Johns Hopkins Medicine Initiates Use of Profound Medical’s TULSA-PRO System

The Johns Hopkins Hospital has treated its first non-clinical-trial prostate cancer patient using Profound Medical Corp.’s TULSA-PRO system, a milestone that coincides with the opening of the hospital’s new interventional MRI (iMRI) suite.

Considered a major advancement in prostate care, the TULSA Procedure is used by physicians to treat prostate cancer and benign prostatic hyperplasia (BPH, also known as an enlarged prostate). Robotically controlled directional ultrasound is delivered from inside the urethra to precisely and gently 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. Such precision allows physicians to tailor therapy to each patient, 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.

“The implementation of TULSA-PRO in a newly built interventional MR suite specifically designed for surgical procedures that benefit from the precision of real-time MRI to deliver superior clinical outcomes is a growing movement,” Profound Medical Chairman/CEO Arun Menawat stated. “Accordingly, it is not surprising that an institution such as Johns Hopkins Medicine is at the forefront of this trend. Johns Hopkins University was an early participant in the clinical development of TULSA-PRO through participation in the TACT pivotal clinical trial that led to the technology’s FDA clearance, and then in the more recent randomized prospective post-market CAPTAIN trial. We are thrilled to see them now offer TULSA-PRO to their patients as an option to treat prostate cancer or symptoms of BPH.”

Profound Medical is a commercial-stage medical device company that develops and markets artificial intelligence (AI)-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue.

Profound Medical 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, could potentially become 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 BPH; to men with BPH only; and also, to patients requiring salvage therapy for radio-recurrent localized prostate cancer. Virtually all prostate shapes and sizes can be safely, effectively, and efficiently treated with TULSA. The 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, a therapeutic platform that is CE marked for treating 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 non-invasively treating uterine fibroids and has FDA approval under a Humanitarian Device Exemption for treating 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.