Arun Menawat
Analyst · Lake Street Capital Markets
Thank you, Tom, and good afternoon, everyone. As you just heard from Tom, after experimentation and refinement, both his team and their messaging to potential customers, we now know how to sell TULSA programs. As I have presented earlier this week at the Stifel conference, we believe we are now on a path to not just grow, but profitably grow. The math to achieve this target is simple. With this 200 TULSA programs using existing MR installed base, assuming 50 TULSA procedures per site per year and 5,500 in recurring revenue to Profound procedure, we would be at $55 million in procedure revenue, about $10 million in annual service revenue and selling 40 TULSA-PRO systems per year at $500,000, $20 million in new capital revenue. That will put us around $85 million annual revenue. With 70-plus percent gross margin already achieved, we would be profitable well before that. Putting this together, with what Mathieu has already discussed, the trifecta is finally here. The MR is here and high MRI is coming rapidly. In the very near term, our strategy is to focus on existing MRs and achieve an installed base of 200 TULSA-PRO sites. That is where our sales team is focused right now. Simultaneously, we are in the final stages of achieving comparative -- compatibility with the new Siemens Interventional MR, the Free.Max. We believe that as early as next year, TULSA Plus sites with Free.Max plus TULSA-PRO will be operational, opening the door to the future, the interventional MR suite with TULSA. These sites will further streamline the patient and staffing workflow, making it easier to further drive adoption. Second, we are now beginning to get confirmation from multiple hospitals that they are being paid to all -- 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. In some cases, that's based on pre-approvals. In some cases, they are being submitted after the procedure and being paid. And in others, there are initial denials, but we are getting reversals through appeal. So while that is still a bit of a mixed bag at this stage, as we have said earlier, we're tracking appropriately at this stage and remain confident that we will begin to secure national or regional coverage decisions from the commercial payers starting middle of next year as there is an ample clinical data to support our applications. Third, we are excited to be upgrading our AI-powered software to include simpler patient workflow for patients who suffer from BPH symptoms. Having the flexibility to treat a variety of patients with prostate cancer and now with BPH gives our sites the flexibility to create a treatment day which leads to efficiency and easier scheduling for the hospital staff. We believe that altogether, this trifecta gives us a good chance to not only grow in high double-digits, but with high margins, we believe we can achieve profitability and continue to grow profitably. Before my closing remarks, I would like to take a few moments to talk about our second large opportunity, Sonalleve. We're getting more and more incoming calls from both TULSA users and non-TULSA sites that are interested in interventional MRI and the ability to also treat diseases in the body cavity such as diseases of the uterine adenomyosis and fibroids and cancers such as liver and pancreatic cancers. In fact, FMS, who we announced an exclusive distribution agreement with, for Saudi Arabia, earlier this week originally called us about Sonalleve. Once they were introduced to TULSA-PRO as well, they quickly wanted to discuss both and not only for Saudi Arabia, but also potentially other countries they're active in, such as other Gulf region countries and Brazil, where they own multiple hospitals. Sonalleve, which is offered primarily as a onetime capital sale, uses the same MR imaging and thermography technology as TULSA-PRO and combines that with focused ultrasound from outside the body 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 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 diseases. To summarize, Profound is the only company that combines the real-time imaging and thermography capabilities of MR and AI-driven treatment designs to allow physicians to precisely and gently address disease tissue without any incision, associated tissue boiling or charring, blood loss, severe or prolonged pain, or need for overnight hospital stay The sales team is clearly delivering and the pipeline, as we define it, now over 50 as compared to 80 in mid-August. TULSA-PRO installed base now sits at 70, and we expect to reach at least 75 installs by the end of the year. The new TULSA-AI Volume Reduction module to treat patients with BPH symptoms in 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. Adding the BPH module also enables physicians to create a full TULSA day during which both their prostate cancer patients and BPH patients are treated. From the perspective of ease of scheduling and creating a TULSA program, this ability is important. The second technology platform, Sonalleve, is poised to start becoming a more core part of our story in the coming months and quarters, both internationally and in the United States. And finally, as user interest in Profound's technologies continues to build, we're deploying our 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 for both TULSA-PRO and Sonalleve. This ends our prepared remarks for today. With that, we're happy to take any questions you might have. Operator?