Mauna Kea Technologies - Corporate Presentation - November 2018

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Mauna Kea Technologies - Corporate Presentation - November 2018
Mauna Kea Technologies

Corporate Presentation - November 2018
Mauna Kea Technologies - Corporate Presentation - November 2018
Disclaimer
• This document has been prepared by Mauna Kea Technologies (the "Company") and is provided for information purposes only.
• The information and opinions contained in this document speak only as of the date of this document and may be updated, supplemented, revised, verified
    or amended, and such information may be subject to significant changes. Mauna Kea Technologies is not under any obligation to update the information
    contained herein and any opinion expressed in this document is subject to change without prior notice.
•   The information contained in this document has not been independently verified. No representation, warranty or undertaking, express or implied, is made
    as to the accuracy, completeness or appropriateness of the information and opinions contained in this document. The Company, its subsidiary, its advisors
    and representatives accept no responsibility for and shall not be held liable for any loss or damage that may arise from the use of this document or the
    information or opinions contained herein.
•   This document contains information on the Company’s markets and competitive position, and more specifically, on the size of its markets. This information
    has been drawn from various sources or from the Company’s own estimates. Investors should not base their investment decision on this information.
•   This document contains certain forward-looking statements. These statements are not guarantees of the Company's future performance. These forward-
    looking statements relate to the Company's future prospects, developments and marketing strategy and are based on analyses of earnings forecasts and
    estimates of amounts not yet determinable. Forward-looking statements are subject to a variety of risks and uncertainties as they relate to future events
    and are dependent on circumstances that may or may not materialize in the future. Mauna Kea Technologies draws your attention to the fact that as
    forward-looking statements cannot under any circumstance be construed as a guarantee of the Company's future performance and that the Company’s
    actual financial position, results and cash flow, as well as the trends in the sector in which the Company operate may differ materially from those proposed
    or reflected in the forward-looking statements contained in this document. Furthermore, even if Mauna Kea Technologies’ financial position, results, cash-
    flows and developments in the sector in which the Company operates were to conform to the forward-looking statements contained in this document, such
    results or developments cannot be construed as a reliable indication of the Company's future results or developments. The Company does not undertake
    any obligation to update or to confirm projections or estimates made by analysts or to make public any correction to any prospective information in order
    to reflect an event or circumstance that may occur after the date of this presentation. A description of those events that may have a material adverse effect
    on the business, financial position or results of Mauna Kea Technologies, or on its ability to meet its targets, appears in the "Risk Factors" section of Mauna
    Kea Technologies Registration Document registered with the Autorité des marches financiers on April 27, 2018 under number R.18-0429.
•   Certain figures and numbers appearing in this document have been rounded. Consequently, the total amounts and percentages appearing in the tables are
    therefore not necessarily equal to the sum of the individually rounded figures, amounts or percentages.
•   This document does not constitute or form part of an offer to sell or to purchase securities or the solicitation of an offer to purchase securities in the
    United States of America or in any other jurisdiction. The securities mentioned in this presentation have not been and will not be registered under the U.S.
    Securities Act of 1933, as amended (the “Securities Act”) or under any other legislation of any jurisdiction in the United States of America and may not be
    offered or sold in the United States absent registration or an applicable exemption from registration under the Securities Act.

2    ©2018 Mauna Kea Technologies
Mauna Kea Technologies - Corporate Presentation - November 2018
Cellvizio®: cellular vision at your fingertips

                           First miniaturized confocal
                           microscope designed to
                           provide physicians and
                           surgeons with digital cellular
                           visualization at the bedside
Mauna Kea Technologies - Corporate Presentation - November 2018
Investment opportunity : A highly attractive value proposition

             1           First and only: Transformational probe-based Confocal Laser Endomicroscopy Platform
                                 Large addressable market: early cancer diagnosis in GI, Urology, Interventional
                     2
                                 Pulmonology, others

                             3       Clinically-validated: 1,100+ publications on endomicroscopy

                                 4      Strong regulatory support: Approved in 40+ countries;
                                        15 US FDA 510(k) clearances

                                 5      Favorable economics: Strong CMS reimbursement in the US;
                                        plan to secure commercial payers

                             6         Utilization-focused: Driving US adoption & recurring revenue
                                       via pay-per-use model
                         7       New seasoned US based executive leadership to drive commercial expansion
                 8       Robust R&D pipeline to drive growth through application expansion
        9            Broad IP protection: 236 issued patents on Cellvizio® technologies
4   ©2017 Mauna Kea Technologies
Mauna Kea Technologies - Corporate Presentation - November 2018
A breakthrough technology
         platform
Mauna Kea Technologies - Corporate Presentation - November 2018
Digital optical biopsies: a powerful new paradigm

From H&E histology…
one image - static view

 …to Cellvizio®
 720 live biopsies
 per minute -
 functional view

                                 Brain             Colon               Esophagus

                                         “Patients are better served if biopsies can be
                                             better targeted. That’s where in vivo
                                                    microscopy comes in”.
6 ©2018 Mauna Kea Technologies
Mauna Kea Technologies - Corporate Presentation - November 2018
Versatile Cellvizio® platform reveals key invisible information
                                   pCLE (probe/catheter)   Proprietary
                                                           technology
                                                           for virtual
                                                           tissue slicing

                                      nCLE (needle)

                                   pCLE (lap / robotics)

                                     Miniprobes                Breakthrough Confocal Laser Endomicroscopic
    Clinical
                                     for various               Scanning through 30,000 custom optical fibers
    Cellvizio
                                     access methods            produces 12 microscopic optical sections per
    Platform
                                     (0.8 to 2.5 mm)           second during standard endoscopy procedures
7   ©2018 Mauna Kea Technologies
Mauna Kea Technologies - Corporate Presentation - November 2018
Seamless integration into endoscopy workflow

        During an endoscopic procedure, an
1       area of interest is identified

        Cellvizio miniprobe is inserted into
2       operating channel of any endoscope

        Simple contact between the tip of the
3       miniprobe and the tissue generates
        real-time microscopic cellular images
        viewed directed on the Cellvizio screen

    Our mission: eliminate diagnostic and treatment uncertainties
©2018 Mauna Kea Technologies
Mauna Kea Technologies - Corporate Presentation - November 2018
Core focus :
Gastroenterology applications
Mauna Kea Technologies - Corporate Presentation - November 2018
Core commercial focus:
                             A significant Cellvizio U.S. gastroenterology
                                          market opportunity

          U.S. Target                               U.S. Procedure                                      Key Market                                     U.S. market
           Hospitals                                    volume                                            Drivers                                      opportunity
                                                                                                             Society
            3,000+*                                           3.6                                            recom-                                       $2.8 billion*
                                                                                                          mendations and
           with large                                        million*                                    increased CMS
                                                                                                                                                             annual
           GI volume                                     annual upper GI                                 reimbursement                                     recurring
                                                           procedures                                         rates                                         revenue

* Millenium research group : Custom Urology report 2014 and 2012; 2013 U.S. laparoscopic proceduresMedtech Insight : U.S. Procedure Volume 2010iData : 2015 EUS Market; U.S. Procedure
   10
volume ©2018   Mauna
         2012; 2015  Kea Technologies
                    ERCP  report, M&A acquisition figures : Covidien; Medtronic Advamed presentations : 2013 Advamed presentation; E&Y; Presentations citing other sources
Enhancing traditional endoscopy is a recognized need…

