UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

WASHINGTON,

D.C. 20549

FORM

10-K

(MARK

ONE)

FOR

THE FISCAL YEAR ENDED DECEMBER 31, 2023

FOR

THE TRANSITION PERIOD FROM TO

COMMISSION

FILE NUMBER 001-36159

STEREOTAXIS,

INC.

(Exact

name of the Registrant as Specified in its Charter)

(State or Other Jurisdiction of (I.R.S. Employer

Incorporation or Organization) Identification Number)

710

North Tucker Boulevard, Suite 110

St.

Louis, MO63101

(Address

of Principal Executive Offices including Zip Code)

(314)678-6100

(Registrant’s

Telephone Number, Including Area Code)

Securities

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

Title of each class Trading Symbol(s) Name of each exchange on which registered

Common Stock, par value $0.001 per share STXS NYSE American

Securities

registered pursuant to Section 12(g) of the Act: None

Indicate

by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

Indicate

by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒

Indicate

by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange

Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)

has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate

by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule

405 of Regulation S-T “See 232.405 of this Chapter” during the preceding 12 months (or for such shorter period that the registrant

was required to submit such files). Yes ☒ No ☐

Indicate

by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a 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.

Emerging growth company ☐

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate

by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness

of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered

public accounting firm that prepared or issued its audit report. ☐

securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant

included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate

by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation

received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate

by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒

The

aggregate market value of the registrant’s common stock held by non-affiliates of the registrant on the last business day of the

registrant’s most recently completed second fiscal quarter (based on the closing sales prices on the NYSE American on June 30,

2023) was approximately $100.9 million.

The

number of outstanding shares of the registrant’s common stock on February 29, 2024, was 82,128,762.

DOCUMENTS

INCORPORATED BY REFERENCE

Portions

of the Proxy Statement for the registrant’s 2024 Annual Meeting of Shareholders are incorporated by reference in Part III, Items

10, 11, 12, 13 and 14.

STEREOTAXIS,

INC.

INDEX

TO ANNUAL REPORT ON FORM 10-K

STEREOTAXIS,

INC.

INDEX

TO FORM 10-K

Page

Part I

Item 1. Business 3

Item 1A. Risk Factors 16

Item 1B. Unresolved Staff Comments 33

Item 1C. Cybersecurity 33

Item 2. Properties 34

Item 3. Legal Proceedings 34

Item 4. Mine Safety Disclosures 34

Part II

Item 6. Selected Financial Data 35

Item 8. Financial Statements and Supplementary Data 41

Item 9A. Controls and Procedures 63

Item 9B. Other Information 64

PART III

Item 10. Directors and Executive Officers of the Registrant 64

Item 11. Executive Compensation 64

Item 14. Principal Accounting Fees and Services 65

PART IV

Item 15. Exhibits and Financial Statement Schedules 65

PART

ITEM 1. BUSINESS

this report, “Stereotaxis”, the “Company”, “Registrant”, “we”, “us”, and

“our” refer to Stereotaxis, Inc. and its wholly owned subsidiaries. Genesis RMN®, Niobe®, Navigant®,

Odyssey®, Odyssey CinemaTM, Vdrive®, Vdrive DuoTM, V-CASTM,

V-LoopTM, V-SonoTM, QuikCASTM, Cardiodrive®, and MAGiC TM are

trademarks of Stereotaxis, Inc. All other trademarks that appear in this report are the property of their respective owners.

FORWARD-LOOKING

STATEMENTS

This

annual report on Form 10-K, including the sections entitled “Business” and “Management’s Discussion and Analysis

of Financial Condition and Results of Operations,” contains forward-looking statements. These statements relate to, among other

things:

● our business, operating, sales and marketing, and regulatory strategies;

● our value proposition;

● our overall liquidity and our ability to fund operations;

● our ability to convert backlog to revenue;

● the adoption of our products by hospitals and physicians;

● the success of our business partnerships and strategic relationships;

● our industry generally, and overall macroeconomic conditions;

● our estimates regarding our capital requirements;

● our plans for hiring additional personnel; and

These

statements relate to future events or future financial performance, and involve known and unknown risks, uncertainties, and other factors

that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results,

levels of activity, performance or achievements expressed or implied by such forward-looking statements. In some cases, you can identify

forward-looking statements by terminology such as “may”, “will”, “should”, “could”, “expects”,

“plans”, “intends”, “anticipates”, “believes”, “estimates”, “predicts”,

“potential”, or “continue”, or the negative of such terms or other comparable terminology. Although we believe

that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity,

performance, or achievements. These statements are only predictions.

