UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) of the
SECURITIES EXCHANGE ACT OF 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02.Results of Operations and Financial Condition.
On January 13, 2020, AtriCure, Inc. (“AtriCure” or the “Company”) issued a press release announcing its preliminary financial results for the fourth quarter and full year ended December 31, 2019. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference.
Item 7.01.Regulation FD Disclosure.
During the week of January 13, 2020 the Company is holding meetings with investors discussing, among other topics, an overview of the Company’s business and growth strategy. A copy of the investor presentation, which is available at www.atricure.com, is furnished as Exhibit 99.2 to this Form 8-K and is incorporated herein by reference.
The Company’s presentation discloses certain financial results both in accordance with generally accepted accounting principles (“GAAP”) and on a non-GAAP basis with adjustments for certain items. The Company’s management believes that presentation of these non-GAAP financial measures and their related reconciliations are useful to investors because the non-GAAP financial measures provide investors with a basis for comparing the results to financial results from prior periods.
Information in the presentation contains forward-looking statements regarding future events and performance of the Company. All such forward-looking statements are based largely on the Company’s experience and perception of current conditions, trends, expected future developments and other factors, and on management’s expectations, and are subject to risks and uncertainties that could cause actual results to differ materially, including, but not limited to, those factors described in the presentation and in the Company’s filings with the Securities and Exchange Commission. The Company disclaims any intention or obligation to update or revise any financial or other projections or other forward-looking statements, whether because of new information, future events or otherwise.
The information in each of Item 2.02 and Item 7.01 of this Form 8-K and in the press release attached as Exhibit 99.1 and the presentation attached as Exhibit 99.2 is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. The information in each of Item 2.02 and Item 7.01 of this Form 8-K and each of Exhibit 99.1 and Exhibit 99.2 shall not be incorporated by reference in any filing (whether made before or after the date hereof) or any other document under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in any such filing or document.
Item 9.01Financial Statements and Exhibits.
(d)Exhibits
No.Description
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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| ATRICURE, INC. | |
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Dated: | January 13, 2020 | By: | /s/ M. Andrew Wade |
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| M. Andrew Wade |
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| Senior Vice President and Chief Financial Officer |
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Exhibit 99.1 |
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For immediate release
January 13, 2020
AtriCure Reports Preliminary Results for Fourth Quarter and Full Year 2019
Provides Financial Outlook for 2020
MASON, Ohio, January 13, 2020 – AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in treatments for atrial fibrillation (Afib) and left atrial appendage (LAA) management, announced preliminary financial results for the fourth quarter and full year 2019 and provided 2020 financial guidance.
Preliminary, unaudited revenue for fourth quarter 2019 is expected to be approximately $61.3 million, reflecting growth of approximately 16% over the fourth quarter of 2018. U.S. revenue is expected to be $49.5 million, reflecting growth of 15% and driven again by strong sales of open ablation and appendage management products. International revenue is expected to be approximately $11.8 million, an increase of 20% as reported and an increase of 23% on a constant currency basis.
Preliminary revenue for full year 2019 is expected to be $230.8 million, reflecting growth of approximately 14% over full year 2018 (15% on a constant currency basis). Adjusted EBITDA for the full year 2019 is currently estimated to be a loss in the previously communicated range of $7 to $9 million. Adjusted EBITDA and constant currency revenue growth are non-GAAP measures. AtriCure will provide a reconciliation of non-GAAP measures to the related GAAP measure in the release of final 2019 results.
“Throughout 2019, we generated consistent double-digit revenue growth while achieving several important milestones. We acquired SentreHEART to bolster our Left Atrial Appendage Management portfolio and leverage our growing commercial channel in the electrophysiology market, completed enrollment in the aMAZE IDE clinical trial, received approval for Continued Access Protocols for both CONVERGE and aMAZE IDE trials, surpassed 200,000 AtriClip devices sold, and launched the cryoICE® cryoSPHERETM device for pain management,” said Michael Carrel, President and Chief Executive Officer of AtriCure. “We are excited about the strength of our open ablation and appendage management businesses as we enter 2020 as well as our longer-term prospects for significant market-expansion resulting from the completion of our CONVERGE and aMAZE IDE trials.”
