General form for registration of securities under the Securities Act of 1933



BGCOLOR="WHITE">




Table of Contents






As filed with the Securities and Exchange Commission on July 12, 2021




Registration

No. 333-











SECURITIES AND EXCHANGE COMMISSION




Washington, D.C. 20549










FORM

S-1





REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933










ACUTUS MEDICAL, INC.



(Exact
Name of Registrant as Specified in Its Charter)

































Delaware




3841





45-1306615




(State or Other Jurisdiction of



Incorporation or Organization)





(Primary Standard Industrial



Classification Code Number)





(I.R.S. Employer



Identification Number)





2210 Faraday Ave., Suite 100




Carlsbad, CA 92008




(442)

232-6080




(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s
Principal Executive Offices)










Vince Burgess




Chief
Executive Officer




Acutus Medical, Inc.




2210 Faraday Ave., Suite 100




Carlsbad, CA 92008




(442)

232-6080




(Name, Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent For
Service)










Copies to:

























Alan F. Denenberg




Davis Polk & Wardwell LLP




1600 El Camino Real




Menlo
Park, CA 94025




(650)

752-2000







Tom Sohn




Senior Vice President, General Counsel & Secretary




Acutus Medical, Inc.




2210
Faraday Ave., Suite 100




Carlsbad, CA 92008




(442)

232-6080







Kristin VanderPas




Charles S. Kim




Dave
Peinsipp




Denny Won




Cooley LLP




4401 Eastgate
Mall




San Diego, CA 92121




(858)

550-6000












Approximate date of commencement of proposed sale to the public:

As soon as practicable after the effective date of this
Registration Statement.



If any of the securities being registered on this Form are to be offered on a delayed or continuous
basis pursuant to Rule 415 under the Securities Act of 1933, check the following box.  ☐



If this Form is
filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for
the same offering.  ☐



If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the
Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐



If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and
list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐



Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a

non-accelerated

filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and
“emerging growth company” in Rule

12b-2

of the Exchange Act. (Check one):































Large accelerated filer  ☐


Accelerated filer  ☐



Non-accelerated filer  ☑



Smaller reporting company  ☑


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 7(a)(2)(B) of the Securities Act.  ☐










CALCULATION OF REGISTRATION FEE





























































Title of Each Class of Securities to be Registered




Amount to be


Registered

(1)





Proposed Maximum


Offering Price


Per Share

(2)






Proposed Maximum




Aggregate Offering


Price

(1)(2)







Amount of




Registration Fee




Common stock, $0.001 par value per share




6,325,000


$15.48


$97,911,000


$10,682















(1)


Includes the aggregate amount of 825,000 additional shares that the underwriters have the option to purchase.









(2)


Estimated solely for the purpose of computing the amount of the registration fee pursuant to Rule 457(a)
under the Securities Act of 1933, as amended. The proposed maximum offering price per share and the proposed maximum aggregate offering price are calculated on the basis of the average high and low prices per share of the registrant’s common
stock reported on The Nasdaq Global Select Market on July 9, 2021, pursuant to Rule 457(c) under the Securities Act.





The registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective
date until the registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration
Statement shall become effective on such date as the Commission acting pursuant to said Section 8(a) may determine.
















Table of Contents







The information in this preliminary prospectus is not complete and
may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and it is not soliciting an offer
to buy these securities in any state or other jurisdiction where the offer or sale is not permitted.








SUBJECT TO COMPLETION, DATED JULY 12, 2021





5,500,000 Shares





LOGO




Common Stock



We are offering 5,500,000 shares of our common stock. Our common stock is listed on The Nasdaq Global Select Market under the symbol
“AFIB.” On July 9, 2021, the last reported sale price of our common stock on The Nasdaq Global Select Market was $15.48 per share.



We are an emerging growth company under the federal securities laws and, as such, have elected to comply with certain reduced public company
reporting requirements.




Investing in our common stock involves a high degree of risk. See “

Risk
Factors

” beginning on page 15.







































































Per


Share





Total




Public offering price




$




$




Underwriting discounts and
commissions

(1)




$




$




Proceeds, before expenses, to us




$




$











(1)


See “Underwriting” for additional disclosure regarding the underwriting discounts and commissions
and estimated offering expenses.




We have granted the underwriters an option for a period of 30 days to purchase up to
825,000 additional shares of our common stock.



The underwriters expect to deliver the shares against payment in New York, New York on
                , 2021.




Neither the Securities and
Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.




Goldman Sachs & Co. LLC




, 2021










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TABLE OF CONTENTS

















We and the
underwriters have not authorized anyone to provide any information or to make any representations other than those contained in this prospectus or in any free writing prospectuses we have prepared. We and the underwriters take no responsibility for,
and can provide no assurance as to the reliability of, any other information that others may provide you. We are offering to sell, and seeking offers to buy, shares of common stock only in jurisdictions where offers and sales are permitted. The
information contained in this prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery of this prospectus or of any sale of the common stock.



This prospectus includes industry and market data that we obtained from periodic industry publications, third-party studies
and surveys, filings of public companies in our industry and internal company surveys. These sources may include government and industry sources. Industry publications and surveys generally state that the information contained therein has been
obtained from sources believed to be reliable. Although we believe the industry and market data to be reliable as of the date of this prospectus, this information could prove to be inaccurate. Industry and market data could be wrong because of the
method by which sources obtained their data and because information cannot always be verified with complete certainty due to the limits on the availability and reliability of raw data, the voluntary nature of the data gathering process and other
limitations and uncertainties. In addition, we do not know all of the assumptions regarding general economic conditions or growth that were used in preparing the forecasts from the sources relied upon or cited herein.





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PROSPECTUS SUMMARY




This summary highlights selected information contained in greater detail elsewhere in this prospectus or in the documents
incorporated by reference in this prospectus and does not contain all of the information that you should consider in making your investment decision. Before investing in our common stock, you should carefully read the entire prospectus, including
the section titled “Risk Factors” herein and the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the consolidated financial statements and related notes incorporated
by reference in this prospectus from our Annual Report on Form

10-K

for the fiscal year ended December 31, 2020, or our 2020 Annual Report, and our Quarterly Report on Form

10-Q

for the three months ended March 31, 2021, or our March 2021 Quarterly Report. As used in this prospectus, references to “we,” “our,” “us,” the “Company” and
“Acutus” refer to Acutus Medical, Inc. and, where appropriate, its wholly-owned subsidiary unless the context requires otherwise.




Overview



We are an
arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated. Despite several decades of efforts by incumbents in this field, the clinical and economic challenges associated with arrhythmia treatment
continue to be a huge burden for patients, providers and payors. We are 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, we have established a global sales presence delivering a broad portfolio of highly differentiated electrophysiology products. Our goal is to provide our
customers with a complete solution for catheter-based treatment of cardiac arrhythmias in the geographic markets that we serve.



We design, manufacture and market a range of tools for catheter-based ablation procedures to treat various arrhythmias.
Cardiac ablation involves using high-energy radio frequency or extreme cold to target tissue in the heart that is responsible for triggering or sustaining an abnormal heart rhythm. Our product portfolio includes novel access sheaths, transseptal
crossing tools, diagnostic and mapping catheters, conventional and contact force ablation catheters (currently available only in our European markets), mapping and imaging consoles and accessories, as well as supporting algorithms and software
programs. Our foundational and most highly differentiated product is our AcQMap imaging and mapping system, which offers a paradigm-shifting approach to mapping the drivers and maintainers of arrhythmias with unmatched speed and precision. With the
ability to rapidly and accurately identify ablation targets and to confirm both ablation success and procedural completion, we believe our AcQMap System addresses the primary unmet need in electrophysiology procedures today.



While multiple trials have established that cardiac ablation is effective when the source of the arrhythmia is accurately
identified and successfully ablated, visualization of various complex arrhythmias and creation of durable ablation lesions remains challenging with long, unpredictable procedure times and inconsistent outcomes. For example, data from large,
multi-center trials of cardiac ablation have demonstrated that approximately 30 to 50% of ablations for atrial fibrillation result in arrhythmia recurrence within the first 12 months of the initial ablation procedure. Currently marketed mapping
systems are not able to quickly and consistently identify the source of the arrhythmia in more complex cases, which can contribute to these unsatisfactory outcomes. Current competitive mapping systems sequentially collect data,


point-by-point,


by contacting the heart surface at multiple locations throughout the chamber. This is a time-consuming process that often takes 15 to 20 minutes per map.
Additionally, because contact-based mapping relies on a fixed timing reference to sequence the data points, it precludes these systems from being able to quickly and reliably identify the drivers and maintainers of unstable arrhythmias, such as
atrial fibrillation, many types of supraventricular tachycardias and certain ventricular arrhythmias.









