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AtriCure, Inc.
11/3/2026
Good afternoon and welcome to HRECURE's third quarter 2026 earnings conference call. This call is being recorded for replay purposes and at this time all participants are in listen-only mode. We will be facilitating a question and answer session following prepared remarks from HRECURE's management. I would now like to turn the call over to Marisa Beitsch from the Gilvorn Group for a few introductory comments. Please go ahead.
Thank you. By now, you should have received a copy of the earnings press release. If you have not received a copy, please call 513-644-4484 to have one emailed to you. Before we begin today, let me remind you that the company's remarks include forward-looking statements under the Private Securities Litigation Reform Act, Safe Harbor. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond HRCURE's control. including risks and uncertainties described from time to time in Atricure's most recent Form 10-K and Form 10-Q reports. These statements include, but are not limited to, financial expectations and guidance, expectations regarding the potential market opportunity for Atricure's franchises and growth initiatives, future product launches, approvals and clearances, competition, reimbursement, and clinical trial enrollment readouts and outcomes. Atricure's results may differ materially from those projected. Atricure undertakes no obligation to publicly update any forward-looking statement except as required by law. Additionally, we refer to non-GAAP financial measures, specifically constant currency revenue growth, adjusted EBITDA, and adjusted earnings or loss per share. A reconciliation of these non-GAAP financial measures with the most directly comparable GAAP measures is included in our press release, which is available on our website. And with that, I would like to turn the call over to Mike Carrel, President and Chief Executive Officer.
Great. Good afternoon, everyone, and thank you for joining us today. Atricare delivered another strong quarter, generating worldwide revenue of $154.5 million, an increase of 15% year over year. Growth in the third quarter was led by our U.S. business, which increased 17%, driven by broader adoption across several key products, including CryoSphere Max and Cryo XT probes, Atriclip Flex Mini and Pro Mini, and the Encompass Clamp. Our top line strength again converted to expanded profitability with $4 million in net income and $27 million in adjusted EBITDA for the quarter. As we enter the final months of the year, progress across our strategic priorities, improving financial performance, and the breadth of our business reinforces our confidence and our momentum and the opportunities ahead. Before turning to third quarter performance, I'd like to provide an update on our BoxX NOAAF clinical trial, which is evaluating the benefits of ablation and LAA management in cardiac surgery procedures for patients without a history of atrial fibrillation. We have now enrolled over 880 patients and have less than 100 patients to reach full enrollment in this trial. We remain on track to complete enrollment before the end of the year, followed by the readout of clinical data for the first primary endpoint in the spring of 2027. We believe the pace of enrollment and robust site engagement underscore the importance that cardiac surgeons place on addressing the most common complication of cardiac surgery, highlighting a significant opportunity ahead. Studies have shown early postoperative AFib is associated with an increased risk of short-term stroke and hospitalization and extended recoveries. In the longer term, It is associated with clinical AFib recurrence and higher rates of stroke and mortality. In the United States alone, healthcare spending associated with postoperative atrial fibrillation is estimated to exceed $2 billion annually. Box-X NOAAF is designed to evaluate both the short and long-term benefits of ablation and LAA management for cardiac surgery patients without preoperative AFib, helping address the significant for both patients and physicians. Alongside our progress with BoxEx and OAF, we continue to follow the more than 6,500 patients enrolled in LEAPS, our clinical trial evaluating the stroke reduction benefit of LAA management in cardiac surgery patients without AFib. Together, these complementary trials represent meaningful growth catalysts and the cardiac surgery market with the potential to address most cardiac surgery patients with therapies designed to reduce the rate of complications before they occur. Over the past several months, I've had the privilege of meeting with many investigators at sites participating in the BOX-X, NOAAF and LEAPS trials. Our conversations about these clinical trials, our ablation and LAA management technologies and their impact on patients have been highly encouraging and reinforces our conviction in these opportunities. Together, these trials could meaningfully advance clinical practice and improve outcomes for cardiac surgery patients around the world. To every investigator and trial site team supporting this work, thank you for your partnership and commitment to patients. Turning now to our third quarter performance, worldwide revenue in our open ablation franchise grew 17%, accelerating from the first half of 2026. This acceleration was driven by continued strong adoption of the Encompass clamp in the United States. Encompass is generating growth across both new and existing accounts and now represents more than 70% of our U.S. open ablation revenue. We believe this quarter shows the strength of our innovation and its ability to make cardiac surgery ablation much easier to adopt. Equally important, the growing body of evidence supporting the Encompass clamp and our Atriclip devices is remarkable. Data from our TRAC AF registry recently presented at the European Association of Cardiothoracic Surgery meeting in Barcelona included more than 1,700 patients and demonstrated 91% freedom from AFib at one year and 86% at two years following the epicardial ablation with the encompass clamp. We believe these compelling outcomes together with the innovative design of the Encompass Clamp are growing adoption. We are also encouraged by the outcomes in the LAX2 trial showing the benefit of left atrial appendage management using atrial group devices in high-risk patients. Additionally, the new STS quality metric for concomitant AFib treatment represents another important catalyst for the treatment of AFib. As mentioned on our second quarter call, quality metrics have historically been powerful drivers of adoption in cardiac surgery. And we expect this change will support broader use of both surgical aphid ablation and left atrial appendage management for years to come. Our appendage management business grew more than 12% worldwide in the third quarter, led by open appendage management and continued adoption of AtriaClip Flex Mini in the United States. Nearly 50% of our U.S. appendage management revenue this quarter came from sales of our AtriaClip Flex and ProMini devices. Surgeon feedback on atrial clip mini devices remains extremely positive, in particular regarding the improved visibility provided by the smallest profile surgical left atrial appendage management device available, combined with the proven product and clinical performance of the atrial clip platform. Building on this momentum, we recently received FDA 510 clearance for a 30 millimeter atrial clip flex mini device, further differentiating the atrial clip platform. We expect to launch a 30-millimeter device in December and remain focused on advancing development of our H-Clip Flex Mini-V in anticipation of a late-2027 launch. Our commitment to continued innovation, supported by robust clinical data demonstrating the safety and performance of H-Clip devices, positions H-Acure to defend our leadership in cardiac surgery, left atrial appendage management. While our confident cardiac surgery business remains healthy, Minimally invasive ablation again faced pressure as the market for standalone AFib treatment continues to focus on PFA catheter therapy. We remain committed to the hybrid AF therapy and believe that it offers an important treatment option for patients with long-standing atrial fibrillation. And finally, pain management delivered another outstanding quarter, with worldwide revenue growing 33%, led by continued adoption of CryoSphere Maxx. We continue to add new accounts at a steady pace, deepen penetration in thoracic surgery, and gain traction in sternotomy procedures. We are also encouraged by the progress of Cryo-XT, our newest pain management innovation for use in amputation procedures. Early feedback has been consistent. Clinicians and care teams are seeing reduced post-surgical pain and a better recovery experience. Even fundamental activities, such as changing surgical dressing can be incredibly painful, and doing so without severe pain can meaningfully improve recovery after surgery. We have now surpassed 1,000 Cryo XT devices sold to date, an early milestone as we build awareness and adoption of this therapy. We remain confident in the long-term potential of Cryo XT in amputation procedures and in the continued growth of our pain management franchise. In summary, we delivered another strong quarter with 15% revenue growth and expanding profitability. Disciplined execution and meaningful progress against our strategic initiatives are positioning H-Acure for the next phase of growth, expanding markets we can serve for many, many years to come. And with that, I'll turn the call over to our CFO, Angie Weirich.
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