Randomized Controlled Trial of MRI-Guided Transurethral Ultrasound Ablation (TULSA) Versus Robotic Radical Prostatectomy” at the 2025 Radiological Society of North America (“RSNA”) Annual Meeting, which just concluded today in Chicago.

RSNA recognizes outstanding education exhibits at its annual meeting with awards of Magna Cum Laude, Cum Laude and Certificate of Merit. Awards are based on review by subspecialty panels within the RSNA Education Exhibits Awards Committee. Dr. Ghanouni’s poster presentation was one (1) of only six (6) that received Cum Laude Awards at RSNA 2025, representing the top 5% of the scientific posters presented at the meeting.

“We would like to congratulate Dr. Ghanouni on receiving the prestigious Cum Laude award from RSNA, a significant professional achievement, as well as a testament to the fact that CAPTAIN enlisted some of the nation’s best academic physicians, which was critical for successful randomization,” said Profound CEO and Chairman, Arun Menawat. “To put the perioperative data that Dr. Ghanouni presented into context, robotic RP patients take almost three weeks of recovery on average to feel like TULSA Procedure patients do the very next day after their procedure. To put it another way, the TULSA Procedure is giving more than two weeks back to the patient. We have always known that the TULSA Procedure has no blood loss and no overnight stay with an improved post-treatment patient experience. Now, it is proven with head-to-head Level 1 data. Importantly, these are some of the same metrics that drove patient demand and initial adoption of the surgical robot for prostate cancer many years ago.”

Profound would also like to congratulate Satoru Takahashi, MD, PhD, of Takatsuki General Hospital in Japan, for receiving a Certificate of Merit award from RSNA for his presentation titled “TULSA for Prostate Cancer: MRI-based Pre-treatment Planning and Post-Treatment Assessment - an Emerging Alternative in the Focal Therapy Spectrum.”

The TULSA Procedure is a significant advancement in prostate care. Instead of surgery or radiation, treatment is performed inside an MRI suite using robotically controlled, directional ultrasound to precisely ablate prostate tissue while protecting surrounding structures. TULSA-PRO is the only AI-powered, MRI-guided robotic system for prostate therapy, enabling real-time MRI thermography and autonomous temperature control. This allows physicians to see, monitor and adjust treatment throughout the procedure — delivering personalized therapy with exceptional precision.

About CAPTAIN

CAPTAIN is a prospective, multi-center randomized controlled trial aimed at comparing the safety and efficacy of the TULSA Procedure™ (performed with the TULSA-PRO® system) with Robotic Radical Prostatectomy (“RP”) in men with organ-confined, intermediate-risk, Gleason Score 7 (Grade Group 2 and 3) prostate cancer. Starting in 2022, CAPTAIN patients were recruited at 20 sites in the United States, two in Canada and one in Europe. As of January 2025, 210 patients were randomized (69% TULSA, 31% RP) in this post-market study, and the last patient treatment occurred in August 2025. Baseline patient characteristics are balanced for TULSA vs RP, with median (IQR) age 63 (58-68) vs. 64 (59-68) years, proportions with PSA ≤10ng/mL 77% vs. 74%, and 23% vs 26% with PSA>10ng/mL. Proportions of TULSA vs. RP patients with GG2/3 disease were 76%/24% vs. 74%/26%. All patients were EPIC pad-free at baseline.

About Profound Medical Corp.

Profound is a commercial-stage medical device company that develops and markets AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue.

Profound is commercializing TULSA-PRO®, a technology that combines real-time MRI, AI-enhanced planning, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. The TULSA Procedure™, performed using the TULSA-PRO system, has the potential of becoming a mainstream treatment modality across the entire prostate disease spectrum; ranging from low-, intermediate-, or high-risk prostate cancer; to hybrid patients suffering from both prostate cancer and benign prostatic hyperplasia (“BPH”); to men with BPH only; and also, to patients requiring salvage therapy for radio-recurrent localized prostate cancer. The TULSA Procedure employs real-time MR guidance for precision to preserve patients’ urinary continence and sexual function, while killing the targeted prostate tissue via precise sound absorption technology that gently heats it to 55-57°C. TULSA is an incision- and radiation-free “one-and-done” procedure performed in a single session that takes a few hours. Virtually all prostate shapes and sizes can be safely, effectively, and efficiently treated with TULSA. There is no bleeding associated with the procedure; no hospital stay is required; and most TULSA patients report quick recovery to their normal routine. TULSA-PRO is CE marked, Health Canada approved, and 510(k) cleared by the U.S. Food and Drug Administration (“FDA”).

Profound is also commercializing Sonalleve®, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids, adenomyosis, pain palliation of bone metastases, desmoid tumors and osteoid osteoma. Sonalleve has also been approved by the China National Medical Products Administration for the non-invasive treatment of uterine fibroids and has FDA approval under a Humanitarian Device Exemption for the treatment of osteoid osteoma. Profound is in the early stages of exploring additional potential treatment markets for Sonalleve where the technology has been shown to have clinical application, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy.

Forward-Looking Statements

This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, any express or implied statements or guidance regarding current or future financial performance; the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer, BPH, uterine fibroids, adenomyosis, pain palliation of bone metastases, desmoid tumors and osteoid osteoma; and the success of Profound’s commercialization strategy and activities for TULSA-PRO®. 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 Profound, including risks regarding the medical device industry, regulatory approvals, reimbursement, economic factors, the equity markets generally and risks associated with growth and competition, statements and projections regarding financial guidance and goals and the attainment of such goals may differ from actual results based on market factors and Profound’s ability to execute its operational and budget plans; and actual financial results may not be consistent with expectations, including that revenue, operating expenses and cash usage may not be within management's expected ranges. 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.ca 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


FAQ

What did Profound (PROF) report about the CAPTAIN trial at RSNA on December 4, 2025?

Profound highlighted CAPTAIN perioperative data showing TULSA patients recover by the next day versus ~three weeks after robotic radical prostatectomy.

How significant was the RSNA recognition for the CAPTAIN presentation by Dr. Pejman Ghanouni?

Dr. Ghanouni received a Cum Laude award, one of six given at RSNA 2025 and representing the top 5% of posters.

What clinical advantages did the CAPTAIN perioperative data attribute to the TULSA Procedure versus robotic RP?

Reported advantages include faster recovery (next-day), no blood loss, and no overnight stay.

What is TULSA-PRO and how is it described in the announcement from Profound (PROF)?

TULSA-PRO is described as an AI-powered, MRI-guided robotic system providing real-time MRI thermography and autonomous temperature control for prostate ablation.

Does the CAPTAIN trial represent randomized Level 1 evidence for TULSA versus robotic prostatectomy?

The announcement describes CAPTAIN as a randomized controlled trial with head-to-head Level 1 perioperative data versus robotic radical prostatectomy.