Profound Medical (OTCQX:PRFMF;TSXV:PRN) announced the first TULSA-PRO patient paid procedure has been successfully conducted at the ALTA Klinik in Bielefeld, Germany under the supervision of Dr. Agron Lumiani.
TULSA-PRO combines real-time MRI with transurethral, robotically-driven therapeutic ultrasound and closed-loop thermal feedback control designed to provide precise ablation of the prostate while simultaneously protecting critical surrounding anatomy from potential side effects.
The technology, which was CE Marked last year, has demonstrated accurate and precise ablation of malignant prostate tissue, while providing a favorable safety profile, with low rates of serious or long-term adverse events.
Dr. Lumiani is an early adopter of MRI diagnostics and MRI-targeted prostate biopsy. He intends to leverage TULSA-PRO technology for focal therapy in the treatment of patients with localized prostate cancer, and also believes the technology holds promise for ablation in other prostate conditions.
In a statement, Dr. Lumiani said MRI continues to become a more trusted tool for diagnostics and biopsy of prostate cancer. “Profound’s TULSA-PRO system aligns well with this concept, now enabling treatment under real-time MR guidance and control," he added.
According to Dr. Lumiani, TULSA-PRO can complete this paradigm shift, potentially offering patients a therapy that is safe and effective, with minimal side effects.
Arun Menawat, Profound’s CEO, said this is a great step forward in Profound’s journey to commercialize the TULSA-PRO system in Europe and build awareness about the technology as an attractive clinical option for patients with localized prostate cancer.
“We also believe it will act as a strong catalyst for further adoption of the therapy as we continue our penetration into other European and international markets,” he added.
Profound is currently conducting a pilot commercial launch of TULSA-PRO in key European and other CE mark jurisdictions. The company is also sponsoring a multicenter, prospective FDA-registered clinical trial, TACT, which is designed to further demonstrate the safety and effectiveness of this innovative technology. If successful, TACT is expected to support Profound's application to the FDA for approval to market TULSA-PRO in the U.S.