Stereotaxis Investor Presentation 4Q2018
Stereotaxis Investor Presentation 4Q2018
Stereotaxis Investor Presentation 4Q2018
4Q 2018
Stereotaxis at a Glance
Attractive Market
$4B+ Existing Market | 10-15% Annual Growth | No Robotic Competitor
Financial Highlights*
>$30m Sales | >80% Recurring Revenue | >75% Gross Margin .
$12.0m Cash and No Debt
Enterprise Value ~$100m
* Income statement data reflects full year 2017 results excluding a non-cash inventory-
2 related charge. Balance sheet as of 6/30/2018. Enterprise value as of 10/1/2018.
Surgical Progress
Technological innovation has enabled various procedures to progress to less invasive surgery.
This progress shifts clinical practice but more importantly causes a significant overall increase
in the number of patients treated as reduced surgical risk and invasiveness increases access to therapy.
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Endovascular Surgery
Traditional Endovascular Surgery is Widely Utilized Across Broad Clinical Applications.
…but with Inherent Limitations.
Multi-Billion Dollar Endovascular Surgery Markets Include:
Mechanism of Action Catheter Design
Clot Aspiration/Retrieval
& Endovascular Coils
Manipulation of the tip of the In order to allow for the transfer of
catheter is accomplished in an force along its length, catheters
indirect inelegant fashion. Force is must be designed with rigid shafts
transferred from the physician’s and internal pull wires.
Transcatheter Valves fingers/hands to the base of the
catheter and then over the entire
length of the catheter.
Cardiac Ablation
Reliance on X-Ray Difficult & Complex
Navigation and visualization of the Performing endovascular surgeries
catheter in the vascular system is requires significant training and
Endovascular Stent Grafts
accomplished using x-ray imaging. skill. Procedures often take
significant amounts of time. Often
simple movements are difficult to
accomplish.
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Robotics in Surgery
The last decade has seen dramatic adoption of robotic technologies
that address the limitations of open and laparoscopic surgery.
Two observations
• Robotics captured significant market share despite a lack of material clinical superiority data
• Robotics provides for ‘Democratization of Skill’: more surgeons enabled to perform more procedures more effectively
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Endovascular Robotics
Three Mechanisms of Action for Robotics in Endovascular Surgery:
Comments
Relatively simple and inexpensive system can Increased navigational capabilities compared Control of a catheter directly at the tip allows
be used with existing catheters. Does not with traditional catheter. More rigid catheter for unmatched catheter precision, reach and
address the inherent limitations or expand the and increased size raises safety concerns. stability. Removal of pull-wires and shaft
capabilities of traditional catheters. rigidity creates a very safe catheter.
Stereotaxis is the only company that has developed a functional ‘pull’ robotic system.
The system is robust with significant validation in >100,000 procedures at >100 hospitals.
The ‘pull’ mechanism of action is the most elegant in allowing for the design and control of
catheters in ways otherwise unachievable.
The benefits of robotics can be combined in an additive fashion with other innovation in the field.
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Robotic Magnetic Navigation
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Cardiac Ablation Market
Arrhythmia: (n.) a condition in
which the heart beats with an
irregular or abnormal rhythm .
Cardiac Ablation Market
(Endovascular Catheter Procedures)
Health Risk Mortality
Arrhythmias progressively Ventricular fibrillation is the most Large
increase the risk of Stroke, common cause of sudden cardiac >850,000 procedures performed per year US/EU/JPN.
Congestive Heart Failure, and death in the US, leading to $4 Billion in annual sales of ablation and mapping products.
more serious arrhythmias. 300,000 deaths annually.
Rapidly Growing
Widespread 10-15% annual growth: Consistent, long-term robust growth driven by
Atrial Fibrillation alone affects: 5 million in the US (15m US/EU/JPN) clinical evidence, demographic trends and improved technology.
Prevalence of other arrhythmias greater than AF (likely by multiples) • Clinical evidence – growth to date has been generated without well
Growing Rapidly designed trials measuring mortality. First trial showing significant
Demographics: Incidence increases significantly with age and obesity. mortality benefit of cardiac ablation vs drug therapy (46% reduction
Awareness: Significant efforts to increase awareness, detection and in all cause mortality at 3 years) presented 8/2017 at ESC.
diagnosis – Apple watch, mobile patch monitoring, etc.
Significant Headroom for Long-term Growth
Large growing incidence, prevalence and diagnosis of arrhythmias.
Cardiac ablation often performed multiple times per patient.
Current market reflects small fraction of patients eligible for therapy.
Clinical evidence increasingly supporting cardiac ablation as front-line
therapy from clinical outcome and cost effectiveness perspectives.
Primary Therapies Available
Even Niches of the Market are Large
•Pharmaceuticals: beta blockers, calcium channel blockers
• Ventricular Arrhythmias: >70,000 procedures performed annually.
