UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) of the
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): January 10, 2022
(Exact name of registrant as specified in charter)
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
(Address of Principal Executive Offices, and Zip Code)
(513 ) 755-4100
(Registrant’s Telephone Number, Including Area Code)
Not Applicable
(Former name or former address, if changed since last report)
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):
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
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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 o
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. o
Item 2.02. Results of Operations and Financial Condition.
On January 10, 2022, 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, 2021. 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 10, 2022 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.
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 9.01 Financial Statements and Exhibits.
(d)Exhibits
| No. | Description | |||||||
| 99.1 | ||||||||
| 99.2 | ||||||||
| 104 | Cover Page Interactive Data File--the cover page XBRL tags are embedded within the Inline XBRL document. | |||||||
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.
| ATRICURE, INC. | |||||||||||
| Dated: | January 10, 2022 | By: | /s/ Angela L. Wirick | ||||||||
| Angela L. Wirick | |||||||||||
| Chief Financial Officer | |||||||||||
 | Exhibit 99.1 | |||||||
For immediate release
January 10, 2022
AtriCure Reports Preliminary Results for Fourth Quarter and Full Year 2021,
Provides Financial Outlook for 2022
MASON, Ohio, January 10, 2022 – AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical treatments and therapies for atrial fibrillation (Afib), left atrial appendage (LAA) management, and post-operative pain management, announced preliminary financial results for the fourth quarter and full year 2021 and provided 2022 financial guidance.
Preliminary, unaudited revenue for fourth quarter 2021 is expected to be approximately $73.2 million, reflecting growth of approximately 27% over the fourth quarter of 2020. U.S. revenue is expected to be $61.2 million, reflecting growth of 29%, as demand across key product lines continues to increase. International revenue is expected to be approximately $12.0 million, an increase of 16% as reported and an increase of 19% on a constant currency basis.
Preliminary, unaudited revenue for full year 2021 is expected to be $274.3 million, reflecting growth of approximately 33% over full year 2020 (32% on a constant currency basis). As previously communicated, adjusted EBITDA for the full year 2021 is estimated to be a loss of approximately $10 million and adjusted loss per share for the full year 2021 is estimated at approximately $1.20. Adjusted EBITDA, adjusted loss per share 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 audited 2021 results.
“Our strong revenue growth reflects the tremendous efforts of our team and physician partners as we continue to improve the lives of patients with Afib and related conditions against the challenges of an ongoing pandemic,” said Michael Carrel, President and Chief Executive Officer of AtriCure. “We are well positioned for growth acceleration in 2022, as reflected in our guidance range, and we remain very optimistic about the opportunity to continue driving an increased impact against the global Afib epidemic over the coming year and beyond.”
2022 Financial Guidance
Management projects 2022 revenue of approximately $315 million to $330 million, reflecting growth of approximately 15% to 20% over full year 2021. As with previous guidance, continued uncertainty relating to the dynamic environment with the COVID-19 pandemic could materially impact this projection.
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 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 LAA management devices worldwide. AtriCure’s Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure’s cryoICE cryoSPHERE® probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. 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. This press release also includes forward-looking projected financial information that is based on current estimates and forecasts. Actual results could differ materially. For information on the uncertainties that may cause our actual results to be materially different from those expressed in our forward-looking statements, visit http://www.atricure.com/forward-looking-statements as well as our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q which contain risk factors. Except where otherwise noted, the information contained in this release is as of January 10, 2022. We assume no obligation to update any forward-looking statements contained in this release as a result of new information or future events or developments.
Angie Wirick
AtriCure, Inc.
