1. BRAVO System Presentation pH System
pH Monitoring with No Strings Attached

2. 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
                        

3. 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

4. Vision: Bravo Technology at Work

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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)

12. 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

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

14. 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

15. 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

16. 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)

17. 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
% time pH <4 – upright
% time pH <4 – supine
Longest reflux episode (minutes)
# > 5 min Reflux Episodes
# Reflux Episodes
DeMeester Composite Score (95th percentile)
12.9
13.3
14.7

18. 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

19. 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 % %
*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.

20. 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

21. At Last…
Patient and Physician friendly pH Monitoring