BRAVO System Presentation pH System pH Monitoring with No Strings Attached

Current Technology and it’s Limitations Catheter Based Systems: Patient Intolerance Uncomfortable Pharyngeal and Throat Discomfort Runny Nose Artifact Prone Alters Regular Diet and Activity Requires Manometry                         

Bravo pH System™ Catheter-Free pH Monitoring System pH Capsule attached to the esophageal wall transmits data to pager-sized Receiver Eliminates uncomfortable 24-hr trans-nasal catheter Allows normal activities, showering and does not interfere with sleeping pH Monitoring with No Strings Attached

Vision: Bravo Technology at Work

Bravo pH System Components 1) Bravo Calibration Stand 2) Bravo pH Receiver 3) Bravo pH Capsule with Delivery System 4) Bravo pH Capsule 5) Bravo DataLink 6) Lithium AA Battery 7) Calibration Solutions (pH 7.01 & 1.07) 8) POLYGRAM NET pH Testing Application Optional: Vacuum Pump

Bravo pH Capsule with Delivery System For trans-nasal or trans-oral placement Single-Use item One-handed operation 100 cm long with working length of 80 cm Distance marks every 5 cm up to 60 cm Handle Catheter pH Capsule

Bravo pH Capsule with Delivery System Bravo pH Capsule placed via nose or mouth Trans-nasal placement relative to manometrically identified LES upper boarder Trans-orally placement relative to endoscopically identified Scuama-Columnar Junction Flexible Tip pH Capsule

Bravo pH Capsule pH Capsule measures esophageal pH with Antimony pH sensor Uses Radio-Telemetry to send data to Receiver Dimensions: 6 x 6.3 x 26 mm Contains: suction chamber, locking pin, 2 batteries, PCB, transmitter and pH sensor+ref. pH Capsule

Capsule Attachment Step 1 Step 2 Step 3 Step 4 Step 5 Position Bravo Capsule Step 2 Apply Suction Step 3 Advance Pin Step 4 Release Capsule Step 5 Begin pH Recording

Bravo pH Receiver pH Capsule transmits data to pager-sized Receiver Eliminates uncomfortable 24-hr trans-nasal catheter Allows showering and does not interfere with sleeping Receiver pH Capsule

Digital Radio-Telemetry Use Digital Radio-Telemetry Capsule measures pH every 6 sec and transmits data to receiver every 12 sec Keep the receiver within 1m to prevent data loss (range up to 3m)

Analysis Software pH study data uploaded to computer via DataLink Connects to Serial Port NB: Need own Serial Port as it cannot share with IRda for Digitrapper pH DataLink

POLYGRAM NET pH Testing Application User friendly Windows® software simplifies pH studies Report includes comprehensive pH study analysis

Features and Benefits Feature Benefit Catheter-Free Enhances Patient Comfort Eliminates Pharyngeal & Throat Discomfort, not Socially Embarrassing Patients are Less Likely to Miss Work Increases Freedom Patients Carry True Physiologic Data Reduces Chance of Artifact Increases Accuracy Easy to Perform Perform Same Time as EGD Available to All GI Docs Increase Physician Revenue Opportunity

Features and Benefits Feature Benefit 48-Hour Study Double the Diagnostic Information Bravo Designed for “Atypical” Patients - ENT, Pulmonary, Chest Pain Patient Acceptance Pre/Post Treatment Clinically Document Therapeutic Outcome or Drug Effectiveness

Clinicals Study Objectives Evaluate the Bravo pH Procedure Trans-nasally and Trans-orally Normal Range for 24/48-Hour pH Monitoring (Nasal & Oral) Assess the Complication Rates for Bravo pH System User Interface Performed at: University of Southern California (Dr. T.DeMeester) Cleveland Clinic (Dr. J. Richter) Northwestern University, Chicago (Dr. P.Kahrillas)

Bravo Clinicals - Preliminar Normal values Composite Parameters Nasal N=20 Oral N=27 Catheter N=50 Total % time pH <4 2.6 +1.6 4.2 +3.3 1.5 +1.4 % time pH <4 – upright 3.0 +2.1 4.9 +3.8 2.3 +2.3 % time pH <4 – supine 1.8 +4.0 2.5 +5.6 0.6 +1.0 Longest reflux episode (minutes) 7.5 +7.2 14.0 +17.1 6.7 +7.8 # > 5 min Reflux Episodes 1.1 +1.7 2.4 +3.6 0.8 +1.2 # Reflux Episodes 35.2 +21.0 41.6 +24.2 19.0 +12.8 DeMeester Composite Score (95th percentile) 12.9 13.3 14.7

Bravo Performs Clinically - Summary Bravo Market Studies Confirm/Validate Clinical Performance Bravo’s Capsule is Comparable to the Conventional Catheter in Quantifying Esophageal pH* The Bravo “Catheter-Free System” should Lead to Increased Patient Acceptance and Compliance of this Test for GERD* So in summary, how does Bravo perform? I think we have clearly demonstrated through our mkting studies Bravo’s clinical performance. As a conservative Brit would say, “ “ With that I would like to hand it back over to JK to wrap things up Thank You. *Christopher Streets, M.D. – DDW 2001

Would you undergo the pH test again? Yes No Bravo 100% 0 Patient Acceptance* Would you undergo the pH test again? Yes No Bravo 100% 0 Catheter 50% 50% *Christopher Streets, M.D., DDW 2001 How did the patients respond? As you can see there was a demonstrable difference between Bravo and Medtronic’s catheter based system. I would also like to point out that the 50% of patients who would undergo a second Medtronic study, would do so only if the doctor thought it was absolutely necessary.

Effect on Activities* A Lot 0.02 0.03 Moderate 0.006 0.05 N/S Slight None A Lot Moderate Slight 0.02 0.03 0.05 0.006 N/S Mentioned yesterday Dr. Fass data which indicated that catheter pH systems clearly effect study results. This study done by Dr. Christopher Streets at USC further substantiates Dr. Fass’ study. Having a catheter reduces the subjects activity and interaction with society (work, housework and shopping), but the sedentary and more private activities are not significantly affected by the catheter. A pValue of .03 means that there is a 3% chance that the difference b/w the 2 systems is due to chance alone. Therefore the difference b/w the 2 systems is 97% due to the Bravo capsule rather than eating itself. N/S N/S *Christopher Streets, M.D. – DDW 2001

At Last… Patient and Physician friendly pH Monitoring