Factors

that may cause our actual results to differ materially from our forward-looking statements include, among others, changes in general

economic and business conditions and the risks and other factors set forth in “Item 1A—Risk Factors” and elsewhere

in this annual report on Form 10-K.

Our

actual results may be materially different from what we expect. We undertake no duty to update these forward-looking statements after

the date of this annual report, even though our situation may change in the future. We qualify all of our forward-looking statements

by these cautionary statements.

OVERVIEW

Stereotaxis

designs, manufactures and markets robotic systems, instruments and information systems for the interventional laboratory. Our proprietary

robotic technology, Robotic Magnetic Navigation, fundamentally transforms endovascular interventions using precise computer-controlled

magnetic fields to directly control the tip of flexible interventional catheters or devices. Direct control of the tip of an interventional

device, in contrast to all manual hand-held devices that are controlled from their handle, can improve the precision, stability, reach

and safety of these devices during procedures.

Our

primary clinical focus has been electrophysiology, specifically cardiac ablation procedures for the treatment of arrhythmias. Cardiac

ablation has become a well-accepted therapy for arrhythmias and a multi-billion-dollar medical device market with expectations for substantial

long-term growth. We have shared our aspiration and a product strategy to expand the clinical focus of our technology to several additional

endovascular indications including coronary, neuro, and peripheral interventions.

There

is substantial real-world evidence and clinical literature for Robotic Magnetic Navigation in electrophysiology. Hundreds of electrophysiologists

at over one hundred hospitals globally have treated over 100,000 arrhythmia patients with our robotic technology. Clinical use of our

technology has been documented in over 400 clinical publications. Robotic Magnetic Navigation is designed to enable physicians to complete

more complex interventional procedures with greater success and safety by providing image-guided delivery of catheters through the blood

vessels and chambers of the heart to treatment sites. This is achieved using externally applied computer-controlled magnetic fields that

govern the motion of the working tip of the catheter, resulting in improved navigation. The more flexible atraumatic design of catheters

driven using magnetic fields may reduce the risk of patient harm and other adverse events. Performing the procedure from a control cockpit

enables physicians to complete procedures in a safe location protected from x-ray exposure, with greater ergonomics, and improved efficiency.

We believe these benefits can be applicable in other endovascular indications where navigation through complex vasculature is often challenging

or unsuccessful and generates significant x-ray exposure, and we are investing in research and development in these areas.

Our

primary products include the Genesis RMN System, the Odyssey Solution, and other related devices. Through our strategic

relationships with fluoroscopy system manufacturers, providers of catheters and electrophysiology mapping systems, and other parties,

we offer our customers x-ray systems and other accessory devices.

The

Genesis RMN System is designed to enable physicians to complete more complex interventional procedures by providing image-guided

delivery of catheters through the blood vessels and chambers of the heart to treatment sites. This is achieved using externally applied

magnetic fields that govern the motion of the working tip of the catheter, resulting in improved navigation, efficient procedures, and

reduced x-ray exposure.

The

Odyssey Solution consolidates lab information onto one large integrated display, enabling physicians to view and control all the

key information in the operating room. This is designed to improve lab layout and procedure efficiency. The system also features a remote

viewing and recording capability called Odyssey Cinema, which is an innovative solution that delivers synchronized content for

optimized workflow, advanced care, and improved productivity. This tool includes an archiving capability that allows clinicians to store

and replay entire procedures or segments of procedures. This information can be accessed from locations throughout the hospital local

area network and over the global Odyssey Network providing physicians with a tool for clinical collaboration, remote consultation, and

training.

have arrangements with fluoroscopy system manufacturers to provide such

systems in a bundled purchase offer for hospitals establishing robotic interventional operating rooms. These are single-plane, full-power

x-ray systems and include the c-arm and powered table. The combination of RMN Systems with our partnered x-ray systems reduces the cost

of acquisition, the ongoing cost of ownership, and the complexity of installation of a robotic electrophysiology practice.

promote our full suite of products in a typical hospital implementation, subject to regulatory approvals or clearances. This implementation

requires a hospital to agree to an upfront capital payment and recurring payments. The upfront capital payment typically includes equipment

and installation charges. The recurring payments typically include disposable costs for each procedure, equipment service costs beyond

the warranty period, and ongoing software updates. In hospitals where our full suite of products has not been implemented, equipment

upgrade or expansion can be implemented upon purchasing of the necessary upgrade or expansion.

