Mauna Kea Technologies · !2 ©2018 Mauna Kea Technologies Disclaimer • This document has been prepared by Mauna Kea Technologies (the "Company") and is provided for information

Corporate Presentation - November 2018

Mauna Kea Technologies

©2018 Mauna Kea Technologies!2

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.

Cellvizio®: cellular vision at your fingertips

First miniaturized confocal microscope designed to provide physicians and surgeons with digital cellular visualization at the bedside

©2017 Mauna Kea Technologies

Investment opportunity : A highly attractive value proposition

1 First and only: Transformational probe-based Confocal Laser Endomicroscopy Platform

2 Large addressable market: GI, Urology, Interventional Pulmonology, others

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

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

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

5

6

7

9

Utilization-focused: Driving US adoption & recurring revenue via pay-per-use model

Robust R&D pipeline to drive growth through application expansion

Broad IP protection: 236 issued patents on Cellvizio® technologies

8

New seasoned US based executive leadership to drive commercial expansion

!4

A breakthrough technology platform

©2018 Mauna Kea Technologies©2018 Mauna Kea Technologies

Tissue characterization relies on old paradigms

!6

Random/blind samples

Low sensitivity

Diagnostic and treatment uncertainty

Invasive, multi-step process

Repeat procedures

Creates anxiety for patients and frustration for surgeons

Real-time digital biopsies to eliminate uncertainties and provide instantaneous, reliable and actionable results

Biopsy today Unmet need

Digital optical biopsies: a powerful new paradigm

“Patients are better served if biopsies can be better targeted. That’s where in vivo

microscopy comes in”.


From H&E histology…one image - static view

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

Brain Colon Esophagus


Probe-based Confocal Laser Endomicroscopy (pCLE) provides real time digital optical sections of tissues through all types of access methods

Cellvizio reveals key invisible information

pCLE (lap / robotics)

nCLE (needle)

pCLE (probe/catheter)


Seamless integration into endoscopy workflow

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

Cellvizio miniprobe is inserted into operating channel of any endoscope 2

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

Our mission: eliminate diagnostic and treatment uncertainties

Gastroenterology applications

©2018 Mauna Kea Technologies 11

Core commercial focus: A significant Cellvizio U.S. gastroenterology

market opportunity

Society recom-

mendations and

increased CMS reimbursement

rates

Key Market Drivers

U.S. Procedure volume

U.S. market opportunity

3.6 million*

annual upper GI procedures

$2.8 billion* annual

recurring revenue

U.S. Target Hospitals

3,000+* with large GI volume

* 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 volume 2012; 2015 ERCP report, M&A acquisition figures : Covidien; Medtronic Advamed presentations : 2013 Advamed presentation; E&Y; Presentations citing other sources


Enhancing traditional endoscopy is a recognised need…

Dr. Brian Fennerty, past President, ASGE (American Society of Gastrointestinal Endoscopy)

New York Society of Gastroenterology meeting, 17 Dec 2010, New York

!12

©2010-2018 Mauna Kea Technologies

… for important reasons

More than 25% of esophageal adenocarcinoma are diagnosed within a year after the index endoscopy

among adults with non dysplastic Barrett’s esophagus (or Barrett’s esophagus with low-grade dysplasia) (1)

1.Visrodia K et al. Magnitude of Missed Esophageal

Adenocarcinoma After Barrett’s Esophagus Diagnosis: A

Systematic Review and Meta-analysis. Gastroenterology. 2016

!13

Additional resources / technologies should be allocated to detect missed cases


Growing, unmet need in esophageal cancer

!14

Esophageal cancer is the fastest growing cancer2

Symptoms of acid reflux, including

heartburn, occur monthly in

44% of adults11 Shaheen N, Ransohoff DF. Gastroesophageal reflux, Barrett's esophagus and esophageal cancer. Journal of the American Medical Association. 2002; 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.

25% of esophageal cancers diagnosed within one year of

standard endoscopy3


Addressing the Random Biopsy Limitation

!15

6% yieldInefficient random

sampling1

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. 3.Sharma P et al. White Paper AGA: Advanced Imaging in Barrett's Esophagus. Clin Gastroenterol Hepatol. 2015

Seattle Protocol

“biopsies of columnar lined epithelium in the esophagus[…]because of sampling error,

goblet cells may not be detected, thereby underdiagnosing BE”3

…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

Goblet cells

The Cellvizio digital optical biopsy solution

intestinal metaplasiasquamous epithelium

©2016 Mauna Kea Technologies©2016 Mauna Kea Technologies!16

Improved detection of Barrett’s Esophagus for enhanced patient management

2. M. Canto, et al. In vivo endomicroscopy improves detection of Barrett’s esophagus–related neoplasia: a multicenter international randomized controlled trial, GIE 2013.

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.

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.

DON'T BIOPCE trial multi-center, randomized controlled

trial, 101 patients, 2 arms 4

68%

76%

pCLE or WLE

pCLE or

WLE or NBI

WLE or NBI

WLE

WLE : White Light Endoscopy NBI : Narrow Band Imaging

pCLE: endomicroscopy

x 1.7

34%

45%

Sensitivity

x 2

Sensitivity

CEBE trial multi-center, randomized controlled

trial, 192 patients, 2 arms 5

40%

96%

HD-WLE +

CLE

HD-WLE : High Definition White Light Endoscopy CLE: endomicroscopy

HD-WLE

x 2.4

Sensitivity

MODENA BARRETT’S STUDY single-center, randomized trial, 100

patients, 2 arms

Dysplasia Detection tripled with Cellvizio

over white light

Biopsies could have been

avoided for 58% of patients

White Light

White Light +

Cellvizio

10%

28%

~2x improvement in sensitivity for dysplasia detection 36% of patient treatment plans improved

3x diagnostic yield


New data on improved detection of Barrett’s Esophagus

!17

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 endomicroscopy 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

2017 Meta analysis of detection of neoplasia in BE with NBI vs CLE 2

• 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.