Chief Financial Officer
(513) 755-5334
awirick@atricure.com
Lynn Lewis
Gilmartin Group
Investor Relations
(415) 937-5402
lynn@gilmartinir.com
© 2022 AtriCure, Inc. All rights reserved. AtriCure Investor Presentation Creating a World Class Afib Platform
This presentation and oral statements made in connection with this presentation contain “forward-looking statements,” which are statements related to future events that by their nature address matters that are uncertain. Forward-looking statements address, among other things, AtriCure’s expected market opportunity, future business, financial performance, financial condition, and results of operations, and often contain words such as “intends,” “estimates,” “anticipates,” “hopes,” “projects,” “plans,” “expects,” “seek,” “believes,” "see," “should,” “will,” “would,” “opportunity,” “target,” and similar expressions and the negative versions thereof. Such statements are based only upon current expectations of AtriCure. All forward-looking information is inherently uncertain and actual results may differ materially from assumptions, estimates, projections or expectations reflected or contained in the forward-looking statements as a result of various risk factors. 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. These risks, uncertainties and other factors include, but are not limited to, those identified at http://www.atricure.com/forward-looking-statements and/or described in AtriCure’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q, particularly the “Risk Factors” sections thereof, as filed with the U.S. Securities and Exchange Commission and available at http://www.sec.gov. With respect to all forward-looking statements, AtriCure claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Forward-looking statements speak only as of the date they are made. AtriCure undertakes no obligation, and does not expect, to publicly update or revise any forward-looking statements to reflect new information or future events or otherwise unless required by law. © 2022 AtriCure, Inc. All rights reserved. Forward Looking Statements 2
© 2022 AtriCure, Inc. All rights reserved. Large Markets Addressing an underserved and growing patient population Strong Portfolio Existing products and solutions driving consistent growth Bright Future Novel therapies supported by growing body of clinical evidence 3 We are passionately focused on reducing the global Afib epidemic and healing the lives of those affected
Afib: a Serious Problem Atrial Fibrillation (Afib) is an irregular heartbeat (or arrhythmia) that affects more than 33 million people worldwide.1 Approximately 1.2 million Afib diagnoses annually in the US.2 1 in 4 adults over 40 will develop Afib in their lifetime.3 © 2022 AtriCure, Inc. All rights reserved. Risk of Stroke4 Greater risk of all cause Mortality6 Higher risk of Heart Failure5 5x >5x 46% 4
Significant Global Market Opportunity © 2022 AtriCure, Inc. All rights reserved. US market opportunity $3B+ annually 5 International market opportunity $2B+ annually International Market Focus • Penetration of large markets first • Expand product availability • Improve market access via reimbursement • Continued build of dedicated sales and training expertise US Market Focus • Continued build of dedicated sales and training expertise • Clinical data supporting multiple label expansions • New product development • Enhanced reimbursement Market opportunity based on internal estimates and research, as well as from publicly available information. See Supplemental Information for additional detail.
Concomitant Open Procedures (Ablation/LAAM) Two Distinct Patient Profiles © 2022 AtriCure, Inc. All rights reserved. STRUCTURAL HEART ISSUE Surgery required – Afib corrected at same time (Valve, CABG) NO STRUCTURAL ISSUE Afib is primary concern Intervention is better choice Medicine is effective Paroxysmal (occasional) Long-Standing Persistent GUIDELINES7 Surgical Ablation is RECOMMENDED LAA management is REASONABLE Standalone Hybrid Procedures (Ablation/LAAM) Catheter often first line of treatment 6 Persistent Referring Physician: GP, Cardiologist
$350M Pain Management Procedures (Ablation) $2B+ and growing Standalone Hybrid Procedures (Ablation/LAAM) $700-800M Concomitant Open Procedures (Ablation/LAAM) US Market Opportunity © 2022 AtriCure, Inc. All rights reserved. Medicine is effective 7 Steady Growth in penetration of Cardiac Surgery Market • Estimated 300,000 total patients (Afib, non-Afib) annually with structural heart issue • Only PMA product for the concomitant surgical treatment of Afib Boosting Growth via adjacent new market Estimated 140,000 thoracic patients annually Expansive Growth from development of Standalone Afib Market Vastly underpenetrated market with 10-15% estimated annual market expansion • Addressable market is more than 3 million patients; less than 1% treated today − 25,000 long-standing persistent patients treated by catheter ablation only today • Multiple approaches to treatment − Hybrid Convergent + AtriClip®, DEEP Market opportunity based on internal estimates and research, as well as from publicly available information. See Supplemental Information for additional detail.
