1. Given® Patency System is an investigational device in the USA

2. 2 RAPID ® 3 Software Platform Advanced Tools for Diagnostic Proficiency Small Bowel Imaging Enhancements: Tissue Color Bar simplifies locating anatomical landmarks QuadView mode improves reading efficiency Advanced Reporting with My GI Dictionary QuickView provides pre-scanning overview of case Esophageal Capabilities: PillCam ESO captures forward and retrograde images Individual or simultaneous display of both videos Displays esophageal transit time Small Bowel Imaging Esophageal Imaging

3. 3 RAPID ® 3 Software Platform Small Bowel Imaging

4. 4 RAPID ® 3 Software Platform Esophageal Imaging

5. 5 INDICATIONS First line diagnostic exam for visualization of small bowel mucosa Clinical data reviewed 32 independent studies which indicate CE diagnostic yield of 71% vs. 41% diagnostic yield for all other modalities combined 1 Established as gold standard for diagnosis of disease of small intestine 2 Now cleared in the US for pediatric population from 10-18 years old 1.Internal data at Given Imaging Ltd. Reviewed by the FDA 2.Rex, et. Al; WIRELESS CAPSULE ENDOSCOPY DETECTS SMALL BOWEL ULCERS IN PATIENTS WITH NORMAL RESULTS FROM STATE OF THE ART ENTEROCLYSIS The American Journal of Gastroenterology, Vol. 98, No. 6 PillCam™ Endoscopy of the Small Bowel

6. 6 CONTRAINDICATIONS In patients with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile. In patients with cardiac pacemakers or other implanted electromedical devices 1. In patients with swallowing disorders. 1 Leighton JA,, et al, SAFETY OF CAPSULE ENDOSCOPY IN PATIENTS WITH PACEMAKERS, Gastrointest Endosc. 2004 Apr;59(4):567-9. Concludes that capsule endoscopy appears to be safe in patients with cardiac pacemakers and does not appear to be associated with any significant adverse cardiac event. Pacemakers do not interfere with capsule imaging. PillCam™ Endoscopy of the Small Bowel

7. 7 PillCam™ Endoscopy Easily ingested, painless procedure Progresses naturally through the GI tract via peristalsis Ambulatory/office examination Disposable PillCam™ video capsule

8. 8 1. The PillCam™ Capsule 2. SensorArray™ SB 3. Given ® DataRecorder™ PillCam™ SB Exam Set 2 1 3

9. 9 PillCam™ SB Capsule Components 1.Optical dome 2.Lens holder 3.Lens 4.Illuminating LEDs (light emitting diodes) 5.CMOS (Complementary Metal Oxide Semiconductor) image 6.Battery 7.ASIC (Application Specific Integrated Circuit) transmitter 8.Antenna Dimensions: Height: 11mm Width: 26mm Weight: 3.7gr 1.Optical dome 2.Lens holder 3.Lens 4.Illuminating LEDs (light emitting diodes) 5.CMOS (Complementary Metal Oxide Semiconductor) image 6.Battery 7.ASIC (Application Specific Integrated Circuit) transmitter 8.Antenna Dimensions: Height: 11mm Width: 26mm Weight: 3.7gr

10. 10 PillCam™ SB Patient Experience Liquid diet from lunch the day before 12 hour fast the night before Capsule ingested in the morning Liquid diet after 2 hours Light meal 4 hours after ingestion Disconnect after 8 hours

11. 11 Images Taken by the PillCam™ SB Video Capsule

12. 12 Click on image to view video Normal Villi in the Small Bowel

13. 13 Small Bowel Crohn’s Disease Click on image to view video

14. 14 Click on image to view video Small Bowel Carcinoid Tumor

15. 15 Click on image to view video Malabsorption, Celiac Sprue

16. 16 Angiodysplasia Click on image to view video

17. 17 Click on image to view video Colonic diverticula

18. 18 PillCam™ SB Patient Outcomes and Management in OGIB

19. 19 Change in Patient Management & Positive Outcome in OGIB CE results led to treatments resolving the bleeding in 86.9% of patients undergoing the procedure while actively bleeding. (12 – 25 month follow up) Pennazio M, Santucci R, Rondonotti E, et al. Gastroenterology 2004; 126: 643-653

20. 20 Pennazio M, Santucci R, Rondonotti E, et al. Gastroenterology 2004; 126: 643-653 82.6 % Negative predictive value 97.0 % Positive predictive value 95.0 %Specificity 88.9 %Sensitivity (Analysis of patients with verified final diagnosis, n = 56) PillCam™ SB High Sensitivity & Specificity in OGIB

