Endocardial Solutions Inc The En Site 3000 Advanced

Endocardial Solutions, Inc. The En. Site 3000® Advanced Arrhythmia Mapping and Catheter Navigation System

Agenda Non-Contact Mapping Company Background Current Technology & Trends The En. Site 3000® System Clinical Experience & Validation System Costs, Training & Support

The En. Site ® 3000 System High resolution non-contact mapping provides: l Real-time maps of global heart chamber activation during a single-beat l A 3 D patient specific model of heart chamber anatomy (Geometry) l Global site specific electrogram assessment (3, 000+ Virtual Electrograms) l Precise non-fluoroscopic catheter navigation . . . En. Site® Catheter

Procedure Summary

Non Contact Mapping

Single Beat Mapping Right Atrial Sinus Rhythm

Single Beat Mapping Left Ventricular Sinus Rhythm Caution: Left ventricular studies are Investigational in the US.

Indications for Use Unstable Patients l Rapid rhythm with hemodynamic compromise Non-sustained Rhythms l Transient rhythms not sustained long enough for conventional evaluation Polymorphic Rhythms l Multiple pathways make analysis difficult

Mission To Expand Opportunities for Therapeutic Ablation l Improving procedure productivity & outcomes for patients with complex arrhythmias currently mapped by conventional methods. l Expanding indications for therapeutic ablation to the wider arrhythmia population currently not indicated for ablation because conventional technology limits the ability to identify critical activation sites.

Company Background l Founded: » 1992 » by Graydon Beatty l Headquarters: » St. Paul, Minnesota l Employees » 170+ l Research & Development » $ 60, 000+ l Market Interest » Exclusively EP Focused

Current Technology Contact Mapping Single-point l Basket Electroanatomic Resolution limited by the time available to acquire data and is restricted to sustained, monomorphic, & hemodynamically-tolerated arrhythmias

US Arrhythmia Population Prevalence Vs. EP Procedures Treatment Options l Palliative Therapies 130, 000 Procedures » Antiarrhythmic Medications » Anticoagulant Medications » Permanent Pacing Modalities » ICD Therapy l Curative Therapies » Ablation Therapy Source: John G. Kinnard & Co. Research Report 12 -10 -98 Medical Data International; Vol. IX: No. 11 -12, November 1999 4, 000

Supraventricular Tachycardia U. S. Prevalence vs. EP Procedures SVTs 3, 000 Source: John G. Kinnard & Co. Research Report 12 -10 -98 Medical Data International; Vol. IX: No. 11 -12, November 1999 * 50, 000 * 20, 000 * 10, 000 * n. s. 85, 000 WPW/AVNRT AFL AT AFIB Total

Ventricular Tachycardia U. S. Prevalence vs. EP Procedures Source: John G. Kinnard & Co. Research Report 12 -10 -98 Medical Data International; Vol. IX: No. 11 -12, November 1999 * 30, 000 * 15, 000 45, 000 Non sustained, Post MI Sustained, Tolerated Total

Demographic Trends 350, 000 4% CAGR 300, 000 250, 000 Total Population 55+ Population 200, 000 150, 000 11% CAGR 100, 000 50, 000 1995 2000 2010 CAGR: Compounded Annual Growth Rate Source: Bureau of the Census; U. S. Department of Commerce

Arrhythmia Trends l Volume and complexity of EP cases are expected to increase significantly in the near future. » Demographics » Cardiovascular disease » Redo procedures » Increased patient expectations for better therapies

Productivity Trends Arrhythmia Population # of Patients & Productivity Complexity Productivity Time

Clinical Management Options l As demand increases: » (A) You can add people (EPs, Techs, Nurses) & capital (Labs) » (B) Improve productivity » (C) Both A & B » (D) Turn away patients

System Overview

The l ® En. Site Specifications: Length 110 cm Introducer: 9 French Braid size 1. 8 x 4. 5 cm Balloon size 7. 5 ml Electrodes 64 microelectrodes Catheter

The En. Site ® 3000 System Silicon Graphics Workstation - Receives Signals from PIU - Graphically Displays Data Patient Interface Unit - Receives & Amplifies Signals - Converts: Analog to Digital

Methodology

Methodology Overview l Location Algorithms » Are used to create an accurate replication of heart chamber anatomy (Geometry). » Geometry (distance & location) is required for solving Laplace (Signal Algorithms). » Location algorithms are also used to orient (navigate) any standard EP catheter relative to the En. Site® Catheter Electrode Array. l Signal Algorithms » The Inverse Solution of Laplace’s equation, uses voltages measured on the En. Site® Catheter to calculate voltage on the endocardium. » The Boundary Element Method (BEM) is used to create a voltage field across the endocardium by solving Laplace for each of the 64 electrodes on the En. Site®, over time.

