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

http://www.employeeuniversity.com/videos/healthcare_6890.htm

http://www.employeeuniversity.com/videos/healthcare_6890.htm

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 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


//upload.wikimedia.org/wikipedia/commons/1/19/Circulatory_System_no_tags.svg

//upload.wikimedia.org/wikipedia/commons/1/19/Circulatory_System_no_tags.svg

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.


• 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 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


Future:Live 3D

navigation in 3D geometry

Future:Automatic path

planning

Image Integration and 3D Tracking


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


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 drugTARE – 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

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


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

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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


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


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

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