EPi-Sense® Guided Coagulation System approved by FDA for treatment of long-standing persistent Afib Expanded labeling for Cryo Nerve Block Therapy in adolescents 510k clearance of ENCOMPASS® clamp Impacting more than 300,000 patients worldwide. © 2022 AtriCure, Inc. All rights reserved. 8 AtriCure: A Decade of Progress Isolator Synergy Ablation System approved by FDA for treatment of persistent or long-standing persistent Afib concomitant to open heart procedures… the first medical device to receive FDA approval for the treatment of persistent Afib • Maze IV Training Program initiated; Advanced Ablation Courses later endorsed by the Society of Thoracic Surgeons (STS) • Continued innovation in AtriClip platform with FLEX, PRO2 and V- Clip devices for open heart and minimally invasive procedures • Changes in clinical practice guidelines recommend Afib ablation treatment and state management of LAA reasonable • Expansion of AtriClip labeling with electrical isolation of LAA • Completed three acquisitions, moving into EP space with minimally invasive therapies • Entered pain management market with release of cryoSPHERE® probe and dedicated commercial team 2011 2021 Differentiated portfolio of solutions built from continuous innovation and strong clinical evidence, supported by robust training and education.
Standalone Hybrid Procedures Pain Management Concomitant Open Procedures © 2022 AtriCure, Inc. All rights reserved. 9 2022 Priorities: Driving Therapy Expansion Launch EnCompass clamp in U.S. Initiate clinical trial for LAAM in cardiac surgery Grow commercial team globally; continue awareness Train and Expand Hybrid AF Therapy: Adoption by new and existing accounts Addition of LAAM to procedures
• Superior outcomes with hybrid Convergent procedure when compared to endocardial catheter ablation alone in patients with drug refractory long-standing persistent Afib • Data for long-standing persistent patients in the trial demonstrated compelling efficacy and durability • Improved EP lab efficiency demonstrated by reduction in endocardial ablation time as a result of adding epicardial ablation CONVERGE: Long-standing Persistent Afib Patient Analysis 10 29% differential ~78% improvement 35% differential >100% improvement p = 0.022 p = 0.006 © 2022 AtriCure, Inc. All rights reserved. Freedom from AF/AFL/AT from 3-month blanking period through 12-months and 18-months
Benefits of the EPi-Sense System and Hybrid AF Therapy Benefits based on 7-day continuous rhythm monitoring at 18-months post procedure © 2022 AtriCure, Inc. All rights reserved.11 ≥90% LESS TIME IN AF For most patients at 1 year Epicardial: Outside the heart Endocardial: Inside the heart TRIGGER AREAS TARGETED where atrial fibrillation begins 2 2x (vs endocardial RF ablation alone) Patients are MORE LIKELY TO NO LONGER NEED AF MEDICATION Patients in the Hybrid AF Arm report feeling better, both physically + emotionally8 Emphasizes value of team-based approach for advanced AF treatment 2x (vs endocardial RF ablation alone) More than AS EFFECTIVE AT STOPPING AA Additive to endocardial catheter ablation
Commercial Strategy for the EPi-Sense System © 2022 AtriCure, Inc. All rights reserved.12 TARGET Drive utilization with existing and new sites BUILD Train and develop programs, build referral channel AMPLIFY Spread awareness of Hybrid AF Therapy to patients LEVERAGE Add AtriClip to Hybrid AF Therapy EXPAND Grow commercial + training teams, broaden internationally
Innovative and Expanding Product Portfolio © 2022 AtriCure, Inc. All rights reserved. Ablation LAA Management EPI-SENSE® DEVICE ATRICLIP PRO•V® DEVICE ATRICLIP FLEX•V® DEVICE cryoICE® CRYOABLATION PROBE ISOLATOR® SYNERGY™ CLAMP ATRICLIP® FLEX DEVICE ATRICLIP PRO® DEVICE cryoSPHERE® CRYOABLATION PROBE ISOLATOR SYNERGY ENCOMPASS® CLAMP 13 Continuous innovation toward less invasive, simpler to use, and more efficient products
