CONFIDENTIAL 1 PillCam ™ COLON Trial Results

2 Agenda  First Feasibility Studies – Overview  Study Results of MA-48 Feasibilit

3 Type # of sites PISubjects Comparative Arm Presenta tion Publication Completed 1Feasibility3Eliakim, Israel 91ColonoscopyACG 06 Endoscopy, 10/06 2Feasibility1Deviere, Belgium 41ColonoscopyUEGW 06 Endoscopy, 10/06 3Feasibility1Lewis, US 51 Colonoscopy, VC ACG 06 Work In Progress Work in progress 4Pivotal8Deviere, Belgium 225 / 340ColonoscopyDDW 07? 5Pivotal7Rex-Eisen, US 25 / 340Colonoscopy To commence within few months 6CRC screening12Galmiche, France 600Colonoscopy 7Feasibility1Sung, China 40Colonoscopy 8Feasibility3Riemann, Germany 50Colonoscopy 9Feasibility5PI tbd, Italy 60Colonoscopy 10 /11 2 feasibilities6-8 Munoz/Herrerias, Spain 60Colonoscopy Clinical Trials

4 Conclusions from Feasibility Trials “Colon Capsule Endoscopy showed promising accuracy compared with colonoscopy. This new noninvasive technique deserves further evaluation as a potential CRC screening tool.” October2006I

5 Conclusions from Feasibility Trials October2006 “PillCam Colon capsule endoscopy appears to be a promising new modality for colonic evaluation. Further improvements in the procedure will probably increase capsule examination completion and polyp detection rates. Additional studies are needed to evaluate the accuracy of PillCam Colon endoscopy in other populations with different prevalence levels.” II

