Arun Menawat
Analyst · Lake Street Capital Markets
Thank you, Tom, and good afternoon, again. Prostate cancer treatment has been a bipolar world up till now. Whole-gland robotic prostatectomy or radiation therapy are the primary tools for treating prostate cancer today. Trying to take some share away from these mainstream whole-gland modalities are focal therapy alternatives such as HIFU, cryoablation and IRE that treat typically less than 35% of the gland by focusing only on the visible cancer within the prostate. But TULSA is establishing itself as a third distinct category. TULSA-PRO can treat the whole-gland, a small portion of the gland and everything in between. At the same time, the TULSA procedure provides the best of both worlds. The same good clinical outcomes of whole-gland prostate cancer treatment but with lower side effect of focal gland treatment. The fact that the TULSA procedure is a third category all by itself is an important message. But it can be difficult for urologists and hospitals to understand the differences as they're getting bombarded by the focal messages from multiple companies. Difficult, but not impossible. Virtually, all surgeons who have used both TULSA-PRO and other technologies have ended up favoring TULSA by far because of its expanded capability to treat the full spectrum of prostate disease while minimizing quality-of-life side effects like urinary incontinence and erectile dysfunction. Today, we believe that whole-gland robotic prostatectomy and radiation therapy have run their course. And alternative focal prostate therapies are not enough. The TULSA-PRO system stands apart in its proven ability to treat the full spectrum of prostate disease as well as providing better economics to providers and more value to payers. TULSA uses real-time MR imaging that has several significant clinical and economic advantages. First, the real-time MR thermometry enables continuous visualization and autonomous temperature adjustment throughout the procedure. This level of precision allows the physicians to tailor therapy to each patient while minimizing side effects typically associated with robotic surgery or radiation. Second, MR produces standardized to the cross-sectional images enabling AI analysis unlike what may be possible using other imaging modalities, such as ultrasound. Using this capability, TULSA-PRO incorporates an AI-based treatment plan. Upon one click, the AI software segments the prostate and shows the surgeon a treatment design while keeping the nerve bundle and the sphincter muscle region safely outside the boundaries. Using a digital pen, the surgeon can either accept the AI-generated plan or quickly modify it, if necessary, making overall treatment planning fast and reliable. The TULSA-AI contouring assistant is based upon treatment designs by the best-known radiologist and is proven to be superior to surgeon designs. Third, MR enables real-time temperature monitoring. Using this capability and directional ultrasound from a catheter placed in the urethra, TULSA-PRO, gently heats tissue only to kill temperature between 55 to 57 degrees centigrade without boiling or charring the tissue. The net effect is that the whole-gland or any surgeon prescribed region can be treated effectively and the dead tissue is reabsorbed by the body. In the FDA registered TACT clinical trial, post-treatment prostate size was measured over time. The data showed that the median reduction in prostate size was 91% by effectively shrinking the prostate around the urinary channel, which is proactively protected during the procedure. Fourth, TULSA-AI enables cleaner margins. During TULSA procedure, real-time MR enables the treating surgeons to see abundance of cancer in the prostate. If necessary, the surgeon can engage another TULSA-AI module, Thermal Boost to apply additional heat to the region and ensure [ kill ] temperatures to the outer margin of the prostate or even slightly beyond the margin. Fifth, not to confuse things, we believe even TULSA partial gland or focal procedures are superior to other focal modalities, which all rely on ultrasound imaging. TULSA procedures are based upon real-time MR diffusion and T2 images. These images combined together visualize the abnormal cell regions of the prostate, which may be cancers. This real-time visualization allows surgeons to define the treatment region to completely include the suspicious zones, thereby increasing the likelihood of a more durable focal/partial gland treatment while maintaining minimal side effects. And finally, advanced real-time MR imaging provides confirmation and precision of cell kill at the end of the procedure, no matter what the intent to kill it in turn improves predictability of outcomes. To summarize, TULSA-PRO solves a debate about whether prostate cancer treatment should be whole-gland or focal without compromise. TULSA-PRO can be used to treat the whole-gland, a small portion of the gland or anything in between in large prostates, small prostates or even radio recurrent prostate, and with the clear benefit of MR imaging and guidance. And it is being used successfully to treat low, medium or high-risk cancers as well as salvage cases. Switching briefly to BPH. Mainstream treatment with transurethral resection of the prostate or TURP is largely unchanged over the past 100 years. Many alternative treatment methods have emerged that aim to improve the patient experience and reduce the rate of complications such as bleeding, erectile dysfunction, loss of ejaculation, and the need to stay in the hospital overnight for 1, 2 or more days. As demonstrated in the recently published study from the University of Turku, TULSA offers significant improvements in International Prostate Symptom Score, peak urine volume rates and discontinuation of BPH medications. That said, while urologists have been treating lots using TULSA-PRO since we received 510(k) clearance in 2019, and the technology is only 1 capable of treating hybrid patients suffering from both prostate cancer and BPH. Our BPH patient volumes have been low to date due to the relatively larger treatment duration compared to other modalities. The latest TULSA-AI module volume reduction is changing the BPH treatment paradigm. TULSA-AI volume reduction is designed to maintain all of the many proven advantages of treating cancer with TULSA, while leveling the playing field on the time it takes for a urologist to plan and complete the procedure by quickly identifying the overgrowing region of the BPH. The software streamlines the workflow