TULSA Abstracts at the 15th Interventional MRI Symposium Strengthen Real-World Evidence, Clinical Differentiation, and Platform Expansion Opportunity

Randomized functional results favor TULSA, while cancer-control follow-up and requirements for deployment on the additional MRI platform remain.

Rhea-AI Summary

Profound Medical (PROF) announced five symposium abstracts reporting clinical outcomes for its TULSA prostate procedure and technical feasibility on another MRI platform. In the randomized CAPTAIN trial, whole-gland TULSA patients were more than twice as likely as robotic prostatectomy patients to preserve both erectile function and pad-free continence at six months (risk ratio 2.1; p=0.004). Hospitalizations for complications were 0.7% versus 6.3%.

Mayo Clinic studies and the 197-patient CARE Registry added clinical evidence, but the Rochester study reported biopsy-confirmed recurrence in 22% of patients. CAPTAIN cancer-control outcomes continue to mature. Technical feasibility was validated on the Siemens 0.55T Free.Max MRI platform; this does not establish FDA clearance, clinical validation or commercial availability for the combined platform. Future deployment requires further development and applicable regulatory requirements.

12 points · 1 major

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0 major · 6 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Major pointCAPTAIN's six-month combined functional endpoint favored whole-gland TULSA over robotic prostatectomy: risk ratio 2.1; p=0.004.
• Minor pointCAPTAIN hospitalizations for complications were 0.7% with whole-gland TULSA versus 6.3% with robotic prostatectomy.
• Minor pointCAPTAIN whole-gland TULSA showed no blood loss or overnight hospitalization, faster recovery and earlier work return versus robotic prostatectomy.
• Minor pointCAPTAIN preserved flaccid penile length statistically better at one month with whole-gland TULSA versus robotic prostatectomy.
• Minor pointMayo Florida reported 100% pad-free and 94% leak-free continence among 58 patients with up to 4.5 years' follow-up.

7 minor points

• Minor pointMayo Florida reported erections sufficient for penetration preserved in 87.5% of men beyond 12 months.
• Minor pointMayo Florida reported no strictures or fistulas; serious adverse events were uncommon.
• Minor pointMayo Florida's median PSA nadir, the lowest prostate-specific antigen level, was 0.9 ng/mL.
• Minor pointMayo Rochester mean PSA fell from 7.7 to approximately 2.3–2.6 ng/mL, approximately 62%–66% through one year.
• Minor pointCARE median PSA nadirs were 0.23, 0.60 and 1.10 ng/mL after whole-gland, subtotal and focal treatment, respectively.
• Minor pointCARE median catheterization was seven days after subtotal or focal treatment versus 13.5 days after whole-gland treatment.
• Minor pointSiemens 0.55T Free.Max technical feasibility was validated, supporting a potential additional MRI platform for TULSA deployment.

Negative

• Moderate pointMayo Rochester reported 22% biopsy-confirmed recurrence: 12% in-field and 10% out-of-field among 41 patients.
• Moderate point. Forward-looking: it has not happened yet and may not happen.CAPTAIN cancer-control outcomes continue to mature; reported functional advantages do not resolve longer-term outcomes.
• Minor pointMayo Florida reported 12% required secondary prostate cancer treatment during follow-up.
• Minor pointMayo Rochester adverse events mostly involved urinary or sexual function.
• Minor pointMayo Florida findings have single-center, patient-selection and treatment-heterogeneity limitations.
• Minor pointCombined TULSA-PRO/Free.Max deployment requires further development and applicable regulatory requirements; clearance, clinical validation and availability are not established.

Key Figures

Mayo Clinic Florida patients: 58 patients Pad-free continence: 100% Secondary prostate cancer treatment: 12% +5 more

Mayo Clinic Florida patients

58 patients

Single-center experience with up to 4.5 years of follow-up

Pad-free continence

100%

Mayo Clinic Florida real-world experience

Secondary prostate cancer treatment

12%

Mayo Clinic Florida patients during follow-up

Biopsy-confirmed recurrence

22%

Prospective 41-patient Rochester study

CARE Registry patients

197 patients

Five centers; median follow-up of 24 months

Functional endpoint risk ratio

2.1; p=0.004

CAPTAIN six-month endpoint for preserving erectile function and pad-free continence versus robotic RP

Hospitalizations for complications

0.7% versus 6.3%

Whole-gland TULSA versus robotic RP

Temperature-measurement precision improvement

40%

New three-dimensional thermometry protocols versus conventional approaches

Key Terms

psa, randomized controlled trial, risk ratio, biparametric mri

4 terms

psa medical

"median PSA nadir was 0.9 ng/mL"

Prostate-specific antigen (PSA) is a protein produced by prostate tissue and measured in blood to help detect and monitor prostate conditions, including prostate cancer and benign enlargement. For investors, changes in PSA levels reported in clinical studies or regulatory filings can signal how well a drug or diagnostic test is working, similar to how a gauge on a dashboard indicates the health of a machine and can affect a company’s valuation and regulatory outlook.