HIGHLIGHTS • cryoICE® probe made available for Cryo Nerve Block applications in 2015 • Dedicated commercial team established in 2019 and expanding • Q1 2019 launch of cryoSPHERE probe • Label expansion includes adolescent patients as young as 12 years of age • ~8% of 2021 worldwide revenue, up from ~5% of 2020 worldwide revenue • International launch begins in Europe in 2022 • Continuing to gather data to support evidence development for therapy SPOTLIGHT: Cryo Nerve Block for Pain Management © 2022 AtriCure, Inc. All rights reserved. 14 A new way to freeze out post- operative pain: cryotherapy for temporary pain relief in thoracic surgical procedures Therapy Overview • Temporarily stops transmission of pain signals coming from the chest wall during surgery • Nerve “scaffolds” remain intact allowing axons to regenerate and restore nerve function over time • Applicability in a wide variety of thoracic surgical approaches (thoracotomy, video- assisted, robotic) and procedures (resection, transplant, thoracoabdominal, surgical rib fixation, pectus repair) • Can be an important tool in combatting the opioid epidemic – 1 in 7 thoracic surgery patients become reliant upon opioids after their procedure9
HIGHLIGHTS SPOTLIGHT: Isolator Synergy EnCompass® Clamp © 2022 AtriCure, Inc. All rights reserved. 15 • FDA 510(k) clearance in July 2021 • Limited initial release began 3Q 2021 • Broad commercial launch in U.S. in 2022 • Continue to drive penetration of cardiac surgery market Product Overview • FDA 510(k) clearance to ablate cardiac tissue during surgery • Designed with same benefits of the AtriCure Isolator Synergy Clamps: + Parallel closure + Uniform pressure + Synergy algorithm provides custom power • Compatible with existing AtriCure RF generator A simpler and faster approach to ablating the heart in open procedures
© 2022 AtriCure, Inc. All rights reserved. AtriCure Pillars Foundation of our past and strengthening our future Innovation Increasing pipeline to drive LAAM penetration and build MIS market Clinical Science Hybrid AF Therapy proven by CONVERGE trial: a complimentary and differentiated approach for advanced Afib… now focused on expansion of clinical data across franchises Education Significant investment in physician education, providing multiple training options 16 Aligning Expertise with Opportunity Dedicated commercial and education teams U.S. Cardiac 125 Sales and Clinical Specialists U.S. Hybrid Therapies 41 Sales and Clinical Specialists U.S. Cryo Nerve Block 29 Sales and Clinical Specialists U.S. Sales Leadership 23 Area Directors across our specialized teams U.S. Education Over 40 Physician + Field Supporting Roles International Over 50 Sales and Education Professionals Key Investments Driving Growth
History of Strong Growth © 2022 AtriCure, Inc. All rights reserved. History of Consistent Revenue Growth pre-COVID19 5-Year historical organic revenue CAGRs: • U.S. AtriClip ~32% • U.S. Open Ablation ~11% excluding CryoSPHERE • U.S. MIS Ablation ~8% • International ~10% 17 COVID19 IMPACT *2021 Revenue is preliminary and unaudited **Based on midpoint of 2022 Revenue guidance range Revenue ($ Millions) 5-Year historical organic Revenue CAGR ~15% growth 2022 Revenue Guidance Accelerating Growth (15-20% YoY) $315-330M worldwide revenue
An Exciting Future Ahead LARIAT contribution © 2022 AtriCure, Inc. All rights reserved.18 ACCELERATING GROWTH IN EP LANDSCAPE Hybrid AF Therapy EXPANDING WITH PAIN MANAGEMENT COMPREHENSIVE PLATFORM OF THERAPIES for differentiated population of Afib patients Surgical Ablation || AtriClip Cryo Nerve Block
Thank You! © 2022 AtriCure, Inc. All rights reserved.19
Supplemental Information References for any comments, statistics, or figures in this presentation are available upon request. © 2022 AtriCure, Inc. All rights reserved. 20