and reduces procedure times to 60 to 90 minutes. Adoption of TULSA-PRO is also making more and more business sense. The economic proposition of an interventional MR has become stronger as of January 2026. CMS has studied reimbursement for prostate biopsy and made the determination that reimbursement for real-time MR in-bore biopsy should be separated from the method, which is prevalent today, which uses real-time ultrasound with prior diagnostic MR image registered to it. This allows the surgeon to visualize the cancerous region through the registered MR image, but have the convenience of ultrasound to perform the biopsy. While this technique is better than one where MR images are not used, clinical data shows that registration of MR images still create an error of about 20%. For that reason, CMS has now provided separate reimbursement for real-time in-bore MR biopsy as it is more accurate but more costly to perform. The reimbursement for a standard MR registered ultrasound image biopsy is about $3,500, whereas reimbursement for the real-time MR biopsy has been set at about $5,500, which is 57% higher. This is a huge change, and the implication is just beginning to get attention. And comparing Medicare national average payments hospital reimbursement for the TULSA procedure in 2026 is $13,479 compared to $10,860 for robotic surgery and $9,672 for focal therapies like HIFU and cryoablation. So now at the start of 2026, there is superior reimbursement for both in-bore MR prostate biopsy and the TULSA Procedure. Putting all this together, our thesis that the future of prostate disease care will be MR centered is coming true. This sufficient clinical evidence -- there is sufficient clinical evidence that if prostate cancer is visible on an MR, it should be treated immediately, making iMRI, in-bore biopsy and diagnostic modality of choice. Typically, there are 3 to 5 biopsy procedure performed for each one prostate cancer treatment and whereas there are about 1 million prostate biopsies done every year. No one single prostate cancer treatment modality is currently used for more than 100,000 patients per year. Doing the math, there is currently a clear disconnect between the preferred MR-guided diagnostic approach and mainstream treatment modalities. We believe only TULSA is suited to bridge that gap as we move forward. Our strategy in the near term is to focus on existing MRs and achieve the installed base of 200 TULSA-PRO sites. At the same time, we are in the final stages of achieving compatibility for the new Siemens Interventional MR, the Free.Max. We believe that as early as later in 2026, TULSA plus sites with the Free.Max plus TULSA-PRO will be operational, opening the door to the future and interventional MR suite with TULSA. These sites will further streamline the patient and staffing workflow, making it easier to further drive adoption. We continue to get confirmation that hospitals that are being paid for all qualified Medicare patients and that they are satisfied with the amount received. In addition, many commercial payers are also now covering the procedure on a case-by-case basis. And we are excited by the recent upgrading of our AI-powered software to include simpler patient workflow for patients who suffer from BPH symptoms. Having the flexibility to safely, effectively and efficiently treat a variety of patients with prostate cancer and now with BPH, gives our sites the flexibility to stack cases, creating a full TULSA Procedure day, which leads to efficiency and easier scheduling for the hospital staff. It also significantly expands our TAM. And the economics associated with real-time iMRI procedures, in prostate cancer, like MR in-bore biopsy and TULSA are becoming increasingly compelling. Before my closing remarks, I would like to take a few minutes to talk about our second large opportunity, Sonalleve. This technology, which is currently offered primarily as a onetime capital sale uses same MR imaging and thermographic technology, as TULSA-PRO and combines that with focused ultrasound from outside the body delivers -- delivered via a disk to treat disease. There are currently 10 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 fibroid diseases of the uterus that can cause chronic pain and heavy and/or prolonged menstruation. 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. We are working on an FDA regulatory strategy for the technology and a potential new recurring revenue opportunity on top of the initial capital sale for the device. And we'll provide more details on our progress later this year. To summarize, Profound is pioneering iMRI procedures, which enable precise incision-free therapies that improve clinical confidence, procedural control, and patient outcomes. By leveraging real-time MR guidance, Profound technology -- the technologies are designed to replace uncertainty with clarity across treatment planning, delivery and confirmation. We're the only company that has the technology to kill tissue from the inside of the body, via a catheter that is placed via a natural orifice, which is our TULSA technology, or from the outside via a disc, which is the Sonalleve technology. In either product configuration, MR is used to image and measure temperature in real time and enable cell kill with a minimum energy requirement. Our sales team is clearly delivering, and the pipeline as we define is now growing over 110 as compared to 97 at the end of 2025. TULSA-PRO install base was at 78 at year-end, and we expect that to reach approximately 120 by end of 2026. The new AI volume reduction module to treat patients with BPH symptoms is significantly reducing the procedure time, making it very competitive with other BPH treatment technologies. This application has the potential to add 400,000 patients to our annual TAM essentially tripling our previous TAM. Having the BPH module also enables physicians to create a full TULSA day during which both their prostate cancer and/or BPH patients are treated. From the perspective of the ease of scheduling and creating a vibrant TULSA program, this ability is particularly important. Our second technology platform, Sonalleve is poised to start becoming a more core part of our story in the coming months and quarter, both internationally and in the United States. And finally, we believe that on the basis of the many catalysts we see ahead, we can reach high double-digit to low triple-digit revenue growth. This ends our prepared remarks for today. With that, we're happy to take any questions you might have. Operator?