2020 Financial Guidance
Management projects 2020 revenue of approximately $254 million to $261 million, reflecting growth of approximately 10% to 13% over full year 2019. Adjusted EBITDA, a non-GAAP measure, is projected to be a loss of approximately $10 million for 2020.
About AtriCure
AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure’s Isolator® Synergy™ Ablation System is the first and only medical device to receive FDA approval for the treatment of persistent Afib. AtriCure’s AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold left atrial appendage management devices worldwide. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.
Forward-Looking Statements
This press release contains “forward-looking statements”– that is, statements related to future events that by their nature address matters that are uncertain. For details on the uncertainties that may cause our actual results to be materially
different than those expressed in our forward-looking statements, visit http://www.atricure.com/fls as well as our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q which contain risk factors. We do not undertake to update our forward-looking statements. This document also includes forward-looking projected financial information that is based on current estimates and forecasts. Actual results could differ materially.
CONTACTS:
Andy Wade
AtriCure, Inc.
Senior Vice President and Chief Financial Officer
(513) 755-4564
awade@atricure.com
Lynn Pieper Lewis
Gilmartin Group
Investor Relations
(415) 937-5402
lynn@gilmartinir.com
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Exhibit 99.2
AtriCure Investor Presentation Creating a World Class Afib Platform January 2020 © 2020 AtriCure, Inc. All rights reserved. AtriCure 1
Forward Looking Statements This presentation contains “forward-looking statements,” which are statements related to future events that by their nature address matters that are uncertain. All forward-looking information is inherently uncertain and actual results may differ materially from assumptions, estimates or expectations reflected or contained in the forward-looking statements as a result of various factors. For details on the uncertainties that may cause our actual results to be materially different than those expressed in our forward-looking statements, see our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC and available at http://www.sec.gov, which contain risk factors. Forward-looking statements address our expected future business, financial performance, financial condition as well as results of operations, and often contain words such as “intends,” “estimates,” “anticipates,” “hopes,” “projects,” “plans,” “expects,” “seek,” “believes,” "see," “should,” “will,” “would,” “could,” “target,” “guidance,” “forecast,” “goal,” “objective,” “aim,” and similar expressions and the negative versions thereof. Such statements are based only upon current expectations of AtriCure. Any forward-looking statement speaks only as of the date made. Reliance should not be placed on forward-looking statements because they involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to differ materially from those expressed or implied. Forward-looking statements include statements that address activities, events or developments that AtriCure expects, believes or anticipates will or may occur in the future, including, without limitation, statements about AtriCure’s anticipated future operating and financial performance, business plans, and prospects and expectations for our product pipeline. Forward-looking statements are based on AtriCure’s experience and perception of current conditions, trends, expected future developments and other factors it believes are appropriate under the circumstances and are subject to numerous substantial risks and uncertainties, many of which are beyond AtriCure’s control. With respect to the forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. We undertake no obligation to publicly update or revise any forward-looking statements to reflect new information or future events or otherwise unless required by law. © 2020 AtriCure, Inc. All rights reserved. AtriCure 2
