Profound Medical (NASDAQ: PROF; TSX: PRN) announced that total revenues for the third quarter of 2025 were $5.3 million, representing year-over-year revenue growth of 87%. The gross margin for the third quarter of 2025 was 74.3%, up 1,119 basis points year-over-year from 63.1% in the prior year period.
In the company’s press release and on its corresponding investor call, Profound’s CEO Arun Menawat playfully set the tone for how the investment community might view the company’s strong growth trajectory and prospects, noting that the theme of his presentation at the Stifel Healthcare Conference earlier this week was “It’s Happening!”
In a statement, Dr. Menawat commented, “As demonstrated by our strong revenue and TULSA Procedure volume growth, increased gross margin, improved bottom line, and rapidly expanding TULSA-PRO installed base, we were not only able to successfully navigate through an unusually challenging second quarter, but also delivered record results in Q3-2025.”
He added, “So far, that positive momentum has continued into the fourth quarter, and we look forward to updating investors as we progress.”
U.S. commercialization of TULSA-PRO, designed specifically for the treatment of prostate disease (prostate cancer and/or benign prostatic hyperplasia, BPH), remains the top priority for the Profound’s direct sales team. The TULSA Procedure, performed using Profound’s TULSA-PRO system, is a significant advancement in prostate care. Instead of surgery or radiation, the TULSA procedure is performed inside an MRI suite to precisely and gently heat prostate tissue to ‘kill temperature’ (55-57°C) with directional ultrasound, while protecting surrounding nerves and anatomy. By intention-to-treat, while TULSA-PRO has the flexibility to be used for all ablations, including focal and hemi-gland, the majority of TULSA Procedures are either whole-gland or near-whole-gland ablations. In late 2024, the U.S. Centers for Medicare & Medicaid Services (CMS) issued its outpatient prospective payment system (OPPS) final rule (“Final Rule”) for the three new CPT® Category 1 codes and their descriptors covering the TULSA procedure, which became effective on January 1, 2025. With the Final Rule, TULSA reimbursement was established at Urology Level 7 Ambulatory Payment Classification (APC). To-date, more than 4,000 men have undergone the TULSA Procedure, and as of last report (in today’s Q3 press release), Profound’s TULSA-PRO installed base stood at 70 systems.
Profound’s second product, Sonalleve, which is offered primarily as a one-time capital sale, is also gaining increasing commercial interest, particularly outside of the United States. Sonalleve uses the same MR imaging and thermographic technology as TULSA-PRO, and combines that with focused ultrasound from outside the body to treat disease. There are currently ten Sonalleve devices operational in parts of Europe, China and Southeast Asia – where over 4,000 women have already been treated with the technology for adenomyosis and uterine fibroids, diseases of the uterus that can cause chronic pain and heavy and/or prolonged menstruations. Treatment with Sonalleve has demonstrated pain and symptom relief without affecting the ovarian reserve, and with reports of women preserving their fertility. Sonalleve is also now being used in research and clinical trials in Europe for the ablation of pancreatic cancer tissue and other oncological disease. Over the last five years, approximately $10 million has been granted by research organizations in Europe and Canada to further conduct clinical research using Sonalleve for multiple, often life-threatening, diseases.
As user interest in Profound’s technologies continues to build, the Company is deploying its own direct sales team in North America, while partnering with select strategic distribution partners to support the business potential and the customer base in other parts of the world.