6 Capsule Colonoscopy – A Pilot Three Arm, Blinded Trial of Capsule Colonoscopy, Virtual Colonoscopy and Colonoscopy Blair Lewis 1, Douglas Rex 2, David Lieberman 3 Private practice, New York, New York 1 ; Indiana University School of Medicine, Indianapolis, Indiana 2 ; Oregon Health and Science University, Portland, Oregon 3 Introduction: Colon capsule endoscopy (CCE) is a new endoscopic capsule for visualization of the colon. The capsule is 31x11mm. It has two imagers and obtains 4 frames per second. It is not a FDA approved device. A blinded trial was being performed to assess the feasibility and efficacy of this technology in screening patients at risk for colon polyps and cancer. Materials and Methods: At risk volunteers were recruited. Study entry required age over 50 and not having colonoscopy within 5 years or having a family history of colon cancer or the presence of symptoms suspicious for cancer. Volunteers were paid and signed IRB approved consent forms. Patients initially underwent CCE and within 3 weeks took a second preparation and underwent virtual (VC) and standard colonoscopy (SC) on the same day. The colonoscopist was blinded to the findings of the previous tests. At SC, results of the two previous tests were serially unblinded. Results were reviewed. Significant findings were defined as any polyp ≥6mm in size or 3 or more polyps of any size. Conclusions: Colon capsule endoscopy appears to be a promising new technology for screening the colon for polyps in patients at risk for colorectal cancer.  This feasibility study demonstrates that capsule colonoscopy appears to be a safe and promising new technology for visualizing the colon  This capsule colonoscopy may complement traditional colonoscopy for: Contraindicated colonoscopy Incomplete colonoscopy Patients unwilling to undergo standard colonoscopy  Capsule colonoscopy appears to be more sensitive than virtual colonoscopy in detecting small colon polyps Inclusion Criteria:  Patients between the ages of Indicated for CRC screening, who did not have colonoscopy in last 5 years, OR with current or recent history of IDA  Patients between the ages of With family history of colonic polyps or CRC With FOBT positive  Patients sign an IRB informed consent form Exclusion Criteria:  Dysphagia  Known or suspected bowel obstruction  High risk for capsule retention and abdominal surgery of the GI tract within the last six months  Contra-indication for any procedure prescribed in the study, e.g., ingestion of oral sodium phosphate or polyethylene glycol solutions, Tegaserod or Bisacodyl suppository  Congestive heart failure or renal insufficiency or liver disease  Cardiac pacemakers or other implanted electro medical-device  Pregnancy  MRI examination within 7 days after capsule ingestion  Current life threatening conditions Study Overview: Capsule procedure: Day -1: Clear liquids and evening laxative as below Day 0: Laxatives and prokinetic agents, Capsule ingestion Capsule video review by Investigators DR, DL* Within 3 weeks following Capsule procedure: Early morning: Virtual colonoscopy by investigator JM* Midday: Colonoscopy by investigator BL* then sequential un-blinding * all investigators blinded to each other Capsule Colonoscopy Preparation: Day -1 Clear Liquid diet – Liter PEG Exam day7 00 – Liter PEG mg Tegaserod 8 30 Capsule ingestion Boost I (30ml NaP) * mg Tegaserod Boost II (15ml NaP) Suppository 10mg Bisacodyl - if needed Regular meal * Pending verification that the capsule had exited the the stomach using a real-time viewer. Assessment of Bowel Cleansing: Poor- Large amount of fecal residue Fair- Enough feces or dark fluid present to preclude a completely reliable examination Good- Small amount of feces or dark fluid, but not enough to interfere with examination Excellent- No more then small bits of adherent feces PoorFairGoodExcellent Study Results - Enrollment: 64 patients screened - 12 failed 52 enrolled - 1 discontinued 51 completed trial -Average age 54 (40-74) -28 Males, 23 Females -31 for screening -16 for family history -3 for blood in stool -1 for personal history of polyps Results - Bowel cleanliness: Transit time from ingestion to excretion 2% 90 % 6% 2% Results - Capsule Transit: Capsule Location at 10 hrs Results - Polyp Detection:  Polyps of any size/path were found in 29/51 patients (57%) 60 polyps by un-blinded colonoscopy 60 polyps by un-blinded colonoscopy 55 polyps by colonoscopy 55 polyps by colonoscopy 94 polyps by capsule colonoscopy 94 polyps by capsule colonoscopy 26 polyps by virtual colonoscopy 26 polyps by virtual colonoscopy  Adenomatous polyps were found in 15/51 patients (29%) 17 total polyps in 15 patients - 3 TVA, 14 TA, 2-15mm, 8 polyps > 6mm 17 total polyps in 15 patients - 3 TVA, 14 TA, 2-15mm, 8 polyps > 6mm 16/17 detected by standard colonoscopy (1 missed and found on unblinding) 16/17 detected by standard colonoscopy (1 missed and found on unblinding) 12/17 detected by capsule 12/17 detected by capsule 5/17 detected by virtual colonoscopy 5/17 detected by virtual colonoscopy Results - Sensitivity and Specificity: ColonoscopyCapsuleVirtual Colonoscopy For any polyp Sensitivity93% (95% CI, 85-93%)83% (95% CI, 72-92%)38% (95% CI, 27-44%) Specificity100% (95% CI, %)45% (95% CI, 31-57%)86% (95% CI, 72-95%) PPV100% (95% CI, %)67% (95% CI, 58-74%)79% (95% CI, 56-92%) NPV92% (95% CI, 82-92%)67% (95% CI, 46-83%)51% (95% CI, 43-56%) For significant findings * Sensitivity89% (95% CI, 77-89%)56% (95% CI, 38-71%)33% (95% CI, 20-38% Specificity100% (95% CI, %)76% (95% CI, 66-84%)97% (95% CI, 90-99%) PPV100% (95% CI, %)56% (95% CI, 38-71%)86% (95% CI, 52-97%) NPV94% (95% CI, 88-94%)76% (95% CI, 66-84%)73% (95% CI, 67-75%) * Significant findings: Polyps ≥ 6 mm OR three or more polyps of any size The Capsule: 11 x 31mm Wider angle of view 2 Frames/second from each side 10 gig recording device Ø11 mm 31 mm Virtual Colonoscopy: "Top CAT” GE 64-detector VCT was used to scan the patients' cleansed colons. Data was compiled and reviewed in 2D and 3D on a Vitrea workstation. Colonoscopy: Performed under conscious sedation (Demerol/Versed) Complete in all patients Limited withdrawal time to less than 10 minutes to limit study effect Polyp seen at colonoscopyPolyp seen on capsule III Conclusions from Feasibility Trials – ACG 2006 Poster