Location Algorithm Process: Result: E 1 & E 2 Alternated @ 200 X Sec (Distance) EA 5 k. Hz E 2 The Signal Generator (PIU) sends a 5 k. Hz signal through the roving catheter. Electrodes (E 1 & E 2) on the En. Site® Catheter alternately receive & then return the 5 k. Hz signal to the (PIU). The 64 electrodes on the EA also sense the 5 k. Hz signal and by a process similar to triangulation (using the alternating return paths) are able to precisely locate the roving catheter. The output of this process is the 3 -Dimensional location of the electrode tip of the roving catheter.

Location Algorithm

Geometry Creation l With the ability to locate the tip of a roving catheter, distance (d) can be calculated. l By moving the roving catheter along the outer boundaries of the heart chamber, the system will sample and store geometry points at a rate of 100 X per second. l The system automatically stores only the most distant points. l The calculation of these points creates the geometry of the chamber 1 En. Guide Beacon EA (d) Roving Catheter 2 3

Geometry Creation

Signal Algorithms l Based upon knowledge of chamber geometry, the Boundary Element Method (BEM) is used to obtain the Inverse Solution (IS) of Laplace’s equation, by using voltages measured on the EA to calculate voltage on the endocardium. l This process is used to create a voltage field across the endocardium by solving the (IS) for each of the 64 electrodes on the EA, over time @ 1200 times per second. All electrodes are influenced by all Endocardial potentials. EA

Signal Algorithms l Colors represent voltage; purple for most positive, white for most negative l Isopotential maps display voltage at any site for a given sample point in time l Maps represent real-time animated displays of Endocardial potentials

Features & Benefits

Real-time Mapping One Geometry Infinite Maps

Virtual™ Electrograms Virtual EGMs l Electrical activity for any site on the map can be obtained in the form of “Virtual” electrograms by clicking the mouse cursor on the site of interest.

Interactive Map Display Map Rotation l Map Scaling Maps can be viewed from any anatomical perspective, and may be zoomed in or out, and labeled as desired to facilitate data interpretation.

Precise Catheter Navigation l The En. Guide™ signal visually displays the location of a roving catheter l Accuracy is within +/- 1 mm.

Isochronal & Isopotential

Mapping Method Comparison Single-point Electro-anatomic Mapping Non-contact Mapping Geometry creation = Mapping is independent of Geometry creation. If rhythm changes, a new map (geometry) must be created (80 400 contact points per map @ 30 seconds per point). If rhythm changes, new maps can be recorded instantaneously from just one beat.

Benefits Summary Non Contact, Single Beat, Real-Time, Precision Catheter Navigation l Expanded indications for ablation » Non sustained rhythms » Unstable patients » Polymorphic rhythms l Reduced procedure times » Case Times YTD: (N=850) » < 20 min: Geometry Creation » < 20 min: Arrhythmia Induction & Mapping l Reduced radiation exposure » En. Guide™ catheter navigation requires less reliance on fluoroscopy » < 1 Hr: Average Fluoroscopy Time

Case Study Examples

Atrial Flutter

Atrial Flutter l Objective: » Identification of the reentrant circuit l Isthmus Region: » If the reentrant circuit includes activation of this region, then successful isthmus ablation will cure this arrhythmia. l Surgical Scar: » If the reentrant circuit travels around a surgical scar, ablative cure is possible by performing a successful ablative lesion from the surgical scar to a conduction boundary.

Case Study Example

® En. Site l System Advantages Isthmus Ablation: » En. Guide beacon guides linear lesion ablation along isthmus. » Lesion Markers are cataloged on En. Site anatomical model. » One CS paced beat and one lateral paced beat are used to assess bidirectional block of linear lesion. » Gaps in linear lesion can be identified and targeted on En. Site map and thus fewer additional lesions if any are needed to complete lesion. » If flutter is still present, a differential diagnosis between an unsuccessful isthmus ablation and another arrhythmia is available from mapping one beat. l Surgical Scar: » With each RF ablation, the architecture of the heart and hence the activation pattern changes. Validating the completeness of an ablative lesion bounded by a surgical scar and an anatomical boundary is possible and quicker by one-beat mapping with En. Site.

Confirming Line of Block

LOB Gap Identification

Atrial Tachycardia

Atrial Tachycardia l Objective: » Identification of the site of earliest activation; specifically the earliest activation that precedes the P wave. l Conventional Mapping: » Placing multiple multipolar catheters throughout the atria along regions of likely tachycardia sites, moving these multipolar catheters around the chamber until the earliest activation is found.

