8-K: Mount Sinai Adopts Profound's TULSA-PRO for Prostate Cancer

Mount Sinai Hospital becomes the first in Metro New York to offer Profound Medical's TULSA-PRO system for incision-free, MRI-guided prostate treatment.

Summary

• Profound Medical Corp. announced that Mount Sinai Hospital successfully treated its first prostate cancer patient using the TULSA-PRO system.
• Mount Sinai is the first health system in the New York Metro Area to offer this AI-driven, MRI-guided, and incision-free TULSA Procedure.
• The TULSA Procedure treats prostate cancer and benign prostatic hyperplasia (BPH) by robotically controlled directional ultrasound, precisely heating prostate tissue to 55-57C while protecting surrounding nerves and anatomy.
• Real-time MRI thermography enables continuous visualization and autonomous temperature adjustment throughout the procedure.
• Key benefits include no procedural blood loss, no overnight hospital stay, a quicker return to everyday life, and minimized side effects typically associated with surgery or radiation, such as urinary incontinence and/or erectile dysfunction.
• The patient responded well to the treatment and was discharged the same day.
• Mount Sinai Hospital is ranked No. 6 nationally for Urology by US News & World Report for 2025-26.
• Profound also commercializes Sonalleve, a therapeutic platform CE marked for uterine fibroids, adenomyosis, pain palliation of bone metastases, desmoid tumors, and osteoid osteoma, with additional approvals in China and the U.S. (HDE).

Sentiment

Score: 8

Explanation: The announcement of a major, highly-ranked hospital adopting Profound's TULSA-PRO system for patient treatment is a significant positive development. It validates the technology, expands market reach in a key metropolitan area, and highlights the patient benefits of the procedure. This is a strong commercial milestone that should positively impact the company's trajectory.

Positives

• World-renowned Mount Sinai Hospital successfully treated its first prostate cancer patient with the TULSA-PRO system.
• Mount Sinai is the first health system in the New York Metro Area to offer this innovative, AI-driven, MRI-guided, and incision-free prostate treatment.
• The TULSA Procedure offers significant patient benefits including no procedural blood loss, no overnight hospital stay, a quicker return to everyday life, and minimized side effects like urinary incontinence and erectile dysfunction.
• The technology combines real-time MRI, AI-enhanced planning, robotically-driven transurethral ultrasound, and closed-loop temperature feedback control for high precision.
• TULSA-PRO can treat an unrivaled range of prostate diseases, including low-, intermediate-, or high-risk prostate cancer, hybrid patients with both prostate cancer and BPH, men with BPH only, and patients requiring salvage therapy for radio-recurrent localized prostate cancer.
• The adoption by a top-ranked urology hospital like Mount Sinai validates the technology and is expected to pave the way for future studies and guidelines.
• TULSA-PRO is CE marked, Health Canada approved, and 510(k) cleared by the U.S. Food and Drug Administration (FDA).

Risks

• Risks regarding the medical device industry.
• Risks related to regulatory approvals.
• Risks concerning reimbursement.
• Economic factors.
• Risks associated with the equity markets generally.
• Risks associated with growth and competition.
• Other factors and risks that may cause actual results to differ materially from those set out in 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.

Future Outlook

Expectations are for the continued efficacy of Profound's technology in treating prostate cancer, BPH, uterine fibroids, palliative pain treatment, and osteoid osteoma. The company anticipates success in its commercialization strategy for TULSA-PRO, believing it has the potential to become a beacon of iMRI's future and a mainstream treatment modality across the entire prostate disease spectrum. Profound is also 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

• "With this milestone, Mount Sinai continues to establish itself as a leader in robotic surgical care, becoming the first health system in the New York Metro Area to offer the innovative, AI-driven, MRI-guided, and incision-free TULSA Procedure to prostate disease patients." Arun Menawat, Profound's CEO and Chairman.
• "This unique collaboration between the Department of Urology and the Department of Interventional Radiology at Mount Sinai will pave the way for future studies and guidelines in prostate cancer and BPH using TULSA-PRO. Patients will have another option for best-in-class treatment of these complex conditions." Ash Tewari, MD, MBBS, MCh, Surgeon-in-Chief Tisch Cancer Hospital & System, Chair of Urology and Professor at the Mount Sinai Health System.
• "Today, interventional Magnetic Resonance Imaging, or iMRI, is emerging as a way of transforming how complex procedures and unmet medical needs are addressed, and we believe TULSA-PRO has the potential to become a beacon of iMRIs incredible future." Dr. Menawat.
• "What makes the TULSA Procedure unique is its ability to treat an unrivaled range of prostate diseases, severities, and aggressions, while preserving crucial functions like continence and sexual health. We are excited to welcome Mount Sinai as a valued TULSA-PRO site." Dr. Menawat.

Industry Context

This announcement highlights the growing trend towards minimally invasive, precision-guided therapies in oncology and urology. The integration of AI and real-time MRI guidance positions TULSA-PRO at the forefront of technological advancements in medical devices, aligning with the broader industry shift towards personalized and less debilitating patient treatments. The adoption by a prestigious institution like Mount Sinai, a top-ranked urology hospital, underscores the increasing acceptance and demand for such innovative solutions in a competitive healthcare landscape, potentially setting a new standard for prostate care.

Comparison to Industry Standards

• Mount Sinai Hospital is ranked No. 6 nationally for Urology by US News & World Report for 2025-26, indicating a high standard of care and expertise in the field.
• The TULSA Procedure offers significant advantages over traditional surgery or radiation by minimizing severe side effects such as urinary incontinence and erectile dysfunction, which are common concerns with existing prostate treatments.
• The incision-free nature, lack of blood loss, same-day discharge, and quick recovery associated with the TULSA Procedure represent a substantial improvement in patient experience and outcomes compared to more invasive surgical options for prostate disease.

Stakeholder Impact

• Shareholders: Positive impact due to increased market adoption, validation of technology, and potential for future revenue growth.
• Patients: Significant positive impact through access to a less invasive, highly precise treatment option for prostate cancer and BPH with reduced side effects and quicker recovery.
• Healthcare Providers (Mount Sinai): Enhances reputation as a leader in robotic surgical care and advanced prostate treatment, offering cutting-edge options to patients.
• Employees (Profound Medical): Positive morale and validation of their work in developing innovative medical devices.

Next Steps

• Future studies and guidelines in prostate cancer and BPH using TULSA-PRO, potentially stemming from the Mount Sinai collaboration.
• Continued commercialization of TULSA-PRO in other markets.
• Early-stage exploration of additional potential treatment markets for Sonalleve, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy.

Key Dates

Recommendation

The adoption of Profound Medical's TULSA-PRO system by a prestigious institution like Mount Sinai, a top-ranked urology hospital in a major metropolitan area, represents a significant commercial and clinical validation. This milestone is highly likely to accelerate market acceptance, drive sales, and enhance the company's reputation. The TULSA Procedure's demonstrated patient benefits (incision-free, minimal side effects, quick recovery) position it favorably against existing treatments. This news indicates strong positive momentum for the company's growth trajectory and future revenue potential, making it a compelling investment opportunity.

Keywords

Prostate cancer, TULSA-PRO, MRI-guided, Incision-free, Ultrasound ablation, Medical device, Profound Medical, Mount Sinai, Urology, Interventional Radiology, AI-powered therapy, Benign Prostatic Hyperplasia, BPH