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Profound Medical Corp.
11/13/2025
Profound had cash of $24.8 million. As we will discuss later in the call, we believe that we are now on a path to profitable growth. In keeping with that, we expect our cash barn to decline and eventually turn cash flow positive. As our revenue continues to grow and our margins remain high. That said, we have recently received some inquiries about potential future financing plans and if we have a shelf registration statement filed in the U.S. With respect to our thoughts on future financing, while we have not made any current plans, we'd like to assure investors that we'll continue to be opportunistic with the goal of limiting shareholder dilution as much as is practicable. And with respect to a shelf, we do not currently have one in place, but plan to file a S3 later this evening as a matter of good corporate housekeeping to keep our options open as we move forward with our financial growth. With that, I will now turn the call over to Matthew for an update on clinical and development activities.
Thank you, Rashid, and good afternoon. Last quarter, we initiated the pilot release of our new Tulsa AI volume reduction software, which is specifically designed to shrink benign enlarged prostates primarily caused by the condition known as BPH. I am delighted to announce today that the full product release will be launched at this year's annual meeting of the Radiological Society of North America, or RSNA, which is taking place in Chicago at the end of this month. The new volume reduction software leverages AI-powered planning and accelerated ablation, together with the same Tulsa hardware, the same regulatory indication for use, and the same reimbursement codes, to provide fast and efficient workflows which are on par with mainstream BPH treatment options. The PI release had two primary objectives. The first was to demonstrate total procedure time of 60 to 90 minutes, and the second was to obtain early user feedback to incorporate into the complete feature set included in the full product release. Both of these objectives have been resolutely met. To date, early surgeon feedback has exceeded our expectations. With the precision of real-time MRI guidance and the flexibility of transurethral ultrasound ablation, surgeons have described that they can create treatment designs that mimic any other BPH procedure, whether it's coring the apple, like resume and aquablation, or a more complete resection, like hole-up. In other words, no matter the prostate shape or size, and the needs of the patient for a small or large ablation, Tulsa with volume reduction can do it. Tulsa also goes beyond with the ability to precisely carve out the ejaculatory ducts, visualize and target cancer lesions, or even prophylactically ablate regions suspicious for cancer, such as PI-RADS 3 lesions or in patients with high PSA or that have a known genetic risk. Surgeons have also described how they can use the efficiency benefits of the new software features for patients with prostate cancer. With the improved workflows and flexibility to customize each treatment to the individual patient, surgeons will have the ability to create what they call TALTA days, where they stack multiple cases in one day with predictable and efficient outcomes, whether with prostate cancer, BPH, or patients with both cancer and BPH. And that is all with no overnight stay, no blood loss, no fulguration, no grade 4 adverse events, and no need for patients to discontinue their anticoagulant therapy. The pilot launch of the volume reduction software has motivated incremental increase in BPH procedures from Q2 to Q3 and into the first half of Q4. With the full product launch at RSNA later in November, we believe we are well positioned to demonstrate increased utilization in BPH with double digit percentages of our total procedures in 2026. Speaking of RSNA, we're just two short weeks away from the meeting in Chicago where the Tulsa Pro will be featured prominently. Our booth will feature the full product launch of our new Tulsa AI volume reduction software, and the final perioperative outcomes from the CAPTEN trial will be presented by Dr. Peji Ganuni from Stanford. In addition, the Innovation Theatre will host a special session titled Discover Tulsa Pro, AI-powered MRI-guided precision prostate ablation, which will be presented by both Dr. Joseph Bush from the Bush Center, as well as Dr. Daniel Costa from the MD Anderson Cancer Center. In a separate session, Dr. Bush will deliver an oral presentation describing his Tulsa outcomes from a cohort of 160 patients. And finally, the Tulsa procedure will be the subject of three different educational exhibits from each the University of Texas Southwestern, the NIH, or the National Institute of Health, as well as from the Sapporo, Hokuyu Hospital in Japan. We certainly look forward to an impactful event. I would like