AtriCure Overview Large Markets Addressing an underserved and growing patient population Approximately 33 million Afib patients globally, with majority having advanced forms of the disease Current standard of care does not adequately address this population Strong Portfolio Existing products and solutions driving consistent growth 29 straight quarters of double-digit revenue growth, driven by great products, commitment to education, and societal guideline support Only PMA product for the surgical treatment of Afib The AtriClip® device is the most widely used Left Atrial Appendage (LAA) device with over 220,000 sold to date Expanding product portfolio from internal development and acquisitions Bright Future Novel therapies supported by growing body of clinical evidence PMA pivotal trials underway for hybrid approaches for Afib: CONVERGE, aMAZE, DEEP Launched pain management business to address pain associated with surgery Early in market development process – Evolution to minimally invasive therapies will drive growth, diversifying and accelerating in 2021 and beyond © 2020 AtriCure, Inc. All rights reserved. AtriCure 3
Afib: a Serious and Costly Problem Atrial Fibrillation (Afib) is an irregular heartbeat (or arrhythmia) that affects more than 33 million people worldwide. Approximately 1.2 million Afib diagnoses annually in the US. Afib leads to: Total annual cost to US Healthcare $26B Higher medical costs 73% Annual physician encounters 50+ Annual hospital visits 10+ Afib diagnosis means: 5x Risk of Stroke 5x Risk of developing Heart Failure 46% Greater risk of post-operative Mortality © 2020 AtriCure, Inc. All rights reserved. AtriCure 4
Two Distinct Patient Profiles Referring Physician: GP, Cardiologist STRUCTURAL HEART ISSUE Surgery required – Afib corrected at same time (Valve, CABG) GUIDELINES Surgical Ablation is RECOMMENDED LAA management is REASONABLE Concomitant Open Procedures (Ablation/ LAAM) NO STRUCTURAL ISSUE Afib is primary concern 50% Intervention is better choice 50% Medicine is effective Paroxysmal (occasional) Non-Paroxysmal (Persistent/ LS Persistent) Type of Afib matters! Afib is a progressive disease Standalone Hybrid Procedures (Ablation/ LAAM) Catheter often first line of treatment © 2020 AtriCure, Inc. All rights reserved. AtriCure 5
Significant Market Opportunity US Standalone Market: Expanding Growth More than 150k Afib patients annually Vastly underpenetrated and increasing market (estimating 10-15% market expansion) Multiple approaches to treatment Convergent + AtriClip, DEEP, LARIAT® US Concomitant Markets: Steady Growth Cardiac Surgery (“Open”) Estimated 300k total patients annually (Afib, non-Afib Surgical market opportunity is steady Pain Management Estimated 140k thoracic patients annually Boosting growth via new, adjacent market Atrial Fibrillation $1.0-1.6B US Ablation + Appendage Management $700-800M US Ablation + Appendage Management $350 US Ablation $3B+ Worldwide Total US market opportunity $2B+ annually International Afib market $1B+ annual See Supplemental Information for market workups. © 2020 AtriCure, Inc. All rights reserved. AtriCure 6
Strong Financial Performance Worldwide Revenue ($ Millions) $250 $200 $150 $100 $50 $0 2015 $129.8 2016 $155.1 2017 $174.7 2018 $201.6 2019 $230.8 Revenue Growth 20.8% 19.5% 12.6% 15.4% 14%1 Gross Margin 71.6% 71.6% 72.2% 73.0% 73-74%2 Consistent Revenue Growth 29 consecutive quarters of double-digit YoY growth Q4 2019 Revenue at $61.3M 16% growth over Q4 2018 $100M Cash & Investments at September 30, 2019 Steady Improvement to Gross Margin 2020 Revenue Guidance 10-13% growth or $254-261M 1 2019 revenues (annual and Q4) are preliminary and unaudited. 2 2019 gross margin reflects fiscal year guidance. © 2020 AtriCure, Inc. All rights reserved. AtriCure 7
Innovative and Expanding Product Portfolio Ablation ISOLATOR® SYNERGY™ CLAMP cryoICE® CRYOABLATION PROBE EPI-SENSE® DEVICE cryoSPHERE™ CRYOABLATION PROBE 2020 Product Launch: ISOLATOR® SYNERGY™ ENCOMPASS™ CLAMP 2000 to 2015: Foundation in surgical Afib tools Future pipeline expansion across franchises 2015 and Beyond: Building the future in minimally invasive therapies Innovation toward less invasive, simpler, and more efficient products Appendage Management ATRICLIP® FLEX DEVICE ATRICLIP PRO® DEVICE ATRICLIP PRO•V® DEVICE ATRICLIP® FLEX•V® DEVICE LARIAT® DEVICE © 2020 AtriCure, Inc. All rights reserved. AtriCure 8