                      Dr. Brian Fennerty, past President, ASGE (American Society of Gastrointestinal Endoscopy)
                         New York Society of Gastroenterology meeting, 17 Dec 2010, New York
11 ©2016 Mauna Kea Technologies
… for important reasons

      More     than     25% of
      esophageal adenocarcinoma are
      diagnosed within a year after a
      negative endoscopy
      among adults with non dysplastic Barrett’s
      esophagus (or Barrett’s esophagus with
      low-grade dysplasia) (1)

          Additional resources / technologies should
             be allocated to detect missed cases

     1.Visrodia K et al. Magnitude of Missed Esophageal
      Adenocarcinoma After Barrett’s Esophagus Diagnosis: A
      Systematic Review and Meta-analysis. Gastroenterology. 2016
12   ©2010-2018 Mauna Kea Technologies
Growing, unmet need in esophageal cancer
                                                                                                                                      Esophageal adenocarcinoma is the fastest
                                                                                                                                                  growing cancer2

                                                                                                                                               Symptoms of acid
                                                                                                                                                                    25% of esophageal
                                                                                                                                                 reflux, including
                                                                                                                                                                    cancers diagnosed
                                                                                                                                                    heartburn,
                                                                                                                                                                     within one year of
                                                                                                                                                occur monthly in
                                                                                                                                                                   standard endoscopy3
1 Shaheen N, Ransohoff DF. Gastroesophageal reflux, Barrett's esophagus and esophageal cancer. Journal of the American Medical Association. 2002; 44% of adults
                                                                                                                                                                 1
287: 1972-1981.
2. The Wall Street Journal - Emerging Type of Heartburn Defies Drugs, Diagnosis - online.wsj.com/news/articles/
SB10001424127887323894704578115031699278010
3. K. Visrodia, at al. Magnitude of Missed Esophageal Adenocarcinoma After Barrett's Esophagus Diagnosis: A Systematic Review and Meta-analysis.
AGA Institute, 2016.

 13   ©2018 Mauna Kea Technologies
Cellvizio addresses the Random Biopsy Limitation
Seattle Protocol
                                                                                        …random biopsy protocol can be time-consuming,
                                                                                      expensive, and prone to sampling error, as very little
                                                                                       of the esophageal surface area is actually sampled.”2

                                                                                                                  “biopsies of columnar lined epithelium in the
                                                                                                                    esophagus[…]because of sampling error,
                                                                                                                   goblet cells may not be detected, thereby
                                      6% yield                                                                               underdiagnosing BE”3
                                  Inefficient random
                                      sampling1                            The Cellvizio digital optical biopsy solution

                                                                                                       Goblet cells
                                                                                                                                        squamous epithelium                                     intestinal metaplasia

                                  1. M. Canto, et al. In vivo endomicroscopy improves detection of Barrett’s esophagus–related neoplasia: a multicenter international randomized controlled trial, GIE 2013.
                                  2. Guidelines for Surgical Treatment of GERD. SAGES. February 2010.
14 ©2018 Mauna Kea Technologies   3.Sharma P et al. White Paper AGA: Advanced Imaging in Barrett's Esophagus. Clin Gastroenterol Hepatol. 2015
High quality, long term clinical data on esophageal disease characterization
              DON'T BIOPCE trial                                                                  CEBE trial                                         MODENA BARRETT’S STUDY
    multi-center, randomized controlled                                         multi-center, randomized controlled                                single-center, randomized trial, 100
         trial, 101 patients, 2 arms 4                                               trial, 192 patients, 2 arms 5                                           patients, 2 arms

                                                   Sensitivity
Sensitivity                            76%                                                           96%                                                              28%
                     68%
                                       pCLE
                                                        x 1.7                                        Sensitivity                                                              Dysplasia Detection
    x2
                                         or                                              HD-WLE
                                        WLE
                                       or NBI
                                                                                            +
                                                                                                                                                       White
                                                                                                                                                                              tripled with Cellvizio
                                                                                                          x 2.4
                                                                                          CLE
                      pCLE
                                                45%                                                                                                    Light +                   over white light
                     or WLE
                                                                                                                                                      Cellvizio
           34%                        WLE or                                                                                                                                       Biopsies could
                                       NBI
                     WLE                                                                              40%                                                              10%           have been
                                                                                         HD-WLE                                                                                   avoided for 58%
                                                                                                                                                        White
                                                                                                                                                        Light                        of patients
              WLE : White Light Endoscopy
                                                                                         HD-WLE : High Definition
               NBI : Narrow Band Imaging
                                                                                          White Light Endoscopy
                pCLE: endomicroscopy
                                                                                          CLE: endomicroscopy

                                        ~2x improvement in sensitivity for dysplasia detection
                                              36% of patient treatment plans improved
                                                         3x diagnostic yield
 1. Sharma P. et al. Real-time Increased Detection of Neoplastic Tissue in Barrett’s Esophagus with probe- based Confocal Laser Endomicroscopy: Final Results of a Multi-center Prospective International
 Randomized Controlled Trial. GIE 2011.
 2. M. Canto, et al. In vivo endomicroscopy improves detection of Barrett’s esophagus–related neoplasia: a multicenter international randomized controlled trial, GIE 2013.
  3. Bertani H. et al. Improved Detection of Incident Dysplasia by Probe-Based Confocal Laser Endomicroscopy in a Barrett’s Esophagus Surveillance Program. Digestive Diseases and Sciences, 2013.
 15 ©2016 Mauna Kea Technologies
New data on improved detection of Barrett’s Esophagus

                                                                        >+100%
                                                                          with
                                                                        Cellvizio
                                    140
                                    120                                                              2017 Meta analysis of detection of
                                    100                                Positive for IM               neoplasia in BE with NBI vs CLE 2
                                                                       Negative for IM
                                     80
           172                       60
         patients                    40
                                     20

                                      Seattle Protocol
• Using Cellvizio, physicians at 8 non academic medical
centers detected more than double the number of patients
with Barrett’s Esophagus than with the Seattle Protocol.
• This number was confirmed by expert review on discrepant
cases where biopsies were negative.              1. Sharma P. et al.
                                                                 Real-time Increased Detection of Neoplastic Tissue in Barrett’s Esophagus with probe- based Confocal Laser
                                                   Endomicroscopy: Final Results of a Multi-center Prospective International Randomized Controlled Trial. GIE 2011.
                                                 2. Xiong Y-Q, et al. Comparison of narrow-band imaging and confocal laser endomi- croscopy for the detection of neoplasia in
                                                    Barrett’s esophagus: A meta-analysis. Clin Res Hepatol Gastroenterol (2017), https://doi.org/10.1016/j.clinre.2017.05.005
16   ©2018 Mauna Kea Technologies
Strong endorsements from medical societies

