
Profound Medical Receives 510(k) Clearance for Thermal Boost AI Module for Use With TULSA PRO Prostate Cancer Ablation Technology
Profound Medical Corp. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Thermal Boost module designed for use with TULSA-PRO®. The technology enables surgeons to perform customizable, incision-free ablation of diseased prostate tissue, for prostate cancer patients. The procedure uses a transurethral ablation catheter and uses magnetic resonance imaging to guide the treatment
TULSA-PRO® is a medical technology that empowers surgeons to ablate whole- or partial-gland prostate tissue, making it suitable for treating patients with low-, intermediate-, or high-risk prostate cancer, as well as those with benign prostatic hyperplasia (BPH). Profound’s data shows that around 60% of TULSA patients require whole gland ablation, while the remaining 40% undergo partial gland ablation. Moreover, TULSA-PRO® can treat prostates of various shapes and sizes, ranging from under 20cc to over 250cc, making it adaptable for different patients. Additionally, Profound has developed a series of software modules to enhance TULSA-PRO®’s customizability, ease of use, and clinical outcomes. These modules, collectively referred to as ‘TULSA AI,’ offer a tailored approach to treatment.
Thermal Boost, the first FDA-cleared TULSA AI module, allows surgeons to temporarily increase the ablation target temperature in areas where advanced-stage cancer may be present. This innovation boosts confidence in successfully ablating aggressive cancer cells. European surgeons using Thermal Boost have reported improved treatment outcomes in 88% of prostate cancer cases.
In clinical studies in men treated with TULSA-PRO, 80% had no significant disease at year one and after 5 years only 21% underwent an additional procedure such as prostatectomy or radiation therapy. Patients also had lower rates of side effects such as incontinence and impotence following the procedure. Today most men pay almost $30,000 out of pocket for the procedure but the company was recently notified by the American Medical Association that a new category 1 CPT code was approved in June 2023 that will be ready by Jan. 1, 2025.
Dr. Mikael Anttinen, Urologic Oncologist at Turku University Hospital in Finland, praised Thermal Boost, stating, “Achieving complete thermal coverage is critical to successful prostate disease treatment, so being able to customize ablation temperature in real time has improved treatment efficacy as well as workflow efficiency.”
Profound’s CEO and Chairman, Arun Menawat, highlighted the potential impact of Thermal Boost, stating that it could significantly enhance treatment ease and speed, particularly for late-stage disease cases. Profound believes that TULSA technology has the potential to treat up to 600,000 patients annually in the United States including patients with prostate cancer (approximately 200,000 of the roughly 280,000 diagnosed per year) and 400,000 patients with enlarged prostates or benign prostatic hyperplasia.
The company is actively developing additional TULSA AI modules, including one that will create an AI-driven automated treatment plan based on a database of successful physician-created treatment designs. Profound is collaborating with the FDA to secure clearance for this module.