SPOTLIGHT: Cryo Nerve Block for Pain Management Therapy Overview Long-lasting pain management therapy, designed for use in thoracic surgical procedures Temporarily stops the transmission of pain signals coming from the chest wall during surgery Nerve “scaffolds” remain intact allowing axons to regenerate and restore nerve function over the course of 1-3 months Applicability in a wide variety of thoracic surgical approaches (thoracotomy, video-assisted, robotic) and procedures (resection, transplant, thoracoabdominal, surgical rib fixation, pectus repair) Growth Drivers Q1 2019 launch of cryoSPHERE™ probe Building a small team to begin market development Continuing to gather data to support evidence development the therapy Potential to contribute to combatting the opioid epidemic – 1 in 7 thoracic surgery patients become reliant upon opioids after their procedure1 1 STS press release https://www.sts.org/media/news-releases/1-7-lung-surgery-patients-risk-opioid-dependence AtriCure 9
Advancing Clinical Outcomes Multiple studies to generate clinical evidence and expand indications Trial/Study Description Status CONVERGE Pivotal Designed to support FDA approval of EPi-Sense device specifically for the treatment of persistent Afib through an abdominal approach Final PMA module submitted; continued access protocol approved aMAZE Pivotal Designed to support FDA approval of LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage, adjunct to pulmonary vein isolation (PVI) catheter ablation, for persistent or longstanding persistent Afib Enrolled and in follow up; continued access protocol approved DEEP Pivotal Designed to support FDA approval of various devices specifically for the treatment of persistent Afib through a bi-lateral totally thoracoscopic approach Enrolling FROST Study Designed to demonstrate that intraoperative intercostal cryoanalgesia in conjunction with standard of care (SOC) provides improved analgesic efficacy in patients undergoing unilateral thoracotomy cardiac procedures as compared to current SOC Complete; submitting abstract to STS ICE-AFIB Pivotal Designed to support FDA approval of CryoICE Ablation System for the treatment of persistent and long-standing persistent Afib during concomitant open chest cardiac surgery Enrolling ABLATE Pivotal Designed to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating permanent atrial fibrillation during concomitant on-pump cardiac surgery Complete – PMA obtained in 2011 © 2020 AtriCure, Inc. All rights reserved. AtriCure 10
CONVERGE Overview SUPERIORITY TRIAL designed to support FDA approval of EPi-Sense device specifically for the treatment of persistent Afib STUDY DESIGN Summary Multi-center, prospective, open label randomized 2:1 (Convergent procedure vs endocardial catheter ablation) pivotal study Number of Subjects and Sites Up to 153 subjects Up to 30 sites (27 US and 3 OUS) Study Duration 5 year follow-up of all subjects PRIMARY ENDPOINTS Effectiveness Primary efficacy endpoint is success or failure to be AF/AT/AFL free absent class I and III AADs except for a previously failed or intolerant class I or III AAD with no increase in dosage following the 3 month blanking period through the 12 months post procedure follow-up visit Safety Primary safety endpoint for the study is 12% freedom from MAE’s as adjudicated by the CEC for the procedural to 30-day post procedure time period CONVERGE Clinical Trial HIGHLIGHTS Completed enrollment in August 2018 Final PMA module submitted in late 2019 Submitting late-breaker for HRS in May 2020 Continued Access Protocol approved; enrollment begins in 2020 © 2020 AtriCure, Inc. All rights reserved. AtriCure 11
aMAZE Overview SUPERIORITY TRIAL designed to evaluate safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage for the treatment of persistent or longstanding persistent Afib STUDY DESIGN Study is conducted in two stages: Limited Early Stage (Stage 1): up to 250 subjects at up to 65 sites – COMPLETE Pivotal Stage/ Phase III (Stage 2): up to 600 subjects at up to 65 sites – ONGOING All subjects from both stages will be included in the primary analysis PRIMARY ENDPOINTS Freedom from episodes of atrial fibrillation > 30 seconds at 12 months post index pulmonary vein isolation Time Frame: 12 months following pulmonary vein isolation catheter ablation procedure, measured by 24-hour Holter monitoring amaze LARIAT Clinical Trial HIGHLIGHTS Acquired SentreHEART August 2019 Trial enrollment completed December 2019 Continued Access Protocol recently approved; enrollment begins in 2020 Expect PMA in 2022; will update with more specific timing as trial progresses © 2020 AtriCure, Inc. All rights reserved. AtriCure 12
