BRAVO p H System Presentation p H Monitoring

BRAVO p. H System Presentation p. H Monitoring with No Strings Attached MEDTRONIC GASTROENTEROLOGY

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

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

Vision: Bravo Technology at Work MEDTRONIC GASTROENTEROLOGY

Bravo p. H System Components 1) Bravo Calibration Stand 2) Bravo p. H Receiver 3) Bravo p. H Capsule with Delivery System 4) Bravo p. H Capsule 5) Bravo Data. Link 6) Lithium AA Battery 7) Calibration Solutions (p. H 7. 01 & 1. 07) 8) POLYGRAM NET p. H Testing Application n Optional: Vacuum Pump MEDTRONIC GASTROENTEROLOGY

Bravo p. H Capsule with Delivery System n n Handle Catheter n n n p. H Capsule 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 MEDTRONIC GASTROENTEROLOGY

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

Bravo p. H Capsule n p. H Capsule measures esophageal p. H with Antimony p. H sensor n Uses Radio-Telemetry to send data to Receiver n Dimensions: 6 x 6. 3 x 26 mm n Contains: suction chamber, locking pin, 2 batteries, PCB, transmitter and p. H sensor+ref. MEDTRONIC GASTROENTEROLOGY

Capsule Attachment Step 1 Step 2 Step 3 Step 4 Step 5 Position Bravo Capsule Apply Suction Advance Pin Release Capsule Begin p. H Recording MEDTRONIC GASTROENTEROLOGY

Bravo p. H Receiver n n n Receiver p. H Capsule transmits data to pager-sized Receiver Eliminates uncomfortable 24 -hr trans-nasal catheter Allows showering and does not interfere with sleeping MEDTRONIC GASTROENTEROLOGY

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

Analysis Software n p. H study data uploaded to computer via Data. Link n Connects to Serial Port Data. Link NB: Need own Serial Port as it cannot share with IRda for Digitrapper p. H MEDTRONIC GASTROENTEROLOGY

POLYGRAM NET p. H Testing Application n User friendly Windows® software simplifies p. H studies n Report includes comprehensive p. H study analysis MEDTRONIC GASTROENTEROLOGY

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 Same Time as EGD Available to All GI Docs Increase Physician Revenue Opportunity MEDTRONIC GASTROENTEROLOGY

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 MEDTRONIC GASTROENTEROLOGY

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

Bravo Clinicals - Preliminar Normal values Nasal N=20 Oral N=27 Catheter N=50 Total % time p. H <4 2. 6 +1. 6 4. 2 +3. 3 1. 5 +1. 4 % time p. H <4 – upright 3. 0 +2. 1 4. 9 +3. 8 2. 3 +2. 3 % time p. H <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 De. Meester Composite Score (95 th percentile) 12. 9 13. 3 14. 7 Composite Parameters MEDTRONIC GASTROENTEROLOGY

Bravo Performs Clinically - Summary n n n Bravo Market Studies Confirm/Validate Clinical Performance Bravo’s Capsule is Comparable to the Conventional Catheter in Quantifying Esophageal p. H* The Bravo “Catheter-Free System” should Lead to Increased Patient Acceptance and Compliance of this Test for GERD* *Christopher Streets, M. D. – DDW 2001 MEDTRONIC GASTROENTEROLOGY

Patient Acceptance* Would you undergo the p. H test again? Yes No Bravo 100% 0 Catheter 50% *Christopher Streets, M. D. , DDW 2001 MEDTRONIC GASTROENTEROLOGY

Effect on Activities* 0. 02 A Lot Moderate Slight 0. 03 0. 05 None 0. 006 N/S N/S *Christopher Streets, M. D. – DDW 2001 MEDTRONIC GASTROENTEROLOGY

At Last… Patient and Physician friendly p. H Monitoring MEDTRONIC GASTROENTEROLOGY