Key Investment Rationale © 2022 AtriCure, Inc. All rights reserved. Large Markets Addressing an underserved and growing patient population • Approximately 33 million Atrial Fibrillation patients globally, with majority having advanced forms of the disease1 • Multibillion dollar annual market opportunity • Current standard of care for intervention (catheter ablation) does not adequately address the most advanced forms of the disease Strong Portfolio Existing products and solutions driving consistent growth • Strong history of double-digit revenue growth, driven by great products, clinical evidence, commitment to education, and societal guideline support • Only PMA product for the concomitant surgical treatment of Afib • The AtriClip device is the most widely used Left Atrial Appendage device with over 300,000 sold to date • Diverse and expanding product portfolio from internal development and acquisitions Bright Future Novel therapies supported by growing body of clinical evidence • Only PMA product for treatment of LS persistent Afib with Hybrid AF Therapy • Growing pain management business to address pain associated with surgery • Early in market development process – evolution to minimally invasive therapies expected to drive growth, diversifying and accelerating in 2022 and beyond 21
COVID-19 Response © 2022 AtriCure, Inc. All rights reserved. Positioning AtriCure for long-term growth • Maintaining manufacturing, assembly, fulfillment – modified to adhere to safety recommendations • Continuing case coverage support • Utilizing online and mobile training venues to educate our customers • Enabling employees to work remotely and implementing hybrid workplans • Providing personal protection and other measures to ensure the safety of those working in our offices and with customers • Limiting non-essential travel Provide a safe work environment for our employees Deliver products and support to our customers Health & Safety Maintaining Operations 22 While our plans will continue to evolve in response to changes caused by the COVID-19 pandemic, we remain committed to the AtriCure Team and to the execution of our strategic initiatives.
• US annual cardiac surgery volume steady over the past 5 years with shifts in procedure types10 • Pre-Op Afib occurs frequently in cardiac surgery patients11 • New onset Post-Op Afib is a well-documented complication of cardiac surgery, even if patients do not present with pre-op Afib12 US Concomitant Market Opportunity © 2022 AtriCure, Inc. All rights reserved. Estimated Afib Opportunity in Cardiac Surgery Annual Cardiac Surgeries13 300,000 Pre-Operative Afib Rate11 ~28% Cardiac Opportunity – Pre-Op Afib 85,000 ASP Mix (Ablation and Appendage Management)14 $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)14 $1,750 Open Cardiac Surgery Opportunity – Non-Afib $376M 23
US Standalone Market Opportunity © 2022 AtriCure, Inc. All rights reserved. Market opportunity in analysis at left considers: • Addition of ablation and LAAM to existing catheter ablation procedures − Catheter ablation procedures have grown 10-15% annually15 • Incremental penetration of advanced Afib patient population − Today, long-standing persistent Afib population represents more than 3 million patients in the United States, expected to grow to more than 4.4 million by 202516 • ASP Mix reflects both ablation and AtriClip Estimated Standalone Afib Opportunity 2020 Projected 2025 Long-standing Persistent Afib Catheter Ablation17 25,000 45,000 ASP Mix (Ablation + Appendage Management)14 $15,000 $15,000 Immediate Standalone Afib Opportunity $375M $675M Additional penetration Long-standing Persistent Afib patients (estimated at 5% penetration) 150,000 175,000 ASP Mix (Ablation + Appendage Management)14 $15,000 $15,000 Incremental Standalone Afib Opportunity (estimated at 5% penetration) $2B+ $3B+ 24