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We designed our AcQMap System to improve procedure efficiency and outcomes
by rapidly and accurately identifying ablation targets and confirming both ablation success and procedure completion. Our AcQMap System consists of our

single-use

AcQMap catheter as well as our console,
workstation and proprietary software algorithms. With 48 ultrasound transducers interspersed between 48 biopotential electrodes, our innovative mapping catheter collects the data required to create a comprehensive map of the cardiac anatomy and
electrical propagation pathways and patterns in under three minutes, without contacting the chamber wall. Our proprietary software algorithms analyze the biopotential data and are collectively able to map any type of stable or unstable arrhythmia,
including atrial fibrillation, as well as all supraventricular tachycardias and ventricular arrhythmias.



We believe that
by creating high definition, clinically accurate activation maps of all types of arrhythmias, our AcQMap System offers physicians better decision-making tools for determining where to ablate. Similarly, we believe the speed and ease of creating a
map makes it practical for physicians to iteratively map, treat,

re-map

and adjust additional therapy as needed. We believe these features will drive more efficient and predictable procedures and better
outcomes for a broader range of arrhythmias.



We have established a broad portfolio of electrophysiology products that
complements our AcQMap System. In addition to our AcQMap System, our commercial product portfolio includes a suite of access devices, our transseptal crossing device and full product lines of diagnostic and, in our European markets, ablation
catheters. In our European markets, our portfolio provides our customers with a complete solution—from vascular access to diagnosis and treatment of arrhythmias. In the United States, we are currently seeking regulatory approval for our
ablation catheters to complement our portfolio of access and mapping devices. We also recently expanded our portfolio to include the AcQBlate Force

gold-tip,

irrigated, radiofrequency force sensing ablation
catheters and Qubic Force control unit, or AcQBlate Force Sensing Ablation System, which we commercialized following the December 2020 receipt of the CE Mark in Europe. Biotronik SE & Co. KG, or Biotronik, had previously performed the
BioConcept Study, which was used as the base data for CE Mark submission, and no additional clinical data was required for CE Mark approval. We are also planning two investigational device exemption, or IDE, trials for U.S. Food and Drug
Administration, or FDA, Premarket Approval, or PMA, in the United States. In the first half of 2021, the first IDE trial seeking a right atrial typical flutter indication received an IDE approval from the FDA and commenced enrollment. The second IDE
trial seeking a paroxysmal and persistent atrial fibrillation indication received IDE approval in May 2021 and we expect to commence enrollment in the second half of 2021. We currently anticipate FDA PMA and the U.S. commercial launch of our
AcQBlate Force Sensing Ablation System in the second half of 2022 or early 2023. We believe that our ability to offer a broad and differentiated product portfolio will support the adoption and utilization of our AcQMap System and drive an efficient
business model. Once an AcQMap console and workstation is established in a customer account, our revenue from that account becomes predominantly recurring in nature and derived from the sale of our portfolio of disposable products used with our
system.



We market and sell our electrophysiology products worldwide to hospitals and electrophysiologists that treat
patients with arrhythmias. We have strategically developed a direct selling presence in the United States and select markets in Western Europe where cardiac ablation is a standard of care and third-party reimbursement is well-established. In other
international markets, we leverage our partnership with Biotronik, a large multi-national, privately-held biomedical technology company with a leading portfolio across cardiac rhythm management, electrophysiology and vascular intervention, to sell
and distribute our products. In the United States and Western Europe, our target market is highly concentrated. We plan to leverage the concentrated nature of procedure volumes and the recurring nature of our sales to drive an increasingly efficient
commercial model.



Our research and development activities are focused on advancing the field of electrophysiology by
increasing the AcQMap System’s utility and seeking approval for additional labeled indications as well as expanding our product portfolio to further improve and simplify the entire procedural experience. Our near-term









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pipeline includes products that broaden our commercial portfolio, increase functionality and/or reduce costs across catheters, accessory devices, mapping systems and software.




Our Market and Industry



Cardiac arrhythmias, or heart rhythm disorders, are common and can occur when the heart beats too rapidly, too slowly or
irregularly. If left untreated, arrhythmias can result in debilitating symptoms, heart failure, stroke and sudden cardiac death.



Atrial fibrillation, or AF, is the most common arrhythmia and is characterized by rapid and irregular activation of the heart.
This irregular behavior increases the potential to develop blood clots within the upper chambers of the heart, which can then circulate to other organs, leading to reduced blood flow and strokes. We estimate that there were approximately 470,000
cardiac ablation procedures globally for atrial fibrillation in 2020.



Supraventricular tachycardias, or SVTs, are
characterized by a rapid heartbeat in the upper chambers of the heart. These arrhythmias, which include atrial flutter and atrial tachycardia, among others, can arise organically or as a result of an incomplete ablation for atrial fibrillation. We
estimate there were approximately 415,000 ablation procedures worldwide for SVTs in 2020.



Ventricular arrhythmias affect
the lower chambers of the heart and consist primarily of ventricular tachycardias, or VTs, and premature ventricular contractions, or PVCs. If left untreated, VTs and PVCs can lead to heart failure, ventricular fibrillation and sudden cardiac death.
We estimate that there were approximately 87,000 global ablation procedures for ventricular arrhythmias in 2020.



Because
currently marketed mapping systems rely on tissue contact and a fixed timing reference to collect and align data in the proper sequence, they are designed to map simple, stable and repetitive arrhythmias, including certain SVTs and VTs. Collecting a
critical mass of data points to see even a stable rhythm is time consuming with contact mapping technologies, often taking 15 to 20 minutes per map. In addition, these technologies can only map one rhythm from each data collection session and are
not capable of quickly and reliably mapping unstable or complex arrhythmias such as AF, certain VTs, PVCs or many types of SVTs.




Our Solution



We design, manufacture and market a range of tools for catheter-based ablation procedures to treat various arrhythmias. Our
foundational and most highly differentiated product is our AcQMap imaging and mapping system which offers a paradigm-shifting approach to mapping the drivers and maintainers of arrhythmias with unmatched speed and precision. With the ability to
rapidly and accurately identify ablation targets and to confirm both ablation success and procedural completion, we believe our AcQMap System addresses the primary unmet need in electrophysiology procedures today.





Overview of Our AcQMap System




We developed our AcQMap System to address the key challenges that electrophysiologists face during ablation procedures and
remove the barriers to adopting ablation for complex arrhythmia procedures.



Our AcQMap System consists of our AcQMap
catheter, console and workstation. With 48 ultrasound transducers interspersed between 48 biopotential electrodes, our innovative mapping catheter collects the data required to create a comprehensive map of the cardiac anatomy and electrical
propagation patterns and pathways without contacting the chamber wall. This allows us to create comprehensive diagnostic maps of the chamber









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anatomy and electrical propagation patterns and pathways in under three minutes. Our proprietary software algorithms analyze the biopotential data and are collectively able to map any type of
stable or unstable arrhythmia, including atrial fibrillation, as well as all supraventricular tachycardias and ventricular arrhythmias.





Key
Benefits of AcQMap




We believe the unique attributes of our AcQMap System offer significant clinical benefits
relative to the current standard of care.




Allows for an Iterative Whole-Chamber Mapping Approach

. With increased
mapping speed and precision, electrophysiologists are empowered in real time to iteratively map, treat,

re-map

and adjust additional therapy as needed. This allows physicians to determine when ablation is
complete, which we believe will drive more efficient and predictable procedures and better outcomes for a broader range of arrhythmias.




Increased Mapping Accuracy

.




Ultrasound technology allows us to create an anatomically accurate image of
the heart chamber, and

non-contact

charge density mapping provides a more localized and sharper view of cardiac activation, resulting in images with four times higher resolution than voltage-based maps
produced by currently marketed contact-based mapping systems. We believe the combination of these two features allows electrophysiologists to reliably identify and ablate the source of the arrhythmia, which will help improve clinical outcomes and
reduce the need for repeat procedures.




