Arun Menawat
Analyst · Jefferies. Please go ahead
Thanks, Aaron. As many of you know, most of the MedTech sector faced additional headwinds from COVID-19 Delta variant resurgence in the third quarter. Unfortunately, the pace of new US TULSA-PRO system installations as well as revenues generated in international markets like China and Japan continued to be negatively impacted by the pandemic. TULSA-PRO procedure volumes in the United States, however, grew 20% sequentially over the second quarter of 2021. This isn’t a blip, but rather a developing trend as procedure volumes grew by the same percentage in Q2 compared with Q1. On our last two calls, I focused my remarks on explaining why the disruptions from COVID had translated into are being any less bullish on our business in the mid and long-terms. Today, I would like to reiterate that by underscoring how the foundation we have been laying this year should translate into exciting 2022 and beyond. We believe the strong and steady increase in utilization we have seen throughout 2021 even in the phase of COVID, is a testament to the high quality of our installed base, and the unrivaled variety of prostate disease patients that are being treated with our technology, and both bode well for the future. With respect to building a high quality US installed base, we have been targeting three major types of end-users, early adopters, independent imaging center companies and opinion-leading teaching hospitals. Our early adopter TULSA-PRO sites have continued to treat a growing number and an increasing variety of patients. With respect to the imaging center companies, we have already signed multi-center agreements with two industry leaders, RadNet and Akumin and hope to sign additional agreements in the future. Finally, as I highlighted in our last call, we also have agreements with renowned institutions like UCLA, Stanford, Johns Hopkins, Yale Cancer Center, WellSpan Advanced Prostate Cancer Center, Mayo Jacksonville and Mayo Rochester, MGH Cancer Center, UT Southwestern, Memorial Hermann and Methodist San Antonio. We expect that list will continue to grow as we move forward. Recurring revenue in Q3 was generated from a total of 16 sites. We already have sufficient contracts in hand to install a total of more than 30 sites in the United States and expect to have more by year end. Initially, the typical time from the signing of a sales contract to the site being operational was generally around three months. During this COVID period, however, we have been experiencing delays due to a variety of factors, including a lack of labor at hospitals, parts shortages from our MR partners, and hospital administration’s desire to delay deployment of new technology during uncertain times. These delays have increased the average time from contract to installation to 5.2 months. As a result, we now expect that the US installed base will be approximately 20 by year end, as compared to our previous estimate of 25. While not what we had hoped, there are actually two good new stories buried in this headline. First, we believe we are only about two months behind at this point, such that we now anticipate achieving the 25 site goal by end of February. Second, we are cautiously optimistic that the delays will begin to diminish by year end. And in the meantime, the team will continue to focus on optimizing the onboarding process, with the goal of achieving installation times of even less than three months once the pandemic impact is behind us. While the pace of installation is likely to be ebb and flow somewhat, even without COVID challenges. The available market for TULSA-PRO is as large, if not larger than what we first envisioned due to its flexibility to treat an unrivaled variety of patients. Based on a utilization analysis that we shared on our last call, Tulsa was used in all grades of cancers, ranging from low risk to the highest risk patients in the first half of 2021. Importantly, the percentages of patients treated in those risk categories roughly corresponded with what we see in the real world with respect to patient population distribution. Recently, one of the major universities even treated a patient with metastatic cancer, first ablating the patient’s prostate with Tulsa, and following that up with radiation therapy to kill lymph nodes and other remaining cancer outside the prostate. Based upon the patient population that is being treated with Tulsa, we believe Tulsa can treat more than 80% of prostate cancer patients. In addition, publications continue to show that patients treated with Tulsa continued to show superior outcomes that include, minimal side effects, such as urinary incontinence or severe erectile dysfunction. Interim results of a European trial named, FARP, which was conducted at Oslo University Hospital, were presented at the AUA in September. Oslo University is widely considered to be one of the most credible sites in Europe. So, this interim analysis garnered quite a bit of attention with urologists. This is a single site, Level 1 study, where they compare whole-gland robotic prostatectomy or RP for short, two focal therapy using either HIFU or Tulsa. Their interim results were poor for robotic prostatectomy, with more than 75% of those patients reporting urinary incontinence or erectile dysfunction of various degrees. The trial design only used HIFU or Tulsa for the focal therapy arm. So, as you can imagine, the reported results for focal therapy were significantly superior to RP. And accordingly, Oslo is recommending focal therapy for a certain subset of patients, where localized therapy is possible. Since we joined relatively late in the study, the full results of Tulsa won’t be reported until next summer. But, even without published data in this trial, there is rather telling indication of how Tulsa performed, instead of returning the TULSA-PRO system after completing patient recruitment, the site purchased it from us for commercial use, as they informed us that Tulsa was clearly the technology of choice as a wide variety of patients could be treated with it, and that it was the easiest technology to use. To summarize, while we look forward to the full data, which will include the Tulsa results, we believe there are already two key takeaways from this study. First, the FARP study was the first direct comparison between HIFU and Tulsa and the investigators voted with their pocketbook in favor of Tulsa. Second, FARP’s Robotic Radical Prostatectomy arm is similar to that in our planned, level 1 CAPTAIN trial. Accordingly, if the RP outcomes in CAPTAIN match what was seen in FARP, we believe there is potential to demonstrate clear superiority, even though the CAPTAIN trial has been designed with a non-inferiority end point. That provides a good segue to updating you on our reimbursement strategy. We continue to view coding and ultimately payment coverage as a three-year plus process. In the short to medium-terms, we are operating in a cash pay and fee code environment. And we think we can continue to grow well there for the next couple of years. As I mentioned in our last call, based upon feedback from the relevant societies, including the American Urological Society and the American College of Radiology, we continue to believe that the clinical publications on the Tulsa procedure, including those, we anticipate later this year, will likely be sufficient to meet the requirements for our CPT-1 application by end of this year. If the adoption of Tulsa usage continues to increase as we anticipate, we may get the support that we need to file in 2022. In the meantime, we expect to initiate patient recruitment in the CAPTAIN trial before end of this year. In the study, 201 prostate cancer patients will be randomized 2:1 to receive the total procedure or RP. The primary endpoints will include safety and efficacy, including measurements of side effects and non-inferior, progression-free survival over time. So, as you can see, our strategy is to run CAPTAIN in parallel with the filing of the CPT-1 application. Our rationale is that even though CAPTAIN is not a requirement to obtain the CPT-1 code, the trial may support coverage by insurance payers, and will also provide additional critical data to support significant adoption. To summarize, our team has continued to execute well. We are building a high quality install base with users, including an attractive mix of early adopters, large imaging center companies and some of the country’s most prestigious teaching hospitals. We continue to see broader Tulsa adoption, both in terms of procedure volumes and types of patients treated. Our utilization data points to Tulsa becoming a mainstream treatment in the US, providing us with a large market opportunity. And finally, we are progressing TULSA-PRO’s reimbursement strategy by conducting additional studies to apply for a specific CPT code and ultimately, a reimbursement determination. This ends our prepared remarks for today. With that, we’re happy to take any questions you might have. Operator?