21. 21 If done early in the course of the workup, PillCam™ endoscopy could: Shorten considerably the time to diagnosis Lead to definitive treatment in a relevant proportion of patients Spare a number of alternative investigations with low diagnostic yield Pennazio et al. 2004 Conclusions for OGIB: Pennazio M, Santucci R, Rondonotti E, et al. Gastroenterology 2004; 126: 643-653

22. 22 PillCam™ SB Endoscopy in Detecting Crohn’s Disease

23. 23 1.Although 75% of patients with Crohn's disease have small bowel involvement, more than one third have disease isolated to the small bowel. 2.Recent capsule data reveals that there is more extensive small bowel involvement in Crohn's disease than previously recognized. Crohn's disease often involves the proximal small bowel, and may be isolated to the proximal or mid-small bowel in many cases. Facts about PillCam™ Endoscopy and Crohn’s Disease

24. 24 Capsule endoscopy is more sensitive for small bowel ulcers than the best enteroclysis available. 1 Capsule endoscopy is the new gold standard for detection of small bowel Crohn´s disease. 1 1 Rex et al. American Journal of Gastroenterology. 2003, 98 (6): 1295-1298 PillCam™ SB Endoscopy The Gold Standard for Small Bowel Imaging

25. 25 * P < 0.04 Diagnostic yield (% of patients) 0 10 20 30 40 50 60 70 80 PillCam CapsuleSBFTEntero-CT 1 Eliakim et al. European Journal of Gastroenterolgy & Hepatology 2003, 15: 1-5 PillCam™ SB is superior to SBFT/Entero CT in suspected Crohn´s Disease 1

26. 26 PillCam™ SB Detecting Crohn´s Disease Strictured ulcer A deep fissure can be seen in the histological examination Typical granulomas can be seen in the wall of the small intestine

27. 27 PillCam™ SB Crohn´s Disease Click on image to view video

28. 28 PillCam™ SB Clinical Acceptance

29. 29 Clinical Acceptance In use in over 1,800 sites worldwide (4/04) 1 More than 100,000 ingestions worldwide (4/04) 1 202 Peer Reviewed studies published to date (7/04) 2 1 Data on file www.givenimaging.com 2 Medline, 07/04

30. 30 Peer Reviewed Publications (cumulative)

31. 31 5 24 %** 56 % (p<0.05)**89 430 % 55 %21 3 28 % 59 % (p<0.05) 29 256 % 75 % (p=0.04) 57 1 28 %* 66 % (p<0.001)* 32 Ref.PEPillCam SBN * lesions = definite source of symptoms ** Method only was diagnostic 1 Ell et al. Endoscopy 2002; 34 (9): 685 - 689 2 Delvaux et al. Gastrointestinal Endoscopy, April 2002, Vol 55, 5, p: AB88 (Abstract 400) 3 Demedts et al. Gastrointestinal Endoscopy, April 2002, Vol 55, 5, p: AB146 (Abstract M2027 4 Lewis and Swain. Gastrointestinal Endoscopy 2002; 56: 349-353 5 Pennazio et al. Endoscopy 2002; 34 (Suppl II) A91 PillCam™ SB: Superior diagnostic yield vs Push-Enteroscopy

32. 32 38 lesions22 lesions 14 2 15 % *85 % * 20 1 32 – 37 %70 % 20 Ref.X-rayN * Positive findings 1 Eliakim et al. European Journal of Gastroenterolgy & Hepatology 2003, 15: 1-5 2 Costamagna et al. Gastroenterology 2002; 123: 999-1005 3 Voderholzer et al. Gastrointestinal Endoscopy, April 2002, Vol 55, 5, p: AB139 (Abstract M1999) + Poster, DDW 2002 PillCam™ SB: Superior diagnostic yield versus X-Ray PillCam™ SB

33. 33 Efficacy of PillCam™ Endoscopy in OGIB

34. 34 Efficacy of PillCam™ Endoscopy in Suspected Crohn’s Disease

35. 35 Efficacy of PillCam™ Endoscopy in Tumors and Small Bowel Polyps

36. 36 PillCam™ Endoscopy and Pediatrics

37. 37 Efficacy of PillCam™ Endoscopy in Celiac disease

38. 38 Global Reimbursement Status

39. 39 Global Reimbursement Reimbursement for PillCam™ SB is approved in many regions of the world including: Australia, Austria, Denmark, Italy*, Mexico, New Zealand, Portugal, Sweden, and the United States. * Piemonte

40. 40 Global Reimbursement Status (1) Includes suspected Crohn’s disease and may include additional suspected small bowel pathologies Small Bowel Reimbursement Coverage 39 53 62 100 152 193 206 221 235

41. 41 Reimbursement Developments in US (April 2004) Assignment of a permanent (level I) CPT code by the AMA (effective January 1, 2004) BC/BS Tech Assessment finds PillCam™ SB suitable for initial diagnosis of Crohn’s disease Adopted by BC/BS carriers with 20 million covered lives in total

