hansen medical investor highlights - corporate update 2016
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Hansen Medical, Inc.
Overview January 2016
Intravascular Robotics
2
Forward-Looking Statements
This fact sheet contains forward-looking statements regarding, among other things, statements relating to goals, plans,
objectives, milestones and future events. All statements, other than statements of historical fact, are statements that could be
deemed forward-looking statements, including statements containing the words “plan,” “expects,” “potential,” “believes,” goal,”
“estimate,” and similar words. These statements are based on the current estimates and assumptions of our management as of
the date of this press release and are subject to risks, uncertainties, changes in circumstances and other factors that may cause
actual results to differ materially from the information expressed or implied by forward-looking statements made in this press
release. Examples of such statements include statements about, the potential benefits of our Magellan Robotic System on the
vascular procedures and the timing and results of commercializing our Magellan Robotic System. Important factors that could
cause actual results to differ materially from those indicated by such forward-looking statements include, among others:
engineering, regulatory and sales challenges in developing new products and entering new markets; potential safety and
regulatory issues that could slow or suspend our sales; the uncertain timelines, costs and results of pre-clinical and clinical trials;
the rate of adoption of our systems and the rate of use of our catheters; the scope and validity of intellectual property rights
applicable to our products; competition from other companies; our ability to recruit and retain key personnel; our ability to
maintain our remedial actions over previously reported material weaknesses in internal controls over financial reporting; the
effect of credit, financial and economic conditions on capital spending by our potential customers; our ability to manage
expenses and obtain additional financing; and other risks more fully described in the "Risk Factors" section of our Quarterly
Report on Form 10-Q for the quarter ended March 31, 2012 filed with the SEC on May 7, 2012 and the risks discussed in our
other reports filed with the SEC. Given these uncertainties, you should not place undue reliance on the forward-looking
statements in this press release. We undertake no obligation to revise or update information herein to reflect events or
circumstances in the future, even if new information becomes available.
Hansen Medical, Heart Design (Logo), Hansen Medical (with Heart Design), and Sensei are registered trademarks, and
Magellan is a trademark of Hansen Medical, Inc. in the United States and other countries.
WWW.HANSENMEDICAL.COM
Investor Highlights
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Over 20,000 successful robotic procedures performed to date
Multi Billion-Dollar market opportunity improving clinical outcomes and hospital economics
Advanced robotic catheter product line (10Fr – 3Fr)
Best in class Robotic Precision, Stability & Control
WWW.HANSENMEDICAL.COM
Robotic Systems Catheters & Accessories Service
Training
Installation
Service
Capital Recurring
Magellan
The Hansen Medical Business Model
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IP Summary
Over 800 patents in-licensed
New technologies focused on navigation, imaging & robot ic navigation
~50 in the surgical space
~150 patents in the Endoluminal space
Over 200 Patents issued worldwide
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Hansen IP; Vascular(NO RESTRICTION)
Hansen IP, Non-Vascular
(ASSIGNABLE)
ISI IP, Vascular
(ASSIGNABLE)
ISI IP, Non-Vascular
(RETAINED BY ISI)
ISI X-License
“[the Agreement] may not be transferred or assigned by either party without the prior written consent of the other party; provided that, either party may, without the other party’s prior written consent, assign or transfer this Cross License and its rights and obligations hereunder in connection with an Acquisition or Asset Transfer."
Intuitive IP X-License Summary
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Robotic arm at patient table Remote physician workstation
Magellan Transport System
Magellan Robotic System
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2012 2014 2015 2017
Magellan Robotic Catheters
8
2016
3Fr
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Large Addressable Market
Magellan
U.S. JapanEurope*
Sensei
Endovascular Procedures 2,076,000
Embolization Procedures 175,000
384,000
91,000
Source: Millennium Research Group 2008, 2009, 2012, 2013 reportsMRG Transcatheter Embolization and Occlusion Device market, 2012* France, Germany, Spain, Italy, U.K.
741,000
71,000
AF Procedures 236,000 247,000 78,000
Total Current Universe ~ 4.1 mil annual procedures
Follow-On Markets (U.S.)Neuro Intervention: ~52,000 annual procedures
Structural Heart: ~33,000 annual procedures
Intravascular Robotics Segment
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240,000
50,000
29,000
Hysterectomy for Fibroids
Stand-Alone Myomectomy
UFE
Target Therapies
Cancer (Liver & Colorectal)
Uterine Fibroids Enlarged Prostate (BPH)
* http://www.ucfibroids.com/who-gets-them.html**Millennium Research Report, 2011 Figures***Millennium Research Report, 2013
10 million inactive
5.5 mil Seek
Therapy
Approximately 15.5 Million U.S. Women
Treatment*
Disease State
0 50,000 100,000 150,000 200,000
Liver Cancer Metastatic Colorectal Camcer
Annual Cases
Annual Deaths
Annual Cases
Annual Deaths
Disease State
4,275
5,100
15,200
10,700
Radioembo for primary liver cancer
Radioembo for metastatic colorectal cancer
Chemoembo for primary liver cancer
Chemoembo for metastatic colorectal cancer
Treatment***
Disease State
143,000
100,00043,000
132,000
35,000 16,000
475,000 BPH Surgical Procedures
Treatment**
TUMT (microwave)
TURPPhotoLaser
Holmium Laser
RF Stents
Target Embolization Procedures: U.S.
