UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 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 13, 2021

 

ACUTUS MEDICAL, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

Registrant’s Telephone Number, Including Area Code: (442) 232-6080

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:

 

Securities registered pursuant to Section 12(b) of the Act:

 

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. ☐

 

 

 

 

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Item 2.02.  Results of Operations and Financial Condition.

On January 13, 2021, Acutus Medical, Inc. (the “Company”) issued a press release announcing preliminary results for the fourth quarter and year ended December 31, 2020.  A copy of the press release is furnished with this report as Exhibit 99.1.

Item 7.01  Regulation FD Disclosure

The Company will present at the 2021 J.P. Morgan Healthcare Conference on Wednesday, January 13, 2021, at 7:00 A.M. Pacific Time. A live webcast of the presentation, which will contain information regarding the Company, including the Company’s priorities for 2021, will be available at https://ir.acutusmedical.com/. A replay will be available on the Company’s website following the presentation. The Company’s written presentation materials for the conference, have been posted to the Company’s website. Such written presentation is also furnished as Exhibit 99.2 to this Current Report on Form 8-K. The information set forth in Exhibit 99.2 is incorporated herein by reference and constitutes a part of this report.

This information is furnished pursuant to Item 2.02 and Item 7.01 of Form 8-K promulgated by the Securities and Exchange Commission (the “SEC”) and shall not be deemed to be “filed” with the SEC for the 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, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing. By filing this Current Report on Form 8-K and furnishing this information, the Company makes no admission as to the materiality of any information contained in this report.

Please refer to the press release attached hereto as Exhibit 99.1 and to page 2 of the presentation attached hereto as Exhibit 99.2 for a discussion of certain forward-looking statements included therein and the risk and uncertainties related thereto.

Item 9.01  Financial Statements and Exhibits.

(d) Exhibits.

 

 

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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 thereunto duly authorized.

 

 

2

Exhibit 99.1

 

 

Acutus Medical Reports Preliminary, Unaudited Fourth Quarter and Full Year 2020 Results

 

 

 

Carlsbad, Calif. – January 13, 2021 – Acutus Medical, Inc. (“Acutus”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today reported preliminary unaudited revenue results for the quarter and full year ended December 31, 2020.

 

Preliminary Fourth Quarter and Full Year Results:

 

“During the fourth quarter, we made important progress across virtually all aspects of our business. This included the expected continued installed base build; rapid release of key enhancements on many elements of our product line; our first approval to initiate an IDE indication trial as negotiated with the FDA; continued strong momentum with our global marketing partnership with Biotronik; and significant regulatory approvals allowing us to market our novel left heart access products and our state-of-the-art force sensing ablation system into CE Mark governed geographies” said Vince Burgess, President & CEO of Acutus. “As a result, we are well positioned to deliver on our strategy of providing the large and fast growing EP market with a truly comprehensive and highly differentiated EP product line. As with many procedurally-based medtech companies, during the quarter we experienced significant business disruptions at many hospitals due to renewed pandemic concerns and procedural slowdowns/shutdowns in all of our key geographies. Based on the trends we are seeing, we expect these COVID-related headwinds to continue at least into the first half of 2021. During these challenging times, our efforts remain focused on continuing to build our installed base and driving positive customer experiences, which we believe will position the company for rapid share growth and revenue expansion when pandemic headwinds soften.”

 

Acutus Medical to Present at J.P. Morgan Healthcare Conference

Vince Burgess, President & CEO of Acutus Medical, will present at the J.P. Morgan Healthcare Conference on Wednesday, January 13, 2021 at 10:00 AM Eastern Time / 7:00 AM Pacific Time.  A live webcast of this event, as well as an archived recording, will be available in the Investors section of Acutus’ website at www.acutusmedical.com.

 

 

About Acutus Medical

Acutus Medical is an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated. Acutus is committed to advancing the field of electrophysiology with a unique array of products and technologies which will enable more physicians to treat more patients more efficiently and effectively. Through internal product development, acquisitions and global partnerships, Acutus has established a global sales presence delivering a broad portfolio of highly differentiated electrophysiology products that provide its customers with a complete solution for catheter-based treatment of cardiac arrhythmias. Founded in 2011, Acutus is based in Carlsbad, California.

 

 

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Caution Regarding Forward-Looking Statements

This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe,” “estimate,” “project,” “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, the finalization of our financial statements and the related audit by our independent registered public accounting firm for our year ended December 31, 2020, the Company's ability to continue to manage expenses and cash burn rate at sustainable levels, continued acceptance of the Company's products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its systems and the timing of such purchases, competitive factors, changes resulting from healthcare policy in the United States, including changes in government reimbursement of procedures, dependence upon third-party vendors and distributors, timing of regulatory approvals, the impact and duration of the coronavirus (COVID-19) pandemic and our response to it, and other risks discussed in the Company's periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

 

Investor Contact:

Caroline Corner

Westwicke ICR

D: 415-202-5678

caroline.corner@westwicke.com

 

Holly Windler

M: 619-929-1275

media@acutusmedical.com

 

Guided Ablation Therapy for Cardiac Arrhythmias Exhibit 99.2

Legal Disclaimer 2 This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, business strategy, prospective products, availability of funding, ability to maintain existing, and establish new, strategic collaborations, licensing or other arrangements, the scope, progress, results and costs of developing our products or any other future products, the potential market size and size of the potential patient populations for our products, the timing and likelihood of success of obtaining product approvals, plans and objectives of management for future operations, the scope of protection we are able to establish and maintain for intellectual property rights covering our products, and future results of anticipated products, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.  This presentation concerns anticipated products that are or are expected to be under clinical investigation and which have not yet been approved for marketing by the U.S. Food and Drug Administration (FDA). No representation is made as to these products’ safety or effectiveness for the purposes for which it is being or will be investigated.

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