Ability to Identify Multiple Complex Arrhythmias

.




The AcQMap
System is the only commercially available mapping system that can quickly and reliably map both stable and unstable rhythms, allowing electrophysiologists to see changes in conduction during the procedure and providing them with an optimal solution
to better customize therapy.




Excellent Clinical Outcomes

. Our UNCOVER AF post-market approval trial, which
assessed the effectiveness of the AcQMap System in identifying patient-specific targets for ablation, demonstrated favorable freedom from AF outcomes. The results are particularly favorable in the context of other landmark trials in the
electrophysiology space, including the STAR AF II trial, which evaluated a similar population of persistent AF patients. We believe the key differentiator in outcomes was the use of our AcQMap System to map and identify key ablation patterns and
targets.





Our Broad Portfolio




We have established a broad portfolio of electrophysiology products that complements our AcQMap System. In addition to our
AcQMap System, our commercial product portfolio includes a suite of access devices, our transseptal crossing device and full product lines of diagnostic and, in our European markets, ablation catheters. In our European markets, our portfolio
provides our customers with a complete solution—from vascular access to diagnosis and treatment of arrhythmias. In the United States, we are currently seeking regulatory approval for our ablation catheters to complement our portfolio of access
and mapping devices. We also recently expanded our portfolio to include the AcQBlate Force Sensing Ablation System, which we commercialized following the December 2020 receipt of the CE Mark in Europe. In the first quarter of 2021, we commenced
enrollment in one of two IDE trials for FDA PMA in the United States with the second IDE trial planned to commence enrollment in the second half of 2021. We currently anticipate FDA PMA, and the U.S. commercial launch, of our AcQBlate Force Sensing
Ablation System in the second half of 2022 or early 2023.



We believe that our ability to offer a broad and differentiated
product portfolio will support the adoption and utilization of our AcQMap System and drive an efficient business model. Once an AcQMap console and workstation is established in a customer account, our revenue from that account becomes predominantly
recurring in nature and derived from the sale of our portfolio of disposable products used with our system.









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Our Growth Strategies



We are 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. We seek to establish our AcQMap System as the standard of care for mapping and diagnosis of cardiac arrhythmias and to leverage its paradigm-shifting nature to drive adoption
and utilization of our portfolio of differentiated electrophysiology products.



Our growth strategies include:













•



utilizing our superior mapping technology and open platform to establish our presence with a broad base of
customer accounts and physicians;














•



strategically expanding our commercial organization across key global markets to increase physician awareness
and drive adoption;














•



driving market penetration and portfolio utilization;














•



continuing to expand our portfolio of products and broaden indications for existing products;














•



leveraging our strategic partnerships to efficiently scale globally and broaden our product portfolio; and














•



continuing to build our clinical evidence base.





Recent Developments





Letter Agreement with
Deerfield and OrbiMed




On July 11, 2021, we entered into a letter agreement with each of Deerfield Partners, L.P.
and Deerfield Private Design Fund III, L.P., or Deerfield, and OrbiMed Private Investments IV, LP and OrbiMed Royalty Opportunities II, LP, or OrbiMed, pursuant to which, within 30 days following and contingent upon the completion of this offering,
each of Deerfield and OrbiMed agreed to negotiate, enter into and consummate exchanges, or the Exchanges, pursuant to exchange agreements, or the Exchange Agreements, which would provide, among other things, for the exchange of all of our common
stock held by Deerfield and OrbiMed (including any shares of our common stock purchased in this offering), other than such number of shares of our common stock representing 9.5% of the outstanding shares of our common stock held by Deerfield and
9.5% of the outstanding shares of our common stock held by OrbiMed, for newly issued shares of a new series of our preferred stock to be designated as Series A Preferred Stock, par value $0.001 per share, or the Series A Preferred Stock, which would
be substantially equivalent to our common stock except that it would have no voting rights (subject to limited exceptions), would be subject to a beneficial ownership limitation of 4.9% of our outstanding common stock for each of Deerfield and
OrbiMed and would have a liquidation preference of $0.001 per share of Series A Preferred Stock.





Preliminary Financial and Installed Base Data




The following information reflects our preliminary expectations of results for the quarter ended June 30, 2021,
based on currently available information. We have provided ranges, rather than specific amounts, for the financial results below, primarily because our financial closing procedures for the quarter ended June 30, 2021 have just commenced and, as a
result, our final results upon completion of our closing procedures may vary from the preliminary estimates included herein. For instance, we have not begun review of most account reconciliations or expense accruals, or prepared notes to our
financial statements.









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Preliminary Financial Results



Although the financial results for the quarter ended June 30, 2021 are not yet finalized, we estimate that the financial
results will fall within the following ranges, as compared to the quarter ended June 30, 2020:




































































































Three Months Ended June 30,






2021





2020




(in thousands)




Low





High





Actual






(unaudited)




Revenue




$

4,600



$

4,700



$

1,134



Loss from operations




$

27,000



$

29,000



$

19,465



We estimate that our revenue for the quarter ended June 30, 2021 will be between
$4.6 million and $4.7 million, compared to $1.1 million for the quarter ended June 30, 2020, a change of $3.5 million, reflecting growth of over 300%, calculated using the midpoint of the range. The change in revenue for the
quarter ended June 30, 2021 compared to the same period of 2020 is primarily due to growth in sales volume with an increase in installed base, including an increase in disposable sales, system sales and distributor/distribution sales. Our U.S.
business led overall performance in the quarter, while our U.K. and Europe teams continued to drive solid execution amidst continuing regional COVID-19 disruptions.



We estimate that our loss from operations for the quarter ended June 30, 2021 will be between $27.0 million and $29.0 million,
compared to a loss from operations of $19.5 million for the quarter ended June 30, 2020, a change of $8.5 million or 44%, calculated using the midpoint of the range.



We estimate that our cash, cash equivalents and marketable securities as of June 30, 2021 was approximately $81 million.




Installed Base Data



Although the operational results for the quarter ended June 30, 2021 are not yet finalized, we estimate that our installed base
data was as follows, as compared to the quarter ended June 30, 2020:














































































































As of


June 30,






2021





2020




Installed base:












United States





42




20



International





28




18




















Total





70




38




















We define our installed base as the cumulative number of AcQMap consoles and workstations
placed into service at customer sites. We increased our worldwide installed base of second generation AcQMap consoles to 68 as of June 30, 2021, up from 57 as of March 31, 2021, bringing the total installed base of AcQMap consoles to 70 as of June
30, 2021.





Inclusion of Preliminary Financial and Installed Base Data




The preliminary financial and installed base information included in this prospectus reflect management’s estimates based
solely upon information available to us as of the date of this prospectus and are the responsibility of management. The preliminary consolidated financial results presented above are not a comprehensive statement of our financial results for the
quarter ended June 30, 2021 and have not been audited, reviewed or









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compiled by our independent registered public accounting firm, KPMG LLP. The preliminary consolidated financial results presented above are subject to the completion of our financial closing
procedures, which have not yet been completed. Our actual results for the quarter ended June 30, 2021 will not be available until after this offering is completed and may differ materially from these estimates. Accordingly, you should not place
undue reliance upon these preliminary financial results. For example, during the course of the preparation of the respective financial statements and related notes, additional items that would require material adjustments to be made to the
preliminary estimated consolidated financial results presented above may be identified. There can be no assurance that these estimates will be realized, and estimates are subject to risks and uncertainties, many of which are not within our control.
See “Risk Factors” and “Special Notes Regarding Forward-Looking Statements.”




Risks Associated with Our Business



Our business is subject to numerous risks and uncertainties, including those highlighted in the section titled “Risk
Factors.” These risks include, but are not limited to, the following:













•



We have a history of net losses, and we expect to continue to incur losses for at least the next several
years. If we ever achieve profitability, we may not be able to sustain it.














•



We have a limited history operating as a commercial company; if we fail to effectively train our sales force,
increase our sales and marketing capabilities or develop broad brand awareness in a cost-effective manner, our growth will be impeded, and our business will suffer.














•



The commercial success of our products will depend upon attaining significant market acceptance of these
products among hospitals, physicians, patients and payors.














•



We have significant international operations, and intend to further expand our business internationally, which
exposes us to market, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States.














•



We rely on our strategic relationship with Biotronik to enhance our product portfolio and to distribute our
products in key international markets.