•Poor compliance, lifetime use, limited efficacy
Lower penetration of cardiac ablation despite increased disease
•Implantation of Pacemakers and ICDs:
severity because of procedure technical difficulty
•$7 Billion market. Does not address underlying disease
• Congenital Arrhythmias: ~0.3% of children are born with critical
•Cardiac Ablation Procedures: surgical and endovascular
congenital heart disease and treated with heart surgery. Almost all
•Surgical ablation is niche due to invasiveness. Endovascular
develop arrhythmias as an adult. ~30,000 incidence (prevalence
is relatively new and a significantly growing approach.
multiple-fold) in US/EU/JPN.
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Current Benefits
Robust Clinical & Real-World Validation • Unmatchable Robotic Precision
350+ Peer-Reviewed Publications
Robotic Ensures Right Tissue is Treated
100,000+ Procedures Performed
Precision
• Robotic Precision and Reach
Enables Treatment of Otherwise • Gentle Magnetic Catheter
Impossible/Difficult Arrhythmias Reduces Complication
• Stable Catheter-Tissue Contact Gentle • 62% Reduction in
Improves Lesion Formation Touch Major Complications
• Lower Risk of Complications Procedure • 43% Reduction in
• Democratization of Skill Success Minor Complications
• Focus on Treatment vs Nav.
• Reduced Reliance on X-Ray
• Operate Seated & Outside Reduced Lowers Radiation Exposure
of Radiation Exposure
Physician Radiation • 235 Chest X-Rays: Average
• Occupational Risk
Amount Reduced Per Patient
Significant: 85% of Safety
Per Procedure
brain tumors on left
side; 49% suffer ortho
injury from cath lab • Improving Patient Outcomes
Patient & Reducing Adverse Events
Career Care
• Reduced Exertion Longevity
• Reduced Risk of Injury
• Cognitive Skill Elevated & • Differentiation in Competitive
Reduced Reliance on Hand Skill Market: Patients, Talent,
Efficient Strategic
Referral Network, Payors
Workflow Benefit
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Global Presence
>9,000 Procedures Annually at >100 Hospitals by >300 Physicians
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Leadership in Complex Procedures
Stereotaxis is the most effective, and sometimes only option, for the most complicated
ablation procedures.
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Automated Navigation
Stereotaxis currently has functional automation software designed into its system that
allows for automated movement of the catheter to specific points, along defined paths,
and in preprogrammed motions.
Plan is in place to methodically improve the software towards reliable, reproducible and
rapid automation. This would allow rapid mapping using software as a replacement for
expensive mapping catheters. It would also allow efficient ablation in both the atrium
and ventricle in a patient-specific individualized fashion.
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Market Outlook
Convergence & Differentiation
While the cardiac ablation market is highly attractive, the Robotics has a differentiated mechanism of action providing
challenge for companies operating in it over the coming additive clinical benefits to patients and physicians when
years will be maintaining differentiation and avoiding combined with manual technologies. Stereotaxis is the only
commoditization. robotic EP company and significant barriers to entry exist.
The convergence of features is characterized by: The advances in manual technologies do not address four
•Ablation Catheters - the development of balloon-based key ways robotics provides meaningful differentiation:
technologies for rapid pulmonary vein isolation, high- •Safety - Unmatched safety for patients and physicians.
flow and contact force sensing capability in single point Gentle catheter significantly reduces perforation risk.
catheters, and tools for lesion prediction and assessment. Reduced radiation exposure to patients and physicians.
•Mapping Systems - localization is being performed Reduced orthopedic injury to physicians.
using electric fields as well as an imbedded sensor, and •Catheter Precision & Reach - Navigation of catheter
more rapid and detailed anatomic and electrical mapping from the tip allows precise access to difficult to reach
is being pursued using multi-electrode catheters. anatomies, enabling otherwise impossible procedures.
•Catheter Stability - Magnetic catheter maintains contact
with beating heart tissue at consistent force ensuring
effective lesions and maintained contact.
•Automation - Robotics is the only technology that will
enable full automation of procedures, allowing
physicians to focus on designing and planning
individualized therapy of patients rather than mechanics
of catheter manipulation.
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Primary Focus
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Innovation Plan
Navigation Software Robotic System X-Ray Fluoroscopy Ablation Catheter Mapping System
1 2 3
Patient Physician Technology
Care Choice Availability
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Commercial Initiatives
#TogetherTo100K Campaign
Remote Support Capabilities
SCRN Physician Society
Physician Procedure
Relationships Support Field Clinical Team
Management Direct Engagement
Computer Simulators
Materials for Hospitals
Physician Commercial Practice • Patients
Robotic EP Fellowships • Referral Physician
Training Initiatives Growth • Fellows / EPs
Best Practices Portal
Increasing Publications
Social Media Campaign
Patient Clinical • 37 in 2017 and 22 in 2016
• VT meta analysis very positive
Patient Oriented Website Demand Literature
MAGNETIC-VT Trial
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Financial Summary
Revenue Profitability
Alignment of Interest
CEO and Board Members are significant shareholders
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