Dr. Arun Menawat
Analyst · Raymond James
Thank you, Rashed. As you know, our primary focus for the past several quarters has been on the U.S. commercialization of our next-generation prostate disease treatment technology, TULSA-PRO. While that focus continues, we have not forgotten about Sonalleve and its potential importance to our future as a company over the longer term. Like TULSA, Sonalleve combines real-time magnetic resonance imaging and thermometry with thermal ultrasound to enable precise and incision-free ablation of diseased tissue. The major difference between the two therapeutic platforms is how the ultrasound energy is applied to the diseased tissue is different. Sonalleve brings high-intensity focused ultrasound, or MR-HIFU, where a small area is ablated with real-time MR visualization versus TULSA, where the thermal ultrasound is delivered directionally like a blade in a sweeping pattern contacting a large volume of tissue in minimal time. Profound is the only company that has both technology capabilities. One of the reasons we use the directional blade ultrasound in TULSA is because in the prostate application, it ablates at about 10x faster than HIFU technology. Up until recently, we have been exclusively commercializing Sonalleve in all U.S. markets for the treatment of uterine fibroids and palliative pain treatment of bone metastasis. In late 2020, we received FDA approval under a Humanitarian Device Exemption, or HDE, for the treatment of osteoid osteoma. Osteoid osteoma is a noncancerous bone tumor that occurs most often in the femur and tibia of young children and adolescents. And osteoid osteoma causes a dull aching pain that is moderate in intensity, but can worsen and become severe, especially at night. CT-guided FRA is currently the most commonly used osteoid osteoma treatment, but it is invasive and exposes young patients to radiation. Sonalleve offers these patients a treatment that can be performed safely with clinical improvement, but without any incisions, needles or ionizing radiation exposure. While the osteoid osteoma market is small, I’m pleased to tell you that the capital sales that we recorded in Q2 represent the sale of 2 Sonalleve systems to 2 of the most prestigious pediatric health care centers in North America, the National Children’s Hospital in Washington, D.C. and the Hospital for Sick Children in Toronto. These were the first sales of the platform in the United States and Canada, respectively. Not only will these institutions use the systems to treat osteoid osteoma, but they will also further conduct clinical studies for other applications where severe unmet need arises in young patients, including treatment of cancer. And now let’s talk about TULSA. As you may recall, the TULSA systematic review paper that was published online in March by the Journal of Endourology provided Level 2A evidence, the highest available in support of TULSA, demonstrating that TULSA is safe and effective for treating primary prostate cancer, recurrent prostate cancer and locally advanced prostate cancer as well as for the simultaneous treatment of prostate cancer and the lower urinary -- sorry, urinary tract symptoms normally caused by BPH. This publication also completed the clinical requirements for us to qualify to file a CPT Category 1 application, which we did in mid-June. We are cautiously approaching the upcoming CPT editorial panel meeting in September. Our caution emanates from the fact that history has shown some CPT applications for new game-changing technologies like TULSA have taken an extra year before the AMA advanced them further. That said, we are pleased that one of the unique aspects of the TULSA application is that it is cosponsored and filed with support from multiple societies. In any case, we’re very pleased to see that CMS has recently proposed a 5% increase in the reimbursement for C9734, the temporary code that is currently being used by hospitals for TULSA. The new proposed national payment is $13,274. This will be finalized by the end of September. We believe that the proposed payment is sufficient to help further advance adoption of TULSA in the near to midterm in the United States. To maximize the incredible opportunities we see ahead for both TULSA and Sonalleve, it’s vital that we continue to foster the growing interest physicians and patients have shown in our ablative technologies through the generation of additional post-market clinical data, participation in relevant medical congresses and execution of our own professional marketing initiatives. With respect to clinical data, our sponsored CAPTAIN trial, which is the first Level 1 study ever conducted comparing emerging technologies head-to-head with Radical Prostatectomy in men with prostate cancer continues to progress well. To date, 7 sites have been activated and currently recruiting patients. We have increased the number of target sites from 8 to 12 in the U.S. as there is strong interest in participation. We do have 2 sites in