8-K: Profound Exceeds TULSA-PRO System Installation Goal

Profound Medical Corp. announced its TULSA-PRO installed base reached 78 systems by year-end 2025, surpassing its goal of 75, with a sales pipeline of 97 new systems.

Summary

• Profound Medical Corp. reported its TULSA-PRO system installed base reached 78 systems as of December 31, 2025.
• This figure exceeded the company's previously announced goal of 75 installs for the end of 2025.
• The qualified sales pipeline for TULSA-PRO grew to 97 new systems, categorized within the Verify, Negotiate, and Contracting stages.
• The TULSA Procedure is an AI-powered, MRI-guided, incision-free therapy for prostate disease, including cancer and BPH, designed to preserve patient functions.
• Profound also commercializes Sonalleve for uterine fibroids, bone metastases, and other conditions, and is exploring new applications.

Sentiment

Score: 8

Explanation: The company exceeded its key operational goal for TULSA-PRO installations and reported strong growth in its sales pipeline, indicating positive momentum and future revenue potential. Management's comments reinforce a positive outlook on recurring revenue growth.

Positives

• Exceeded the TULSA-PRO installed base goal for 2025, reaching 78 systems against a target of 75.
• Significant growth in the qualified sales pipeline for TULSA-PRO, now at 97 new systems.
• Management anticipates the growing installed base will lead to higher patient treatment rates and increased high-margin recurring revenue.
• TULSA Procedure offers a broad treatment spectrum for prostate diseases while preserving crucial patient functions.

Risks

• Risks inherent in the medical device industry.
• Uncertainties related to regulatory approvals.
• Challenges concerning reimbursement policies.
• Impact of general economic factors.
• Fluctuations in the equity markets.
• Risks associated with company growth and competition.

Future Outlook

Management expects the growing TULSA-PRO installed base to drive higher patient treatment rates and continued growth in high-margin recurring revenue. The company also plans to release its fourth quarter and full year 2025 financial results near the end of February 2026 and is exploring additional treatment markets for its Sonalleve technology.

Management Comments

• "As the installed base grows, we expect that it will lead to higher patient treatment rates and, correspondingly, continued growth of our high margin recurring revenue."
• "That is being driven primarily by the TULSA Procedures ability to treat an unrivaled range of prostate diseases, severities, and aggressions, while preserving crucial functions like continence and sexual health of the patient."
• "We look forward to releasing our fourth quarter and full year 2025 financial results near the end of February 2026."

Industry Context

Profound Medical operates in the competitive medical device industry, specifically targeting prostate disease treatment with its TULSA-PRO system and other conditions with Sonalleve. The TULSA Procedure's focus on MRI-guided, incision-free ablation with functional preservation positions it as a potentially less invasive and more patient-friendly alternative to traditional prostate treatments, aligning with a broader trend towards minimally invasive procedures in healthcare. The growth in its installed base and sales pipeline suggests increasing adoption within this niche.

Comparison to Industry Standards

• The TULSA Procedure, utilizing real-time MRI guidance and transurethral ultrasound, offers an incisionand radiation-free "one-and-done" treatment for prostate disease, which contrasts with more invasive surgical options or radiation therapies that often carry higher risks of side effects like incontinence and sexual dysfunction.
• Its ability to treat a wide range of prostate diseases (low-, intermediate-, high-risk cancer, BPH, hybrid patients, salvage therapy) positions it as a versatile solution compared to therapies with narrower indications.
• The reported quick recovery, no hospital stay, and no bleeding associated with the TULSA Procedure suggest a favorable patient experience relative to traditional surgical interventions like radical prostatectomy.

Stakeholder Impact

• Shareholders: Positive impact due to exceeding operational goals, strong sales pipeline, and anticipated growth in high-margin recurring revenue, potentially leading to increased share value.
• Patients: Benefit from access to an advanced, incision-free, MRI-guided treatment for prostate disease that aims to preserve crucial functions and offers quick recovery.
• Employees: Potential for increased job security and growth opportunities as the company expands its installed base and market reach.
• Healthcare Providers/Hospitals: Gain access to an innovative technology (TULSA-PRO) that can enhance their treatment offerings for prostate conditions, potentially attracting more patients.

Next Steps

• Continue to grow the TULSA-PRO installed base to drive higher patient treatment rates and recurring revenue.
• Release fourth quarter and full year 2025 financial results near the end of February 2026.
• Explore additional potential treatment markets for Sonalleve, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy.

Key Dates

Recommendation

The company has demonstrated strong operational execution by surpassing its TULSA-PRO installation goal for 2025 and significantly expanding its sales pipeline. This indicates robust market adoption for its flagship product, which is poised to drive future high-margin recurring revenue. The TULSA Procedure's unique benefits in prostate disease treatment position Profound Medical favorably in a growing market. While financial results are pending, the operational momentum suggests a positive trajectory, making it an attractive investment for growth-oriented portfolios.

Keywords

Profound Medical, TULSA-PRO, Prostate Cancer, BPH, Medical Device, MRI-guided, Ultrasound Therapy, Sonalleve, Ablation, Healthcare Technology