•



We face significant competition, and if we are unable to compete effectively, we may not be able to achieve or
maintain significant market penetration or improve our results of operations.














•



If we are unable to manage the anticipated growth of our business, our future revenue and operating results
may be adversely affected.














•



We may not be able to develop, license or acquire new products, enhance the capabilities of our existing
products to keep pace with rapidly changing technology and customer requirements or successfully manage the transition to new product offerings, any of which could have a material adverse effect on our business, financial condition and results of
operations.














•



Our quarterly and annual results may fluctuate significantly and may not fully reflect the underlying
performance of our business.














•



We depend upon third-party suppliers, including single-source suppliers, making us vulnerable to supply
disruptions and price fluctuations.














•



Adoption of our products depends upon appropriate physician training, and inadequate training may lead to
negative patient outcomes, affect adoption of our products and adversely affect our business.














•



Defects or failures associated with our products could lead to recalls, safety alerts or litigation, as well
as significant costs and negative publicity.










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•



Coverage and adequate reimbursement may not be available for the procedures that utilize our products, which
could diminish our sales or affect our ability to sell our products profitably.














•



Regulatory compliance, including compliance with U.S. federal and state fraud and abuse and other healthcare
laws and regulations, is expensive, complex and uncertain, and failure to comply could lead to enforcement actions against us and other negative consequences for our business.














•



If we are unable to obtain and maintain patent protection or freedom to operate for any products we develop
and for our technology, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize
any products we may develop, and our technology may be adversely affected.














•



Our operations and financial results have been, and will continue to be, adversely impacted by the

COVID-19

pandemic in the United States and the rest of the world.





Company Information



We were incorporated in Delaware on March 25, 2011 as Acutus Medical, Inc. Our principal executive offices and
manufacturing facilities are located at 2210 Faraday Ave., Suite 100, Carlsbad, CA 92008, and our telephone number is

(442) 232-6080.

Our website address is www.acutusmedical.com. The information on,
or that may be accessed through, our website is not a part of this prospectus and the inclusion of our website address in this prospectus is an inactive textual reference only.



“Acutus,” the “Acutus” logo, “Acutus Medical,” the “Acutus Medical” logo,
“AcQMap,” the “AcQMap” logo, “AcQBlate,” the “AcQBlate” logo, “AcQGuide,” the “AcQGuide” logo, “AcQRef,” the “AcQRef” logo, “AcQCross,” the
“AcQCross” logo, “SuperMap,” the “SuperMap” logo, “UNCOVER AF” and the “UNCOVER AF” logo are trademarks or registered trademarks of our company. Our logo and our other trade names, trademarks and
service marks appearing in this prospectus are our property. Solely for convenience, our trademarks and trade names referred to in this prospectus appear without the

™

or

®

symbol, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights, or the right of the applicable licensor to
these trademarks and trade names. Other trade names, trademarks and service marks appearing in this prospectus are the property of their respective owners.




Implications of Being an Emerging Growth Company and a Smaller Reporting Company



We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act.
As such, we are eligible for exemptions from various reporting requirements applicable to other public companies that are not emerging growth companies, including, but not limited to, presenting only two years of audited financial statements in
addition to any required unaudited interim financial statements with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure in this prospectus, not being required to
comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation, and an exemption from the requirements to obtain a

non-binding

advisory vote on executive compensation or golden parachute arrangements.



In addition, an emerging growth company can take advantage of an extended transition period for complying with new or revised
accounting standards. This provision allows an emerging growth company to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves of this provision of
the JOBS Act. As a result, we will not be subject to new or revised accounting standards at the same time as other public companies that are not emerging growth companies. Therefore, our consolidated financial statements may not be comparable to
those of companies that comply with new or revised accounting pronouncements as of public company effective dates.









8










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We will remain an emerging growth company until the earliest of:
(i) December 31, 2025; (ii) the last day of the fiscal year in which we have total annual gross revenue of at least $1.07 billion; (iii) the last day of the fiscal year in which we are deemed to be a “large accelerated
filer” as defined in

Rule 12b-2

under the Securities Exchange Act of 1934, as amended, or the Exchange Act, which would occur if the market value of our common stock held by

non-affiliates

exceeded $700.0 million as of the last business day of the second fiscal quarter of such year; or (iv) the date on which we have issued more than $1.0 billion in

non-convertible

debt securities during the prior three-year period.



We are also a
“smaller reporting company” as defined in the Exchange Act. We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to
smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as our voting and

non-voting

common stock held by

non-affiliates

is less than $250.0 million measured on the last business day of our second fiscal quarter, or our annual revenue is less than $100.0 million during the most recently completed fiscal year and our voting and

non-voting

common stock held by

non-affiliates

is less than $700.0 million measured on the last business day of our second fiscal quarter.









9










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THE OFFERING

































































Common stock offered by us





5,500,000 shares.






Option to purchase additional shares





We have granted the underwriters an option for a period of 30 days to purchase up to 825,000 additional shares of our
common stock.






Common stock to be outstanding immediately after this offering









33,613,165 shares (or 34,438,165 shares if the
underwriters exercise their option to purchase additional shares in full).






Use of proceeds





We estimate that the net proceeds from the sale of our common stock in this offering will be approximately $79.5 million (or
approximately $91.5 million if the underwriters exercise their option to purchase additional shares in full), based on the assumed public offering price of $15.48 per share, which was the last reported sale price of our common stock on The Nasdaq
Global Select Market on July 9, 2021, and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us.





We currently intend to use the net proceeds from this offering to support our commercial expansion, including hiring additional commercial
personnel, for our research and development activities, and the remainder, if any, for general corporate purposes. We may also use a portion of the net proceeds of this offering for acquisitions or strategic transactions, though we have not entered
into any agreements or commitments with respect to any specific transactions and have no understandings or agreements with respect to any such transactions at this time. See the section titled “Use of Proceeds” for more
information.






Risk factors





See the section titled “Risk Factors” and other information included in this prospectus for a discussion of
factors you should carefully consider before deciding to invest in shares of our common stock.






Nasdaq trading symbol





“AFIB”




The number of shares of common stock that will be outstanding after this offering is based
on 28,113,165 shares of our common stock outstanding as of March 31, 2021, and excludes:













•



824,608 shares of our common stock issuable upon the exercise of warrants to purchase shares of our common
stock outstanding as of March 31, 2021, with a weighted-average exercise price of $9.10 per share;














•



3,379,575 shares of our common stock issuable upon the exercise of options to purchase shares of our common
stock outstanding as of March 31, 2021, with a weighted-average exercise price of $13.45 per share;














•



907,657 shares of our common stock issuable upon the exercise of options to purchase shares of our common
stock granted after March 31, 2021, with a weighted-average exercise price of $13.78 per share;














•



466,785 shares of our common stock issuable upon the vesting and settlement of outstanding performance-based
restricted stock units, or PSUs, and restricted stock units, or RSUs, as of March 31, 2021;










10










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•



471,096 shares of our common stock issuable upon the vesting and settlement of outstanding PSUs and RSUs
granted after March 31, 2021;














•



2,132,646 shares of our common stock reserved for future issuance under our 2020 Equity Incentive Plan,
or our 2020 Plan, as of March 31, 2021, plus shares of our common stock subject to the 2,636,188 awards outstanding under our 2011 Equity Incentive Plan, or our 2011 Plan, as of March 31, 2021, which expire or otherwise terminate without
having been exercised in full or are forfeited to or repurchased by us, which shares will be added to the shares to be reserved under our 2020 Plan, as well as any automatic increases in the number of shares of our common stock reserved for future
issuance pursuant to the 2020 Plan; and














•



387,063 shares of our common stock reserved for future issuance under our 2020 Employee Stock Purchase Plan,
or our 2020 ESPP, as of March 31, 2021, as well as any automatic increases in the number of shares of our common stock reserved for future issuance pursuant to the 2020 ESPP.




In addition, unless otherwise indicated, all information in this prospectus does not assume or give effect to:













•



any exercise of outstanding options or warrants or settlement of outstanding PSUs or RSUs described above;














•



any exercise by the underwriters of their option to purchase up to an additional 825,000 shares of our common
stock in this offering; or














•



the consummation of the Exchanges. See “Prospectus Summary—Recent Developments.”










