Arun Menawat
Analyst · Jefferies. Go ahead
Thank you, Aaron. As we mentioned in today’s press release announcing the Q3 results, our recent financing, combined with the increasing interest in our technology from opinion-leading hospitals and independent imaging centers, enables us to strategically and responsibly lay the groundwork to drive significant adoption of the TULSA procedure. We’re bolstering our management team, field force, clinical development programs and manufacturing capacity. With respect to adding talent, we recently welcomed two very experienced senior management team members. Jacques Cornet, our new VP of Marketing and Business development, is leading patient recruitment and digital marketing strategies as well as relationships with our MR partners. Jacques joined us from Philips, where he was VP of Sales and Marketing of one of the Healthcare division. He has more than 25 years of experience in global leadership roles, in-depth knowledge of global imaging systems market including health care IT and a broad network of contacts at leading-edge hospitals and health care organizations within the United States. Most importantly, Jacques and I have worked together in the past and have known each other personally for over 20 years. Welcome, Jacques. In addition, I am very pleased to welcome Michael Mydra, who joins us as of Monday as VP, Head of Global Market Access and will take on the dedicated role of leading TULSA’s reimbursement strategies. Michael joins us from Boston Scientific, where he was the VP of Global Market Access and Reimbursement for all of the company’s urologic products. Prior to that, Michael led reimbursement strategies at Augmenix, which developed the SpaceOAR device to reduce side effects associated with prostate cancer. Michael has more than 20 years of startup and large company medical device and health plan reimbursement experience. Welcome, Michael. The senior management team at Profound reflects a good mix of relevant experience and homegrown talent, resulting in a full complement of the necessary skill sets and experience to support Profound’s success. And I feel particularly honored to lead such a high-performance team. As you probably know, our U.S. market entry strategy includes three types of end users. We continue to see traction among early adopters, which includes urologists specializing in cutting-edge alternative prostate disease treatment. The second group includes independent imaging center companies such as RadNet, which I am pleased to report, is still on track to treat their first patient in the current quarter despite initially experiencing delays related to COVID-19. The third group is comprised of opinion-leading teaching hospitals, and we are delighted with the caliber and the number of hospitals that are now offering the TULSA procedure. I invite you to visit our tulsaprocedure.com website to see the list of centers, offering the TULSA procedure, which is updated regularly. As you can see today, the site now includes the Mayo Clinic, University of Texas Southwestern Medical Center and Prostate Advanced Prostate Cancer Center. We also have additional contracts that are not in public domain yet but that we expect to be operational by the end of this year. We will be adding them to the tulsaprocedure.com website as they begin treating patients. Continued traction in the early adopter segment, progress in imaging center segment and an impressive group of top-tier hospitals, adopting the technology is also an early indicator that our core recurring revenue business model is working. I would now like to provide an update on the clinical front. Four important studies were published in Q3 that has added to the evidence establishing TULSA-PRO as a safe, effective and flexible tool for customized ablation of prostate disease. First, the 12-month outcomes of our TACT pivotal clinical trial, which supported FDA appearance of the TULSA-PRO last year, was published in the Journal of Urology, the official Journal of the American Urological Society Association. This marks an important milestone for Profound as the publication establishes TULSA-PRO as a minimally-invasive procedure for effective prostate cancer ablation with a favorable side effect profile, minimal impact on quality of life and low rate of residual disease. Second, 3-year follow-up data from the Phase I safety and precision study of TULSA-PRO were published, demonstrating durability of safety, efficacy, quality of life and functional outcomes as well as predictability of oncological follow-up based upon early imaging and PSA, all without precluding any potential salvage treatment options. PSA at 3 years was stable at 0.8 nanograms per millimeters with repeat biopsy findings, consistent with those previously reported at 12 months. From year 1 to year 3, there were no new serious adverse events. And new onset or mild adverse events were rare with little or no change in urinary, sexual or bowel quality of life. From my perspective, results at the end of 1 year seemed to be a good predictor of results after 3 years of ablative treatment. Third, I will review early data from a prospective study of TULSA-PRO in 10 BPH patients. Urinary function improved during the initial 3 month follow-up, among the first 7 patients treated with no adverse events seen on sexual or bowel functions. The average International Prostate Symptom Score, or IPPS, decreased from 17.7 to 4.6. Quality of life IPPS – I’m sorry, IPSS decreased from 4.3 to 1.0, and peak flow rate or QMAX, increased from 11.5 to 26.8 milliliters per second, granted that the number of patients treated so far is small. These are outstanding results and in line with improvements that we have seen even in patients who received the TULSA procedure primarily for prostate cancer. We are also looking forward to more data in a larger number of subjects as the study is ongoing and will recruit a total of 40 patients. Finally, investigators at Turku University Hospital in Finland have published results from an investigator-initiated clinical trial, demonstrating the safety and feasibility of TULSA-PRO for palliation of severe urinary retention and intractable hematuria in men suffering from symptomatic, localized, advanced prostate cancer. Prior to undergoing the TULSA procedure, all 10 men had continuous catheterization and gross hematuria or blood loss, requiring frequent hospitalization. At 1 year post TULSA, 80% of men had improved catheterization. 70% were completely catheter-free, and 100% were free of gross hematuria or blood loss. Notably and importantly, the average hospitalization time from local complications reduced from 7.3 days in 6-month period before TULSA to only 1.4 days in the 6-month period after the TULSA. In conclusion, the [indiscernible] evidence that TULSA-PRO is a versatile and flexible technology that can be deployed in customized ablative treatment of prostate disease continues to grow, and Profound remains committed to supporting significant additional studies and building the evidence base for TULSA in the future. To that end, we are extending the trials for the TACT trial for another 35 patients to achieve a total number of patients treated to 150. The Johns Hopkins University and UCLA are among 2 of the sites that are already recruiting in this study. It is a core strategy of our company to continue to support additional clinical trials both in the United States and other parts of the world, and we plan to announce additional trials as protocols are finalized. So to summarize, first, I would like to echo Aaron’s concluding comments that there remains significant uncertainty with respect to the TULSA procedure’s adoption rate in the very near-term, primarily due to COVID-19. However, we are energized with the performance in Q3, particularly with respect to the new sites that have now started their TULSA programs. Second, we have strengthened our leadership team and are investing in increasing our capacity to grow the business. And third, we are delighted with the recent clinical publications and the reinitiation and continuation of the TACT trial. This ends our prepared remarks for today. With that, we’re happy to take any questions that you might have. Operator, please proceed.