42. 42 Suspected Crohn’s Disease Exclusion of small bowel tumors Gastrointestinal Bleeding * Guidelines will vary by payer and state Medicare guidelines Examples of Covered Indications (April 2004)

43. 43 Examples of Medicare Global Fees for the Physician office: San Francisco, CA$1,298 Manhattan, NY $1,220 Chicago, IL $1,007 Boston$1,122 Miami, FL $ 976 * Medicare payment varies by geographic index US Reimbursement (April 2004)

44. 44 PillCam™ Endoscopy of the Esophagus

45. 45 PillCam™ ESO Examination Set 2 1 3 1. PillCam™ ESO Capsule 2. SensorArray™ ESO 3. Given ® DataRecorder™ 2

46. 46 PillCam™ ESO Capsule Components Dimensions: Height: 11mm Width: 26mm Weight: 3.7gr Dimensions: Height: 11mm Width: 26mm Weight: 3.7gr Dome Cover Optics Batteries Dome PCB Spacer +Switch

47. 47 Why Screen the Esophagus? 1.Barrett’s Esophagus (BE) is a sequelae of chronic gastroesophageal reflux and is a known pre-malignant lesion. 2.Up to 10% of white males with chronic GERD may harbor BE. 3.It is estimated that patients with BE have approximately a 0.5% per patient year incidence of esophageal adenocarcinoma. Eliakim et al. Esophageal Capsule Endoscopy (ECE) is Comparable to Traditional Endoscopy for Screening Patients with GERD Symptoms. Gastrointest Endosc 2004 Apr;59(5) AB 187

48. 48 Why Screen the Esophagus? 4.Current accepted practice includes endoscopic screening for BE in those with chronic symptoms. 5.Current society guidelines do recommend screening for this disorder. 6.Patient compliance and economic factors are major barriers to traditional endoscopic screening. 7.The PillCam ESO capsule may provide a promising less-invasive approach to endoscopic screening for disorders of the esophagus. Eliakim et al. Esophageal Capsule Endoscopy (ECE) is Comparable to Traditional Endoscopy for Screening Patients with GERD Symptoms. Gastrointest Endosc 2004 Apr;59(5) AB 187

49. 49 AIM To compare the performance of the PillCam™ ESO video capsule to standard endoscopy in the detection of esophageal pathologies. PillCam™ ESO Video Capsule Feasibility Study Eliakim et al. Esophageal Capsule Endoscopy (ECE) is Comparable to Traditional Endoscopy for Screening Patients with GERD Symptoms. Gastrointest Endosc 2004 Apr;59(5) AB 187

50. 50 PillCam™ ESO Video Capsule Feasibility Study METHODS 17 eligible patients signed a written informed consent. Following 6 hours of fast, patients swallowed the twin capsule using a specific supine maneuver. Patients underwent a standard gastroscopy. The physician interpreting the RAPID ® video was blinded to endoscopy results and vice versa. Success rates were compared to Gastroscopy as the “gold standard”. Eliakim et al. Esophageal Capsule Endoscopy (ECE) is Comparable to Traditional Endoscopy for Screening Patients with GERD Symptoms. Gastrointest Endosc 2004 Apr;59(5) AB 187

51. 51 Results All 17 patients swallowed the capsule without any difficulties. There were no adverse events. Mean esophageal passage time was 189+280 sec. Compared to 2 sec. in Pillcam SB procedure. 12/17 patients had esophageal pathologies. Capsule identified all pathologies. Capsule sensitivity was 100%. PillCam™ ESO Video Capsule Feasibility Study Eliakim et al. Esophageal Capsule Endoscopy (ECE) is Comparable to Traditional Endoscopy for Screening Patients with GERD Symptoms. Gastrointest Endosc 2004 Apr;59(5) AB 187

52. 52 Normal Z-line PillCam™ ESO Normal Z-line

53. 53 Esophagitis PillCam™ ESO Esophagitis

54. 54 Suspected Barrett’s PillCam™ ESO Suspected Barrett’s

55. 55 Polyps PillCam™ ESO Polyps

56. 56 Traditional Endoscopy detected findings in 12 of 17 pts PillCam™ ESO detected findings in same 12 of 17 pts, plus 1 additional patient Endoscopic Findings

57. 57 1.PillCam™ endoscopy of the esophagus is a convenient, patient friendly and highly sensitive method for visualization of esophageal disorders. 2.PillCam™ endoscopy of the esophagus with bi- directional viewing, may have diagnostic yield advantages over traditional endoscopy. 3.Patients prefer PillCam™ endoscopy of the esophagus over traditional endoscopy. 4.PillCam™ endoscopy of the esophagus may provide an effective method to screen patients for Barrett’s esophagus. 5.Further studies are needed to statistically confirm above results. Conclusions