7 Capsule Colonoscopy – A Pilot Three Arm, Blinded Trial of Capsule Colonoscopy, Virtual Colonoscopy and Colonoscopy Blair Lewis 1, Douglas Rex 2, David Lieberman 3 Private practice, New York, New York 1 ; Indiana University School of Medicine, Indianapolis, Indiana 2 ; Oregon Health and Science University, Portland, Oregon 3 Introduction: Colon capsule endoscopy (CCE) is a new endoscopic capsule for visualization of the colon. The capsule is 31x11mm. It has two imagers and obtains 4 frames per second. It is not a FDA approved device. A blinded trial was being performed to assess the feasibility and efficacy of this technology in screening patients at risk for colon polyps and cancer. Materials and Methods: At risk volunteers were recruited. Study entry required age over 50 and not having colonoscopy within 5 years or having a family history of colon cancer or the presence of symptoms suspicious for cancer. Volunteers were paid and signed IRB approved consent forms. Patients initially underwent CCE and within 3 weeks took a second preparation and underwent virtual (VC) and standard colonoscopy (SC) on the same day. The colonoscopist was blinded to the findings of the previous tests. At SC, results of the two previous tests were serially unblinded. Results were reviewed. Significant findings were defined as any polyp ≥6mm in size or 3 or more polyps of any size. Inclusion Criteria:  Patients between the ages of Indicated for CRC screening, who did not have colonoscopy in last 5 years, OR with current or recent history of IDA  Patients between the ages of With family history of colonic polyps or CRC With FOBT positive  Patients sign an IRB informed consent form Exclusion Criteria:  Dysphagia  Known or suspected bowel obstruction  High risk for capsule retention and abdominal surgery of the GI tract within the last six months  Contra-indication for any procedure prescribed in the study, e.g., ingestion of oral sodium phosphate or polyethylene glycol solutions, Tegaserod or Bisacodyl suppository  Congestive heart failure or renal insufficiency or liver disease  Cardiac pacemakers or other implanted electro medical-device  Pregnancy  MRI examination within 7 days after capsule ingestion  Current life threatening conditions Study Overview: Capsule procedure: Day -1: Clear liquids and evening laxative as below Day 0: Laxatives and prokinetic agents, Capsule ingestion Capsule video review by Investigators DR, DL* Within 3 weeks following Capsule procedure: Early morning: Virtual colonoscopy by investigator JM* Midday: Colonoscopy by investigator BL* then sequential un-blinding * all investigators blinded to each other Capsule Colonoscopy Preparation: Day -1 Clear Liquid diet – Liter PEG Exam day7 00 – Liter PEG mg Tegaserod 8 30 Capsule ingestion Boost I (30ml NaP) * mg Tegaserod Boost II (15ml NaP) Suppository 10mg Bisacodyl - if needed Regular meal * Pending verification that the capsule had exited the the stomach using a real-time viewer. Assessment of Bowel Cleansing: Poor- Large amount of fecal residue Fair- Enough feces or dark fluid present to preclude a completely reliable examination Good- Small amount of feces or dark fluid, but not enough to interfere with examination Excellent- No more then small bits of adherent feces PoorFairGoodExcellent Study Results - Enrollment: 64 patients screened - 12 failed 52 enrolled - 1 discontinued 51 