have received regulatory clearances and approvals necessary for us to market the Genesis RMN System in the U.S. and Europe,

and we are in the process of obtaining necessary registrations for extending our markets in other countries. The Niobe

System, our prior generation robotic magnetic navigation system, the Odyssey Solution, Cardiodrive, e-Contact, and

various disposable interventional devices have received regulatory clearances and approvals in the U.S., Europe, Canada, China, Japan and various

other countries. We have received the regulatory clearances and approvals that allow us to market the Vdrive and Vdrive

Duo Systems with the V-CAS device in the U.S. and Canada. We are pursuing regulatory approvals for the Stereotaxis MAGiC

catheter, a robotically-navigated magnetic ablation catheter designed to perform minimally invasive cardiac ablation procedures, in

various global geographies. Approval processes can be lengthy and uncertain, submissions may require revised or additional

non-clinical and clinical data, and regulatory applications could be denied.

Not

all products have and/or require regulatory clearance in all of the markets we serve. Please refer to “Regulatory Approval”

in Item 1 for a description of the regulatory clearance, licensing, and/or approvals we currently have or are pursuing.

of December 31, 2023, we had approximately $14.7 million of backlog, consisting of outstanding purchase orders and other commitments

for these systems. Of the December 31, 2023 backlog, we expect approximately 81% to be recognized as revenue over the course of 2024.

We had backlog of approximately $14.8 million as of December 31, 2022. There can be no assurance that we will recognize such revenue

in any particular period or at all because some of our purchase orders and other commitments are subject to contingencies that are outside

our control. These orders and commitments may be revised, modified or canceled, either by their express terms, as a result of negotiations

or by project changes or delays. In addition, the sales cycle for the robotic magnetic navigation system is lengthy and generally involves

construction or renovation activities at customer sites. Consequently, revenues and/or orders resulting from sales of our robotic magnetic

navigation system can vary significantly from one reporting period to the next.

have strategic relationships with technology leaders and innovators in the global interventional market. Through these strategic relationships

we provide compatibility between our robotic magnetic navigation system, x-ray systems, and digital imaging and 3D catheter location

sensing technology, as well as disposable interventional devices. The maintenance of these strategic relationships, or the establishment

of equivalent alternatives, is critical to our commercialization efforts. There are no guarantees that any existing strategic relationships

will continue, and efforts are ongoing to ensure the availability of compatible systems and devices and/or equivalent alternatives. We

cannot provide assurance as to the timeline of the ongoing availability of such compatible systems or our ability to obtain equivalent

alternatives on competitive terms or at all.

were incorporated in Delaware in June, 1990 as Stereotaxis, Inc. Our principal executive offices are located at 710 North Tucker Boulevard,

Suite 110, St. Louis, Missouri 63101, and our telephone number is (314) 678-6100.

THE

STEREOTAXIS VALUE PROPOSITION

Although

great strides have been made in manual interventional devices and techniques, significant challenges remain that reduce interventional

productivity and limit both the number of complex procedures and the types of diseases that can be treated manually. These challenges

primarily involve the inherent mechanical limitations of manual instrument control and the lack of integration of the information systems

used by physicians in the interventional lab as well as a significant amount of training and experience required to ensure proficiency.

As a result, many complex cases in electrophysiology are treated with palliative drug therapy, and many procedures are still performed

as invasive surgeries rather than as minimally invasive endovascular interventions.

Our

systems address the current challenges in the interventional lab by providing precise computerized control of the working tip of the

interventional instrument and by integrating this control with the visualization technology and information systems used during electrophysiology

and endovascular interventional procedures, on a cost-justified basis.

believe that our technology can:

PRODUCTS

Robotic

Magnetic Navigation

Our

proprietary robotic magnetic navigation systems (“RMN”) include the Genesis RMN and the prior generation Niobe

Systems. These systems are designed to enable physicians to complete more complex interventional procedures by providing image-guided

delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites. This is achieved using externally

applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting in improved navigation, efficient

procedures and reduced x-ray exposure. Our systems provide physicians with precise remote digital instrument control in combination with

sophisticated image integration. It can be operated either from an adjacent room and outside the x-ray fluoroscopy field or beside the

patient table, as in traditional interventional procedures. The RMN system allows the operator to navigate disposable interventional

devices to the treatment site through complex paths in the blood vessels and chambers of the heart to deliver treatment by using computer

controlled, externally applied magnetic fields to directly govern the motion of the working tip of these devices, each of which has a

magnetically sensitive tip that predictably responds to magnetic fields generated by our system. Because the working tip of the disposable

interventional device is directly controlled by these external magnetic fields, the physician has the same degree of control regardless

of the number or type of turns, or the distance traveled by the working tip to arrive at its position in the blood vessels or chambers

of the heart. This results in highly precise digital control of the working tip of the disposable interventional device while still giving

the physician the option to manually advance the device.