58. 58 Given ® Patency System Given ® Patency System is an investigational device not cleared for marketing in the USA

59. 59 Given ® Patency System Given ® Patency Capsule Given ® Patency Scanner 26mm long X 11mm diameter (same dimensions as PillCam™ SB) A dissolvable capsule containing a detectable Radio Frequency Identification (RFID) tag and is propelled through the GI tract by natural peristalsis. CE Mark Permits marketing in Europe Given Patency System is an investigational device not cleared for marketing in the USA

60. 60 Advantages of Given ® Patency Capsule Simple procedure No prep required Safe Low cost Radiation-free Minimally-invasive Clinic-based diagnostic tool Provides effective evaluation of functional patency Given Patency System is an investigational device not cleared for marketing in the USA

61. 61 To assess suspicion of strictures Chronic NSAID use Crohn’s disease Radiation enteritis For strictures not seen radiographically Post-operative Assessment of anastomosis Adhesion related disease Need for Given ® Patency Given Patency System is an investigational device not cleared for marketing in the USA

62. 62 Before After Timer plug Lactose body w/barium RFID tag Exposed window Parylene coating 12mm Given ® Patency Capsule Given Patency System is an investigational device not cleared for marketing in the USA

63. 63 Capsule disintegrates after 40 hours Capsule excreted intact in >80% of patients in less than 40 hours Capsule disintegrates after 40 hours - Patency proven Ingestion Scanning* (24-36 hours) Patency NOT proven *If Given ® Patency Scanner is contraindicated, use fluoroscopy Given ® Patency Procedure Given Patency System is an investigational device not cleared for marketing in the USA

64. 64 Given ® Patency Capsule Clinical Results ReferenceContent Spada C, Spera G, Riccioni ME, et al. M2A Patency Capsule Prior to Video Capsule Endoscopy in Patients with Morphological Small Bowel Strictures.Gastrointest Endosc 2004 Apr; 59(5) AB 1698 11 patients with a diagnosis of Crohn’s disease were prospectively studied. 2 of the 9 patients were excluded from ingesting an imaging capsule. In the other 7 cases the video capsule passed with no adverse events. The video capsule showed the presence of ulcers, cobblestone pattern, mucosal erosions, and a substenotic area. The patency capsule may indicate functional bowel patency in cases with known morphological intestinal strictures. Costamagna G, Spada C, Spera G, et al.. Evaluation of the Given Patency System in the GI tract: Results of a Multi-Center Study. Gastrointest Endosc 2004 Apr; 59 (5) AB 1697 61 patients ingested the patency capsule, 36 were excreted intact, 27 disintegrated in the GI tract, 1 capsule was retained in a long stricture that was resected at laparotomy. Of the 54 patients who had radiolographically indicated strictures, 31 passed the capsule intact. The Given patency capsule is a simple, radiation free ingestible diagnostic tool. It indicates functional patency for video capsule passage even in cases where radiography indicates stricture. The excretion of an intact Given patency capsule, within a short time can be used as a predictor of GI patency before the Given video capsule. Given Patency System is an investigational device not cleared for marketing in the USA

65. 65 Given ® Patency Capsule ingested 1 month later Stricture detected Given ® Patency Capsule excreted 7.5 hours following ingestion Result I: Patency when Stricture is indicated by Radiology Given Patency System is an investigational device not cleared for marketing in the USA

66. 66 In 4/4 PillCam™ SB capsules following Given ® Patency capsules: X-ray image with stricture, prior to ingestions Natural excretion of intact Given ® Patency capsule PillCam™ provided additional diagnostic information and video of stricture in small bowel Result II: When Given ® Patency Capsule indicates patency, PillCam™ SB passes naturally Given Patency System is an investigational device not cleared for marketing in the USA

67. 67 PillCam™ SB video capsules excreted naturally following intact excretion of Given ® Patency Capsule (17/17 w/SBFT based strictures, all sites) PillCam™ SB provided additional diagnostic information and video of stricture Given® Patency Capsule ingested 2 months later Stricture detected Given® Patency Capsule excreted 5.5 hours following ingestion PillCam™ SB video capsule ingested 1 day after Patency examination PillCam™ SB video capsule excreted 30 hours after ingestion Given Patency System is an investigational device not cleared for marketing in the USA Result III: When Given ® Patency Capsule indicates patency, PillCam™ SB passes naturally

68. 68 Conclusions Given ® Patency Capsule is a practical test to assess suspicion of strictures. May provide direct indication of functional patency, even in cases where radiology indicates physiological stricture. After Given ® Patency Capsule is excreted intact, ingestion of PillCam™ SB video capsule may follow. Given Patency System is an investigational device not cleared for marketing in the USA