Guided Ablation Therapy for Cardiac Arrhythmias Exhibit 99.2
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Investment Highlights 3 1 2 3 4 5 6 7 8 Paradigm-shifting ablation guidance technology, future in electroporation Pure-play electrophysiology company / Comprehensive, differentiated portfolio Large, growing and underpenetrated market Efficient commercial model and access to labs Global presence via marketing alliance with Biotronik Established and attractive reimbursement Robust patent portfolio Highly experienced management team
Global Electrophysiology (“EP”) Ablation Market ~$5.7 Billion
~1.1 million ablation procedures
Global 2019 EP ablation supplies market (1) (2)
~13%
Annual growth rate of ablation procedures worldwide since 2016 (1) Progressive disease,
function of aging Western
lifestyle Increasing utilization of
self monitoring devices Well established reimbursement in developed markets Key drivers of the arrhythmia epidemic 4 (1) Based on internal Company estimate
(2) Market size reflects disposable products
5 Attractive ~$5.7bn market for electrophysiology products that has grown ~13% annually since 2016 (1) (2) Based on internal Company estimates
Market size reflects disposable products Difficult to map
Long and unpredictable procedures (2-6hrs)
Patients often need a repeat procedure Current market challenges Often unable to locate the source of arrhythmia
Current technologies cannot address 40-60% of SVT patients who also have AF (1) Unstable and aggravated by contact with the ventricular wall
Long and unpredictable procedures (2-6hrs) Atrial Fibrillation (AF) Supraventricular Tachycardias (SVTs) 2019 prevalence (1) Number of procedures in 2019 (1) 2019 market size (1)(2) 30.0mm 475,000 $3.4bn 17.1mm 516,000 $1.7bn 5.5mm 90,000 $0.6bn ~52.6mm ~1,081,000 ~$5.7bn Global Electrophysiology (“EP”) Ablation Market
Efficient, Effective Treatment of Complex Arrhythmias Remains Elusive Persistent Atrial Fibrillation Example 6 High therapy failure rates
~50% of ablations for Persistent AF result in recurrence within 12 months (2) High cost of retreatment procedures
High cost of hospitalization from complications
Drug therapy low success rates and increased risk of adverse side effects (1) Antiquated platforms not able to diagnose unstable arrhythmias
Long procedures with unpredictable durations
Physical toll on physicians Lack of Progress, Standardization Patients Payors No real improvement in outcomes for decades (Persistent AF) (1)
No agreement on best ablation strategies
Industry still looking for answers Providers (1) Based on internal Company estimates
(2) Kornej et al. Time-dependent prediction of arrhythmia recurrences during long-term follow-up in patients undergoing catheter ablation of atrial fibrillation: The Leipzig Heart Center AF Ablation Registry. Published online www.nature.com/scientificreports.
Our Vision – Lead the Field of Guided Ablation Therapy for Cardiac Arrhythmias Comprehensive Suite of Highly Differentiated Products for EP 7 * Partnerships
Ϯ Development, not currently marketed
Acutus’ Guided Ablation Therapy Platform Whole Heart Chamber Mapping in Under 3 Minutes 8
Whole-Chamber Views of Complex Rhythms in Under 3 Minutes
Full Function System -- Individualized for Physicians and Patients 9 Ultrasound
Anatomy Vein Build Tool SuperMap
Automated Processing Isochronal Local
Activation Time Map Propagation History
Map Conventional Contact Map
Why Is the Market Less Than 5% Penetrated? (1) How and Where Acutus Can Add Value / Solve Problems 10 Atrial Fibrillation Supraventricular Tachycardias (1) Based on internal Company estimates
(2) AcQMap catheter is not currently indicated for use in the ventricle Percentages above based on company estimates of ~1,081k WW electrophysiology procedures in 2019 including 475k atrial fibrillation procedures (of which 53% were for paroxysmal atrial fibrillation, 33% were for persistent atrial fibrillation and 14% were for long-standing persistent atrial fibrillation), 516k SVT procedures and 90k VT procedures
Acutus Comparative Outcomes for Persistent AF*
Meaningful Clinical Improvement vs. Stagnant Standard of Care 11 UNCOVER AF (AcQMap): We believe fundamentally different mapping approach & therapy strategy (non-contact mapping & map/treat/re-map strategy) leads to improved success rates 1: Willems et al; Charge Density Mapping for Atrial Fibrillation:Circ Arrhythm Electrophysiol. 2019;12:e007233.