11










Table of Contents










SUMMARY CONSOLIDATED FINANCIAL DATA



The following tables set forth a summary of our historical consolidated financial data as of and for the periods indicated. We
have derived the summary consolidated statements of operations and comprehensive loss data for the years ended December 31, 2020 and 2019 from our audited consolidated financial statements incorporated by reference herein from our 2020 Annual
Report. We have derived the summary consolidated statements of operations and comprehensive loss data for the three months ended March 31, 2021 and 2020 and the consolidated balance sheet data as of March 31, 2021 from our unaudited
interim consolidated financial statements incorporated by reference herein from our March 2021 Quarterly Report. You should read this data together with our consolidated financial statements and related notes incorporated by reference in this
prospectus and the information in the sections titled “Selected Financial Data” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” appearing in our 2020 Annual Report and in our March
2021 Quarterly Report, which are incorporated by reference herein. The summary consolidated financial data included in this section are not intended to replace the consolidated financial statements and related notes and are qualified in their
entirety by our consolidated financial statements and related notes incorporated by reference in this prospectus. Our historical results are not necessarily indicative of the results to be expected for any other period and our interim results are
not necessarily indicative of the results to be expected for the full year ending December 31, 2021 or for any other period.



























































































































































































































































































































































































































































































































































































































































































Year Ended December 31,





Three Months Ended


March 31,




(in thousands, except share and per share data)




2020





2019





2021





2020









(unaudited)





Consolidated Statements of Operations and Comprehensive Loss Data:




















Revenue

(1)




$

8,464



$

2,836



$

3,591



$

1,583



Costs and operating expenses:




















Cost of products sold

(2)





15,889




9,243




6,955




3,194



Research and development

(2)





33,454




23,029




9,370




7,973



Research and development—license acquired





—




15,000




—




—



Selling, general and
administrative

(2)





50,357




26,847




16,252




10,235



Impairment of property and equipment





—




786




—




—



Change in fair value of contingent consideration





97




500




(1,153

)



(2,219

)



































Total costs and operating expenses





99,797




75,405




31,424




19,183




































Loss from operations





(91,333

)



(72,569

)



(27,833

)



(17,600

)



































Other income (expense):




















Change in fair value of warrant liability





(5,555

)



(1,919

)



—




581



Loss on debt extinguishment





—




(1,447

)



—




—



Interest income





436




1,164




40




275



Interest expense





(5,506

)



(22,268

)



(1,388

)



(1,354

)



































Total other expense, net





(10,625

)



(24,470

)



(1,348

)



(498

)



































Loss before income taxes





(101,958

)



(97,039

)



(29,181

)



(18,098

)


Income tax benefit





23




—




—




—




































Net loss




$

(101,981

)


$

(97,039

)


$

(29,181

)


$

(18,098

)



































Net loss per common share, basic and
diluted

(3)




$

(8.94

)


$

(144.41

)


$

(1.04

)


$

(25.84

)



































Weighted-average shares outstanding, basic and diluted

(3)





11,407,542




671,953




28,031,686




700,505










































12










Table of Contents














(1)


The following tables set forth our revenue for disposables, systems and service/other for the years ended
December 31, 2020 and 2019 and the three months ended March 31, 2021 and 2020:














































































































































































































































































Year Ended


December 31,





Three Months Ended


March 31,




(in thousands)




2020





2019





2021





2020









(unaudited)




Acutus Direct




















Disposables




$

5,221



$

2,764



$

1,783



$

1,017



Systems





1,660




—




613




520



Service/Other





91




19




35




10




































Total Acutus direct revenue





6,972




2,783




2,431




1,547



Distribution agreements





1,492




53




1,160




36




































Total revenue




$

8,464



$

2,836



$

3,591



$

1,583






























































































































































































































































































































































































Year Ended


December 31,





Three Months Ended


March 31,




(in thousands)




2020





2019





2021





2020












(unaudited)




Acutus Direct




















United States




$

4,625



$

738



$

1,468



$

770



Europe





2,347




2,045




963




777




































Total Acutus direct revenue





6,972




2,783




2,431




1,547




































Distribution Agreements




















United States





229




—




113




—



Europe





1,263




53




1,047




36




































Total revenue through distribution





1,492




53




1,160




36




































Total revenue




$

8,464



$

2,836



$

3,591



$

1,583












































(2)


The following table sets forth the stock-based compensation expense included in our consolidated results of
operations for the years ended December 31, 2020 and 2019 and the three months ended March 31, 2021 and 2020:





































































































































































































Year Ended


December 31,





Three Months Ended


March 31,




(in thousands)




2020





2019





2021





2020












(unaudited)




Cost of products sold




$

440



$

209



$

157



$

108



Research and development





1,002




656




442




211



Selling, general and administrative





10,661




2,129




2,311




1,422




































Total stock-based compensation expense




$

12,103



$

2,994



$

2,910



$

1,741












































(3)


See Note 17 to our consolidated financial statements incorporated by reference in this prospectus for an
explanation of the calculations of our basic and diluted net loss per common share and the weighted-average number of shares used in the computation of the per share amounts.










13










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As of March 31, 2021






Actual





As Adjusted

(1)





(in thousands)




(unaudited)





Consolidated Balance Sheet Data:












Cash, cash equivalents and marketable securities




$

95,519



$

175,026



Working capital

(2)





97,636




177,143



Total assets





161,946




241,453



Contingent consideration, short- and long-term





5,600




5,600



Long-term debt





39,339




39,339



Accumulated deficit





(390,196

)



(390,196

)


Total stockholders’ equity





100,261




179,768










(1)


The as adjusted consolidated balance sheet data gives effect to the issuance and sale by us 5,500,000 shares
of our common stock in this offering based on the assumed public offering price of $15.48 per share, which was the last reported sale price of our common stock on The Nasdaq Global Select Market on July 9, 2021, after deducting the underwriting
discounts and commissions and estimated offering expenses payable by us. Each $1.00 increase or decrease in the assumed public offering price of $15.48 per share would increase or decrease, as applicable, the as adjusted cash, cash equivalents and
marketable securities, working capital, total assets and total stockholders’ equity amounts by $5,170, assuming the number of shares of common stock offered by us, as set forth on the cover page of this prospectus, remains the same, and after
deducting the underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase or decrease of 1.0 million shares in the number of shares of common stock offered by us would increase or decrease the
as adjusted cash, cash equivalents and marketable securities, working capital, total assets and total stockholders’ equity amounts by $14,551 assuming the assumed public offering price of $15.48 per share remains the same, and after deducting
the underwriting discounts and commissions and estimated offering expenses payable by us.









(2)


Working capital is defined as total current assets less total current liabilities. See our consolidated
financial statements and related notes incorporated by reference in this prospectus for further details regarding our current assets and current liabilities.










14










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RISK FACTORS




Investing in our common stock involves a high degree of risk. You should consider carefully the risks and uncertainties
described below, together with all of the other information in this prospectus or incorporated by reference herein, including the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations”
and our financial statements and related notes incorporated by reference herein from our 2020 Annual Report and our March 2021 Quarterly Report, before deciding whether to invest in shares of our common stock. The risks described below are not the
only ones facing us. The occurrence of any of the following risks or additional risks and uncertainties not presently known to us or that we currently believe to be immaterial could materially and adversely affect our business, financial condition,
results of operations and future prospects. In that event, the market price of our common stock could decline, and you could lose all or part of your investment. Please also see the sections titled “Special Notes Regarding Forward-Looking
Statements” and “Market, Industry and Other Data.”




Risks Related to Our Business and Products





We have a limited history operating as a commercial company; if we fail to effectively train our sales force, increase our sales and
marketing capabilities or develop broad brand awareness in a cost-effective manner, our growth will be impeded, and our business will suffer.