Through

our arrangements with fluoroscopy system manufacturers and providers of catheters and electrophysiology mapping systems, we provide compatibility

between the robotic magnetic navigation system and the visualization and information systems used during electrophysiology and endovascular

procedures in order to provide the physician with a comprehensive information and instrument control system. In addition, we have integrated

the robotic magnetic navigation system with 3D catheter location sensing technology to provide accurate real-time information as to the

3D location of the working tip of the instrument.

The

components of therobotic magnetic navigation system

are identified and described below:

Robotic

Magnetic Navigation System. Our robotic magnetic navigation systems utilize two permanent magnets mounted on articulating and pivoting

arms with one magnet on either side of the patient table. These magnets generate magnetic navigation fields that are less than the strength

of fields typically generated by MRI equipment and therefore require significantly less shielding, and cause significantly less interference,

than MRI equipment. The robotic magnetic navigation system is indicated for use in cardiac, peripheral and neurovascular applications.

Cardiodrive®

Automated Catheter Advancement System. As the physician conducts the procedure from the adjacent control room, the Cardiodrive

Automated Catheter Advancement System (“Cardiodrive”), in conjunction with the QuikCAS automated catheter advancement

system, is used to remotely advance and retract the electrophysiology catheter in the patient’s heart while the robotic magnetic

navigation system magnets precisely steer the working tip of the device.

Odyssey®

Solution

The

Odyssey Solution offers a fully integrated, real-time information solution to manage, control, record and share procedures across

networks or around the world. We believe that the Odyssey Solution enhances the physician workflow in interventional labs through

a consolidated user interface of multiple systems on a single display to enable greater focus on the case and improve the efficiency

of the lab. Through the use of a single mouse and keyboard, the Odyssey Solution allows the user to command multiple systems in

the lab from a single point of control. In addition, the Odyssey Solution acquires a real-time, remote view of the lab, capturing

synchronized procedure data for review of important events during cases. The Odyssey Solution enables physicians to access recorded

cases and create snapshots following procedures for enhanced clinical reporting, auditing and presentation. The Odyssey Solution

enables physicians to establish a comprehensive master archive of procedures performed in the lab providing an excellent tool for training

new staff on the standard practices. The Odyssey Solution further enables procedures to be observed remotely around the world

with high-speed Internet access over a hospital VPN, even wirelessly using a standard laptop or Windows tablet computer.

X-ray

systems

have arrangements with fluoroscopy system manufacturers to provide such

systems in a bundled purchase offer for hospitals establishing robotic interventional operating rooms. These are single-plane, full-power

x-ray systems and include the c-arm and powered table. The combination of RMN Systems with our partnered x-ray systems reduces the cost

of acquisition, the ongoing cost of ownership, and the complexity of installation of a robotic electrophysiology practice.

Disposables

and Other Accessories

Our

robotic magnetic navigation systems are designed to use a toolkit of associated disposable interventional devices. Within this toolkit,

we manufacture and distribute:

addition, we also market and distribute other disposable and related devices that can be used with our robotic magnetic navigation systems

and in traditional, manual procedures.

Revenue

from sales of disposable products is recognized when control is transferred to the customers, which generally occurs at the time of shipment,

but can also occur at the time of delivery depending on the customer arrangement. Disposable products are covered by an assurance-type

warranty that provides for the return of defective products. Warranty costs were not material for the periods presented.

With

our partners, we have jointly developed associated location and non-location sensing electrophysiology mapping and ablation catheters

that are navigable with our robotic magnetic navigation system. We believe that these products provide physicians with the elements required

for effective complex electrophysiology procedures: highly accurate information as to the exact location of the catheter in the body

and highly precise control over the working tip of the catheter.

Additionally,

we have other broad strategic collaborations, including the development

of the Stereotaxis MAGiC catheter, our next-generation robotically-navigated magnetic ablation catheter designed to perform cardiac ablation

procedures. Stereotaxis is the owner of the catheter and we are pursuing regulatory approvals for the MAGiC catheter in various global

geographies. Approval processes can be lengthy and uncertain, submissions may require revised or additional non-clinical and clinical

data, and regulatory applications could be denied.