US Commercial Organization Aligning Expertise with Opportunity Commercial Headcount Shifting headcount growth from Sales Managers to Clinical Specialists Managers build relationships, broaden adoption Specialists provide case coverage Improving productivity and leverage Dedicated MIS and cryoNB teams for market development Education Support Significant investment in physician education Multiple training options including didactic, hands-on, proctoring, and case observations AATS Fellowships, STS and EACTs endorsed training program 11 Sales Areas in US support over 1,000 customer accounts Each Area includes: Area Director Regional Sales Managers (5-6) Minimally Invasive Managers (1-2) CryoNB Sales Manager Clinical Specialists (6-8) Trained 2,000+ Physicians Established network of physician trainers supported by dedicated internal training headcount (1 per Area) Accounts by State 85+ 10+ 30+ 1-10 © 2020 AtriCure, Inc. All rights reserved. AtriCure 13
An Exciting Future ATRICURE PILLARS Foundation of our past and strengthening our future Innovation Significant growth from AtriClip devices and cryoSPHERE probe Expanding pipeline to drive Open ablation penetration and build MIS market Clinical Science First and only PMA approved device for surgical treatment of Afib Multiple trials underway; priorities are CONVERGE & aMAZE Education and Awareness Afib training programs delivered to 3,000+ professionals worldwide Updated Guidelines: STS/HRS Class I for surgical ablation 2020 CONVERGE PMA1 2021 Full year Epi-Sense contribution 2022 aMAZE PMA1 2023 Full year LARIAT contribution 2024 Running on all cylinders as a result of broad platform of products Core double-digit growth business with improvement to profitability and continued margin expansion 1 Reflects estimated approval dates © 2020 AtriCure, Inc. All rights reserved. AtriCure 14
AtriCure Highlights Creating a world class Afib platform Large Markets Addressing an underserved and growing patient population Large, vastly underpenetrated markets: over $3B annually US market opportunity in excess of $2B International market opportunity in excess of $1B Current standard of care is not adequate for this population Strong Portfolio Existing products and solutions driving consistent growth Diverse and growing portfolio Broad offering of products/solutions Commitment to innovation, education, and clinical science Multiple product launches in last decade Trained over 3,000 professionals Improving profitability profile Bright Future Novel therapies supported by growing body of clinical evidence Evolution to minimally invasive therapies will drive growth Clinical evidence to support Multiple clinical trials readout out over next few years Launched pain management business Adjacent use of technology adds to growth prospects © 2020 AtriCure, Inc. All rights reserved. AtriCure 15
Thank You! © 2020 AtriCure, Inc. All rights reserved. AtriCure 16
Supplemental Information Note that citations/references for any comments, statistics, or figures in this presentation are available upon request. © 2020 AtriCure, Inc. All rights reserved. AtriCure 17
Q4 2019 Highlights Worldwide revenue of $61.3 million – growth of 16% over Q4 2018 29th consecutive quarter of double-digit growth! Appendage Management continued to be our fastest growing business at 33% worldwide revenue growth year over year Completed enrollment in aMAZE Pivotal Trial 600th patient enrolled in December 2019 Received approval for continued access protocol; expect to begin enrollment in 2020 Multiple submissions to FDA Final CONVERGE PMA module Isolator Synergy EnCompass™ clamp – expect approval and launch in 2020 Expanded Board of Directors with addition of two industry veterans Q4 2019 revenue is preliminary and unaudited. © 2020 AtriCure, Inc. All rights reserved. AtriCure 18
US Concomitant Market Opportunity Estimated Afib Opportunity in Cardiac Surgery Annual Cardiac Surgeries 300,000 Pre-Operative Afib Rate ~28% Cardiac Opportunity – Pre-Op Afib 85,000 ASP Mix (Ablation and Appendage Management) $4,500 Open Cardiac Surgery Opportunity – Afib $382M Estimated Non-Afib Opportunity in Cardiac Surgery Annual Cardiac Surgeries 300,000 Pre-Operative Non-Afib Rate ~72% Cardiac Opportunity – Pre-Op Afib 215,000 ASP Mix (Appendage Management ONLY) $1,750 Open Cardiac Surgery Opportunity – Non-Afib $376M US annual cardiac surgery volume steady over the past 5 years with shifts in procedure types1 Pre-Op Afib occurs frequently in cardiac surgery patients2 New onset Post-Op Afib is a well-documented complication of cardiac surgery, even if patients do not present with pre-op Afib3 1. STS Adult Cardiac Surgery Database, 2018/2019 Harvest Executive Summary 2. McCarthy, Davidson et al, JIVCS 2019 3. Lin et al, Stroke 2019 © 2020 AtriCure, Inc. All rights reserved. AtriCure 19