Canada. And again, due to interest, we may add 1 or 2 sites in Europe. We still expect that a vast majority of patients in the study will be U.S. patients. Turning to medical meetings and marketing initiatives they have had an exciting few months. For example, TULSA-PRO was front and center at the American Urological Association’s 2022 Annual Meeting in May. Of note, Dr. Ken Goldberg from UT Southwestern Medical Center performed a semi-live TULSA procedure during one of the plenary sessions. The AUA designated this activity as AMA PRA Category 1 credit, which requires that a physician-led content review committee determine the education to be valid, fair, balanced, scientifically vigorous and free of commercial bias. Also during an earlier plenary session, Dr. Scott Eggener from the University of Chicago, included the TULSA procedure, and TACT pivotal study follow-up data in his presentation. In addition, Turku University Hospital’s Mikael Anttinen gave a moderated poster presentation, which included updated results from a Phase I/II clinical study evaluating the use of TULSA for treating patients suffering from BPH. The study reported 6-month improvement in patient quality of life, LUTS, sexual function and uroflowmetry with all men discontinuing their BPH medication. Finally, in advance of daily product demonstrations, we unveiled our TULSA-PRO software release 2.11, included two new features. The first, the multiparametric MRI vision is designed to help physicians more confidently delineate targeted prostate tissue between malignant or benign and guide sparing, as well as to identify and avoid intraprostatic calcifications. This feature can be helpful, particularly in defining margins if they are performing subtotal prostate ablation or more commonly known as focal therapy. The second is an optimized bladder suppression algorithm, which was developed in response to most U.S.-based physicians having moved from supra-pubic catheterization in favor of urethral or Foley catheters. In the view of AUA, both TULSA and Sonalleve enjoyed high profiles at the Society of Interventional Radiology meeting in June. Among the many presentations mentioned 1 or 2 of the technology platforms, Dr. Steve Raman from UCLA presented 3-year follow-up data from TACT; Dr. Busch did a presentation on his initial experience with TULSA; and in the presentation titled HIFU pediatric applications, current and future applications, Dr. Karun Sharma from the Children’s National Hospital reviewed osteoid osteoma treatment data and discussed plans for an upcoming trial of Sonalleve designed to examine its use in treating pediatric patients for hyperthermia prior to radiation treatment. Finally, we hosted our inaugural PRO-Talk Live event in Chicago a few weekends ago. These types of events, which we used very effectively in my previous company are designed to bring together both experience and potential physician users for a day of face-to-face presentations and discussions. Quite simply, education by existing users is a great way to sell to future users, and TULSA is an ideal product for that strategy. Since this was the first PRO-Talk Live, we purposely kept it relatively small, with approximately 40 physicians participating, about 12 of whom were existing users, and the rest potential users. Based on the extremely positive feedback we have received from the first event, we’re planning on hosting additional larger meetings as we go forward. To summarize, awareness and adoption of our unique ablative technology continues to grow. We sold our first Sonalleve system in the U.S. and Canada during the first quarter -- during the second quarter. As expected, we filed our CPT Category 1 application for TULSA in June. Enrollment in the capital -- in the CAPTAIN trial comparing TULSA to RP is progressing. Now let me briefly touch on the dreaded word, COVID-19. The kinds of activities and the results that I described to you today are what it always takes to bring adoption of a new game-changing technology to market. But for about 2 years, when we could not do many of them because of the pandemic, it affected our introduction of TULSA to the market. While lingering effects, particularly with respect to supply chain remain, we’re learning how to overcome them and reduce the time frame from installation to effective use. [POC] training, significant podium presentations at society meetings and filing a society sponsor CPT applications are all important aspects of driving adoption for TULSA. Now I’m finally thrilled with the progress. We focused our Q2 sales efforts in starting the new sites that were installed in Q1. But we remain comfortable that we will achieve a total of 35 TULSA sites in the U.S. before the end of 2022 and that the number of patients treated quarter-over-quarter will continue to increase and the pace of adoption will continue to accelerate into 2023. This ends our prepared remarks for today. With that, Rashed and I are happy to take any questions you might have. Operator?