Atrial Tachycardia

Atrial Tachycardia

® En. Site l System Advantages Focal Ablation: » Global single-beat identification of the focal site(s). » Conventional mapping requires that multipolar catheters be continuously repositioned until the early activation site is found. A conventional catheter would need to be at the early activation site during the ectopic beat or tachycardia. » Single-beat non-contact mapping provides a quicker diagnosis.

Clinical Experience and Validation

System Installations as of September, 2000 6/99 10/98

En. Site Procedures as of September, 2000 6/99 10/98

Clinical Case Mix l USA Experience: » 1371 Patients » 76% SVT’s » 24% VT’s

Validation Summary

Validation En. Guide™ locator signal l In vitro » Tank Model » 5 electrodes 12 mm apart » Electrodes paced and located l In vivo » 11 animals with 4 plunge electrodes » Electrodes paced, located, ablated » RF markers examined post-mortem l Summary » The En. Guide locator signal is accurate to within + 1 mm

Validation Virtual Electrograms l In vitro » » l In vivo » » l 11 animals with 4 plunge electrodes Timing and morphology compared to contact catheters Clinical » l Tank Model Virtual EGMs compared to contact catheters for timing and morphology cross-correlation 12 humans studied during AFL Summary » EGM reconstruction is good (. 80 correlation at sites < 4 cm)

System Costs, Training & Post-Acquisition Support

Product/Services l System Components: » En. Site 3000® EP Workstation – Patient Interface Unit (PIU) – Silicon Graphics, Inc. Workstation (SGI) – Slave monitor – Anthro Carts – Cost $194, 520 » En. Site® Catheter – Single-Use Catheter – Packaged in boxes of five (5) – Cost $15, 000 per Box l $3, 000 per Catheter l Warranty Programs: » Standard Warranty – Assurance Plus l @ Purchase no-charge l One Year Coverage » Extended Warranty(s) – Assurance Plus Extended l One Additional Year l $15, 899 l Two Additional Year l $26, 999

Financing Options l The Endocardial Solutions third-party financing program is designed to facilitate the purchase of the En. Site 3000® EP Workstation for the mapping and diagnosis of complex arrhythmias. l In collaboration with Creekridge Capital, Inc. , ESI is prepared to facilitate the following financing options for hospitals interested in the purchase of ESI’s products and associated optional extended warranty programs: » Operating Leases » Capital Leases » Long-term Rentals » Low Interest Financing » Delayed Payments Programs

Capital Purchase Terms » There are no minimum catheter purchase requirements, beyond what is required for training. » Capital purchasers receive a discount of $100 on all catheter purchases. Pricing l System: » Price: l $194, 520 Catheters: » Price (Each): $3, 000 » Discounted Price: $2, 900 » Minimum purchase of fifteen (15) training catheters are required at time of installation. l Maintenance: » One year warranty comes with each system. Additional coverage can be provided.

Leasing Option Terms » Capital or Operating Leases are available from 12 to 48 Months Pricing l System: » Price: $194, 520 » Cost per Month: $4, 000 to $14, 000 » Monthly costs are dependent on term. » Advantage: There are no l Catheters: minimum catheter » Price (Each): $3, 000 purchase requirements, » Discounted Price: $2, 900 beyond what is required » Minimum purchase of fifteen (15) for training. Lease training catheters are required at time purchasers receive a of installation. discount of $100 on all l Maintenance: catheter purchases. » One year warranty comes with each system. Additional coverage can be provided.

Rental Program Terms » Month to Month » 3 Month Minimum Rental » Cancellations require a 30 day notification in advance. » Conversion to Purchase Option: – All rental systems are convertible to purchase at anytime after 3 months. – 50% of all rental payments are applicable the buy-out of the rental contract after 3 months. Pricing l System: » Cost per Month: $6, 224 l Catheters: » Price (Each): $3, 000 » Minimum purchase of fifteen (15) training catheters required at time of rental. l Maintenance: » ESI is responsible for normal maintenance and repair.

Customer Training Goal: Independent Expert Users Wk 1: System Install & Training at ESI Wk 2 -4: FCE support for min. 3 ESI cases/wk Wk 4 (end): FCE & account complete skill assessment Possible visit with En. Site clinical expert Wk 5 -8: FCE support for min. of 3 ESI cases/wk End of wk 8: Account certified -independent expert users

Public Relations Support l Support hospitals interested in cooperative marketing through: » Local Print and Media Campaigns » Patient Referral Development » Patient Education Materials » Cross links to websites

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