US Standalone Market Opportunity Estimated Standalone Afib Opportunity Paroxysmal Afib Catheter Ablation 100,000 Failed Paroxysmal Afib Catheter Ablation (30%) 30,000 Persistent/Longstanding Persistent Afib Catheter Ablation 56,000 ASP Mix (Ablation + Appendage Management) $18,500 Standalone Afib Opportunity (Persistent Only) $1.0B Standalone Afib Opportunity (Failed Paroxysmal & Persistent) $1.6B Prevalence of Afib in the US is 6M patients with ~50% resistant to medical management. ~50% of these patient are classified as persistent Afib, or roughly 1.5M patients.1 However, the US healthcare system lacks sufficient capacity to treat the true prevalence of Afib; market opportunity in analysis at left only considers catheter ablation patients. Catheter ablation procedures have grown 10-15% annually.2 1. Am Journal of Cardiology 2013, 112: 1142-1147, Clinical Epidemiology 2014, American Col of Card 2013, Circulation. 2006; 114:119-125. 2. Catheter manufacturer investor presentations © 2020 AtriCure, Inc. All rights reserved. AtriCure 20
Advancing Surgical Ablation Guidelines SOCIETIES The Society of Thoracic Surgeons American College of Cardiology American Heart Association ESC European Society of Cardiology Heart Rhythm Society COR LOE I A I B I C IIa A IIa B IIa C IIb A IIb B IIb C Considered Reasonable Recommended No Guidelines Concomitant Mitral Operations concomitant w/AVR/CABG/AVR+CABG Stand-Alone LAAM 1987 2014 2016 2017 2019 © 2020 AtriCure, Inc. All rights reserved. 21
Guidelines to Fuel Adoption 2017 STS Guidelines Applies to ALL-COMER Afib patients; previously only “symptomatic patients refractory or intolerant to at least one AAD” Surgical Ablation is RECOMMENDED not just reasonable; it doesn’t increase operative risk LAA Management is mentioned for the first time in the STS Guidelines; LAA Management is reasonable in conjunction with ablation or alone during cardiac surgery Acknowledges the positive impact of hybrid ablations 2017 HRS Guidelines Mitral Valve Replacement is RECOMMENDED for all symptomatic patients refractory or prior to antiarrhythmic drugs Surgical Ablation is RECOMMENDED for CABG and AVR patients who had initiated antiarrhythmics prior to surgery Standalone / Hybrid is REASONABLE for long-standing persistent symptomatic patients refractory or intolerant to at least one AAD and have failed one or more attempts at catheter ablation or prefer a surgical approach WHAT’S NEXT? Educate the market Continue investments in physician training across therapies Generate evidence Numerous clinical trials and studies underway Drive deep understanding of the benefits of hybrid ablation © 2020 AtriCure, Inc. All rights reserved. AtriCure 22
The CONVERGENT Approach PA Aorta SVC RA IVC LV LPV Endocardial Lesions Epicardial Lesions © 2020 AtriCure, Inc. All rights reserved. AtriCure 23
The LARIAT Procedure 1 Access: Routine percutaneous techniques for pericardial and transseptal access are performed using fluoroscopy and transesophageal echocardiography. 2 Delivery: Two magnet-tipped guidewires (FindrWIRZ) are attached to stabilize the LAA with minimal trauma and manipulation for delivery of the LARIAT. 3 Delivery: The LARIAT snare is delivered over the epicardial FindrWIRZ to the apex of the LAA. 4 Capture: The LARIAT snare is positioned to the base of the LAA using the EndoCATH balloon for anatomic land marking of the optimal closure site. 5 Closure: The LARIAT snare is closed and the FindrWIRZ and the EndoCATH are removed prior to release and tightening of the suture. 6 Removal: The suture is released and tightened at the base of the LAA and the LARIAT is removed. The SureCUT suture cutter is used to remotely cut the excess suture. © 2020 AtriCure, Inc. All rights reserved. AtriCure 24
The Cox-Maze IV Procedure Left Atrial Appendage Coronary Sinus Mitral Annulus Circumflex Coronary Artery SVC IVC Right Atrial Appendage Right Coronary Artery Triscuspid Annulus Bipolar RF Clamp Surgical Incision Cryo-Endocardial Cryo-Epicardial © 2020 AtriCure, Inc. All rights reserved. AtriCure 25