                   AGA white paper December 2015                                      American Society of General Surgeons
                    “Why should practice change?”                                     Position Statement on Confocal Laser
                                                                                      Endomicroscopy published September
    Screening: “BE (specifically shorter                                                              2016
  disease) is often misdiagnosed during                                     “Cellvizio, very clearly, is integral to
 endoscopy... often attributed to ...lack of
                                                                             the comprehensive assessment of
  goblet cells in biopsies obtained from
     columnar lined epithelium in the                                      patients suffering from reflux disease”
                esophagus.”
                                                                                  “Clinicians and patients alike need and
             “Workshop panelists agreed that in the
                                                                                   deserve access to Cellvizio® (pCLE) in
              hands of endoscopists who have met
                the PIVI thresholds with specific                                    order to obtain a comprehensive
              enhanced imaging techniques (NBI &                                 assessment of the extent of disease and
             Confocal Laser Endomicroscopy), use                                 to make real-time therapeutic treatment
                of the technique in BE patients is                                              decisions.”
                          appropriate”
Sharma P et al. White Paper AGA: Advanced
Imaging in Barrett's Esophagus. Clin        https://theasgs.org/position-statements/position-statement-on-confocal-laser-endomicroscopy/
Gastroenterol Hepatol. 2015
17   ©2016 Mauna Kea Technologies           http://www.cghjournal.org/article/S1542-3565(15)01306-3/fulltext
A shifting paradigm with in vivo microscopy
                                                                                                                                                              In Vivo Microscopy
                                                                                                                                                              for the Evaluation of
                                                                                                                                                              Barrett Esophagus
                                                                                                                                                              In vivo microscopy uses light of various wavelengths to
                                                                                                                                                              produce 2D and 3D microscopic images of living (in vivo)
                                                                                                                                                              human tissues. One important clinical application is
                                                                                                                                                              imaging of the gastrointestinal tract.

                                                                                              Where to Biopsy?
                                                                                              Patients with Barrett esophagus are at risk of developing
                                                                                              carcinoma. Patients often undergo multiple repeat
                                                                                              biopsies. Even using a 1 cm or 2 cm, four quadrant biopsy
                                                                                              protocol, the rate of detecting dysplasia can be low and
                                                                                              many unnecessary biopsies are taken.

                                                                                                                                                                                             Traditional “white light”
                                                                                                                                                                                             endoscopy shows Barrett-type
                                                                                                                       Targeted Biopsies                                                     epithelium in the distal

  “Patients are better served if biopsies can be
                                                                                                                       Given the usual small size of                                         esophagus. Surveillance
                                                                                                                       the dysplastic areas, traditional                                     requires numerous biopsies.
                                                                  Patients are better                                  screening is a shotgun approach
                                                                  served if the biopsies                               to detection. IVM can help target

      better targeted. That’s where in vivo
                                                                  can be better targeted.                              higher-yield, more diagnostic sites.
                                                                  That’s where in vivo
                                                                  microscopy comes in.

             microscopy comes in”.

                                                                                                                                                  IVM Optical Biopsy Guides Site Selection
                                                                                                                                                  An optical biopsy, using confocal laser endomicroscopy, for

        CAP is actively promoting awareness and                                                                                                   example, is a noninvasive in vivo microscopic assessment
                                                                                                                                                  of tissue architectural and cellular morphology. It provides
                                                                                                                                                  2D images in a parallel tissue plane (en face) with
                                                                                                                                                  1 μm–2 μm resolution at a depth of 10 μm.

        better understanding of IVM opportunities                                                            Traditional surgical
                                                                                                                                                  Photographs reprinted from Kiesslich R, et al. In vivo histology of Barrett’s
                                                                                                                                                  esophagus and associated neoplasia by confocal laser endomicroscopy.
                                                                                                                                                  Clin Gastroenterol Hepatol. 2006;4(8):979-987, with permission from Elsevier.

                     for pathologists
                                                                                                             biopsy, taken transverse                                                         The architectural and cellular
                                                                                                             to the tissue plane,                                                             patterns generated by in vivo
                                                                                                             shows malignant glands                                                           microscopy are interpretable
                                                                                                             corresponding to the                                                             by pathologists to make
                                                                                                             in vivo confocal image                                                           differential diagnoses and
                                                                                                             on the right.                                                                    to identify areas for biopsy,
                                                                                                                                                                                              improving diagnostic yield.
                                                                                                                                                                                              The image on the left shows
                                                                                                                                                                                              a focus of malignant glands.
                                                                    Prepared by the In Vivo Microscopy Work Group: Maria M. Shevchuck, MD, FCAP
                                                                    (chair), and Gary Tearney, MD, PhD, FCAP (vice chair). Illustrations by
                                                                    Eric F. Glassy, MD, FCAP. For more information, email ivminfo@cap.org

                                                                    © 2015 College of American Pathologists. All rights reserved.                                                                                     cap.org
       http://www.cap.org/web/home/involved/council-committees/ivm-committee/ivm-topic-center?
                                                                    23487.0315

_afrLoop=817409063069337#!%40%40%3F_afrLoop%3D817409063069337%26_adf.ctrl-state%3D16bmzn84t_4
18 ©2016 Mauna Kea Technologies
Favorable US reimbursement for Cellvizio in upper GI
Positive payment trends in the past 2 years
     CPT                                                                                   2017        2017
                                     Description       Setting   2016 Rate   2017 Rate                Change   2018 Rate
     Code                                                                                Change ($)     (%)

                   Upper gastrointestinal endoscopy   Hospital   $1,088.00   $2,509.64    $1,421.64    131%    $2743.26
                   including esophagus, stomach,
     43252         and either the duodenum and/or
                   jejunum as appropriate; with
                   optical endomicroscopy               ASC      $608.39     $1,134.02    $525.63      86%      $1212.19

                   Endomicroscopy in upper GI
   CMS             endoscopy procedures, including
 Covered           GERD, Barrett’s Esophagus and
 Services          pancreatic lesions
                                                      ! Catalyst for Cellvizio adoption and utilization

                                                      ! Enhances economical model for Cellvizio customers
Effective           January 1, 2017

                                                      ! Positive tailwind for commercial coverage

19    ©2018 Mauna Kea Technologies
2018 Hospital and ASC Reimbursement for Upper GI Endoscopy
           WITHOUT Endomicroscopy
                                    Patient with
                                                                 Biopsy
                                  GERD/BE getting
                                                            (Seattle Protocol)
                                      an EGD

                 CPT 43239 : $743 Hospital / $387 ASC medicare payment

              WITH Endomicroscopy

                                            Patient with        Targeted biopsy
                                          GERD/BE getting        protocol with
                                              an EGD               improved
                                                                   sensitivity

 CPT 43252 + (CPT 43239)/2 : $3,114* HOPPS / $1,405 ASC medicare payment
                                  *Multi-Procedure Rule
20 ©2016 Mauna Kea Technologies
New business model and sales team to address large market
         Focus on upper GI endoscopies (EGDs)                                                                                                      Potential US Customers

      •    60% in hospital outpatient setting

                                                                                                               # of centers
      •    40% in the 1200 GI-focused ASCs

      •   New pay-per-use business model
          provides attractive adoption option for
          hospitals
                                                                                                             Potential number of procedures per year
      • New sales team in place since February

                                                                                                                    # of procedures in thousands
        2018

           • 2 divisional sales manager, 12 area sales
              managers, 6 clinical account managers
 Sources:
 Burden of Gastrointestinal Disease in the United States: 2012 Update; Peery et al, Gastroenterology. 2012
 November ; 143(5): 1179–1187.e3. doi:10.1053/j.gastro.2012.08.002.
 Repeated Upper Endoscopy in the Medicare Population, Pohl et al, Ann Intern Med. 2014;160:154-160.
 US census;
 Medicare website.

