Check-cap Ltd. · NASDAQ:MBAI

Check-cap — Corporate Update (September 2017)

11 slides from Check-cap's corporate update, Sep 27, 2017

  1. Slide 1: Check-Cap Files CE Mark Registration for C-Scan

    Check-Cap Files CE Mark Registration for C-Scan® September 27, 2017

  2. Slide 2: Safe Harbor Statement: Forward-Looking Statements

    Safe Harborstatement Forward-Looking StatementsThis presentation contains certain statements that may be deemed to be “forward looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended.Forward looking statements app

  3. Slide 3: Highlights: C-Scan Overview

    * Highlights C-Scan OverviewIngestible capsule system for preparation-free colorectal cancer (CRC) screening, submitted for CE Mark approvalPatient friendly: short and autonomous procedure, no change in patient diet and lifestyleClinical study, major outcomesPositive safety profileCapsule well toler

  4. Slide 4: Highlights: Clinical Study Major Outcomes (continued)

    * Highlights Clinical study, major outcomes (continued)Performance: clinical feasibility and clinical utility(1)44% sensitivity, 89% specificity for detection of patients with polyps (n=45)Strong correlation between scanning coverage and polyp detection (R-squared=0.98)78% sensitivity, 90% specifici

  5. Slide 5: Screening in the U.S. and EU a substantially underused strategy

    Screening in the U.S. and EUa substantially underused strategy Sources: CDC NHIS survey results as published in the CDC’s MMWR between 2006 and 2017 Radiology,. 2017, Ahead of Print, https://doi.org/10.1148/radiol.2017170924 (Smith) goal Screening rates Ages ≥ 50 EU U.S. *

  6. Slide 6: CE Mark Clinical Performance Study parameters

    * CE Mark Clinical Performance Study parameters Device technology C-Scan system (current version) Objectives SafetyClinical performance of preparation-free C-Scan system detection of patients with polyps Subjects 66 patients enrolled 43 with un-resected polyps23 average-risk Site locations Israel (3

  7. Slide 7: CE Mark Clinical Performance Study: Safety

    CE Mark Clinical Performance StudySafety 52 ± 32 hours average transit time with no change in routine or diet0.05 mSv average radiation dosage- abdominal CT scan dose exposure is ~6.0 mSvNo device related serious adverse eventsMinor anticipated adverse events- Soft stool, abdominal cramps, headache-

  8. Slide 8: CE Mark Clinical Performance Study: C-Scan clinical performance

    CE Mark Clinical Performance StudyC-Scan clinical performance Effective coverage Sensitivity Specificity Subjects All analyzed procedures 44% 89% 45 >20% 55% 89% 35 >50% 78% (p<0.05) 90% 19 >70% 100% (p<0.05) 86% 12 r2 = 0.98 *

  9. Slide 9: New C-Scan Version: Short-term development objectives

    New C-Scan VersionShort-term development objectives Enhanced performance through:Consistent colon scan coverageMore efficient power managementScan Control Algorithm optimizationImproved tracking accuracyImplementation (mostly software) and clinical testing underwayImproved system manufacturing proce

  10. Slide 10: Development milestones

    Developmentmilestones * Capital and strategic partner dependent Initiate clinical study for CE Marking - safety and clinical performance CE Mark submission U.S. Pilot Trial H117 H217 U.S. Pivotal Trial initiation - safety and effectiveness OUS Post Market Study EU launch* H118 H218 √ √ * H119

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