Hansen Medical Investor Highlights - Corporate update 2016

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
3
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

Robotic Systems Catheters & Accessories Service
Training
Installation
Service
Capital Recurring
Magellan
The Hansen Medical Business Model
4WWW.HANSENMEDICAL.COM

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

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

Robotic arm at patient table Remote physician workstation
Magellan Transport System
Magellan Robotic System

2012 2014 2015 2017
Magellan Robotic Catheters
8
2016
3Fr

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 reports
MRG 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

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)
TURP
Photo
Laser
Holmium Laser
RF Stents
Target Embolization Procedures: U.S.

• 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

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

Procedure Clinical Need Size
TACE/TARE Access to tortuous distal tumors
Stability 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 trunk
Cannulate origin of prostatic
artery & deliver embolics
3Fr ok
2.6Fr
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

Future:
Live 3D
navigation in 3D
geometry
Future:
Automatic path
planning
Image Integration and 3D Tracking

2014 2015 2016 2017 2018 +
6F
MTS
launch
10F MicroCatheter
Driver
Magellan “Next”3D tracking
Clinical studies
Active Drive 4F steerable
Magellan
Enhancements
Magellan Product Development Strategic Plan

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

• 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

epatic
epatic
Target
embolization
locations for
TARE
Target
embolization
locations for
TACE
TACE – Trans-arterial chemo-embolization – beads filled with anti-cancer drug
TARE – Trans-arterial radio-embolization – beads filled with radioactive isotopes
Need for steerable catheters

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

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

 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

Sensei maintains stable tissue contact.
0
20
40
60
80
100
Manual Sensei
grams
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

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

Artisan IDE Study – HMP01
24
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

Artisan IDE Study Overview
25
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

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 year
System ASP: $650,000; Catheter ASP: $1,685
EU5 = Germany, France, UK, Spain, Italy
Immediate Sensei Market Opportunity

Investor Highlights
27
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

Hansen Medical Investor Highlights - Corporate update 2016

Recommandé

Recommandé

Contenu connexe

Tendances

Tendances (20)

En vedette

En vedette (20)

Similaire à Hansen Medical Investor Highlights - Corporate update 2016

Similaire à Hansen Medical Investor Highlights - Corporate update 2016 (20)

Plus de Alessandro Mazzarisi

Plus de Alessandro Mazzarisi (10)

Dernier

Dernier (20)

Hansen Medical Investor Highlights - Corporate update 2016