The

maintenance of these strategic relationships, or the establishment of equivalent alternatives, is critical to our commercialization efforts.

There are no guarantees that any existing strategic relationships will continue, and efforts are ongoing to ensure the availability of

compatible systems and devices and/or equivalent alternatives. We cannot provide any assurance as to the timeline of the ongoing availability

of such compatible systems or our ability to obtain equivalent alternatives on competitive terms or at all.

Other

Recurring Revenue

Other

recurring revenue includes revenue from product maintenance plans, service-type warranties, other post warranty maintenance, and the

implied obligation to provide software enhancements if and when available for a specified period, typically one year following installation

of our systems. Revenue from product maintenance plans and software enhancements, service-type warranties, and the implied obligation

to provide software enhancements are deferred and amortized over the service or update period, which is typically one year. Revenue related

to services performed on a time-and-materials basis is recognized when performed.

Regulatory

Approval

have received regulatory clearance, licensing and/or approvals necessary for us to market the Genesis System with Cardiodrive, iCONNECT,

Navigant, Odyssey and QuikCAS in the U.S. and Europe, and we are in the process of obtaining necessary registrations for extending our

markets in other countries.

have received regulatory clearance, licensing and/or approvals necessary for us to market the Niobe System with Cardiodrive, e-Contact,

Navigant, Odyssey and QuikCAS in the U.S., Canada, China, Japan, and various other countries.

have received regulatory clearance, licensing and/or approvals necessary for us to market the Vdrive and Vdrive Duo Systems with the

V-CAS in the U.S. and Canada.

FINANCIAL

INFORMATION ABOUT CUSTOMERS

single customer accounted for more than 10% of total revenue for the years ended December 31, 2023 and 2022. No single country, other

than the U.S., accounted for more than 10% of total revenue for the years ended December 31, 2023 and 2022.

CLINICAL

APPLICATIONS

have focused our clinical and commercial efforts on applications of our products primarily in electrophysiology procedures for the treatment

of arrhythmias and secondarily in complex interventional cardiology procedures for the treatment of coronary artery disease. Our system

potentially has broad applicability in other areas, such as structural heart repair, interventional neurosurgery, interventional neuroradiology,

peripheral vascular, renal denervation, pulmonology, urology, gynecology and gastrointestinal medicine, and some of our patents may be

applicable in these areas as well.

Electrophysiology

The

rhythmic beating of the heart results from the transmission of electrical impulses. When these electrical impulses are mistimed or uncoordinated,

the heart fails to function properly, resulting in symptoms that can range from fatigue to stroke or death. Over 5.0 million people in

the U.S. currently suffer from abnormal heart rhythms, which are known as arrhythmias. The prevalence of arrhythmias is expected to continue

to rise as the population ages, life expectancy increases, and lifestyle factors such as obesity become more prevalent. Arrhythmias are

a major physical and economic burden and are associated with stroke, heart failure, and adverse symptoms causing patients to be motivated

to seek treatment. The combination of symptoms, prevalence and comorbidities make arrhythmias a major economic factor in healthcare.

Drug

therapies for arrhythmias often have limited efficacy, poor compliance, and side effects. Consequently, physicians have increasingly

sought more permanent, non-pharmacological, solutions for arrhythmias. The most common interventional treatment for arrhythmias is an

ablation procedure in which the diseased tissue giving rise to the arrhythmia is isolated or destroyed. Prior to performing an electrophysiology

ablation, a physician typically performs a diagnostic procedure in which the electrical signal patterns of the heart wall are “mapped”

to identify the heart tissue generating the aberrant electrical signals. Following the mapping, the physician may then use an ablation

catheter to eliminate the aberrant signal or signal path, restoring the heart to its normal rhythm. These procedures may be performed

separately but are more commonly performed at the same time.

believe more than 5,000 interventional labs around the world are currently conducting over one million cardiac ablation procedures annually.

The market has grown rapidly over the last decade with annualized procedure growth of approximately 10%.

believe that Robotic Magnetic Navigation is particularly well-suited for these electrophysiology procedures which are time consuming,

or which can only be performed by highly experienced physicians. These procedures include:

believe that our system can address the current challenges in electrophysiology by permitting the physician to remotely navigate disposable

interventional devices from a control room outside the x-ray field. Additionally, we believe that our system allows for more predictable

and efficient navigation of these devices to the treatment site and enables catheter contact to be consistently maintained to efficiently

apply energy on the wall of the beating heart. We also believe that our system will significantly lower the skill barriers required for

physicians to perform complex electrophysiology procedures and, additionally, improve interventional lab efficiency and reduce disposable

interventional device utilization.