2: Mansour M, et. al; Persistent atrial fibrillation ablation with contact force sensing catheter: The prospective multicenter PRECEPT Trial, JACC: Clinical Electrophysiology (2020)
3: De Lurgio D et. al; Hybrid Convergent Procedure: Epicardial and Endocardial Ablation for the Treatment of Persistent Atrial Fibrillation -CONVERGE Randomized Controlled Clinical Trial Results, HRS Late-Breaking Clinical Trials (2020)
4: Verma A, et al; Approaches to Catheter Ablation for Persistent Atrial Fibrillation N Engl J Med 2015;372:1812-22. Estimated from KM curve data available in NEJM
*Outcome comparisons are difficult due to difference in the detailed effectiveness outcome definitions
NR = Not Reported
Acutus in Atrial Tachycardia ”Safe, Fast and Feasible” Atrial tachycardias (AT) can be observed following up to 25%[1-5] of AF ablation procedures
Prior studies have reported average procedure times of 4-7 hours6 in follow-up ablation procedures to remedy these tachycardias
In a “first use” study published in the Journal of Interventional Cardiac Electrophysiology, the Acutus SuperMap algorithm was used in 7 consecutive AT patients to successfully identify and ablate ALL areas of clinical significance7
Mean procedure time was 56.4 minutes (+/- 12.1 minutes)7
12 1. Calkins H. The dynamic substrate for atrial fibrillation: can we identify it and is it of clinical importance? JACC: ClinElectrophysiol. 2017. https://doi.org/10.1016/j.jacep.2016.12.003.
2. Gerstenfeld EP, Callans DJ, Dixit S, Russo AM, Nayak H, Lin D, et al. Mechanisms of organized left atrial tachycardias occurring after pulmonary vein isolation. Circulation. 2004;110(11):1351–7. https://doi.org/10.1161/01.CIR.0000141369.50476.D3.
3. Wasmer K, Mönnig G, Bittner A, Dechering D, Zellerhoff S, Milberg P, et al. Incidence, characteristics, and outcome of left atrial tachycardias after circumferential antral ablation of atrial fibrillation. Heart Rhythm. 2012. https://doi.org/10.1016/j.hrthm.2012.06.007.
4. Chugh A, Oral H, Lemola K, Hall B, Cheung P, Good E, et al. Prevalence, mechanisms, and clinical significance of macroreentrant atrial tachycardia during and following left atrial ablation for atrial fibrillation. Heart Rhythm. 2005. https://doi.org/10.1016/j.hrthm.2005.01.027.
5. Saghy L, Tutuianu C, Szilagyi J.Atrial tachycardias following atrial fibrillation Ablation. Curr Cardiol Rev. 2014;11(2):149–56. https://doi.org/10.2174/1573403X10666141013122400.
6. Jaïs P, Shah DC, Haïssaguerre M, Hocini M, Peng JT, Takahashi A, et al. Mapping and ablation of left atrial flutters. Circulation. 2000. https://doi.org/10.1161/01.CIR.101.25.2928.
7. Ramak R, Chierchia GB, Paparella G, Monaco C, Miraglia V, Cecchini F, et al. Novel noncontact charge density map in the setting of post-atrial fibrillation atrial tachycardias: first experience with the Acutus SuperMap Algorithm. JICE. 2020. https://doi.org/10.1007/s10840-020-00808-9. The authors concluded that SuperMap proved “safe, fast and feasible in identifying and guiding ablation in the setting of regular atrial tachycardias following index AF Ablation7” Case Example: Procedure Time 48 minutes
Post-ablation patient was non-inducible Earliest breakout Ablation
Termination
Our Comprehensive Portfolio and Partnerships 13 * Partnerships
Ϯ Development, not currently marketed
Comprehensive, Differentiated Therapy Portfolio AcQBlate Force-Sensing Ablation Catheter and System
First and only commercially available irrigated force-sensing catheter in the market featuring a Gold Tip Electrode 14 / / Qubic RF (1) Qiona Pump (1) AcQBlate Gold Flutter AcQBlate Gold EvenTemp All Ablation Catheters and Electronic Components CE Marked AcQBlate® FORCE AcQBlate FORCE RF capable today -- designed for Pulsed Field Ablation compatibility (timing TBD) Ablation Catheters and Electronic Components Commencing IDE trials in 1H 2021
15 Innovation Pipeline: Pulsed Field Ablation Pulsed Field Ablation is a promising new energy modality under investigation for cardiac ablations Conduction blocked at PFA Line This presentation may include products not yet for sale in the U.S. What is it?
