Ryan Rhodes
Analyst · Jefferies. Please go ahead
Thank you, Marc. I first want to say thank you to both Marc and all the EDAP Board members for their confidence my abilities to lead EDAP as the worldwide CEO. As stated, we are focused on an important mission of growth to expand both in the U.S. and in outside U.S. markets. I take personal pride in leading our global teams as we embark together in alignment to further establish EDAP's strong position in the market. As a global leader in therapeutic HIFU, it is becoming increasingly clear that EDAP's technology leadership, product offering, as well as customer support and distribution capabilities are all translating into increased recognition of Focal One Robotic HIFU as a leading non-invasive treatment option for men diagnosed with prostate cancer. As a result, we continue to see ongoing market momentum across our U.S. business. The fourth quarter of 2022 clearly reflects this momentum as we completed a record of nine Focal One transactions, which included six unit sales and three operating leases. As we continue to demonstrate our technological leadership in therapeutic HIFU, we also expect to benefit from higher levels of reimbursement for Focal One procedures. As touched upon earlier, last year, the Centers for Medicare and Medicaid Services, or CMS, released the outpatient prospective payment system final rule on October 31, 2022. The final rule confirmed the upgrade of Medicare hospital payment for prostate HIFU to Ambulatory Payment Classification Level 6 from Level 5 previously, which translates to increased reimbursement of approximately 90% to, on average, $8,558 per procedure. This appropriate increase in reimbursement officially went into effect on January 1, 2023 and should further serve to help drive a positive assessment of cost and ROI to centers who invest and offer Focal One procedures to their patients. As noted on our prior call that bears repeating, higher Medicare reimbursement can oftentimes result in higher reimbursement from commercial payers who typically follow CMS' lead on such decisions. Also, as the global leader in therapeutic HIFU, we are constantly engaged in a multipronged strategy of educating clinicians, patients and providers on the benefits of our technology. Attending major medical meetings publishing peer-reviewed clinical data and sponsoring webinars and symposia are each critical components to this strategy. During the fourth quarter, we attended several noteworthy meetings, including the Society of Urologic Oncology, SUO meeting, which was held in San Diego in early December. The SUO is a large group of leading neurologists whose mission is to collaborate in the care of patients with malignant genitourinary diseases, including patients diagnosed with prostate cancer. EDAP had the largest showing ever as a main exhibitor, given numerous hands-on treatment simulations highlighting the use of Focal One Robotic HIFU. In the area of clinical publications, on October 26, 2022, researchers led by Stefano De Luca from the University of Turin, Italy, published a paper in the peer-reviewed journal, Minerva Urology and Nephrology, entitled MRI real-time ultrasound image fusion guided high-intensity focused ultrasound, HIFU, a prospective comparative and functional analysis of different ablative techniques. Highlights of the publication included the results from 100 patients who were treated with Focal One Robotic HIFU, all having a follow-up control biopsy at one year post treatment. The paper noted that 82% of the patients showed negative biopsy upon follow-up at one year, thus demonstrating excellent short-term cancer control. Also, the paper noted the procedural efficiency delivered by Focal One's proprietary dynamic focusing technology, coupled with the system's robotic capability, which resulted in operative times of only 55 minutes on average. Additionally, we hosted two high-impact peer-to-peer webinars in the fourth quarter, led by leading academic urologists from the University of California Los Angeles, UCLA, and the University of Miami. One webinar was focused on the use of ExactVu Micro-Ultrasound for targeted prostate biopsy presented by Dr. Wayne Brisbane of UCLA. The other webinar was led by Dr. Bruno Nahar from the University of Miami, highlighting the role of Focal One Robotic HIFU technology in the management of prostate cancer. These webinars provide an excellent venue for thought-leading clinicians to present important new data and outcomes to a wider physician audience who are interested in adding these procedures to their clinical practice. As we look outward, EDAP will be hosting the first worldwide live-stream broadcast of the Focal One Robotic HIFU procedure performed by Dr. Andrea [indiscernible] and Dr. Amir Lebastchi from the University of Southern California, USC, Keck School of Medicine. This exciting global event will take place on April 18 at 12 noon Pacific Time. Please all plan to watch. For more information and to register, please visit focalone.com. Another important event will be EDAP's participation at the upcoming meeting of the American Urological Association to be held in Chicago, Illinois from April 28 through May 1. The AUA is the largest gathering of urologists in the world with a defined focus in providing the latest advances in urologic medicine. EDAP will have its largest presence ever while exhibiting during this important scientific congress. We would certainly encourage any of our investors as well as interested clinicians to stop by our booth and to see our Focal One Robotic HIFU technology in action. Looking ahead, I remain very optimistic about our sales pipeline and our team's ability to execute. As of today, we were extremely busy and active in closing the last days of the first quarter. As such, we continue to see positive momentum with customer engagement and a strong interest from new customers in obtaining Focal One Robotic HIFU. In closing, I believe EDAP will continue to build on its ongoing success throughout 2023. And now our CFO, Francois Dietsch, will provide some details on our financial results. Francois?