randomized controlled trial medical

"first fully enrolled, multicenter randomized controlled trial"

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.

risk ratio technical

"risk ratio of 2.1; p=0.004"

The risk ratio is a statistical measure that compares the probability of a specified event occurring in one group with the probability in another group by dividing the first group's event rate by the second's. A risk ratio greater than 1 means the event is more likely in the first group, less than 1 means it is less likely, and equal to 1 means equal risk; it does not show the size of the underlying probabilities and therefore should be interpreted alongside the groups' absolute risks and confidence intervals. It quantifies association but does not by itself prove causation and can be misleading when event rates are very small or when groups are not comparable.

biparametric mri medical

"using biparametric MRI protocols"

A biparametric MRI is a magnetic resonance imaging protocol that uses two tissue-contrast methods—typically high-resolution T2-weighted imaging and diffusion-weighted imaging—to detect and characterize abnormalities without administering intravenous contrast. It is commonly used for prostate imaging as a faster, simpler alternative to multiparametric MRI, but omitting contrast can reduce certain diagnostic information that contrast-enhanced sequences sometimes provide.

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TORONTO, Oct. 14, 2026 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”) today announced that five abstracts presented at the 15th Interventional MRI (“iMRI”) Symposium in Boston, Massachusetts, reinforce the growing body of evidence supporting the real-world performance, clinical differentiation, and platform expansion potential of the TULSA Procedure™ performed using the TULSA-PRO^® system.

Collectively, the presentations underscore three important dimensions of TULSA’s progress:

• Real-world validation: Findings from the CARE Registry and single-center experiences at Mayo Clinic in Florida and Rochester provide complementary evidence of TULSA outcomes across multiple treatment strategies and clinical settings.
• Clinical differentiation: Results from the CAPTAIN randomized controlled trial demonstrate statistically superior preservation of erectile function together with pad-free continence with the TULSA Procedure compared with robotic radical prostatectomy (“robotic RP”) at six months.
• Platform expansion potential: Technical validation on the Siemens 0.55T Free.Max MRI platform demonstrates the feasibility of delivering TULSA on a lower-field-strength MRI system, potentially broadening equipment options and reducing infrastructure barriers for future TULSA-PRO^® adoption.*
  
  

“These presentations illustrate how TULSA’s evidence base is evolving across the dimensions that matter most: meaningful functional outcomes for patients, reproducibility in routine clinical practice, and the potential to extend our technology to a broader range of iMRI platforms,” said Mathieu Burtnyk, Chief Technology Officer of Profound Medical. “Together, they reinforce the differentiation of TULSA-PRO and its potential to support broader clinical adoption over time.”

Mayo Clinic Florida: Real-World Clinical Experience (Page 88)

This analysis reports experience from one of the early U.S. centers to incorporate TULSA-PRO into routine clinical practice, including 58 patients with up to 4.5 years of follow-up.

Patients underwent a range of treatment approaches, including focal, hemi-gland, subtotal and whole-gland ablation. Serious adverse events were uncommon, with no strictures or fistulas reported. Reported functional outcomes included 100% pad-free continence, 94% leak-free continence and preservation of erections sufficient for penetration in 87.5% of men beyond 12 months.

Median PSA nadir was 0.9 ng/mL, and 12% of patients required secondary prostate cancer treatment during follow-up.

These findings add longer-term clinical experience from routine practice to the growing TULSA evidence base, complementing the randomized CAPTAIN trial and multicenter CARE Registry. The results should be interpreted in the context of the study’s single-center design, patient selection and treatment heterogeneity.

Mayo Clinic Rochester: Prospective Single-Center Study (Page 89)

This prospective study evaluated 41 patients with biopsy-proven localized prostate cancer treated with the TULSA Procedure.

Mean PSA declined from 7.7 ng/mL at baseline to approximately 2.3–2.6 ng/mL, representing a sustained reduction of approximately 62%–66% through one year. The safety profile was generally manageable, with most adverse events involving urinary or sexual function.

Biopsy-confirmed recurrence was reported in 22% of patients, including 12% with in-field recurrence and 10% with out-of-field recurrence. The authors concluded that the TULSA Procedure provided substantial, sustained PSA reduction with a generally favorable safety profile.

The findings add prospective evidence from another high-volume Mayo Clinic center, complementing the broader CARE Registry and the randomized CAPTAIN trial. Together, these studies contribute to a more comprehensive understanding of TULSA’s performance across clinical settings, while underscoring the importance of continued follow-up to characterize oncologic durability.

CARE Registry: Treatment Extent, PSA Response and Catheterization Duration (Page 43)

This analysis evaluated 197 patients treated with the TULSA Procedure across five centers, with a median follow-up of 24 months.