21 ©2016 Mauna Kea Technologies
Continuous momentum with new US sales team
         Consignment systems placed per quarter
           since launch of pay-per-use program                         •   Consignment (Pay-per-use or PPU)
 20                                                                        program enables physicians to utilize
                                                                  20
                            2017                  2018                     Cellvizio without upfront capital
 15                                                                        equipment purchase
                                                                       •   Confirmed U.S. commercial traction with
 10                                          11                            20 systems placed under consignment
                                                                           in Q3 2018 and 36 ytd vs 12 ytd last
     5         6
                                                                           year.
                          5                              4             •   Pay-per-use approach provides
     0
                                    2                                      attractive economical model for
                    Q1                  Q2                   Q3            physicians and hospitals / ASCs
                                                                       • Q3 2018 Pay-per-use revenue up 81%
           New US sales                                                    compared to Q3 2017
           team trained end
           of January 2018
22   ©2018 Mauna Kea Technologies
Corporate information and
      performance
Leadership Transition to Support New Phase of Growth

                                        "I share Sacha’s enthusiasm for Cellvizio’s transformational
                                        nature and commercial potential both in the United States
                                       and globally. Moreover, I am confident that my experience as
                                       a CEO and marketing executive will allow me to build on the
                                       remarkable foundation that Sacha and his team have created
                                           over the past 18 years. I welcome the responsibility of
                                       building value on behalf of our employees, shareholders and
                                                   clinical partners.“ – Robert L. Gershon

     Mr. Rob Gershon                      Rob Gershon
     Chief Executive Officer (CEO)
     • Brings 30 years of commercial
                                          •      CEO of Bovie Medical (NYSE: BVX) between 12/2013-12-2017,
       leadership experience                     where he oversaw the successful repositioning of the Company’s
     • Joins Mauna Kea’s board of                product portfolio and commercial operations
       directors
                                          •      Prior roles included leadership positions with Henry Schein and
                                                 Covidien (now Medtronic)
                                          •      Rob has been serving as an advisor to Mauna Kea for several
                                                 months
24 ©2018 Mauna Kea Technologies               Proprietary and Confidential. Not to be distributed or reproduced without permission
Unrivaled regulatory foundations create high barriers to entry
                                  “Cellvizio® 100 Series Systems with
   15 510(k)
   Clearances                     Confocal Miniprobes™ are confocal laser
                                  systems with fiber optic probes that are
                                  intended to allow imaging of the
                                  internal microstructure of tissues
                                  including, but not limited to, the
                                  identification of cells and vessels and
                                  their organization or architecture” —
                                                                             Above images are not FDA
                                  FDA clearance December 2017                 cleared and are shown as
                                                                                 illustrative examples

                                           Clearances in
           2 Chinese FDA
                                           Korea, Japan,         CE mark
           clearances
                                           Turkey, ...
25 ©2018 Mauna Kea Technologies
A growing installed base worldwide

                                                       Clinical                 Clinical
                              Clinical
                                                       130+                     100+
                              160+                                Preclinical
                                         Preclinical   units       70+          units      Preclinical
                              units       30+                                               60+
                                                                   units
                                          units                                             units

                                                 Approx. 645 systems
                                                 installed worldwide
26 ©2018 Mauna Kea Technologies
Strong clinical evidence and intellectual property

                                                          Articles on PubMed for

                 1,100+                                   endomicroscopy across
                                                           multiple applications                          Optoelectronics
                                                                                                         Image Processing
                                                                                                         Machine Learning
  Number of publications

                                                                                                150
                                                                                                      230+ issued patents in
                                                                                                      optics, optronics, image
                                                                                                100
                                                                                                       processing on probe-
                                                                                                       based Confocal Laser
                                                                                                50    Endomicroscopy (CLE)

                               0 4 05 06 07 08 09 10
                                                            011    12 013 014 015 016 017 018
                             0      0   0   0   0   0 2 0 2     2 0   2   2   2   2   2   2
                           2      2   2   2   2   2
27 ©2018 Mauna Kea Technologies                 See appendix for references
Q3 2018: Continued Momentum of U.S. Sales Team
             Q3 2018 Highlights
             • 20 U.S. PPU placements in Q3 vs. 4 in Q3 2017
             • 38% year-over-year increase in U.S. consumable miniprobes sales
             • Global sales up 4% year-over-year, with global miniprobes sales up 31%
                                                                        Re-orders & Pay-Per-Use Probe Units
             20                                               220
                                                         20
              15                                              165

                                                                                                                          2017
                                                                                                                          2018
              10                               11              110                                                  215

                                                                                                         161
                                                                                                   146
               5         6                                     55      107        101   108
                                  5                 4
                                      2
               0                                                   0
                                                                             Q1               Q2               Q3
                             Q1           Q2            Q3

                     Placed more PPU systems in 3Q18 than 1H18 and FY17
28 ©2018 Mauna Kea Technologies                               28
H1 2018 Key figures
                                  Contacts

                Net Sales                     Gross       Opex      Ebitda        Cash
                                              margin

                  € 2,7m                      € 1,7m      € -7,7m   € -5,5m      € 15,1 m
                       Down                                 Up        down          Vs

                     -18%                    64% Vs 68%    3,4%     -0,7m        € 9,4 m

              •   Restart in Q1 with new sales team negatively impact 1H Sales
              •   Gross margin at 64% Vs 68% due to COGS of PPU probes (Costs and
                  transportation) with differed logs revenues.
              •   Effective management of Operating expenses
              •   Strong cash position at €15 million

29 ©2018 Mauna Kea Technologies
H1 2018 Sales
                     System Sales & Consignment Sales
     30                                                                      • U.S. commercial focus gaining traction
     23                                                    9                     with 16 systems placed under consignment
     15
                            14
                                                                                 (compared to 8 systems in 1H17)
                                                           16

      8
                            8
                                                                             • APAC sales +8% above last year,
      0
                          1H17                            1H18
                                                                             •   EMEA and LATAM still low.
                 New Consignments Placed       NewSystem Straight Sales
                                                                                             1H18 Sales                 1H18 Sales
                                                                                             by Product                by Category
                                1H18 vs. 1H17 Sales
                            3 285                                                      520
       3 300                                                        3 500                                                                18,4%
                                                  2 707
       2 475                                                        2 625                                    990

       1 650                                                        1 750

          825                                                        875
                                                                                      1 197                          81,6%
          '- 0                                                        '- 0
                            1H17                  1H18
                                                                                     Systems    Probes    Services      Pre Clinical   Clinical
                  Sales      Systems (LTM*)    Consumables (LTM*)

30   ©2018 Mauna Kea Technologies
1
 Balance sheet

                        ASSETS (in K€)   30/06/2018 31/12/2017                     LIABILITIES (in K€)   30/06/2018 31/12/2017

        Intangible assets                     1 873      2 100       Equity                                  13 738     16 744
        Property, plant, and equipment        1 813      1 466       Long-term loans and borrowings           2 749      6 567
        Non-current financial assets            140        138       Non-current provisions                     379        283
        Total of non-current assets           3 825      3 704
        Inventories & Work in progress        2 251      1 969       Total of non-current liabilities         3 128      6 850
        Trade receivables                     1 618      2 034       Short-term loans and borrowings          4 333        386
        Other current assets                  2 333      2 462       Trade payables                           1 910      1 663
        Current financial assets                 40        125       Other current liabilities                2 091      2 104
        Cash and cash equivalents            15 132     17 453
        Total of current asets               21 374     24 043       Total of current liabilities             8 334      4 153
        TOTAL OF ASSETS                      25 199     27 747       TOTAL OF EQUITY AND LIABILITIES         25 199     27 747

