Transurethral Ultrasound Ablation of the Prostate that aims to maintain quality of life and provides the ability to treat a broad spectrum of patients.
A patient-centric solution, robotically controlled by physicians that prioritizes patient well-being, while ensuring precise and accurate treatment delivery of the targeted disease from inside-out, utilizing real-time MRI imaging.
The TULSA Procedure offers customizable treatment planning and 360-degree targeting capability, providing physicians with the flexibility to ablate prescribed tissue volumes in men with localized prostate cancer, prostate cancer combined with obstructive BPH, localized radiorecurrent prostate cancer, or large volume BPH.
Real-time MRI temperature monitoring enables gradual, gentle heating of prostate tissue to achieve cell death, degree by degree. TULSA-PRO uses this closed-loop feedback to ensure ablation accuracy by automatically adjusting the energy throughout the procedure.
The TULSA Procedure has demonstrated durable efficacy and safety, supported by 67+ peer-reviewed publications up to 5-year clinical outcomes.
Patient safety is paramount in the TULSA Procedure. With MRI guidance, real-time monitoring, and precise control, the treatment is administered accurately, minimizing complications and prioritizing the well-being of the patient.
Profound Medical develops customizable, incision-free therapies which combine real-time Magnetic Resonance (“MR”) imaging, thermal ultrasound and closed-loop temperature feedback control for the radiation-free ablation of diseased tissue
Profound is commercializing TULSA-PRO®, a technology that combines real-time MRI, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. TULSA-PRO® is designed to provide customizable and predictable radiation-free ablation of a surgeon-defined prostate volume while actively protecting the urethra and rectum to help preserve the patient’s natural functional abilities. We believe TULSA-PRO® is demonstrating to be a flexible technology in customizable prostate ablation, including intermediate stage cancer, localized radio-recurrent cancer, retention and hematuria palliation in locally advanced prostate cancer, and the transition zone in large volume benign prostatic hyperplasia (BPH). TULSA-PRO® is CE marked and received 510(k) clearance from the U.S. Food and Drug Administration in August 2019.
Profound is also commercializing Sonalleve®, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids and palliative pain treatment of bone metastases. Sonalleve® has also been approved by the China Food and Drug Administration for the non-invasive treatment of uterine fibroids. The Company 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.