8-K: Profound Medical Reports Record Q3 2025 Preliminary Revenue

Profound Medical Corp. announced preliminary unaudited third-quarter 2025 revenues are expected to reach a record $5.2 million to $5.3 million, marking significant year-over-year growth.

Summary

• Preliminary unaudited total revenues for the three months ended September 30, 2025, are anticipated to be in the range of $5.2 million to $5.3 million.
• This represents revenue growth of between 84% and 87% compared to $2.8 million in the same three-month period a year ago.
• Gross margin is expected to be approximately 72% for the third quarter of 2025, an increase from 64% in the prior year period.
• The TULSA-PRO installed base increased to 67 systems, up from 60 systems previously.
• The company continues to expect to reach at least 75 TULSA-PRO systems by the end of 2025, supported by a strong capital sales pipeline.
• Full third quarter 2025 financial results will be announced after market close on Thursday, November 13, 2025.

Sentiment

Score: 8

Explanation: The filing reports record preliminary revenues, significant year-over-year growth, improved gross margins, and strong installed base expansion for its key product, TULSA-PRO. The outlook for year-end system installations is also positive, indicating strong operational momentum and market acceptance.

Positives

• Record preliminary unaudited total revenues projected between $5.2 million and $5.3 million for Q3 2025.
• Significant year-over-year revenue growth of 84% to 87% compared to $2.8 million in Q3 2024.
• Expected gross margin improvement to approximately 72% in Q3 2025 from 64% in Q3 2024.
• Increased TULSA-PRO installed base to 67 systems, up from 60, indicating strong market penetration.
• Strong capital sales pipeline supports the expectation of reaching at least 75 TULSA-PRO systems by year-end.
• Achieved new highs in both TULSA-PRO installed base growth and existing system utilization.

Risks

• Actual preliminary unaudited revenues may differ from the anticipated range.
• Risks regarding the medical device industry, including regulatory approvals and reimbursement.
• Economic factors and equity market fluctuations could impact financial performance.
• Risks associated with growth and competition in the medical device market.
• Forward-looking statements are subject to known and unknown risk factors and uncertainties, and actual results could differ materially from those anticipated.

Future Outlook

Profound Medical anticipates achieving at least 75 TULSA-PRO systems installed by the end of 2025, driven by a strong and growing capital sales pipeline. The company expects its TULSA Procedure to potentially become a mainstream treatment modality across the entire prostate disease spectrum. Additionally, it is in the early stages of exploring additional potential treatment markets for Sonalleve, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy.

Management Comments

• "During the third quarter, we achieved new highs in terms of both TULSA-PRO installed base growth and existing system utilization, driving record total revenues." Arun Menawat, Profound's CEO and Chairman.
• "Our TULSA-PRO installed base now sits at 67 up from 60 and, due to our strong and growing capital sales pipeline, we continue to expect to reach at least 75 by the end of the year." Arun Menawat, Profound's CEO and Chairman.

Industry Context

Profound Medical operates in the rapidly evolving medical device sector, focusing on incision-free therapies. The TULSA-PRO system, combining real-time MRI, AI-enhanced planning, and robotic ultrasound, positions the company at the forefront of minimally invasive prostate disease treatment. Its expansion of the installed base and utilization rates suggest strong market adoption for advanced, precise ablation technologies, aligning with broader healthcare trends towards less invasive procedures and personalized medicine. The company's exploration of Sonalleve for other cancer therapies indicates a strategy to diversify its therapeutic applications within the high-intensity focused ultrasound (HIFU) market.

Stakeholder Impact

• Shareholders: Positive impact due to strong revenue growth, improved margins, and positive outlook, potentially leading to increased share value.
• Customers (Hospitals/Clinics): Increased adoption and utilization of TULSA-PRO systems suggest satisfaction and clinical benefits.
• Patients: Continued expansion of TULSA-PRO and Sonalleve offers more access to advanced, incision-free treatment options for various conditions.
• Employees: Positive performance and growth could lead to job security and potential expansion opportunities.

Next Steps

• Announce full third quarter 2025 financial results after market close on Thursday, November 13, 2025.
• Host a conference call at 4:30 p.m. ET on November 13, 2025, to review financial results and discuss business developments.
• Continue to expand the TULSA-PRO installed base to reach at least 75 systems by the end of 2025.
• Explore additional potential treatment markets for Sonalleve, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy.

Key Dates

Recommendation

The preliminary Q3 2025 results indicate exceptional performance with record revenue growth (84-87% year-over-year) and significant gross margin expansion (72% from 64%). The strong increase in the TULSA-PRO installed base (60 to 67 systems) and the confident outlook to reach at least 75 systems by year-end demonstrate robust market adoption and a healthy sales pipeline. These metrics suggest strong operational execution and increasing demand for Profound Medical's innovative technologies, making it an attractive investment opportunity.

Keywords

Profound Medical, TULSA-PRO, medical device, prostate cancer, BPH, Sonalleve, ultrasound ablation, MRI-guided therapy, Q3 2025 earnings, revenue growth, gross margin, medical technology