We were incorporated in 2011, began commercializing our products in 2016, and became a publicly traded company in August 2020.
Early versions of our AcQMap System and certain related accessory products have been used in the United States since May 2018 and Western Europe since July 2016 in a limited, pilot launch capacity, where our focus was on optimizing workflow and
validating our value proposition. We fully commenced the launch of our commercial-grade console and software products in the first quarter of 2020. Accordingly, our limited commercialization experience and limited number of approved or cleared
products make it difficult to evaluate our current business and assess our prospects. We also currently have limited sales and marketing experience. If we are unable to establish effective sales and marketing capabilities or if we are unable to
commercialize any of our products, we may not be able to effectively generate product revenue, sustain revenue growth and compete effectively. In order to generate future growth, we plan to continue to expand and leverage our sales and marketing
infrastructure to increase our customer base and grow our business. Identifying and recruiting qualified sales and marketing personnel and training them on our products, applicable federal and state laws and regulations, and on our internal policies
and procedures requires significant time, expense and attention. It often takes several months or more before a sales representative is fully trained and productive. Our business may be harmed if our efforts to expand and train our sales force do
not generate a corresponding increase in revenue, and our higher fixed costs may slow our ability to reduce costs in the face of a sudden decline in demand for our products. Any failure to hire, develop and retain talented sales and marketing
personnel, to achieve desired productivity levels in a reasonable timeframe or timely leverage our fixed costs could have a material adverse effect on our business, financial condition and results of operations. Moreover, the members of our direct
sales force are

at-will

employees. The loss of these personnel to competitors or otherwise could materially harm our business. If we are unable to retain our direct sales force personnel or replace them with
individuals of equivalent technical expertise and qualifications, or if we are unable to successfully instill technical expertise in replacement personnel, our revenue and results of operations could be materially harmed.



Our ability to increase our customer base and achieve broader market acceptance of our products will also depend to a
significant extent on our ability to expand our marketing efforts as we plan to dedicate significant resources to our marketing programs. Our business may be harmed if our marketing efforts and expenditures do not generate a corresponding increase
in revenue. In addition, we believe that developing and maintaining broad awareness of our brand in a cost-effective manner is critical to achieving broad acceptance of our products and penetrating new customer accounts. Brand promotion activities
may not generate patient or physician awareness or increased revenue, and even if they do, any increase in revenue may not offset the costs and expenses we incur in building our brand. If we fail to successfully promote, maintain and protect our
brand, we may fail to attract or





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retain the physician acceptance necessary to realize a sufficient return on our brand building efforts, or to achieve the level of brand awareness that is critical for broad adoption of our
products.



These factors also make it difficult for us to forecast our financial performance and growth, and such
forecasts are subject to a number of uncertainties, including our ability to successfully develop additional products that add functionality, reduce the cost of products sold, broaden our commercial portfolio offerings and obtain FDA 510(k)
clearance or PMA for, and successfully commercialize, market and sell, our planned or future products in the United States or in international markets. If our assumptions regarding the risks and uncertainties we face, which we use to plan our
business, are incorrect or change due to circumstances in our business or our markets, or if we do not address these risks successfully, our operating and financial results could differ materially from our expectations and our business could suffer.





The commercial success of our products will depend upon attaining significant market acceptance of these products among hospitals,
physicians, patients and payors.




Our success will depend, in part, on the acceptance of our products as safe,
effective and, with respect to providers, cost-effective. We cannot predict how quickly, if at all, hospitals, physicians, patients or payors will accept our products or, if accepted, how frequently they will be used. Our products and planned or
future products we may develop or market may never gain broad market acceptance for some or all of our targeted indications. Hospitals, physicians, patients and payors must believe that our products offer benefits over alternative treatment methods.
To date, a substantial majority of our product sales and revenue have been derived from a limited number of customers who have adopted our AcQMap System and accompanying products. Our future growth and profitability largely depend on our ability to
increase physician awareness of our system and our products and on the willingness of hospitals, physicians, patients or payors to adopt them. These parties may not adopt our products unless they are able to determine, based on experience, clinical
data, medical society recommendations and other analyses, that our products are safe, effective and, with respect to providers, cost-effective, on a stand-alone basis and relative to competitors’ products. Healthcare providers must believe that
our products offer benefits over alternative treatment methods. Even if we are able to raise awareness, physicians tend to be slow in changing their medical treatment practices and may be hesitant to select our products for recommendation to their
hospitals or patients for a variety of reasons, including:













•



long-standing relationships with competing companies and distributors that sell other products;














•



competitive response and negative selling efforts from providers of alternative products;














•



lack of experience with our products and concerns that we are relatively new to market;














•



lack or perceived lack of sufficient clinical evidence, including long-term data, supporting safety or
clinical benefits; and














•



time commitment and skill development that may be required to gain familiarity and proficiency with our
products.




Physicians play a significant role in determining the course of a patient’s treatment,
and, as a result, the type of treatment that will be utilized and provided to a patient. We focus our sales, marketing and education efforts primarily on cardiac electrophysiologists, and aim to educate referring physicians regarding the patient
population that would benefit from our products. However, we cannot assure you that we will achieve broad market acceptance among these practitioners.



For example, if electrophysiologists are not made aware of our products, they may not recommend ablation for their patients or
the installation of our AcQMap System in their hospitals. In addition, some physicians may choose to utilize our products on only a subset of their total patient population or may not adopt our products at all. If we are not able to effectively
demonstrate that the use of our products is beneficial in a broad range of patients, adoption of our products will be limited and may not occur as rapidly as we anticipate or at all, which





16










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would have a material adverse effect on our business, financial condition and results of operations. We cannot assure you that our products will achieve broad market acceptance among hospitals
and physicians. Additionally, even if our products achieve market acceptance, they may not maintain that market acceptance over time if competing products, procedures or technologies are considered safer or more cost-effective or otherwise superior.
Any failure of our products to generate sufficient demand or to achieve meaningful market acceptance and penetration will harm our future prospects and have a material adverse effect on our business, financial condition and results of operations.



Our reputation among our current or potential customers, as well as among electrophysiologists, could also be negatively
affected by safety or customer satisfaction issues involving us or our products, including product recalls. For example, in February 2020, we initiated a voluntary recall of a total of 120 of our AcQGuide Flex and AcQGuide Mini sheaths due to
product defects that we determined arose during the manufacturing process by one of our contract manufacturers. Future product recalls or other safety or customer satisfaction issues relating to our reputation could negatively affect our ability to
establish or maintain broad adoption of our products, which would harm our future prospects and have a material adverse effect on our business, financial condition and results of operations.



In most cases, before a hospital can purchase our AcQMap console and workstation for the first time, our system must be
approved for use by a hospital’s new product or value analysis committee, or the staff of a hospital or health system. Such approvals could deter or delay the use of our products by physicians. We cannot provide assurance that our efforts to
obtain such approvals or generate adoption will be successful or increase the use of our products, and if we are not successful, it could have a material adverse effect on our business, financial condition and results of operations.





We have significant international operations, and intend to further expand our business internationally, which exposes us to market,
regulatory, political, operational, financial and economic risks associated with doing business outside of the United States.




As of December 31, 2020, we have sold our products directly in the United States, Belgium, the Czech Republic, Denmark,
France, Germany, Great Britain, Italy, the Netherlands, Sweden and Switzerland. Our business strategy includes plans for significant expansion in the countries in which we currently operate as well as other international markets and may include
establishing and maintaining physician outreach and education capabilities outside of the United States and expanding our relationships with international payors. During the years ended December 31, 2020 and 2019, 43% and 74%, respectively, of
our revenue was generated from customers located outside of the United States, and we anticipate that international sales will continue to represent a substantial portion of our total sales in the future. For example, in May 2020, we entered into an
expansive

bi-lateral

distribution agreement with Biotronik, pursuant to which Biotronik agreed to distribute our products in Germany, Japan, Mexico, Switzerland and multiple countries in Asia-Pacific, Eastern
Europe, the Middle East and South America. In addition, some of our employees, including those of our Belgium subsidiary, suppliers and other strategic partners are located outside of the United States. Doing business internationally involves a
number of risks, including:













•



changes in a country’s or region’s political or economic conditions, including any potential impact
resulting from the U.K.’s exit from the European Union, commonly referred to as Brexit;














•



difficulties in developing effective marketing campaigns in unfamiliar foreign countries;














•



multiple, conflicting and changing laws and regulations such as tax laws, privacy laws, export and import
restrictions, employment laws, regulatory requirements and other governmental approvals, permits and licenses;














•



obtaining regulatory approvals where required for the sale of our products in various countries;














•



requirements to maintain data and the processing of that data on servers located within such countries;






17










Table of Contents













•



complexities associated with managing multiple payor reimbursement regimes, government payors or patient

self-pay

systems;














•



trade protection measures, customs clearance and shipping delays;














•



financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the effect of local
and regional financial pressures on demand and payment for our products and exposure to foreign currency exchange rate fluctuations;














•



natural disasters, political and economic instability, including wars, terrorism, political unrest, outbreaks
of disease or public health crises (including the impact of the

COVID-19

pandemic), boycotts, curtailment of trade and other market restrictions;














•



regulatory and compliance risks that relate to maintaining accurate information and control over activities
subject to regulation under the United States Foreign Corrupt Practices Act of 1977, or FCPA, U.K. Bribery Act 2010 and comparable laws and regulations in other countries;














•



our reliance on international distributors, who we do not control, to effectively market and sell our products
in full compliance with applicable laws;














•



differing protection of intellectual property; and














•



increased financial accounting and reporting burdens and complexities.