       •   PPE increases due to PPU model deployment,            •    Swap of 4M€ from LT debts to Short term
           with 16 new LSU installed in 1H 2018                       due to IPF covenants renegotiation.
       •   Inventories mainly increase due to anticipated
                                                                 •    Other short term debt includes Coface
           purchases.
                                                                      advance (150 K€), fully reimbursed as of
                                                                      sept 2018.
31 ©2017 Mauna Kea Technologies
Strong cash position at the end ofJune 2018

                                                                                                           Key drivers to Cash burn
                          HY 2018 Cash variation - in K€
                                      Hausse    Baisse        Total                         •   Change in EBITDA drives the change in
    20 000                                                                                      cash (€ 0,7m
    18 000      17 453
    16 000                                                            3 625      15 193
                                                                                            • Change in working capital
    14 000                                                                                        - Increase in inventories due to sales gap.-
    12 000
                                  -5 638          - 248
    10 000                                                                                        -   Positive impact on trade payables
     8 000
     6 000                                                                                  •Capex
     4 000
     2 000
                                                                                                  -    New web sites, PLM software development
         0                                                                                  • Cash flow from financing
               BoP Cash     Operating CF       Investing CF       Financing CF   EoP Cash
                                                                                                  -    Paceo capital raise for 3.8 M€

32 ©2018 Mauna Kea Technologies
Seasoned Board of Directors
                                                           Molly O'Neill
                        Sacha Loiseau, Ph.D                Member of the Board
                        Founder, Chairman of the Board     Chair of the Audit Committee
                        Chair of the Strategic Committee
                                                           Chief Growth and Strategy Officer Medforth
                                                           Global Healthcare Education Group

                                                           Joseph DeVivo
                         Robert L. Gershon                 Member of the Board
                         Chief Executive Officer and
                         Member of the Board               CEO of InTouch Health

                        Christopher D. McFadden, CFA
                                                           Jennifer F. Tseng, M.D.
                        Member of the Board
                                                           Member of the Board
                        Chair of the compensation and
                        nomination committee
                                                           Chief and chair of surgery at Boston
                                                           University School of Medicine
                        Managing Director at KKR

33
33 ©2018 Mauna Kea Technologies
Shareholding Profile
                                                   Contacts

                                                                       Shares
                 Market Cap (1)                                                                             Coverage                              Liquidity   (2)
                                                                     outstanding
                                                                                                    • Goetz Partners-M.Brunninger
                                                                                                    • Kepler Chevreux- A.Guekam
                        66 M€                                         25,2 MM                       • Gilbert Dupont - X.Regnard
                                                                                                                                                  92 K / day

                Total Float > 80%                                                                                                         Contacts
                                Shareholders                                           Shareholders by Region                                        Lee Roth
                                                                                                                             Investor Relations      The Ruth Group
              Free Floating                                                                                                  U.S.                    +1 (646) 536-7012
                                                                        France                                                                       lroth@theruthgroup.com
      Institutional investors                                            Switz.

           Other registered                                            Germany                                                                       Newcap
                                                                                                                             Investor Relations      Pierre Laurent
 Directors & Management                                                Benelux                                               Europe                  +33 (0) 1 44 71 94 94
                                                                                                                                                     maunakea@newcap.fr
 Mauna kea Technologies                                                  Japan

                                0%   20%   40%   60%   80%    100%                0%   20%    40%     60%       80%   100%

(1)         As of Oct. 12, 2018
(2)   6 months Avg as of Oct. 12, 2018

 34 ©2018 Mauna Kea Technologies
Applications and products
     pipeline preview
Robotic Assisted Radical Prostatectomy
              Cellvizio now FDA cleared and CE marked for use in conjunction with
                surgical robotics systems. User experience is easy and seamless.

      Provide specificity to pre-op imaging report on tumor extension in order to
                              improve on resection margins
                                  Lymph node interrogation / Nerve sparing guidance
                                     Lopez et al, “Intraoperative Optical Biopsy during Robotic Assisted Radical Prostatectomy Using
36 ©2018 Mauna Kea Technologies      Confocal Endomicroscopy”. Journal of Urology, April 2016
                                     * source Intuitive Surgical investor presentation
Peripheral Nodules / Lymph Nodes / Mediastinal Nodules

        Unique through-the-scope access to the lungs now
        through needles for direct access to the inside of
                peripheral and mediastinal lesions

                                  0.8 mm AQ-Flex probe

                          compatible with 19 gauge needles

     Compatible with Electro-Magnetic Navigation
      systems and novel flexible robotics systems

                                    * CE marked, not yet FDA cleared   Target missed   On target
37 ©2018 Mauna Kea Technologies
Inflammatory Bowel Disease
Real-time in vivo visualization of mucosal barrier at
cellular level during conventional endoscopy with
Cellvizio

 Accurate and immediate mucosal barrier structure
 and function characterization leading to direct
 assessment of mucosal barrier healing and
 dysfunction
                        Patients in endoscopic and clinical remission
                        Patients in inflammation

                    30 %

        70 %                                                                    40 %
                                                                                                 Mucosal barrier defect
                                                                                                 Mucosal healing
                                                                                                                                                  80% Accuracy of Cellvizio (1,2)
                                                                   60 %                                                                           for the prognosis of flare and
                                                                                                                                                  remission at 12 months
  1. Kiesslich, R., Duckworth, C. A., Moussata, D., Gloeckner, A., Lim, L. G., Goetz, M., … Watson, A. J. M. (2012). Local barrier dysfunction identified by confocal laser endomicroscopy predicts relapse in inflammatory
     bowel disease. Gut, 61(8), 1146–1153. https://doi.org/10.1136/gutjnl-2011-300695
  2. Karstensen, J. G., Săftoiu, A., Brynskov, J., Hendel, J., Ciocalteu, A., Klausen, P., … Vilmann, P. (2016). Confocal laser endomicroscopy in ulcerative colitis: a longitudinal study of endomicroscopic changes and
     response to medical therapy (with videos). Gastrointestinal Endoscopy, 84(2), 279–286.e1. https://doi.org/10.1016/j.gie.2016.01.069

38 Mauna Kea Technology Confidential - 2018
Pancreatic cystic lesions : addressing a key medical need
                                                                                                                                                              Mucinous
                                                                                                                                                                  (9)
                                                                                                                                                                        cystic lesions can be
                                                                                                                                                              confirmed with very high specificity
                                                                                                                                                              in about 7 cases out of 10 (1, 2)
                                                                                                                                                               Sensitivity: 59 - 77%

                                                                                                                                                               Specificity: 100%
                                                                                                                                                         0 %INSPECT study, 65 patients, multi-centric    (9)
                                                                                                                                                                   25  %        50   %         75 %                   100 %
                                                                                                                                                            DETECT study, 30 patients, mono-centric (10)

                                                                                                                                                               Serous cystadenomas can be
                                                                                                                                                               confirmed with very high specificity
                                                                                                                                                               in 9 cases out of 10 (3)
                                                                                                                                                                 Sensitivity: 95%