Interventional

Cardiology

than half a million people die annually from coronary artery disease, a condition in which the formation of plaque in the coronary arteries

obstructs the supply of blood to the heart, making this the leading cause of death in the U.S. Despite various attempts to reduce risk

factors, each year over one million patients undergo interventional procedures in an attempt to open blocked vessels and another one

half million patients undergo open heart surgery to bypass blocked coronary arteries.

Blockages

within a coronary artery, often called lesions, are categorized by degree of obstruction as partial occlusions, non-chronic total occlusions

and chronic total occlusions. Lesions are also categorized by the degree of difficulty with which they can be opened as simple or complex.

Complex lesions, such as chronic total occlusions, longer lesions, and lesions located within smaller diameter vessels, are often very

difficult or time consuming to open with manual interventional techniques.

believe approximately 11,000 interventional labs worldwide are currently capable of conducting interventional cardiology. Over 4 million

interventional cardiology procedures are performed annually in the U.S. alone. We estimate that approximately 10-15% of these interventional

cardiology procedures currently being performed are complex and therefore require longer procedure times and may have sub-optimal outcomes.

We believe that our system can substantially benefit this subset of complex interventional cardiology procedures.

Interventional

Neuroradiology, Neurosurgery and Other Interventional Applications

Physicians

used a predecessor to our Niobe System to conduct a number of procedures for the treatment of brain aneurysms, a condition in

which a portion of a blood vessel wall balloons and which can result in debilitating or fatal bleeding and strokes. We believe the robotic

magnetic navigation system also has a range of potential applications in minimally invasive neurosurgery, including biopsies and the

treatment of tumors, treatment of vascular malformations and fetal interventions.

STRATEGIC

RELATIONSHIPS

have entered into business arrangements with technology leaders in the global interventional market, including manufacturers of fluoroscopy

systems, ablation catheters, and electrophysiology mapping systems, that we believe aid us in commercializing our robotic magnetic navigation

system. These arrangements are important to us as they provide for the integration of our system with digital imaging and 3D catheter

location sensing technology, as well as catheters compatible with our system.

have arrangements with fluoroscopy system manufacturers to provide such

systems in a bundled purchase offer for hospitals establishing robotic interventional operating rooms.

have entered into strategic relationships and successfully integrated with diagnostic mapping and imaging technologies to provide an

ecosystem where physicians and patients benefit from the integration of procedure data.

With

our partners, we have jointly developed associated location and non-location sensing electrophysiology mapping and ablation catheters

that are navigable with our robotic magnetic navigation system. We believe that these products provide physicians with the elements required

for effective complex electrophysiology procedures: highly accurate information as to the exact location of the catheter in the body

and highly precise control over the working tip of the catheter.

The

co-developed catheters are manufactured and distributed by Biosense Webster, and both of the parties contributed to the resources required

for their development. Biosense Webster’s distribution rights for co-developed catheters were nonexclusive until December 31, 2022.

We received royalty payments from Biosense Webster during the term of the agreement. The agreement expired in December, 2022, and provides

for a continuation of supply by Biosense Webster of the co-developed catheters to us or our customers for three years following the termination.

The royalty payments were payable quarterly based on net revenues from sales of the co-developed catheters. Royalty revenue from the

co-developed catheters represented 7% of revenue for the year ended December 31, 2022.

Additionally,

we have other broad strategic collaborations, including the development of the Stereotaxis MAGiC catheter, our next-generation robotically-navigated

magnetic ablation catheter designed to perform cardiac ablation procedures.

Stereotaxis is the owner of the catheter and we are pursuing regulatory approvals for the MAGiC catheter in various

global geographies. Approval processes can be lengthy and uncertain, submissions may require revised or additional non-clinical and clinical

data, and regulatory applications could be denied.

The maintenance of these arrangements,

or the establishment of equivalent alternatives, is critical to our commercialization efforts. There are no guarantees that any existing

strategic relationships will continue, and efforts are ongoing to ensure the availability of compatible next generation systems and/or

equivalent alternatives. We cannot provide assurance as to the timeline of the ongoing availability of such compatible systems or our

ability to obtain equivalent alternatives on competitive terms or at all.

RESEARCH

AND DEVELOPMENT

have assembled an experienced group of engineers and physicists with recognized expertise in magnetics, software, control algorithms,

mechanics, electronics, systems integration and disposable interventional device design.