We rely on shipping providers to deliver products to our customers and distributors globally. Labor, tariff or World Trade
Organization-related disputes, piracy, physical damage to shipping facilities or equipment caused by severe weather or terrorist incidents, congestion at shipping facilities, inadequate equipment to load, dock and offload our products,
energy-related

tie-ups,

outbreaks of disease or public health crises (including the impact of the

COVID-19

pandemic) or other factors could disrupt or delay shipping or

off-loading

of our products domestically and internationally. Such disruptions or delays could materially and adversely affect our business, financial condition and results of operations.



If one or more of these risks are realized, our business, financial condition and results of operations could be materially
and adversely affected.





We rely on our strategic relationship with Biotronik to enhance our product portfolio and to distribute our
products in key international markets.




We entered into expansive

Bi-Lateral

Distribution Agreements with Biotronik in May 2020 to round out our product portfolio with a full suite of diagnostic and ablation catheters, and to rapidly and efficiently establish a sales
presence globally. Pursuant to our

Bi-Lateral

Distribution Agreements with Biotronik, we obtained a

non-exclusive

license to distribute a range of Biotronik’s
therapeutic and diagnostic electrophysiology products and accessories in the United States, Canada, China, Hong Kong and multiple countries in Western Europe under our own private label. Biotronik has also agreed to distribute our products and
accessories in Germany, Japan, Mexico, Switzerland and multiple countries in Asia-Pacific, Eastern Europe, the Middle East and South America. Accordingly, the

Bi-Lateral

Distribution Agreements significantly
expand both our product portfolio and our international sales presence. If Biotronik is unable to successfully market and sell our products in these markets, or if we are unable to successfully market Biotronik’s products in the United States
and geographies where we have or establish a direct selling presence, it could materially adversely impact our growth prospects in these markets and our relationship with Biotronik, which would harm our business, financial condition and results of
operations. Our strategic alliance with Biotronik also includes cooperative arrangements with respect to regulatory approval and the commercialization, manufacture and marketing of our respective products in various geographic markets. While we will
depend on Biotronik to sell our products in its designated territories and otherwise cooperate with us in our strategic alliance, we do not control the time and resources Biotronik devotes to such activities, and we may not have the resources
available to satisfy expectations, which may adversely affect our relationship.





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Either party may terminate the

Bi-Lateral

Distribution Agreements with respect to a country if the other party does not meet specified purchase targets for that country following a specified

ramp-up

period. Any termination of the

Bi-Lateral

Distribution Agreements for this or other reasons could have a material adverse effect on our business, financial condition and results of operations. For example,
recruiting and retaining qualified third-party distributors and training them in our technology and products requires significant time and resources. Further, if our relationship with Biotronik terminates, we may be unable to replace this
relationship or develop a direct sales channel without disruption to our business.



We may also seek to enter into
additional strategic partnerships with other third parties in the future, including distribution arrangements. If we fail to develop new relationships with any other strategic partners we seek to engage, including in new markets, fail to manage,
train or incentivize distributors effectively, or fail to provide distributors with competitive products on attractive terms, or if these distributors are not successful in their sales and marketing efforts, our ability to generate revenue growth
could suffer, which could have a material adverse effect on our business, financial condition and results of operations. Moreover, these strategic partnerships may be

non-exclusive,

and some of our strategic
partners may also have cooperative relationships with certain of our competitors. These relationships may not continue, may not be commercially successful or may require our expenditure of significant financial, personnel and administrative
resources from time to time. If we are unable to leverage our existing and future strategic partnerships to achieve and maintain distribution at a global scale or establish and maintain a broad product portfolio, it could have a material adverse
effect on our business, financial condition and results of operations.





We face significant competition, and if we are unable to
compete effectively, we may not be able to achieve or maintain significant market penetration or improve our results of operations.




The medical device industry is intensely competitive, subject to rapid change and significantly affected by new product
introductions and other market activities of industry participants. We compete with manufacturers and distributors of cardiovascular medical devices. Our most significant competitors in the electrophysiology field include Abbott Laboratories,
Biosense Webster Inc. (a Johnson & Johnson Company), Boston Scientific Corporation and Medtronic plc. Many of our competitors are large, well-capitalized companies with significantly greater market share and resources than we have.
Therefore, they can spend more on product development, marketing, sales and other product initiatives than we can. We also compete with smaller medical device companies that have a single product or a limited range of products. Some of our
competitors have:













•



significantly greater name recognition;














•



broader or deeper relations with healthcare professionals, customers and third-party payors;














•



more established distribution networks;














•



additional lines of products and the ability to offer rebates or bundle products to offer greater discounts or
other incentives to gain a competitive advantage;














•



greater experience in conducting research and development, manufacturing, clinical trials, marketing and
obtaining regulatory clearance or approval for products; and














•



greater financial and human resources for product development, sales and marketing and patent prosecution.




We compete primarily on the basis that our products are designed to enable more physicians to treat
more patients more efficiently and effectively. Our continued success depends on our ability to:













•



continue to develop innovative, proprietary products that address significant clinical needs in a manner that
is safe and effective for patients and


easy-to-use


for physicians;














•



obtain and maintain regulatory clearances or approvals;














•



demonstrate safety and effectiveness in our sponsored and third-party clinical trials;






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•



expand our sales force across key markets to increase physician awareness;














•



leverage our strategic partnerships and alliances to achieve distribution at a global scale, broaden our
product portfolio and enable and accelerate global connectivity;














•



obtain and maintain coverage and adequate reimbursement for procedures using our products;














•



attract and retain skilled research, development, sales and clinical personnel;














•



cost-effectively manufacture, market and sell our products; and














•



obtain, maintain, enforce and defend our intellectual property rights and operate our business without
infringing, misappropriating or otherwise violating the intellectual property rights of others.




We can
provide no assurance that we will be successful in developing new products or commercializing them in ways that achieve market acceptance. If we develop new products, sales of those products may reduce revenue generated from our existing products.
Moreover, any significant delays in our product launches may significantly impede our ability to enter or compete in a given market and may reduce the sales that we are able to generate from these products. We may experience delays in any phase of a
product development, including during research and development, clinical trials, regulatory review, manufacturing and marketing. Delays in product introductions could have a material adverse effect on our business, financial condition and results of
operations.





If we are unable to manage the anticipated growth of our business, our future revenue and operating results may be
adversely affected.




We have experienced substantial growth in our operations, and we expect to experience
continued substantial growth in our business. For example, in 2020, our headcount increased by 41%, and we released seven new disposable products, four hardware products and four software updates. This growth has placed, and will continue to place,
significant demands on our management and our operational infrastructure. Any growth that we experience in the future could require us to expand our sales and marketing personnel and manufacturing operations and general and administrative
infrastructure. In addition to the need to scale our organization, future growth will impose significant added responsibilities on management, including the need to identify, recruit, train and integrate additional employees. We cannot assure you
that any increases in scale, related improvements and quality assurance will be successfully implemented or that appropriate personnel will be available to facilitate the growth of our business. Rapid expansion in personnel could mean that less
experienced people manufacture, market and sell our products, which could result in inefficiencies and unanticipated costs, reduced quality and disruptions to our operations. In addition, rapid and significant growth may strain our administrative
and operational infrastructure and could require significant capital expenditures that may divert financial resources from other projects, such as research and development of potential future products. Our ability to manage our business and growth
will require us to continue to improve our operational, financial and management controls, and reporting systems and procedures. If we are unable to manage our growth effectively, including by failing to implement necessary procedures, transition to
new processes or hire necessary personnel, it may be difficult for us to execute our business strategy and our business could be adversely affected.