                                                                                                                                                                 Specificity: 100%
                                                                                                                                                           CONTACT 2 study, 78 patients, multi-centric         (11)
                                                                                                                                                          0%     25 %          50 %           75 %                    100 %
Addressing a fast growing interventional market (3-10% prevalence) with unique solution
                                  1. Konda V.J. et al. A pilot study of in vivo identification of pancreatic cystic neoplasms with needle-based confocal laser endomicroscopy under endosonographic
                                  guidance. Endoscopy 2013
                                  2. Nakai Y. et al. Diagnosis of pancreatic cysts: EUS-guided, through the needle confocal laser-induced endomicroscopy and cystoscopy trial: DETECT study. GIE 2015

39 ©2018 Mauna Kea Technologies   3. Napoleon B, et al. Needle-based Confocal Laser Endomicroscopy (nCLE) for the diagnosis of pancreatic cystic lesions: preliminary results of the first prospective
                                  multicenter study, presentation at UEGW 2016
Upper Tract Urothelial Cancer (UTUC)
  • Important unmet medical needs:
      • Limitations of white light endoscopy
      • Suboptimal yield of endoscopic biopsy
      • Suboptimal clinical staging
      • Optimizing patient selection for organ sparing
      endoscopic management

  •Solid clinical data showing Cellvizio can impact UTUC
  patient management significantly
   • Bui et al, 2015; Villa et al 2016; Breda et al 2017; Liem et al 2018
  • Use of Cellvizio for UTUC now in short list of
  very promising technologies in EAU guidelines

40 ©2018 Mauna Kea Technologies
Endomicroscopy + AI: a perfect combination
                                                                                                  Diagnostic Accuracy of Cellvizio in Bladder
                                                                           100 %
                                                                                                                                                      90%
                                                                                            87%
                                                                                                                                                              82%
                                                                                                     79%                   79%
                                                                            80 %                                                   77%

                                                                            60 %

                                                                            40 %

                                                                            20 %

                                                                              0%
                                                                                             Accuracy                      Sensitivity                Specificity

                                                                                                                 Machine                 Urologists (n=8)

       Work performed by the Stanford Bioinformatics program on a dataset of 81
             subjects (458 Cellvizio videos, 171,000 images, 21 layer CNN)
                                  Chang et al. EUS 2017
41 ©2018 Mauna Kea Technologies   Szegedy C, et al. Proceedings of the IEEE Conference on Computer Vision and Pattern Recognition, 2015:1-9
Endomicroscopy is now a booming field
       Carl Zeiss announced its Convivo Confocal
       Laser Endomicroscopy system for
       neurosurgical applications at the latest
       Neurosurgery shows

       Olympus announced the launch of its
       Endocytoscopy system, integrated in vivo
       microscopy in a high-end endoscope.

       Caliber ID obtained strong reimbursement for
       skin optical biopsy with Confocal Microscopy.

   Cellvizio and its future generations
   are unparalleled products for in vivo
   optical biopsy applications
42 ©2017 Mauna Kea Technologies
In vivo microscopic molecular imaging roadmap

                                                                                   Mauna Kea is the
                                                                                 unique provider of in
                                                                                    vivo molecular
                                                                                  microscopic dual-
                                                                                    band imaging*

                                                                                  Molecular markers
     Fluorescence-guided surgery (open,                                                  +
       laparoscopic, robotic) is now the        Cellvizio
                                               eliminates                       wide-field fluorescence
         norm with wide-field imaging
         systems from a dozen players      uncertainties and                                +
    (Stryker+Novadaq, Olympus, Intuitive    provides micro-                       in vivo microscopy
           Surgical, Bracco, Fluoptics,        guidance                                    =
                 SurgVision…)                                                     precision surgery
43 ©2018 Mauna Kea Technologies            * Not cleared by FDA for human use
Unlimited discoveries with Cellvizio

     March 27th, 2018

44   ©2018 Mauna Kea Technologies
Cellvizio is at the core of key trends in medicine and surgery

                                             Data-driven
                                            digital surgery
 Our technologies                                               Endoluminal
                                                                 therapies
 are key to the
 future of image-
 guided and data-                 Robotic
                                  Surgery
 driven interventions                                                         Minimally invasive
                                                                                interventions

                                                 Real time
                                               microscopic
                                                imaging &
                                             characterization

45 ©2018 Mauna Kea Technologies
Appendix
Beating uncertainty with CLE

     (1) DONT BIOPCE study, 101 patients, multi-centric
     (2)FOCUS study, 112 patients, multi-centric
     (3)Shahid et al., 92 patients, multi-centric
     (4)CONTACT study, 31 patients, multi-centric
     (5)INSPECT study, 65 patients, multi-centric,
         DETECT study, 30 patients, mono-centric

                                                                      State of the art                            + pCLE
                       BE Metaplasia (1)                         66                                        32
                        BE Dysplasia (1)                         55                                        24
           Inflammatory Biliary Strictures (2)                                    27   (73 % NPV)                          18   (82 % NPV)

              Malignant Biliary Strictures (2)                   44                    15-24                11
                   Hyperplastic Polyps (3)                       28                                         0
                     Adenocarcinoma (3)                                            9 (91 % NPV)                            0 (100 % NPV)
                   Serous cystadenoma (4)                        50                      40                31                     0
                      Mucinous Cysts (5)                         50                      40              23-41                    0
                                                          % False Negatives     % False Positives   % False Negatives   % False Positives
47    ©2016 Mauna Kea Technologies
References - Clinical Evidence

GENERAL
1.     Wang, K. K., Carr-Locke, D. L., Singh, S. K., Neumann, H., Bertani, H., Galmiche, J. - P., Arsenescu, R.I.; Caillol, F.; Chang, K.J.; Chaussade, S.; Coron, E.; Costamagna, G.; Dlugosz, A.; Ian Gan,
       S.; Giovannini, M.; Gress, F.G.; Haluszka, O.; Ho, K.Y.; Kahaleh, M.; Konda, V.J.; Prat, F.; Shah, R.J.; Sharma, P.; Slivka, A.; Wolfsen, H.C.; Zfass, A.. (2015). Use of probe-based confocal
       laser endomicroscopy (pCLE) in gastrointestinal applications. A consensus report based on clinical evidence. United European Gastroenterol J, 3(3), 230–254.
2.     Queneherve L et al., nouvelles stratégies d'analyse endoscopique des maladies digestives. Médecine/sciences 2015 ;31:777-83
3.     Sabina Beg, Krish Ragunath,, Image-enhanced endoscopy technology in the gastrointestinal tract: What is available?, Best Practice & Research Clinical Gastroenterology 29 (2015)
       627e638
4.     Ussui Vivian et al. Probe-based confocal laser endomicroscopy with cap for image stabilization… Endosc Int Open 2015

