Dr. Arun Menawat
Analyst · Raymond James. Your line is open
Thank you, Rashed. I talked about our Q1 2022, or achievements and outlook for the rest of the year on like to provide a little more color on resets, financial discussion, and installed base in us has grown to 24. TULSA-PRO system. Just shy of our global of $0.25. And while we said on our last call that we thought some international one-time capital sales with start to trickle in the second half of this year on pleased to report that those sales have already begun, with a 340,000 worth of equipment sales recorded in Q1, 2022. Our worldwide installed base is now 30. We believe that the direct impact of COVID-19 has subsided with respect to our ability to access new U.S. sites to install TULSA pro systems. But we still see some lingering effects in the supply chain, primarily in the form of delayed deliveries of new MRI units to the sites where we have TULSA agreements. The good news is that we expect this to eventually correct itself. And we are seeing the trend to increase utilization in our installed base. Accordingly, independent of future installs, we continue to believe that the pace of utilization will accelerate meaningfully in the second half this year as the newly installed sites get up their learning curves and increase utilization. While we are a medical device company, as you already know, we have chosen to charge on a per patient basis in the United States for bundled services. That include the use of our device, the one-time disposable, and the genius services that we provide to support cases. Because we deploy this unique business model in the U.S. We also want to clarify how we recognize revenues. We recognized no revenue upon installation of the TULSA-PRO system. We recognized part of the revenues upon shipment of the disposable and differ about 24% over per patient revenue until the actual usage of the disposables or the treatment of the patient. We believe that this is the winning model as it creates a true partnership between us and the healthcare provider. In the first quarter of 2022, we continue to see that our -- physicians are using TULSA for whole gland, partial gland or focal therapy, and salvage cases. Two sets of significant datasets were announced. One was the publication on use of TULSA in patients who have had fiducial markers [Indiscernible] in their prostate due to prior SBRT radiation treatment. The authors concluded that TULSA ablation was possible in these patients as long as thorough precautions were taken. The publication continues to enhance the proposition that TULSA is a safe modality for salvage patients. In addition, Dr. Ming recently reported on 50 patients at UT Southwestern that received focal rather than whole-gland treatment with a variety of treatment plans, including partial-gland ablation of intermediate risk lesions, concurrent treatment of BPH along with lesions for men with BPH or lower urinary tract symptoms, near whole-gland treatment for men with multifocal disease and partial Glenn ablation of localized radio recurrent prostate cancer. Early outcomes show that at 12 months following treatment, PSA declines and average of 63% and prostate shrink and average of 19% in terms of quality of life outcomes. Only 6 to 8% of patient reported worsening, voiding, and erectile dysfunction. Respectively at 6 months post treatment. Notably, no recurrence or cancer has been reported. Overall, new Chief southwestern reported minimum adverse events with high rates of potency and continents preservation. And again, the ability to treat a wide variety of prostate disease patients. These include those I just mentioned, as well as very large prostates, up to 260 [Indiscernible]. [Indiscernible] can find high-risk cancer and [Indiscernible] of cases to improve quality of life. You'd see Southwestern's experience affirms that TULSA is the best way to implement focal therapy and can be used to treat malignancy anywhere within the prostate, which is just one of the ways that TULSA helps customize treatment of the whole or the partial gland. UT Southwestern is one of the seven top opinion leading U.S. hospitals that are currently using the TULSA-PRO system and the study that they presented is an example of how we expect opinion leading sites to adopt TULSA. They started first by cautiously analyzing the outcomes and feedback of their old patients. And now that they see promising results, they're on track to expand usage. Another significant development during the quarter was the confirmation of TULSA-PRO's compatibility with GE, making the system compatible with the big three medical technology companies in the Global MRI space, which comprise more than 90% of the installed base of MRIs in the U.S. This is an important achievement as it significantly increased our available opportunity. In addition to the agreement that we announced at Brigham and Women's Hospital, we now have two additional agreements for GEMR site to be installed in Q3 this year. I'd now like to turn to our sponsored CAPTAIN trial, which stands for a comparison of TULSA procedure versus radical prostatectomy or RP, which treated its first patient in January, and continues to progress. To-date, seven sites have been activated and are currently recruiting patients with an expected total of eight or more sites in the United States and two sites in Canada. We remain on track to be able to finish enrollment in the second half of 2023, and anticipate the first readout of early data in Q4 2023. We remain on track to be able to finish enrollment in the second half of 2023, and anticipate the first readout of early data in Q4 2023. We also continue to await fluid data on the FARP trial, whose robotic RP arm is similar to that of our CAPTAIN trial. FARP is a single site Level 1 study conducted at Oslo University Hospital that compared whole gland RP to focal therapy using either HIFU or TULSA. Should the RP outcomes and CAPTAIN match, what we're seeing in FARP, we believe there is potential to demonstrate clear superiority, even though the CAPTAIN trial has been designed with a non-inferiority endpoint? Broadly speaking, we are conducting the CAPTAIN trial to increase awareness and adoption of TULSA-PRO, as well as to support coverage by payers. To further support, the first part of this goal Profound will be very much front and center at the American Urological Association meeting in a few days. Indeed, as many of you know, by semi live TULSA case will be presented during the plenary session. We are limited in what we can say ahead of that, but you should expect us to provide more details closer to the event. As for our ongoing reimbursement strategy, our TULSA systematic review paper that was published online in March by the Journal of Endourology completed the clinical requirements to qualify to file a CPT I application. It also provides the highest level of evidence available in support of TULSA. In this case, Level 2A, demonstrating that TULSA is safe and effective for treating primary prostate cancer, recurrent prostate cancer, and locally advanced prostate cancer, as well as the simultaneous treatment of prostate cancer and the lower urinary tract symptoms normally caused by BPH. Having met the clinical requirements for filing for CPT code, we remain on track to file the application by end of June, which is fast approaching. This application will be up for consideration at the AMA's fall 2022 meeting. And if approved, the CPT I code would be effective in January 2024. To summarize, to-date, well over 2,000 TULSA procedures have been performed by more than 100 physicians. And we anticipate that this number will continue to increase as the new install base begins to ramp treatment. We also see more activity in the international market as the year progresses, as a few one-time capital sale projects are revived. As a result, we anticipate higher recurring and total revenue growth for the remainder of the year. We are pleased to see the clinical data presented recently by UT Southwestern has established that TULSA is the best way to perform focal therapy. TULSA continues to be unrivaled in its flexibility to provide whole gland, partial gland or focal, or salvage ablative treatments in any size or region of the prostate. We are seeing early indications that TULSA's compatibility with all three major manufacturers of MR scanners, GE, Siemens, and Philips is increasing our market access. And we continue to be on track for filing our CPT I application for TULSA-PRO this June. This ends our prepared remarks for today. With that, Rashed and I are happy to take any questions you might have. Operator.