The US Food and Drug Administration (FDA) has granted 510(k) clearance for Profound Medical’s Thermal Boost module for use along with TULSA-PRO.
Surgeons can use the TULSA-PRO technology for ablating whole or partial-gland prostate tissue in patients with low, intermediate, or high-risk prostate cancer. It can also be used to treat benign prostatic hyperplasia (BPH).
The company intends to commercialise new clinically relevant modules under the ‘TULSA AI’ name brand.
Thermal Boost is the company’s first FDA-cleared TULSA AI module that allows surgeons to temporarily increase the ablation target temperature in prostate regions where advanced-stage cancer may be present.
This module, which already received a CE mark, is being used by up to 50% of TULSA patients in Europe.
Furthermore, the company is developing more TULSA AI modules, including one that will allow for the creation of an AI-driven treatment plan based on a successful physician design database.
The TULSA-PRO technology is also suitable for prostate cancer patients on active surveillance seeking treatment and relief from BPH symptoms.
Surgeons are using TULSA-PRO to treat prostates of varying sizes and shapes ranging from 20cc to 250cc for prostate disease treatment.
Profound CEO and chairman Arun Menawat said: “We believe that the TULSA technology can be used to treat up to 600,000 patients per year in the US and based on the utilisation 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.”