to take a moment to provide an update on our captain trial. During our last earnings call, we announced that the CAPTEN trial was fully recruited and all patient treatments were complete, making it the first randomized controlled trial ever, comparing a new technology to the standard of care of robotic radical prostatectomy to successfully recruit to target. We believe one of the reasons for the success is the capability of TULSA to perform safe and effective whole-grain ablations, making it a true incision-free prostatectomy, as opposed to other ablative procedures that can only target small, unifocal disease. Completion of all patient treatment marks a significant milestone as it cements the timing of data readout, including the primary one-year safety and three-year efficacy outcomes. The trial, however, is already collecting important secondary endpoints. The final perioperative outcomes will be presented at RSNA, as well as at the Society of Urological Oncology, or SUO, in early December. The data will prove Tulsa's superiority to robotic surgery and blood loss, hospital stay, post-op pain, and time of recovery. This will be followed closely by its peer-reviewed publication, which we expect to be submitted to a scientific journal before the end of this year, which we believe will be the beginnings of a key driver toward gaining favorable recommendation from the relevant professional society treatment guidelines and positive reimbursement coverage from private payers. Since our S&A starts in just a few days and Captain's side effect data would have been needed to have been submitted prior to any presentation, it won't be part of what's presented there this year. However, we are considering appropriate ways to unveil it relatively soon without risking breaking any embargoes ahead of AUA in May. So please stay tuned on that front. And with that, I'll turn the call over to Tom.
Thank you, Matthew. In Q3 2025, we continue to build on the commercial momentum we established earlier this year. We saw strong traction with our Tulsa Pro platform. As Rashad mentioned earlier, we achieved a year-over-year revenue increase of 87% up from $2.8 million in Q3 2024. Our gross margin also improved significantly, reaching 74% compared to 64% last year. This reflects the growing efficiency and scale of our commercial operations. As of now, we have 70 Tulsa Pro sites. And the company's Tulsa Pro qualified sales pipeline is also growing and currently stands at 93 new systems being classified within one of the verify, negotiate, and contracting stages, which are the final three phases of our sales process. Q3 was a true commercial inflection point. We're seeing broader adoption of Tulsa Pro across both academic and community hospitals. That's largely due to increased awareness of the system's clinical benefits and the streamlined reimbursement pathway made possible by the Category 1 CPT code. Our team remains focused on targeting high-volume urology centers and supporting physician training. We're leveraging positive clinical outcomes and patient testimonials to drive engagement and deepen relationships with our customers. Looking ahead, I'm confident in our ability to sustain this growth. We are well positioned to capitalize on the expanding interest in image guided interventions, and we're continuing to scale our commercial footprint while validating our technology in the prostate care market. We have established flexible business models to drive adoption. With our 25 for 200 program, hospitals perform 25 cases in year one for roughly $200,000 with a path to capital conversion. This model allows hospitals to break even on a per procedure basis, typically by the 12th case, while providing profound with committed revenue. Our standing pricing model includes a capital system priced around $500,000 and disposables averaging $5,500 per procedure. We're seeing success at our model sites. In Texas, the prime hospital system is demonstrating Medicare profitability. And in the near future, we are confident that our Tulsa Plus sites will prove that integration with IMRI can deliver a payback in under two years. Rather than competing with HIFU, IRE, or cryophysicians, we're collaborating with them. These clinicians already prefer alternatives to radical prostatectomy or radiation, but their current options limit patient volume. TOS's versatility enhances their offerings, and over time, many of them gravitate toward adopting our technology. We're also building strategic partnerships on a global basis, whether that be through distribution agreements with the likes of Al-Fasaliya Medical Systems in Saudi Arabia, gets healthcare in Australia and New Zealand, or partnerships with OEMs such as Siemens, there's more to come on the partnership front, and I'm excited about the opportunities ahead. Thank you for your time. I will now turn the call over to Arun.
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