Our

research and development efforts are focused in the following areas:

● development and enhancement of Robotic Magnetic Navigation Systems;

Our

research and development team collaborates with strategic third parties to integrate our robotic magnetic navigation system’s open

architecture platform with key imaging, location sensing and information systems in the interventional lab. We have also collaborated

with a number of highly regarded interventional physicians in key clinical areas and have entered into agreements with a number of universities

and teaching hospitals, which serve to increase our access to world class physicians and to expand our name recognition in the medical

community.

CUSTOMER

SERVICE AND SUPPORT

provide worldwide maintenance and support services to our customers for our compatible products directly or with the assistance of outsourced

product and service representatives. By utilizing these relationships, we provide direct, on-site technical support activities, including

call center, customer support engineers and service parts logistics and delivery. In certain situations, we use these third parties as

a single point of contact for the customer, allowing us to focus on providing installation, training, and back-up technical support.

Our

back-up technical support includes a combination of on-line, telephone and on-site technical assistance services 24 hours a day, seven

days a week. We employ service and support engineers with networking and medical equipment expertise and outsource a portion of our installation

and support services. We offer different levels of support to our customers, including basic hardware and software maintenance, extended

product maintenance, and rapid response capability for both parts and service.

have established a call center in our St. Louis facilities, which provides real-time clinical and technical support to our customers

worldwide.

MANUFACTURING

Robotic

Magnetic Navigation Systems and Odyssey Solution

Our

manufacturing strategy for our Robotic Magnetic Navigation Systems and Odyssey Solution is to sub-contract many of the

manufacture of major subassemblies of our systems to maximize manufacturing flexibility and lower fixed costs. We maintain quality control

for all of our systems by completing final system assembly and inspection in-house.

purchase both custom and off-the-shelf components from a large number of suppliers and subject them to quality specifications and processes.

Some of the components necessary for the assembly of our products are currently provided to us by sole-sourced suppliers (the only recognized

supply source available to us) or single-sourced suppliers (the only approved supply source for us among other sources). We purchase

the majority of our components and major assemblies through purchase orders rather than long-term supply agreements and generally do

not maintain large volumes of finished goods.

Disposable

Interventional Devices

Our

manufacturing strategy for disposable interventional devices is to outsource their manufacture through subcontracting and to expand partnerships

for other interventional devices. We work closely with our contract manufacturers and have strong relationships with component suppliers.

We have entered into manufacturing agreements to provide high volume capability for devices other than catheters.

Software

The

software components of the robotic magnetic navigation system and Odyssey Solution, including control and application software,

are developed both internally and with integrated modules we purchase or license. We perform final testing of software products in-house

prior to their commercial release.

General

Our

manufacturing facility operates under processes that meet the FDA’s requirements under the Quality System Regulation (QSR). Our

ISO registrar and European notified British Standard Institution (BSI) has audited our facility annually since 2001 and found the facility

to be in compliance with relevant requirements. The most recent ISO 13485 and MDSAP Certificate of Registration were issued in 2022 and

are valid through September 2025.

SALES

AND MARKETING

market our products in the U.S and internationally through a direct sales force of senior sales specialists, distributors and sales agents,

supported by account managers and clinical specialists who provide training, clinical support, and other services to our customers.

Our

sales and marketing efforts include two important elements: (1) selling robotic magnetic systems, Odyssey Solutions, and magnetically compatible

x-ray systems directly and through distributors; and (2) leveraging our installed base of systems to drive recurring sales of disposable

interventional devices, software and service.

REIMBURSEMENT

believe that substantially all of the procedures, whether commercial or in clinical trials, conducted in the U.S. with the robotic magnetic

navigation systems have been reimbursed to date. We expect that third-party payors will reimburse, under existing billing codes, procedures

in which compatible ablation catheters are used. We expect healthcare facilities in the U.S. to bill various third-party payors, such

as Medicare, Medicaid, other government programs and private insurers, for services performed with our products. We believe that procedures

performed using our products, or targeted for use by products that do not yet have regulatory clearance or approval, are generally already

reimbursable under government programs and most private plans. Accordingly, we believe providers in the U.S. will generally not be required

to obtain new billing authorizations or codes in order to be compensated for performing medically necessary procedures using our products

on insured patients. We cannot guarantee that reimbursement policies of third-party payors will not change in the future with respect

to some or all of the procedures using the robotic magnetic navigation system.

countries outside the United States, reimbursement is obtained from various sources, including governmental authorities, private health

insurance plans, and labor unions. In most foreign countries, private insurance systems may also offer payments for some therapies. Additionally,

health maintenance organizations are emerging in certain European countries. In Europe, we believe that substantially all of the procedures,

whether commercial or in clinical trials, conducted with the robotic magnetic navigation systems have been reimbursed to date. In other

foreign countries, we may need to seek international reimbursement approvals, and we do not know if these required approvals will be

obtained in a timely manner or at all.