BE/GERD
1.     Guo, J., Li, C. - Q., Li, M., Zuo, X. - L., Yu, T., Liu, J. - W., et al. (2015). Diagnostic value of probe-based confocal laser endomicroscopy and high-definition virtual chromoendoscopy in
       early esophageal squamous neoplasia. Gastrointest Endosc, 81(6), 1346–1354.
2.     Robles, L. Y., Singh, S., & Fisichella, P. M. (2015). Emerging enhanced imaging technologies of the esophagus: spectroscopy, confocal laser endomicroscopy, and optical
       coherence tomography. J Surg Res, 195(2), 502–514.
3.     Muthusamy, V. R., Kim, S., & Wallace, M. B. (2015). Advanced Imaging in Barrett's Esophagus. Gastroenterol Clin North Am, 44(2), 439–458.
4.     Singh, R., Yeap, S. P., & Cheong, K. L. (2015). Detection and characterization of early malignancy in the esophagus: What is the best management algorithm? Best Pract Res Clin
       Gastroenterol, 29(4), 533–544.
5.     Leggett CL, Gorospe EC, Chan DK, Muppa P, Owens V, Smyrk TC, Anderson M, Lutzke LS, Tearney G, Wang KK, Comparative Diagnostic Performance of Volumetric
       Laser Endomicroscopy and Confocal Laser Endomicroscopy in the Detection of Dysplasia Associated with Barrett’s Esophagus, Gastrointestinal Endoscopy (2015)
6.     Prueksapanich, P., Pittayanon, R., Rerknimitr, R., Wisedopas, N., & Kullavanijaya, P. (2015). Value of probe-based confocal laser endomicroscopy (pCLE) and dual focus narrow-band
       imaging (dNBI) in diagnosing early squamous cell neoplasms in esophageal Lugol's voiding lesions. Endosc Int Open, 3(4), E281–8.
7.     Massimiliano di Pietro , Elizabeth L. Bird-Lieberman ,Bchir, , Xinxue Liu , Mphil, Tara Nuckcheddy-Grant , Helga Bertani ,Maria O’Donovan, Rebecca C. Fitzgerald,Autofluorescence-
       directed confocal endomicroscopy in combination with a three-biomarker panel can inform management decisions in Barrett's Esophagus, Am J Gastroenterol, 2015
8.     Rzouq F, Vennalaganti P, Pakseresht K, Kanakadandi V, Parasa S, Mathur SC, Alsop BR, Hornung B, Gupta N, Sharma P, In-class didactic versus self-directed teaching of the porbe-
       based confocal laser endomicroscopy (pCLE) criteria for Barrett's Esopahgus, Endoscopy. 2015 Oct 1
9.     Sharma P, Brill J, Canto M, DeMarco D, Fennerty B, Gupta N, Laine L, Lieberman D, Lightdale C, Montgomery E, Odze R, Tokar J, Kockman M. White Paper AGA: Advanced
       Imaging in Barrett's Esophagus. Clin Gastroenterol Hepatol. 2015 Dec;13(13):2209-18.

STOMACH
1.     Li, Z., Zuo, X. - L., Li, C. - Q., Liu, Z. - Y., Ji, R., Liu, J., et al. (2015). New Classification of Gastric Pit Patterns and Vessel Architecture Using Probe-based Confocal Laser Endomicroscopy. J
       Clin Gastroenterol, .
2.     Li, C. - Q., Zuo, X. - L. I., Guo, J., Yuan, J., Liu, J. - W., & Li, Y. - Q. (2014). Sa1492 A Paralleled Comparison Between Two Sets of Confocal LASER Endomicroscopy in Gastrointestinal
       Tract. Gastrointestinal Endoscopy, 79(5), Ab233.
3.     Imaeda, A. (2015). Confocal laser endomicroscopy for the detection of atrophic gastritis: a new application for confocal endomicroscopy? J Clin Gastroenterol, 49(5), 355–357

     ©2018 Mauna Kea Technologies
References - Clinical Evidence
BILIARY
1.    Slivka, A., Gan, I., Jamidar, P., Costamagna, G., Cesaro, P., Giovannini, M., et al. (2015). Validation of the diagnostic accuracy of probe-based confocal laser endomicroscopy for
      the characterization of indeterminate biliary strictures: results of a prospective multicenter international study. Gastrointest Endosc, 81(2), 282–290.
2.    Baillie, J. (2015). Distinguishing malignant from benign biliary strictures: can confocal laser endomicroscopy close the gap? Gastrointest Endosc, 81(2), 291–293.
3.    Kahaleh, M., Giovannini, M., Jamidar, P., Gan, S. I., Cesaro, P., Caillol, F., Bernard Filoche, Kunal Karia,1 Ioana Smith, Monica Gaidhane and Adam Slivka. (2015). Probe-based confocal laser
      endomicroscopy for indeterminate biliary strictures: refinement of the image interpretation classification. Gastroenterol Res Pract, 2015, 675210.
4.    Johannes-Matthias Löhr, R. L., Serena Stigliano1, 2, Stephan L Haas1, Fredrik Swahn, Lars Enochsson, Rozh Noel, Ralf Segersvärd, Marco Del Chiaro, Caroline S Verbeke and Urban Arnelo.
      (2015). Outcome of probe-based confocal laser endomicroscopy (pCLE) during endoscopic retrograde cholangiopancreatography: A single-center prospective study in 45 patients.
      United European Gastroenterol J, .
5.    Tringali, A., Lemmers, A., Meves, V., Terheggen, G., Pohl, J., Manfredi, G., Hafner, M.; Costamagna, G.; Deviere, J.; Neuhaus, H.; Caillol, F.; Giovannini, M.; Hassan, C.; Dumonceau, J.-M.
      (2015). Intraductal biliopancreatic imaging: European Society of Gastrointestinal Endoscopy (ESGE) technology review. Endoscopy, 47(8), 739–753.
6.    Coté GA., Probe-based confocal laser endomicroscopy for indeterminate bile duct strictures : the inaccuracies of accuracy when appraising the value of a diagnostic test,
      Gastroenterology, 2015 Sep;149(3):817-9
7.    Karia K, Jamal-Kabani A, Gaidhane M, Tyberg A, Sharaiha RZ, Kahaleh M, Probe-based confocal endomicroscopy in primary sclerosing cholangitis : not all inflammatory strictures are the
      same, Dig Dis Sci, 2015 Aug 2 Epub ahead of print
8.    Singh A, Siddiqui UD. The Role of Endoscopy in the Diagnosis and Management of Cholangiocarcinoma. J Clin Gastroenterol. 2015;49(9):725-37.
9.    Balderramo D, Probe-based confocal laser endomicroscopy contribution in the evaluation of indeterminate biliary strictures, Gastrointest Endosc. 2015 Nov;82(5):970