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• Improve performance with the ability to perform fast, predictable cases2
• Reduce radiation exposure3 and lead-related stress4
• Grow physician practice with patient flow and procedure predictability
• State-of-the-art treatment with access to robotic procedural precision1
• Increase revenue and efficiencies2 through incremental patient flow and improved throughput
• Establish technology leadership
• Attract & retain physicians with career and revenue-enhancing technology
1 Tom Carrell, MA, MChir, FRCS, at al. Use of a remotely steerable “robotic” catheter in a branched endovascular aortic graft. J Vasc Surg 2011.2 Bismuth J, Stankovic M, Gerzak B, Lumsden AM. The role of flexible robotics in overcoming navigation challenges in the iliofemoral arteries: a first in man study. 69th SVS Annual Meeting, June 2011. Chicago, USA.3 Riga C, Cheshire N, Hamady M, Bicknell C. The role of robotic endovascular catheters in fenestrated stent grafting. J Vasc Surg 2010 Apr: 51(4):810-9.4 Using the remote workstation
Patients
Hospitals
Physicians
Magellan: The Broad Value Proposition
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Drive top line revenue
• Incremental patient growth
• Improve payer mix
Increase efficiencies through procedure time predictability to address
• Case time overruns
• Overtime and resultant service costs
Improve utilization rates
• Capture additional case revenue
Source: Bismuth J, Stankovic M, Gerzak B, Lumsden AM. The role of flexible robotics in overcoming navigation challenges in the iliofemoral arteries: a first in man study. 69th SVS Annual Meeting, June 2011. Chicago,
USA.
The Hospital Economic Value Proposition
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Procedure Clinical Need Size
TACE/TARE Access to tortuous distal tumorsStability for precise delivery of embolics
4Fr Ok for most 3Fr preferred
UFE Cannulate acute take-off of uterine artery & deliver embolics
4Fr Ok for most
PAE Access to prostato-vesical trunkCannulate origin of prostatic artery & deliver embolics
3Fr ok2.6Fr preferred
Endoleaks Locate and embolize type II endoleaks after EVAR & deliver embolics
4Fr ok for most
BTK Cannulate CTOs and tight stenosis
4Fr and 3Fr
Coronary Cannulate CTOs and tight stenosis
4Fr and 3Fr
Neuro Access to tortuous distal aneursyms/clots
5Fr, 4Fr and 3Fr
Steerable 4F
Magellan 6F
Smaller Catheters: Steerable 4F
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Future:Live 3D
navigation in 3D geometry
Future:Automatic path
planning
Image Integration and 3D Tracking
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2014 2015 2016 2017 2018 +
6F
MTSlaunch
10F MicroCatheterDriver
Magellan “Next”3D tracking Clinical studies
Active Drive 4F steerable
Magellan Enhancements
Magellan Product Development Strategic Plan
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Robotic Catheter Architecture
90°
180°
4cm
Telescoping Architecture Double Bend Architecture
IP that allows us to vary relative tension on the steering wires so that we can have independent control of both bends with the same set of steering wires
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• Endovascular Carotid Procedures
• Venous Procedures
• Thoracic Aneurysm Repair (TEVAR)
• Endovascular Aneurysm Repair (EVAR)
• Fenestrated EVAR (fEVAR)
• Renal Artery Angioplasty and Stenting
• Mesenteric Artery Angioplasty and Stenting
• Splenic Artery Aneurysm Treatment
• Hepatic Chemoembolization (TACE)
• Iliac Angioplasty and Stenting
• Internal Iliac Embolization
• Uterine Artery Embolization (UFE)
• Prostatic Artery Embolization (PAE)
• Crossing of Chronic Total Occlusions
• SFA Angioplasty and Stenting
• Popliteal Angioplasty and Stenting
Procedures Performed with Magellan:
Clinical Applications: Vascular Disease
Interventional Radiology
Multi-Disciplinary Platform: Vascular Surgeons
Interventional Radiologists
Interventional Cardiologists
Clinical Versatility
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epatic
epatic
Target embolization locations for TARE
Target embolization locations for TACE
TACE – Trans-arterial chemo-embolization – beads filled with anti-cancer drugTARE – Trans-arterial radio-embolization – beads filled with radioactive isotopes
Need for steerable catheters
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Magellan 2.0 Features and Benefits
Lighter, smaller – more mobile, less intrusive
Longer robotic travel – access more distal vessels
Shorter wasted length – compatible with more therapy
Fewer parts - Faster, easier setup, less training
Robotic assisted catheter exchange - saves time, fluoro and enables single operator procedure
Increased motor speeds – saves time, user satisfaction
Robotic valve control - better workflow and greater use of remote workstation
Lower COGS – better margins, increased usage
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Magellan 2.0 :Estimated RCM weight <15 lbs
Total System weight <100lb
Current Magellan: RCM weight ~25 lbs
Total system weight: ~170lb
Lighter, sleeker Remote Catheter Manipulator (RCM) Smaller Set-up Joint and Rail; more compact bedside storage Lighter weight, more mobile components; 1 cable connection Longer reach, More access points
Stored
Procedural position
Magellan 2.0: New Bedside Components
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Smaller, more mobile workstation
Lead shielding to protect from radiation
More adaptable to sterile environment
Usable either standing or seated
Quickly disconnected from cables and wheeled to another room
Flexible components to use at bedside or workstation
Magellan 2.0: Workstation Development
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Sensei maintains stable tissue contact.
