Profound Medical (NASDAQ:PROF) reported fourth-quarter 2025 revenue of $6.0 million, including $2.3 million in recurring revenue and $3.7 million from one-time capital equipment sales, according to management on the company’s earnings call. The company said Q4 revenue increased 43% from the prior-year period.
Chief Financial Officer Rashed Dewan said gross margin was 67% in Q4 2025 compared with 71% a year earlier, attributing the decline primarily to product mix and “new market introductory prices” tied to international distributors in Saudi Arabia and Australia. Operating expenses (R&D and SG&A) were roughly CAD 11.4 million, compared with CAD 11.3 million in Q4 2024. Profound posted a Q4 net loss of approximately CAD 8.2 million, or CAD 0.27 per share, versus a net loss of about CAD 4.9 million, or CAD 0.20 per share, a year earlier. Cash on hand was $59.7 million as of Dec. 31, 2025.
CAPTAIN trial update and upcoming data presentation
Management said the first clinical outcomes from CAPTAIN will be presented “ahead of schedule” at the European Association of Urology (EAU) meeting in London, delivered by Dr. Laurence Klotz on Friday, March 13. The company said it expects to report:
- Six-month urinary incontinence rates
- 90-day hospital readmissions
- Time to return to work
- Positive surgical margin rates in the prostatectomy arm (with TULSA biopsy outcomes to be compared later)
In prepared remarks, management contrasted CAPTAIN’s design and endpoints with other studies it referenced—WATER IV, FARP, and HIFI—arguing that those trials either include low-risk patients, focus primarily on quality-of-life endpoints without being designed or powered for comparative oncologic efficacy, use endpoints it considers less meaningful for cancer eradication, or lack randomization.
During Q&A, CEO Dr. Arun Menawat said releasing six-month data is supported by precedent and is a meaningful milestone, particularly for urinary incontinence, and that the company would not compromise the integrity of the trial. He also said earlier dissemination of CAPTAIN data could help accelerate commercial reimbursement decisions.
Commercial traction, sites, pipeline, and reimbursement
Chief Commercial Officer Tom Tamburino said Profound ended 2025 with 78 TULSA-PRO sites and a qualified sales pipeline of 110 systems in the final stages of its sales process (verify, negotiate, and contracting). He characterized Q3 2025 as a “true commercial inflection point,” with momentum continuing in Q4.
Tamburino said adoption has been supported by increased awareness of clinical benefits and a reimbursement pathway enabled by Category I CPT codes. He added that reimbursement was confirmed again for 2026 at “Urology level seven,” and that the company has begun engaging private insurers, expecting coverage decisions in the second half of 2026.
On current private payer dynamics, management said the number of privately insured patients is increasing, with typical payments most often “between 1.5x to 2.5x of Medicare.” Menawat also said the company is tracking better than 90% in overturning rejections, and cited a recent reversal by an independent organization that deemed the procedure “standard of care,” supporting management’s optimism about broader coverage decisions later in 2026.
Menawat also discussed 2026 Medicare economics for interventional MRI procedures, including a CMS decision to provide separate reimbursement for real-time in-bore MR biopsy. He said reimbursement for standard MR-registered ultrasound biopsy is about $3,500, while real-time MR biopsy reimbursement has been set at about $5,500. He also cited 2026 Medicare national average payments, stating that hospital reimbursement for the TULSA procedure is $13,479, compared with $10,860 for robotic surgery and $9,672 for focal therapies such as HIFU and cryoablation.
Mix shift toward capital sales and profitability framework
Management said capital revenue can be harder to predict quarter to quarter and noted that the company offered introductory pricing to certain international distributors in Q4. In Q&A, Menawat said the revenue mix may skew more capital-heavy as the company builds its installed base, but reiterated that Profound expects to be primarily a recurring-revenue business over time, targeting more than 70% of revenue from recurring sources longer term.
When asked about recurring revenue fluctuations, Menawat said quarter-to-quarter recurring revenue may not track perfectly with utilization due to inventory management at sites, and suggested looking at six-month comparisons rather than individual quarters. He also said there was “no discounting at all” on disposables and reiterated the $5,500 disposable price.
Tamburino laid out a model for reaching profitability, describing a scenario in which 200 sites perform 50 TULSA procedures per site per year with $5,500 in recurring revenue per procedure, plus service revenue and capital sales, for a total he estimated at roughly $85 million in annual revenue. Menawat separately said the company believes profitability is achievable in the $80 million to $85 million revenue range.
On cash burn, Menawat pointed to a decline over 2025, stating that quarterly cash burn was a little over $10 million in the first half, about $8 million in Q3, and “a little less than $6.5 million” in Q4, which he said aligns with revenue growth.
BPH module rollout and international distribution
Menawat highlighted the launch of an AI software module called “Volume Reduction,” aimed at improving workflow for benign prostatic hyperplasia (BPH) patients. He said the module is designed to reduce procedure times to 60–90 minutes and described it as making TULSA-PRO more competitive with other BPH treatment technologies. He also said this application could add 400,000 patients to the company’s annual total addressable market, which he described as “essentially tripling” the prior TAM.
In Q&A, Menawat said at least 10 sites had already started using the BPH module, and he projected that by mid-year 2026, 30 to 40 sites would be using it.
Internationally, management said it signed distribution agreements including Al Faisaliah Medical Systems in Saudi Arabia and Getz Healthcare in Australia and New Zealand, with multiple systems sold in Q4 2025. Menawat said the company is approaching international markets carefully through distributors rather than building a direct sales force outside the U.S., and reiterated that the Q4 discounts were limited to new distributors to support market entry.
About Profound Medical (NASDAQ:PROF)
Profound Medical Corp is a medical technology company headquartered in Toronto, Canada, that specializes in the development and commercialization of minimally invasive therapeutic solutions using magnetic resonance–guided ultrasound ablation. The company’s proprietary platform delivers focused ultrasound energy to targeted tissue under real-time MR imaging, offering a non-incisional alternative to traditional surgical approaches.
The company’s lead product, the TULSA-PRO system, is designed for the treatment of prostate conditions, including localized prostate cancer and benign prostatic hyperplasia.
