March 22, 2017 — Profound Medical Corp. announced that it has successfully completed the first sale of a TULSA-PRO system in Finland to the Turku University Hospital (“Tyks”). The deal was completed in collaboration with Philips, who is working in partnership with Profound to commercialize the TULSA-PRO system in Europe.
Profound has also sold TULSA-PRO systems in Spain, the United Kingdom and Germany since receiving CE Mark designation in April 2016.
Operation of the TULSA-PRO system will be administered under Roberto Blanco Sequeiros, M.D., chairman of the Medical Imaging Center at Turku University Hospital and under a leading European urologist, Peter Boström, M.D. According to Blanco Sequeiros, the technology holds promise in multiple areas of prostate treatment and care, including focal therapy for localized prostate cancer, treatment of benign prostate hyperplasia, salvage radiation therapy and the debulking of tumours.
“While there have been significant medical advances in prostate care in recent years, there is no question that an unmet medical need and uncharted medical terrain remains,” commented Blanco Sequeiros. “Survival rates for prostate cancer are high, but current therapies often come with side effects that include erectile dysfunction, incontinence and bowel problems. Though further testing is required, the evidence is compelling, and suggests that the TULSA-PRO system could represent a major breakthrough in prostate treatment, offering patients a therapy that is safe, accurate and effective with minimal side effects. We are keen to assess its potential in both localized prostate cancer and other prostate conditions.”
TULSA-PRO combines real-time magnetic resonance imaging (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. TULSA-PRO 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.
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 U.S. Food and Drug Administration (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 United States.
For more information: www.profoundmedical.com