0
20
40
60
80
100
Manual Sensei
gram
s
Force to Deflect Tip
1. Bench test performed by and data on file at Hansen Medical.
Sensei Provides 200% More Tip Stability than a Manual Catheter1 Intellisense Force Feedback Visual Display
Sensei X2 Robotic System
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Data source: GlobalData, Electrophysiology – Global Analysis and Market Forecasts, March 2014
• Growth in prevalence of atrial fibrillation as the population ages:
‒ 5% in those over 65 years
‒ 9% in those over 80 years
• 12% projected annual growth in catheter ablation procedures driven by:
‒ Aging population
‒ Acceptance of ablation therapy
‒ Ablation technique and technology improvements
76%
2%7%
10%
6%
Arrhythmia Diagnosis Mix
Atrial fibrillation
Atrial flutter
Wolf Parkinson White syndrome
Ventricular tachycardia
Atrio ventricular nodal re-entrant tachycardia
26.5%
73.5%
AF Diagnosis Mix
Paroxysmal
Persistent/permanent
Catheter Ablation Market
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Artisan IDE Study – HMP01
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Primary safety and effectiveness outcomes must meet pre-established target performance goals. A Bayesian adaptive design is used in the study that allows for interim analyses to be performed initially after 125 subjects have been enrolled and after every 25 subjects thereafter. Stopping rules have been incorporated to evaluate for early success or futility.
As of January 6, 2016: 147 subjects have been enrolled and treated, 3 cases pending to complete full enrollment of 150. Once completed enrollment will be closed, planned for February 1, 2016.
Study Update: January 6, 2016
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Artisan IDE Study Overview
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IDE: prospective, single arm study of the Hansen System for introducing and positioning RF ablation catheters in subjects with paroxysmal atrial fibrillation (PAF)
Study endpoints:
• Primary Safety
– Endpoint: The incidence of Major Complications, including the early onset (within 7 days of the ablation procedure) predefined complications; and the incidence of esophageal injury or pulmonary vein stenosis through day 180
– Hypotheses: The study is designed to determine if the Major Complication rate meets the pre-established target performance goal (TPG) of 16%.
• Primary Effectiveness
– Endpoint: Chronic Success: Freedom from symptomatic atrial fibrillation, atrial flutter, and atrial tachycardia episodes from days 91-365 after the initial ablation procedure, as documented by event recording, ECGs and Holter monitoring
– Hypotheses: The study is designed to determine if the effectiveness rate meets the pre-established target performance goal (TPG) of 54%.
Single-Arm Study Design
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Total Market
Systems $308M
Service per year $35M
Catheters per year
$258M
TOTAL $601M
• 474 target hospitals in US and EU5 performing >50 AF procedures per year
• Radiofrequency (non-Cryo) paroxysmal AF and persistent/permanent AF
• Upside potential:
– Countries outside US and EU5
– AF procedure growth
– Multiple systems per hospital
– Lower volume hospitals
– Non-AF EP procedures
Hospital and procedure data sources: Global Data EP Market Report March 2013, 2015 forecast yearSystem ASP: $650,000; Catheter ASP: $1,685EU5 = Germany, France, UK, Spain, Italy
Immediate Sensei Market Opportunity
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Investor Highlights
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Over 20,000 successful robotic procedures performed to date
Multi Billion-Dollar market opportunity improving clinical outcomes and hospital economics
Advanced robotic catheter product line (10Fr – 3Fr)
Best in class Robotic Precision, Stability & Control
WWW.HANSENMEDICAL.COM
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