completed trial -Average age 54 (40-74) -28 Males, 23 Females -31 for screening -16 for family history -3 for blood in stool -1 for personal history of polyps Results - Bowel cleanliness: Transit time from ingestion to excretion 2% 90 % 6% 2% Results - Capsule Transit: Capsule Location at 10 hrs Results - Polyp Detection:  Polyps of any size/path were found in 29/51 patients (57%) 60 polyps by un-blinded colonoscopy 60 polyps by un-blinded colonoscopy 55 polyps by colonoscopy 55 polyps by colonoscopy 94 polyps by capsule colonoscopy 94 polyps by capsule colonoscopy 26 polyps by virtual colonoscopy 26 polyps by virtual colonoscopy  Adenomatous polyps were found in 15/51 patients (29%) 17 total polyps in 15 patients - 3 TVA, 14 TA, 2-15mm, 8 polyps > 6mm 17 total polyps in 15 patients - 3 TVA, 14 TA, 2-15mm, 8 polyps > 6mm 16/17 detected by standard colonoscopy (1 missed and found on unblinding) 16/17 detected by standard colonoscopy (1 missed and found on unblinding) 12/17 detected by capsule 12/17 detected by capsule 5/17 detected by virtual colonoscopy 5/17 detected by virtual colonoscopy Results - Sensitivity and Specificity: ColonoscopyCapsuleVirtual Colonoscopy For any polyp Sensitivity93% (95% CI, 85-93%)83% (95% CI, 72-92%)38% (95% CI, 27-44%) Specificity100% (95% CI, %)45% (95% CI, 31-57%)86% (95% CI, 72-95%) PPV100% (95% CI, %)67% (95% CI, 58-74%)79% (95% CI, 56-92%) NPV92% (95% CI, 82-92%)67% (95% CI, 46-83%)51% (95% CI, 43-56%) For significant findings * Sensitivity89% (95% CI, 77-89%)56% (95% CI, 38-71%)33% (95% CI, 20-38% Specificity100% (95% CI, %)76% (95% CI, 66-84%)97% (95% CI, 90-99%) PPV100% (95% CI, %)56% (95% CI, 38-71%)86% (95% CI, 52-97%) NPV94% (95% CI, 88-94%)76% (95% CI, 66-84%)73% (95% CI, 67-75%) * Significant findings: Polyps ≥ 6 mm OR three or more polyps of any size The Capsule: 11 x 31mm Wider angle of view 2 Frames/second from each side 10 gig recording device Ø11 mm 31 mm Virtual Colonoscopy: "Top CAT” GE 64-detector VCT was used to scan the patients' cleansed colons. Data was compiled and reviewed in 2D and 3D on a Vitrea workstation. Colonoscopy: Performed under conscious sedation (Demerol/Versed) Complete in all patients Limited withdrawal time to less than 10 minutes to limit study effect Polyp seen at colonoscopyPolyp seen on capsule Conclusions: Colon capsule endoscopy appears to be a promising new technology for screening the colon for polyps in patients at risk for colorectal cancer.  This feasibility study demonstrates that capsule colonoscopy appears to be a safe and promising new technology for visualizing the colon  This capsule colonoscopy may complement traditional colonoscopy for: Contraindicated colonoscopy Incomplete colonoscopy Patients unwilling to undergo standard colonoscopy  Capsule colonoscopy appears to be more sensitive than virtual colonoscopy in detecting small colon polyps Conclusions:  This feasibility study demonstrates that capsule colonoscopy appears to be a safe and promising new technology for visualizing the colon and for screening the colon for polyps in patients at risk for colorectal cancer  This capsule colonoscopy may complement traditional colonoscopy for: Contraindicated colonoscopy Incomplete colonoscopy Patients unwilling to undergo standard colonoscopy  Capsule colonoscopy appears to be more sensitive than virtual colonoscopy in detecting small colon polyps