PANCREAS
1.    Nakai, Y., Iwashita, T., Park, D. H., Samarasena, J. B., Lee, J. G., & Chang, K. J. (2015). Diagnosis of pancreatic cysts: EUS-guided, through-the-needle confocal laser-induced
      endomicroscopy and cystoscopy trial: DETECT study. Gastrointest Endosc, 81(5), 1204–1214.
2.    Krishna, S. G., Swanson, B., Conwell, D. L., & Muscarella, P. 2nd. (2015). In vivo and ex vivo needle-based confocal endomicroscopy of intraductal papillary mucinous neoplasm of
      the pancreas. Gastrointest Endosc, 82(3), 571–572.
3.    Karstensen, J. G., Cartana, T., Klausen, P. H., Hassan, H., Popescu, C. F., Saftoiu, A., Vilmann, P. (2015). Endoscopic ultrasound-guided needle-based confocal laser endomicroscopy: a
      pilot study for use in focal pancreatic masses. Pancreas, 44(5), 833–835.
4.    Maria, K., Waxman, I., Konda, V. J., Gress, F. G., Sethi, A., Siddiqui, U. D., Sharaiha, R.Z.; Kedia, P.; Jamal-Kabani, A.; Gaidhane, M.; Kahaleh, M. (2015). Needle-based confocal endomicroscopy
      for pancreatic cysts: the current agreement in interpretation. Gastrointest Endosc, .
5.    Tsujino, T.; Yan-Lin Huang, J.; Nakai, Y.; Samarasena, J.B.; Lee, J.G.; Chang, K.J. Tsujino, T.; Yan-Lin Huang, J.; Nakai, Y.; Samarasena, J.B.; Lee, J.G.; Chang, K.J. In vivo identification of
      pancreatic cystic neoplasms with needle-based confocal laser endomicroscopy. Best Practice & Research Clinical Gastroenterology. 20145 29:601-610
6.    Napoleon B, Lemaistre AI, Pujol B, Caillol F, Lucidarme D, Bourdariat R, Morellon-Miahle B, Fumex F, Lefort C, Lepilliez V, Palazzo L, Monges G, Poizat F, Giovannini M, In
      vivo characterization of pancreatic cystic lesions by needle-based confocal laser endomicroscopy (nCLE) : proposition of a comprehensive nCLE classification confirmed by an
      external retrospective evaluation, Surg Endosc. 2015 Oct 1

     ©2018 Mauna Kea Technologies
References - Clinical Evidence
     COLON/IBD
     1.  Tontini, G. E., Mudter, J., Vieth, M., Atreya, R., Gunther, C., Zopf, Y.,Wildner, D.; Kiesslich, R.; Vecchi, M.; Neurath, M.F.; Neumann, H. (2015). Confocal laser endomicroscopy for
         the differential diagnosis of ulcerative colitis and Crohn's disease: a pilot study. Endoscopy, 47(5), 437–443.
     2. Nguyen, D. L., Lee, J. G., Parekh, N. K., Samarasena, J., Bechtold, M. L., & Chang, K. (2015). The current and future role of endomicroscopy in the management of inflammatory bowel
         disease. Ann Gastroenterol, 28(3), 331–336.
     3. Buchner, A. M., & Wallace, M. B. (2015). In-vivo microscopy in the diagnosis of intestinal neoplasia and inflammatory conditions. Histopathology, 66(1), 137–146.
     4. Gabbani, T., Manetti, N., Bonanomi, A. G., Annese, A. L., & Annese, V. (2015). New endoscopic imaging techniques in surveillance of inflammatory bowel disease. World J Gastrointest
         Endosc, 7(3), 230–236.
     5. Kattah, M. G., & Mahadevan, U. (2015). Confocal laser endomicroscopy for membrane-bound tumor necrosis factor predicts response to therapy in Crohn's disease. Gastroenterology,
         148(5), 1067–1069.
     6. Mace, V., Ahluwalia, A., Coron, E., Le Rhun, M., Boureille, A., Bossard, C., Jean-François Mosnier, Tamara Matysiak-Budnik and Andrzej S Tarnawski. (2015). Confocal laser
         endomicroscopy: a new gold standard for the assessment of mucosal healing in ulcerative colitis. J Gastroenterol Hepatol, 30 Suppl 1, 85–92.
     7. Cheon, J. H. (2015). Advances in the Endoscopic Assessment of Inflammatory Bowel Diseases: Cooperation between Endoscopic and Pathologic Evaluations. J Pathol Transl Med,
         49(3), 209–217.
     8. Rasmussen, D. N., Karstensen, J. G., Riis, L. B., Brynskov, J., & Vilmann, P. (2015). Confocal Laser Endomicroscopy in Inflammatory Bowel Disease – A Systematic Review. J Crohns
         Colitis, .
     9. Tontini GE, Pastorelli L, Ishaq S, Neumann H. Advances in endoscopic imaging in ulcerative colitis. Expert Rev Gastroenterol Hepatol. 2015 ; 12:1-13.
     10. Neurath M. F. Molecular endoscopy and in vivo imaging in inflammatory bowel diseases, Dig Dis 2015;33(suppl 1):32-36
     11. Ott C., From bench to bedsite – predictor of response to an anti-TNF-therapy in patients with Crohn's disease during confocal laser endomicroscopy, Z Gastroenterol,2015 Oct;53(10):
         1202-3

     DUODENUM
     1.    Nonaka, K., Ohata, K., Ban, S., Takita, M., Matsuyama, Y., Tashima, T., et al. (2015). In vivo imaging of duodenal follicular lymphoma with confocal laser endomicroscopy. Endoscopy, 47
           Suppl 1 UCTN, E16–7.
     2.    Ohata, K., Nonaka, K., Ban, S., & Matsuhashi, N. (2015). Gastroenterology: Simultaneous practice of narrow band imaging and confocal laser endomicroscopy for a case of early
           duodenal cancer. J Gastroenterol Hepatol, 30(6), 966.
     3.    Rodriguez-Diaz E, Baffy G, Singh SK. Probe-based confocal laser endomicroscopy quantitative morphometric markers associated with portal hypertension in duodenal mucosa. Liver
           Int. 2015
     4.    Dolak, W., Mesteri, I., Asari, R., Preusser, M., Tribl, B., Wrba, F., Schoppmann, S.F.; Hejna, M.; Trauner, M.; Hafner, M.; Puspok, A. (2015). A pilot study of the endomicroscopic assessment
           of tumor extension in Barrett's esophagus-associated neoplasia before endoscopic resection. Endosc Int Open, 3(1), E19–28.
     5.    Rapat Pittayanon1, Rungsun Rerknimitr1, Boonlert Imraporn1, Naruemon Wisedopas2, Pinit Kullavanijaya, Diagnostic values of dual focus narrow band imaging and probe-based
           confocal laser endomicroscopy in FAP-related duodenal adenoma, Endosc Int Open, 2015
     6.    Nonaka K, ohata K, Ichibara S, Ban S, Hiejima Y, Minato Y, Tashima T, Matsuyama Y, Takita M, Matsuhashi N, Takasugi R, Neumann H, Development of a new classification for in vivo
           diagnosis of duodenal epithelial tumors with confocal laser endomicrosocpy – a pilot study, Dig Endosc. 2015 Oct 29

50        ©2018 Mauna Kea Technologies
References - Clinical Evidence
UROLOGY
1.     G.A. Sonn, K.E. Mach, K. Jensen, P.L. Hsiung S.N. Jones, C.H. Contag, T.D. Wang, J.C. Liao. Fibered Confocal Microscopy of Bladder Tumors: An ex Vivo Study. Journal
       of endourology 2009;23:2.
2.     G.A. Sonn, S.E. Jones, T.V. Tarin, C.B. Du, K.E. Mach, K.C. Jensen and J.C. Liao Optical Biopsy of Human Bladder Neoplasia With In Vivo Confocal Laser Endomicroscopy. The Journal of
       Urology, 2009
3.     W. Adams, K. Wu, J.J. Liu, S.T.T. Hsiao, K.C. Jensen, and J.C. Liao Comparison of 2.6- and 1.4-mm Imaging Probes for Confocal Laser Endomicroscopy of the Urinary Tract. Journal of
       endourology 2011;25:6
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