8-K: Profound Medical Taps Former NFL Star Leonard Wheeler as Global Ambassador for TULSA-PRO System

Profound Medical Corp. announced a landmark partnership with former NFL safety Leonard Wheeler, who successfully underwent the TULSA procedure for prostate cancer, to serve as a Global Ambassador for its TULSA-PRO system.

Summary

• Profound Medical Corp. has appointed Leonard Wheeler, a former NFL safety, as a Global Ambassador for its TULSA-PRO system.
• Mr. Wheeler successfully underwent the TULSA procedure for organ-confined prostate cancer earlier in 2025.
• As Global Ambassador, Mr. Wheeler will establish platforms and communities, both in-person and digital, to educate, connect, and empower men, driving global awareness and advocacy for TULSA-PRO.
• The TULSA procedure, performed using the TULSA-PRO system, is an incisionand radiation-free, one-and-done treatment for prostate disease, including various stages of prostate cancer and benign prostatic hyperplasia (BPH).
• The procedure uses real-time MR guidance and AI-enhanced planning to precisely ablate targeted prostate tissue by heating it to 55-57°C, aiming to preserve urinary continence and sexual function.
• TULSA-PRO is CE marked, Health Canada approved, and 510(k) cleared by the U.S. Food and Drug Administration (FDA).

Sentiment

Score: 8

Explanation: The sentiment is highly positive due to the strategic appointment of a well-known individual as a global ambassador, especially one who is a successful patient of the TULSA procedure. This is a strong marketing and awareness initiative that could significantly benefit the company's product adoption.

Positives

• The appointment of a high-profile individual like Leonard Wheeler, who is also a patient success story, is expected to significantly boost awareness and adoption of the TULSA-PRO system.
• Mr. Wheeler's background as an entrepreneur, author, corporate consultant, and podcaster provides a strong platform for global advocacy and education.
• The partnership leverages a personal testimonial, which can be highly effective in building trust and encouraging patient consideration for the TULSA procedure.
• The initiative aligns with Profound's 2025 deliverables to drive awareness, adoption, access, and advocacy for TULSA-PRO at physician, patient, and private payer levels.
• The TULSA procedure offers a non-invasive, single-session treatment with quick recovery, potentially preserving quality of life for patients, which is a strong selling point.

Risks

• The success of the U.S. commercialization strategy and activities for TULSA-PRO is subject to risks inherent in the medical device industry.
• Regulatory approvals and reimbursement policies can impact the adoption and market penetration of Profound's technologies.
• Economic factors, equity market fluctuations, and general market conditions could affect the company's performance.
• Risks associated with growth and competition in the medical device sector may impact the company's ability to achieve its goals.
• Actual financial results, including revenue, operating expenses, and cash usage, may differ from management's expected ranges due to market factors and execution of operational plans.

Future Outlook

Profound Medical aims to drive awareness, adoption, access, and advocacy for TULSA-PRO at the physician, patient, and private payer levels in 2025. The company expects to launch an immersive TULSA-PRO awareness campaign on multiple fronts, including digital media, social media, and podcasting, in partnership with Leonard Wheeler. The company also continues to explore additional potential treatment markets for its Sonalleve platform, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy.

Management Comments

• "Once I understood the difference, it was an easy decision. The TULSA procedure not only treated my cancer effectively, but it also protected the quality of life I value. I feel incredibly blessed by the results and deeply motivated to help other men become aware of this option." Leonard Wheeler
• "This is bigger than me. Its about helping men and their families see a different way forward. Because once you know your options, you can take control of your health and your future." Leonard Wheeler
• "Our deliverables for 2025 are to drive awareness and adoption of, access to, and advocacy for TULSA-PRO at the physician, patient and private payer levels. To that end, we are excited to partner with Leonard and look forward to working with him to soon launch an immersive TULSA-PRO awareness campaign on multiple fronts, including digital media, social media, podcasting, and more." Tom Tamberrino, Profound's Chief Commercial Officer

Industry Context

This announcement positions Profound Medical to potentially gain significant market share in the prostate disease treatment sector by leveraging a high-profile personal endorsement. In an industry where patient education and awareness are crucial for adoption of new medical technologies, a celebrity ambassador who is also a successful patient can accelerate the shift from traditional, more invasive treatments (like robotic prostatectomy and radiation) towards less invasive options like TULSA-PRO. This strategy aims to differentiate TULSA-PRO in a competitive landscape by emphasizing quality of life benefits and patient experience.

Stakeholder Impact

• **Shareholders**: Potential for increased brand recognition, product adoption, and future revenue growth, which could positively impact share price.
• **Patients**: Increased awareness of a less invasive treatment option for prostate disease, potentially leading to better quality of life outcomes.
• **Physicians**: Greater patient demand for the TULSA-PRO system, potentially leading to increased utilization.
• **Employees**: Positive morale from a high-profile endorsement and potential for business growth.

Next Steps

• Launch an immersive TULSA-PRO awareness campaign on multiple fronts, including digital media, social media, and podcasting.
• Drive awareness, adoption, access, and advocacy for TULSA-PRO at the physician, patient, and private payer levels throughout 2025.
• Continue exploring additional potential treatment markets for the Sonalleve platform, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy.

Key Dates

Keywords

Profound Medical, TULSA-PRO, Prostate Cancer Treatment, Medical Device, Leonard Wheeler, Global Ambassador, Non-invasive Therapy, MR-guided Ultrasound, Prostate Health, BPH Treatment, Healthcare Technology