8 PCCE: European studies MA-48 Jacques Devière Erasme University Hospital First European Feasibility Study * Endoscopy, Vol. 38, October 2006

9 Feasibility Study Objectives  Prospective pilot evaluation of the performance and accuracy parameters of PillCam COLON Capsule compared with traditional colonoscopy  Evaluation the efficacy of colon preparation for colon Capsule endoscopy

10 Inclusion Criteria  Patients between the ages of years  Patients suspected of having colonic disease referred for traditional colonoscopy OR  Patients referred for colonoscopy for CRC screening

11 Exclusion Criteria  All usual contra indication for Small Bowel CE  Patients with high risk for capsule retention: Crohn's disease, SB tumors, radiation enteritis, NSAID, surgical anastomosis  Patients with contraindications to ingest oral sodium phosphate or polyethylene glycol solution  Patients with known allergy to Domperidone or Bisacodyl suppository

12 Process Overview 1. Patient signed informed consent 2. Day -1:Clear liquids and evening laxative 3. Examination day a. Laxative and prokinetic agents b. Ingestion of PillCam COLON c. Traditional colonoscopy performed by investigator #1* following capsule excretion or at 19:00 d. Patient discharged 4. Capsule video reviewed by Investigator #2* * Both investigators blinded to each other results.

13 Day -1 Clear liquids diet (no breakfast) – liters PEG Exam day 7 00 – liter PEG mg Domeperidone and Capsule ingestion Booster I (45ml NaP) * * Pending verification that PillCam COLON had moved out of the stomach with RAPID Access RT (real-time viewer) Traditional colonoscopy prep (clear liquid diet and 4 liters Colopeg ® ) 55% of patients Preparation and Procedure

14 Additional intakes for up to 45% of patients Day -1 Clear liquids diet (no breakfast) – liters PEG Exam day 7 00 – liter PEG mg Domeperidone and Capsule ingestion Booster I (45ml NaP) * * Pending verification that PillCam COLON had moved out of the stomach with RAPID Access RT (real-time viewer) Traditional colonoscopy prep (clear liquid diet and 4 liters Colopeg ® ) 55% of patients Booster II (30ml NaP) Optional low-fiber snack mg Bisacodyl suppository Traditional colonoscopy Preparation and Procedure

15 Large amount of fecal residue Poor Enough feces or dark fluid present to preclude a completely reliable examination Fair Small amount of feces or dark fluid, but not enough to interfere with examination Good No more then small bits of adherent feces Excellent PoorGoodExcellentFair Preparation and Procedure: Assessment of Colon Cleanliness

16  41 Patients enrolled (26 women, mean age 56 years, range 26-75) Three patients out of the first five were excluded from the analysis due to technical capsule failure One patient could not swallow the Capsule because of excessive anxiety In one patient Capsule data compilation failed  Results reported for 36 patients  No adverse events (AE) were reported Results: Demographics and AE

17  Patient referred CRC screening 41 %  Patients suspected of having colonic disease 59% Results: Reasons for Referral

18 Results: Preparation  Overall preparation for PillCam COLON Capsule Excellent: 33% of cases Good: 58% Fair: 6% Poor: 3%  All patients tolerated the preparation without any significant complaints

19 Results Location of Capsule at 10 hours post ingestion 3% 84% 3% 7%

20 Results Tumor and Polyps Detection

21 Case I Sample Cases Colonoscopy : Carcinoma at sigmoid, patient referred to surgical intervention PillCam : Large neoplastic mass at sigmoid PillCam image Colonoscopy image

22 Case II Sample Cases Colonoscopy : Tumor at rectum, patient referred to surgical intervention PillCam : Large rectal neoplastic mass PillCam images

23 Case III PillCam image Colonoscopy image Colonoscopy: 8 mm polyp at sigmoid 5 mm polyp at transverse PillCam: 6-9 mm polyp at sigmoid Sample Cases

24 PillCam images Case VI Colonoscopy : Normal PillCam : Two polyps (<6 mm) at descending colon Sample Cases

25 Polyp Findings of Capsule COLON Endoscopy (CCE) and Traditional Colonoscopy *  CCE identified 19 of 25 patients (76%) with positive findings  CCE identified 10 of 13 patients (77%) with significant lesions*  2 tumors were detected by both methods

26 Findings of Capsule COLON Endoscopy (CCE) vs. Traditional Colonoscopy Polyps > 6 mm Polyps > 6 mm or ≥ 3 polyps Any kind of polyps SensSpecPPVNPV %76%64%83%54% 95% CI, % %77%71%59%84% 95% CI, % %60%73%46%83% 95% CI, %