Profound Medical’s TULSA-PRO Thermal Boost AI Module Gets FDA Nod

Profound Medical has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Thermal Boost Module in conjunction with its TULSA-PRO.
 
TULSA-PRO enables whole- or partial-gland prostate tissue in patients with low-, intermediate-, or high-risk prostate cancer; with benign prostatic hyperplasia (BPH); as well as prostate cancer patients on active surveillance seeking treatment of their cancer and relief from BPH symptoms.
 
The company’s data indicates in a commercial setting that about 60% of patients treated with TULSA need whole gland ablation, with 40% needing partial gland ablation. TULSA surgeons treat prostate volumes ranging from less than 20cc to over 250cc.
 
Thermal Boost is Profound’s first FDA-cleared TULSA artificial intelligence (AI) module. It lets surgeons temporarily increase ablation target temperature in prostate regions where advanced stage cancer might be, in order to boost confidence that aggressive cancer cells have been ablated. The module is CE marked and the company said is used in up to half the TULSA patients being treated in Europe.
 
Based on a recent TULSA-PRO survey, European surgeons indicated Thermal Boost demonstrated improved treatment outcomes in 88% of their prostate cancer cases.
 
“The Thermal Boost feature is a significant development of the TULSA technology,” Dr. Mikael Anttinen, Urologic Oncologist at Turku University Hospital in Finland told the press. “It opens an important degree of freedom for the surgeon, allowing for controlled increased thermal dose to be delivered to selected regions of the treatment plan. 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. The Thermal Boost feature has allowed us to expand our confidence in patient selection, for example to include patients with MRI-visible lesions bulging the prostate capsule, and other higher risk features.”
 
Profound said it’s continuing to develop further modules, including one that will enable creation of an AI-driven automated treatment plan based on a database of successful physician-created treatment designs. 
 
Profound CEO and chairman Arun Menawat, Ph.D., added, “We believe that the TULSA technology can be used to treat up to 600,000 patients per year in the United States, and based on the utilization data from Europe, Thermal Boost may have an application in the majority of late-stage disease cases. In addition, the feedback from European surgeons using the module indicates that Thermal Boost could significantly increase both the ease and speed of treatment in a certain subset of the patient population.”