The findings demonstrate the flexibility of TULSA treatment planning, spanning focal, subtotal and whole-gland ablation. As expected, more extensive ablation was associated with deeper prostate-specific antigen (“PSA”) reductions: median PSA nadir was 0.23 ng/mL following whole-gland treatment, compared with 0.60 ng/mL after subtotal treatment and 1.10 ng/mL after focal treatment.

Biochemical recurrence rates did not differ significantly across treatment extents in this analysis. Less extensive treatments were also associated with shorter catheterization duration, decreasing from a median of 13.5 days following whole-gland treatment to seven days following subtotal or focal treatment.

These findings highlight a key feature of the TULSA Procedure: the ability to individualize treatment extent, balancing the objectives of malignant tissue ablation, functional preservation and recovery according to patient needs and clinical judgment.

CAPTAIN Randomized Trial: TULSA Procedure vs. Robotic Radical Prostatectomy — Six-Month Outcomes (Page 42)

CAPTAIN (A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants with Localized Prostate Cancer) is the first fully enrolled, multicenter randomized controlled trial directly comparing the TULSA Procedure with robotic RP in patients with localized intermediate-risk prostate cancer.

As previously reported, whole-gland TULSA demonstrated perioperative advantages over robotic RP, including no blood loss, no overnight hospitalization, faster recovery and earlier return to work. Hospitalizations for complications were also substantially lower with whole-gland TULSA than with robotic RP (0.7% versus 6.3%).

At the primary six-month functional endpoint, whole-gland TULSA achieved statistically superior outcomes, with patients more than twice as likely to preserve both erectile function and pad-free continence (risk ratio of 2.1; p=0.004). Whole-gland TULSA also demonstrated statistically superior preservation of flaccid penile length at one month compared with robotic RP.

While oncologic outcomes continue to mature, these findings provide important randomized evidence of whole-gland TULSA’s potential to improve peri-operative outcomes and preserve quality of life.

Technical Validation of TULSA on the Siemens 0.55T Free.Max MRI Platform (Page 87)

Investigators successfully validated the technical feasibility of the TULSA Procedure on Siemens’ 0.55T Free.Max MRI platform, a lower-field-strength MRI system that may potentially offer additional options for future TULSA-PRO installations.*

The evaluation incorporated new three-dimensional thermometry protocols that improved temperature-measurement precision by 40% compared with conventional approaches. Temperature-monitoring performance approached that of conventional 1.5T systems, with baseline uncertainty of approximately ±1.1°C. Prostate anatomy and surrounding structures remained clearly visible using biparametric MRI protocols, while simulated treatments demonstrated targeting accuracy of 1.0 ± 0.9 mm.

This technical validation represents a potentially important step toward expanding the range of MRI systems on which TULSA could be deployed. If translated into clinical and commercial use, compatibility with lower-cost, wide-bore MRI systems could help reduce equipment-related infrastructure barriers, broaden the potential TULSA-PRO installed-base opportunity and mitigate susceptibility artifacts associated with implants such as hip prostheses.

*Technical feasibility does not establish U.S. Food and Drug Administration clearance, clinical validation or commercial availability on this combined TULSA-PRO<>Siemens 0.55T Free.Max platform. Any statements regarding future deployment remain subject to further development and applicable regulatory requirements.

Building the Evidence and Expanding the Opportunity

“Our focus is to translate TULSA’s clinical differentiation into a broader opportunity for patients, physicians and healthcare providers,” said Profound’s Chief Executive Officer and Chairman, Arun Menawat. “The evidence presented at this year’s iMRI Symposium reinforces the potential of the TULSA Procedure becoming a mainstream treatment modality across the entire prostate disease spectrum, while our technical progress on lower-field-strength Siemens Free.Max points to a potential path toward reducing potential infrastructure barriers to more widespread adoption over time.”

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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Profound Medical's CAPTAIN trial show at six months?

Whole-gland TULSA patients were more than twice as likely as robotic radical prostatectomy patients to preserve both erectile function and pad-free continence at six months. The risk ratio was 2.1, with p=0.004. CAPTAIN is a fully enrolled, multicenter randomized trial in patients with localized intermediate-risk prostate cancer.

Is Profound Medical's TULSA-PRO available on Siemens 0.55T Free.Max?

Technical feasibility has been validated, but this does not establish commercial availability, FDA clearance or clinical validation of the combined TULSA-PRO/Siemens 0.55T Free.Max platform. Future deployment remains subject to further development and applicable regulatory requirements.

Did treatment extent affect recurrence in Profound Medical's CARE Registry analysis?

Biochemical recurrence rates did not differ significantly across treatment extents in this analysis. It evaluated 197 patients across five centers, with median follow-up of 24 months, and included focal, subtotal and whole-gland treatment.