See

“Item 1A—Risk Factors” for a discussion of various risks associated with reimbursement from third-party payors.

INTELLECTUAL

PROPERTY

The

proprietary nature of, and protection for, our products, processes and know-how are important to our business. We seek patent protection

in the United States and internationally for our systems and other technology where available and when appropriate.

have an extensive patent portfolio that we believe protects the fundamental scope of our technology and systems, including our robotic

magnetic technology, navigational methods, mapping system and procedural workflows, 3D integration technology, and disposable interventional

devices. As of December 31, 2023, we had 44 issued U.S. patents and 2 pending U.S. patent application. In addition, we had 15 issued

foreign patents and 2 pending foreign patent applications. The key patents that protect our technology and systems extend until 2028

and beyond.

also have a number of invention disclosures under consideration and several applications that are being prepared for filing. We cannot

be certain that any patents will be issued from any of our pending patent applications, nor can we be certain that any of our existing

patents or any patents that may be granted in the future will provide us with protection.

would be technically difficult and costly to reverse engineer our robotic magnetic navigation system, which contains numerous complex

algorithms that control our disposable devices inside the magnetic fields generated by the robotic magnetic navigation system. We further

believe that our patent portfolio is broad enough in scope to enable us to obtain legal relief if any entity not licensed by us attempted

to market disposable devices in the U.S. that can be navigated by the robotic magnetic navigation system. We can also utilize security

keys, such as embedded smart chips or associated software that could allow our system to recognize specific disposable interventional

devices in order to prevent unauthorized use of our system.

have also developed substantial expertise in magnet design, magnet physics and magnetic instrument control that was developed in connection

with the development of the robotic magnetic navigation system, which we maintain as trade secrets. This expertise centers around our

proprietary magnet design, which is a critical aspect of our ability to design, manufacture and install a cost-effective magnetic navigation

system that is small enough to be installed in a standard interventional lab. Our Odyssey Solution contains numerous complex algorithms

and proprietary software and hardware configurations, and requires substantial knowledge to design and assemble, which we maintain as

trade secrets. This proprietary software and hardware, some of which is owned by Stereotaxis, and some of which is licensed to Stereotaxis,

is a material aspect of the ability to design, manufacture and install a cost-effective and efficient information integration, storage,

and delivery platform.

addition, we seek to protect our proprietary information by entering into confidentiality, assignment of invention or license agreements

with our employees, consultants, contractors, advisers and other third parties. However, we believe that these measures afford only limited

protection.

COMPETITION

The

markets for medical devices are intensely competitive and are characterized by rapid technological advances, frequent new product introductions,

evolving industry standards and price erosion.

electrophysiology we consider the primary competition to our robotic magnetic navigation system to be traditional catheter-based electrophysiology

ablation approaches including RF (radiofrequency) ablation and non-RF therapies. To our knowledge, we are the only company that has commercialized

remote, digital and direct control of the working tip of catheters for use in RF ablation procedures. Our success depends in part on

convincing hospitals and physicians to convert traditional interventional procedures to procedures using our robotic magnetic navigation

system.

face competition from companies that are developing and marketing new products for use in electrophysiology. These products include next

generation mapping systems and RF ablation devices with which our robotic magnetic navigation system is not currently compatible, as

well as non-RF ablation devices including single-shot cryoablation devices and other new products, such as pulse field ablation, for

use in other interventional therapies. Some of these products are marketed by companies that may have an established presence in the

field of electrophysiology, including major imaging, capital equipment and disposables companies that are currently selling products

in the interventional lab. In addition, we face competition from companies that currently market or are developing drugs, gene or cellular

therapies to treat the conditions for which our products are intended.

also face competition from companies that are developing robotic technologies for electrophysiology and non-electrophysiology interventional

procedures. We are aware of four companies that commercialized endovascular catheter navigation systems which have been cleared by the

STXS US Equity

STXS · 10-K · period ended 2023-12-31

ITEM 1. BUSINESS

STXS US Equity☆

STXS · 10-K · period ended 2023-12-31

ITEM 1. BUSINESS

STXS US Equity