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Profound Medical Corp.
11/3/2022
Good day, and thank you for standing by. Welcome to the Profound Medical Incorporated third quarter 2022 conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 1 1 on your telephone. You will then hear an automated message advising that your hand is raised. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Stephen Kilmer, Investor Relations.
Please go ahead. Thank you. Good afternoon, everyone.
Let me start by pointing out that this conference call will include forward-looking statements within the meaning of applicable securities laws of the United States and Canada. All forward-looking statements are based on profound current beliefs, assumptions, and expectations. and relate to, among other things, expectations regarding the efficacy of the company's treatment technologies, results of future clinical trials, the ability to obtain coding and or reimbursement from third-party payers, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance, and future commitments. Such statements may involve known and unknown risks, uncertainties, and other factors that may cause actual results, performance, or achievements to be materially different from those implied by such statements. No forward-looking statement can be guaranteed. Listeners are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this conference call. Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law. For the benefit of those who are new to the Profound story, I would also like to take a moment to summarize our business. Profound develops and markets customizable and vision-free therapies for the ablation of diseased tissues. We are currently commercializing PULSA Pro, a technology that combines real-time MRI, robotically driven transurethral ultrasound, and closed-loop temperature feedback control. The technology is designed to provide customizable and predictable radiation-free ablation of a surgeon-defined prostate volume while actively protecting the urethra and rectum to help preserve the patient's natural functional abilities. Tulsa Pro is CE Marks, Health Canada approved, and 510 cleared by the FDA. In the U.S., we employ a pure recurring revenue model for Tulsa Pro, where we charge customers on a per-procedure basis for Tulsa Pro consumables, lease of medical devices, and services associated with extended origins. Inside of the United States, we primarily deploy a capital and consumable sales and service models separately as the situation warrants. We are also commercializing subtleties. an innovative therapeutic platform that is C-marked for the treatment of uterine fibroids and palliative pain treatment of bone metastases. Sonalyse has also been approved by the China National Medical Products Administration for the non-invasive treatment of uterine fibroids, and Profound has recently obtained FDA approval under a humanitarian device exemption for the treatment of osteoids osteoma. The business model for Sonalyse systems is currently a one-time sale to the capital equipment. On the call today representing the company are Dr. Arun Manawat, Profound's Chief Executive Officer, and Rashed Dhawan, the company's Chief Financial Officer. With that said, I'll now turn the call over to Rashed.
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