TORONTO, ON — January 15, 2026 — Leads & Copy —
Mount Sinai Hospital, ranked No. 6 nationally for Urology by US News & World Report® for 2025-26, has successfully treated its first prostate cancer patient with the TULSA-PRO® system, according to Profound Medical Corp. The TULSA Procedure™ represents a major advancement in prostate care, used by physicians to treat prostate cancer and benign prostatic hyperplasia (BPH). Robotically controlled directional ultrasound is delivered from inside the urethra to precisely heat prostate tissue to ‘kill temperature’ (55-57°C), while protecting surrounding nerves and anatomy. Real-time MRI thermography enables continuous visualization and autonomous temperature adjustment throughout the procedure.
This precision allows physicians to tailor therapy, resulting in no procedural blood loss, no overnight hospital stay, and a quicker return to everyday life, while minimizing side effects typically associated with surgery or radiation, such as urinary incontinence and/or erectile dysfunction.
Michael Palese, MD, Chair, Department of Urology, Mount Sinai Downtown and Professor, Department of Urology at the Icahn School of Medicine at Mount Sinai; Neil Rofsky, MD, MHA, Dr. Charles and Marilyn Newman Professor and Chair of Diagnostic, Molecular and Interventional Radiology at the Mount Sinai Health System; Kyrollis Attalla, MD, Assistant Professor, Department of Urology and Christine Chen, MD, Associate Professor, Diagnostic, Molecular and Interventional Radiology, recently collaborated to perform the health system’s first TULSA Procedure, with the patient responding well to the treatment and being discharged the same day.
According to Arun Menawat, Profound’s CEO and Chairman, 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.
Ash Tewari, MD, MBBS, MCh, Surgeon-in-Chief Tisch Cancer Hospital & System, Chair of Urology and Professor at the Mount Sinai Health System, said that 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, and that patients will have another option for best-in-class treatment of these complex conditions.
Dr. Menawat continued that interventional Magnetic Resonance Imaging, or iMRI, is emerging as a way of transforming how complex procedures and unmet medical needs are addressed, and the company believes TULSA-PRO has the potential to become a beacon of iMRI’s incredible future.
Dr. Menawat also said that 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, and that the company is excited to welcome Mount Sinai as a valued TULSA-PRO site.
Profound is a commercial-stage medical device company that develops and markets AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue. Profound is commercializing TULSA-PRO®, a technology that combines real-time MRI, AI-enhanced planning, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. The TULSA Procedure™, performed using the TULSA-PRO system, has the potential of becoming a mainstream treatment modality across the entire prostate disease spectrum; ranging from low-, intermediate-, or high-risk prostate cancer; to hybrid patients suffering from both prostate cancer and benign prostatic hyperplasia (“BPH”); to men with BPH only; and also, to patients requiring salvage therapy for radio-recurrent localized prostate cancer. The TULSA Procedure employs real-time MR guidance for precision to preserve patients’ urinary continence and sexual function, while killing the targeted prostate tissue via precise sound absorption technology that gently heats it to 55-57°C. The TULSA Procedure is an incision- and radiation-free “one-and-done” procedure performed in a single session that takes a few hours. Virtually all prostate shapes and sizes can be safely, effectively, and efficiently treated with the TULSA Procedure. There is no bleeding associated with the procedure; no hospital stay is required; and most TULSA patients report quick recovery to their normal routine. TULSA-PRO is CE marked, Health Canada approved, and 510(k) cleared by the U.S. Food and Drug Administration (“FDA”).
Profound is also commercializing Sonalleve®, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids, adenomyosis, pain palliation of bone metastases, desmoid tumors and osteoid osteoma. Sonalleve has also been approved by the China National Medical Products Administration for the non-invasive treatment of uterine fibroids and has FDA approval under a Humanitarian Device Exemption for the treatment of osteoid osteoma. Profound is in the early stages of exploring additional potential treatment markets for Sonalleve where the technology has been shown to have clinical application, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy.
Contact:
Stephen Kilmer
Investor Relations
skilmer@profoundmedical.com
T: 647.872.4849
Susan Thomas
Public Relations
sthomas@profoundmedical.com
T: 619.540.9195
Source: Profound Medical Corp.