We may not be able to develop, license or acquire new products, enhance the capabilities of our existing products to keep pace with
rapidly changing technology and customer requirements or successfully manage the transition to new product offerings, any of which could have a material adverse effect on our business, financial condition and results of operations.




Our success depends on our ability to develop, license or acquire and commercialize additional products and to develop new
applications for our technologies in existing and new markets, while improving the performance and cost-effectiveness of our existing products, in each case in ways that address current and anticipated customer requirements. We intend to develop and
commercialize additional products through our research and





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development program and by licensing or acquiring additional products and technologies from third parties. Such success is dependent upon several factors, including functionality, competitive
pricing, ease of use, the safety and efficacy of our products and our ability to identify, select and acquire the rights to products and technologies on terms that are acceptable to us.



The medical device industry is characterized by rapid technological change and innovation. New technologies, techniques or
products could emerge that might offer better combinations of price and performance or better address customer requirements as compared to our current or future products. Competitors, who may have greater financial, marketing and sales resources
than we do, may be able to respond more quickly and effectively than we can to new or changing opportunities, technologies, standards or customer requirements. Any new product we identify for internal development, licensing or acquisition may
require additional development efforts prior to commercial sale, including extensive clinical testing and approval or clearance by the FDA and applicable foreign regulatory authorities. Due to the significant lead time and complexity involved in
bringing a new product to market, we are required to make a number of assumptions and estimates regarding the commercial feasibility of a new product. These assumptions and estimates may prove incorrect, resulting in our introduction of a product
that is not competitive at the time of launch. We anticipate that we will face increased competition in the future as existing companies and competitors develop new or improved products and as new companies enter the market with new technologies.
Our ability to mitigate downward pressure on our selling prices will be dependent upon our ability to maintain or increase the value we offer to hospitals, physicians, patients and payors. All new products are prone to the risks of failure inherent
in medical device product development, including the possibility that the product will not be shown to be sufficiently safe and effective for approval or clearance by regulatory authorities. In addition, we cannot assure you that any such products
that are approved or cleared will be manufactured or produced economically, successfully commercialized or widely accepted in the marketplace. The expenses or losses associated with unsuccessful product development or launch activities, or a lack of
market acceptance of our new products, could adversely affect our business, financial condition and results of operations.



Our ability to attract new customer accounts and increase revenue from existing customers depends in large part on our ability
to enhance and improve our existing products and to introduce compelling new products. The success of any enhancement to our products depends on several factors, including our ability to drive increased installations of our AcQMap console and
workstation in customer accounts, timely completion and delivery, competitive pricing and overall market acceptance. Any new product that we develop may not be introduced in a timely or cost-effective manner, may contain defects or may not achieve
the market acceptance necessary to generate significant revenue. If we are unable to successfully develop, license or acquire new products, enhance our existing products to meet customer requirements or otherwise gain market acceptance, our
business, financial condition and results of operations would be harmed.



The typical development cycle of new medical
device products can be lengthy and complicated and may require complex technology and engineering. Such developments may involve external suppliers and service providers, making the management of development projects complex and subject to risks and
uncertainties regarding timing, timely delivery of required components or services and satisfactory technical performance of such components or assembled products. If we do not achieve the required technical specifications or successfully manage new
product development processes, or if development work is not performed according to schedule, then such new technologies or products may be adversely impacted and our business and operating results may be harmed.





Our quarterly and annual results may fluctuate significantly and may not fully reflect the underlying performance of our business.




Our quarterly and annual results of operations, including our revenue, profitability and cash flow, may vary
significantly in the future, and


period-to-period


comparisons of our operating results may not be meaningful. Accordingly, the results of any one quarter or other period
should not be relied upon as an indication of future





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performance. Our quarterly and annual financial results may fluctuate as a result of a variety of factors, many of which are outside our control and, as a result, may not fully reflect the
underlying performance of our business. Factors that may cause fluctuations in our quarterly and annual results include, without limitation:













•



the level of demand for our products, which may vary significantly from period to period;














•



expenditures that we may incur to acquire, develop or commercialize additional products and technologies;














•



the timing and cost of clinical trials, including obtaining regulatory approvals or clearances for planned or
future products;














•



the rate at which we grow our sales force and the speed at which newly hired salespeople become effective, and
the cost and level of investment therein;














•



the degree of competition in our industry and any change in the competitive landscape of our industry,
including consolidation among our competitors or future partners;














•



coverage and reimbursement policies with respect to the procedures using our products and potential future
products that compete with our products;














•



the timing and success or failure of clinical trials for our current or planned products or any future
products we develop or competing products;














•



the timing of customer orders or medical procedures, the timing and number of installations of our AcQMap
console and workstation, the number of available selling days in a particular period, which can be impacted by a number of factors, such as holidays or days of severe inclement weather in a particular geography, the mix of products sold and the
geographic mix of where products are sold;














•



the timing and cost of, and level of investment in, research, development, regulatory approval and
commercialization activities relating to our products, which may change from time to time;














•



the cost of manufacturing our products, which may vary depending on the quantity of production and the terms
of our agreements with third-party suppliers and manufacturers;














•



natural disasters, outbreaks of disease or public health crises, such as the

COVID-19

pandemic;














•



the timing and nature of any future acquisitions or strategic partnerships; and














•



future accounting pronouncements or changes in our accounting policies.




Because our quarterly and annual results may fluctuate,


period-to-period


comparisons may not be the best indication of the underlying results of our business and should only be relied upon as one factor in determining how our
business is performing.



In addition, this variability and unpredictability could result in our failing to meet the
expectations of industry or financial analysts or investors for any period. If our revenue or operating results fall below the expectations of analysts or investors or below any forecasts we may provide to the market, it may result in a decrease in
the price of our common stock.





We depend upon third-party suppliers, including single-source suppliers, making us vulnerable to
supply disruptions and price fluctuations.




We rely on third-party suppliers to provide us with certain components
of our products, some of which are single-source suppliers. In some cases, we do not have long-term supply agreements with, or guaranteed commitments from, our suppliers, including single-source suppliers. We depend on our suppliers to provide us
and our customers with materials in a timely manner that meet our and their quality, quantity and cost requirements. These suppliers may encounter problems during manufacturing for a variety of reasons, any of





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which could delay or impede their ability to meet our demand. For example, in response to an outbreak of

COVID-19,

the single-source supplier of flex
circuits for one of our products temporarily suspended production for a period of approximately one week in the first quarter of 2020. Our suppliers may also cease producing the components we purchase from them or otherwise decide to cease doing
business with us. Any supply interruption from our suppliers or failure to obtain additional suppliers for any of the components used in our products would limit our ability to manufacture our products and could have a material adverse effect on our
business, financial condition and results of operations.





Adoption of our products depends upon appropriate physician training, and
inadequate training may lead to negative patient outcomes, affect adoption of our products and adversely affect our business.




The success of our products depends in part on our customers’ adherence to appropriate patient selection and proper
techniques provided in training sessions conducted by our training faculty. For example, we train our customers to ensure correct use of our AcQMap System. However, physicians rely on their previous medical training and experience, and we cannot
guarantee that all such physicians will have the necessary skills or training to effectively utilize our products. We do not control which physicians use our products or how much training they receive, and physicians who have not completed our
training sessions may nonetheless attempt to use our products. If physicians use our products in a manner that is inconsistent with their labeled indications, with components that are not compatible with our products or without adhering to or
completing our training sessions, their patient outcomes may not be consistent with the outcomes achieved by other physicians or in our clinical trials. This result may negatively impact the perception of patient benefit and safety and limit
adoption of our products, which would have a material adverse effect on our business, financial condition and results of operations.





Defects or failures associated with our products could lead to recalls, safety alerts or litigation, as well as significant costs and
negative publicity.




Our business is subject to significant risks associated with manufacture, distribution and use
of medical devices that are placed inside the human




The above information was disclosed in a filing to the SEC. To see the filing, click here.

To receive a free e-mail notification whenever Acutus Medical, Inc. makes a similar move, sign up!

Other recent filings from the company include the following:

Notice of Delisting or Failure to Satisfy a Continued Listing Rule or - June 24, 2022
Acutus Medical, Inc. director just disposed of 60,000 shares - June 3, 2022
Acutus Medical, Inc.'s Chief Financial Officer just picked up 100,000 shares - June 2, 2022

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