CONVERGE Overview 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 Predetermined performance goal for the study is 12% freedom from MAE’s as adjudicated by the CEC for the procedural to 30-day post procedure time period STUDY DESIGN Summary Multi-center, prospective, open label randomized 2:1 (Hybrid Convergent procedure vs endocardial catheter ablation) pivotal study Number of Subjects and Sites 153 subjects 27 sites (25 US and 2 OUS) Study Duration 12 month and 18 month monitoring, then 3 and 5 year follow-up of all subjects SUPERIORITY TRIAL designed to support FDA approval of the EPi-Sense device © 2022 AtriCure, Inc. All rights reserved. 25 • Completed enrollment August 2018 • Data released at virtual Heart Rhythm Society (HRS) conference May 2020 • PMA submission seeking approval for treatment of long-standing persistent Afib November 2020 • Trial results published in Circulation: Arrhythmia and Electrophysiology November 2020 • Long-standing persistent Afib patient sub-group analysis presented at 26th Annual Atrial Fibrillation (AF) Symposium January 2021 and 14th Annual Western AF Symposium February 2021 • FDA approval of EPi-Sense System for treatment of long-standing persistent Afib April 2021 HIGHLIGHTS Achieved statistical superiority for primary endpoints
Hybrid AF Therapy: the Convergent Procedure © 2022 AtriCure, Inc. All rights reserved.26
The Cox-Maze IV Procedure © 2022 AtriCure, Inc. All rights reserved.27
References and Abbreviations © 2022 AtriCure, Inc. All rights reserved. 28 Note Reference 1 Worldwide Epidemiology of Atrial Fibrillation: A Global Burden of Disease 2010 Study 2 The American Journal of Cardiology (2013), 112: 1142-1147 3 Lifetime risk for development of atrial fibrillation. Circulation, 110 (2004): 1042-1046. doi: 10.1161/01.CIR.0000140263.20897.42 4 J Geriatr Cardiol. 2016 Oct; 13(10): 880–882, doi: 10.11909/j.issn.1671-5411.2016.10.004 5 Santhanakrishnan R et al., “AF Begets Heart Failure and Vice Versa,” Circulation, 133 (2016):484-492 6 Odutayo, A. et al. (2016). Atrial fibrillation and risks of cardiovascular disease, renal disease, and deaths systematic review and meta analysis. BMJ 2016; 354:i4482 7 The Society of Thoracic Surgeons 2017 Clinical Practice Guidelines for the Surgical Treatment of Atrial Fibrillation 8 IFU for EPi-Sense® Guided Coagulation System Data: PMA# P200002 9 The Society of Thoracic Surgeons, Current News Release (1/30/2018): 1 in 7 Lung Surgery Patients at Risk for Opioid Dependence 10 STS Adult Cardiac Surgery Database, 2018/2019 Harvest Executive Summary 11 McCarthy, P.M. et al. (2019). Prevalence of atrial fibrillation before cardiac surgery and factors associated with concomitant ablation. J Thorac Cardiovasc Surg, PII: S0022-5223(19)31361-3, DOI: 10.1016/J.JTCVS.2019.06.062. 12 Lin et al, Stroke 2019 Jun; 50(6):1364-1371. doi: 10.1161/STROKEAHA.118.023921. Epub 2019 May 2. 13 Harvested from data previously available through the Society of Thoracic Surgeons 14 Average Selling Prices (ASPs) are management estimates based on a mix of products used for the various procedures 15 Estimated based on various catheter company presentations 16 Medical management estimate: Colilia, et al. Estimates of Current and Future Incidence and Prevalence of Atrial Fibrillation in the U.S. Adult Population. Am Journal of Cardiology 2013, 112: 1142-1147 Persistent patient estimate: Berisso et al Epidemiology of atrial fibrillation: European perspective Clin Epidemiol. 2014; 6: 213–220 17 Estimated based on Advisory Board data, along with various scientific presentations Key Abbreviations Afib or AF Atrial Fibrillation AA Atrial Arrythmia AAD Anti-Arrhythmic Drugs AFL Atrial Flutter AT Atrial Tachycardia CABG Coronary Artery Bypass Graft CEC Clinical Events Committee EP Electrophysiologist FDA Food & Drug Administration LAA Left Atrial Appendage LAAM LAA Management LS Long-standing MAE Material Adverse Event PMA Pre-Market Approval RF Radio Frequency