Sequence of very short duration high voltage pulses that selectively kill tissue by irreversible electroporation delivered catheter
Advantages
Safety
Ablation is non-thermal
Traditional ablation relies of extreme heat (RF) or extreme cold (Cryo) to kill tissue
Selectively destroys cardiac cells
No / low risk of destroying tissue outside the heart (esophagus, nerves, etc.)
Speed
Creates complete and durable lesions in milliseconds
RF ablations take 5 to 30 seconds per lesion and Cryo ablations take 3 to 4 minutes Acutus’ Program
We are developing flexible energy generators and a portfolio of electroporation-capable ablation catheters
Single generator for both RF and Pulsed Field Ablation
Force sensing, irrigated, gold-tip ablation catheter capable of delivering both pulsed field and RF energies
Acutus pulsed field ablation program is in early stages of development with promising pre-clinical results Electroporation lesions with force sensing, irrigated, gold-tip ablation catheter (Preclinical data, porcine model) Contact voltage map at index PFA procedure and non-contact activation maps created at 14-day follow-up demonstrating lesion durability in a porcine model. Photomicrograph showing selective cardiac cell ablation
Broad, Differentiated Left Heart Access Product Line 16 Patient Safety & Physician Confidence
Spring-tensioned safety needle, reduces risk to patient
as well as staff
Length-matched needle to introducer locks together
for control & ease of use
Enhanced Procedural Efficiency
Reduced need for wire exchanges, facilitates repositioning
For use mechanically or with RF energy Addresses Multiple Significant High Growth Markets
All left-sided EP ablations
Structural heart procedures – including LAA and Mitral Repair
Acutus / Biotronik International Alliance for EP 17 Global Reach in Developed Markets Acutus to sell its core mapping, ablation, and accessory products and private (Acutus) labeled products manufactured by Biotronik Same as above, but private (Acutus) labeled products manufactured by Biotronik distribution rights to be phased in over time Biotronik to sell Acutus’ core mapping, ablation and accessory products under private (Biotronik) label Not yet assigned Each company will have a full EP portfolio in its market
Mapping system + access + diagnostic + therapeutic catheters Expect to obtain access to Biotronik’s digital infrastructure
Real-time case monitoring and review
Remote system diagnostics / software push Expected to enable bundling of ablation/CRM product lines OUS Full
Portfolio Digital
Connectivity CRM
Leverage Strategic Highlights
Acutus’ guided ablation therapy platform fully integrated with the Stereotaxis EP robot Synchronized anatomy rotation between robotics and imaging system
Allows precise targeting of pulmonary vein and non-pulmonary vein triggers Stereotaxis® Robot Integration and Partnership 18
Have a favorite? Go ahead and use it! Innovative Health® Partnership 19 This presentation may include products not for sale in the U.S.
This presentation contains products that are not manufactured by Acutus Medical Acutus has partnered with Innovative Health to bring 28+ reprocessed catheters to our open platform
More clearances for EP devices than any other reprocessing company
The more devices are cleared, the higher the hospital savings
Constant flow of new clearances ensures constant growth in reprocessing savings
Pure Play, Stand-Alone EP Company Approved, highly differentiated products in many categories 20 (1) Anticipated timing (Future availability timelines are estimates subject to risks and uncertainties. See “Risk Factors” in the public filings.)
Model and Key Revenue Drivers Up to $10K (1) revenue potential for disposables / procedure 21 X X (1) Based on internal Company estimates
Continue installed base build
Drive adoption and incremental revenue per case via:
Successful product launches of additional/improved accessory products. Launches planned for first half of 2021 include:
Force Sensing Ablation system in (CE markets only)
Improved patch kits
Expanded left heart access line (septal crossing line expansion and new sheaths)
Gen 2 basket mapping catheter
Expanded capabilities and integration with Stereotaxis robot
Conventional diagnostic catheters
Continue to hire and intensively train the best therapy specialists and reps in the EP industry
Key papers accepted and published in persistent AF, redo AF, atrial tachycardia
Continued commercial momentum with Biotronik global marketing alliance, Stereotaxis partnership and build momentum with Innovative Health Partnership in reprocessing
Commence US IDE trials for ablation system in Atrial Flutter and Paroxysmal and Persistent Atrial Fibrillation
Complete First in Man and commence Pilot Trial for Pulsed Field Ablation and specialized VT mapping catheter
Top Priorities for 2021 22
Thank you for your time! 23