20

40

60

80

100

120

140

Seattle Protocol

Positive for IMNegative for IM

>+100% with

Cellvizio

172 patients


Strong endorsements from medical societies

AGA white paper December 2015 “Why should practice change?”

Sharma P et al. White Paper AGA: Advanced Imaging in Barrett's Esophagus. Cl in Gastroenterol Hepatol. 2015

Screening: “BE (specifically shorter disease) is often misdiagnosed during

endoscopy... often attributed to ...lack of goblet cells in biopsies obtained from

columnar lined epithelium in the esophagus.”

“Workshop panelists agreed that in the hands of endoscopists who have met

the PIVI thresholds with specific enhanced imaging techniques (NBI & Confocal Laser Endomicroscopy), use

of the technique in BE patients is appropriate”

“Cellvizio, very clearly, is integral to the comprehensive assessment of

patients suffering from reflux disease”

American Society of General Surgeons Position Statement on Confocal Laser Endomicroscopy published September

2016

“Clinicians and patients alike need and deserve access to Cellvizio® (pCLE) in

order to obtain a comprehensive assessment of the extent of disease and to make real-time therapeutic treatment

decisions.”

https://theasgs.org/position-statements/position-statement-on-confocal-laser-endomicroscopy/

http://www.cghjournal.org/article/S1542-3565(15)01306-3/fulltext

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 epithelium in the distal esophagus. Surveillance requires numerous biopsies.

Targeted BiopsiesGiven the usual small size of the dysplastic areas, traditional screening is a shotgun approach to detection. IVM can help target higher-yield, more diagnostic sites.

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 [email protected]

The architectural and cellular patterns generated by in vivo microscopy are interpretable by pathologists to make differential diagnoses and to identify areas for biopsy, improving diagnostic yield. The image on the left shows a focus of malignant glands.

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.

In Vivo Microscopy for the Evaluation of Barrett EsophagusIn 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.

© 2015 College of American Pathologists. All rights reserved. 23487.0315

cap.org

Patients are better served if the biopsies can be better targeted. That’s where in vivo microscopy comes in.

Traditional surgical biopsy, taken transverse to the tissue plane, shows malignant glands corresponding to the in vivo confocal image on the right.

IVM Optical Biopsy Guides Site SelectionAn optical biopsy, using confocal laser endomicroscopy, for 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.


A shifting paradigm with in vivo microscopy

!19

“Patients are better served if biopsies can be better targeted. That’s where in vivo

microscopy comes in”.

CAP is actively promoting awareness and better understanding of IVM opportunities

for pathologists

http://www.cap.org/web/home/involved/council-committees/ivm-committee/ivm-topic-center?_afrLoop=817409063069337#!%40%40%3F_afrLoop%3D817409063069337%26_adf.ctrl-state%3D16bmzn84t_4


Favorable US reimbursement for upper GI

Setting 2016 Rate 2017 Rate 2017 Change ($)

2017 Change

(%)2018 Rate

Hospital $1,088.00 $2,509.64 $1,421.64 131% $2743.26

ASC $608.39 $1,134.02 $525.63 86% $1212.19

CPT Code Description

43252

Upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate; with optical endomicroscopy

CMS Covered Services

Endomicroscopy in upper GI endoscopy procedures, including GERD, Barrett’s Esophagus and pancreatic lesions

Effective January 1, 2017

! Catalyst for Cellvizio adoption and utilization

! Enhances economical model for Cellvizio customers

! Positive tailwind for commercial coverage

!20

Very positive payment trends in the past 2 years


2018 Hospital and ASC Reimbursement for Upper GI Endoscopy

!21

Patient with GERD/BE getting

an EGD

Biopsy (Seattle Protocol)

Patient with GERD/BE getting

an EGD

Targeted biopsy protocol with

improved sensitivity

*Multi-Procedure Rule

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

CPT 43252 + (CPT 43239)/2 : $3,114* HOPPS / $1,405 ASC medicare payment

WITH Endomicroscopy

WITHOUT Endomicroscopy


New business model and sales team to address large market

Focus on upper GI endoscopies (EGDs)

• 60% in hospital outpatient setting

• 40% in the 1200 GI-focused ASCs

• New pay-per-use business model provides attractive adoption option for hospitals

•New sales team in place since February 2018

• 2 divisional sales manager, 12 area sales managers, 6 clinical account managers

!22

Potential US Customers

# o

f ce

nte

rs#

of

pro

ce

du

res in

th

ou

san

ds

Potential number of procedures per year

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.


• Consignment program enables physicians to utilize Cellvizio without upfront capital equipment purchase

• Confirmed U.S. commercial traction with 20 systems placed under consignment in Q3 and 36 ytd vs 12 ytd last year.

• Pay-per-use approach provides attractive physician economics

• Pay-per-use revenue up 81% compared to Q3 2017

Continuous momentum with new US sales team

!23

New US sales team trained end of January 2018

0

5

10

15

20

Q1 Q2 Q3

20

11

54

2

6

Consignment systems placed per quarter since launch of program

Corporate information and performance


Leadership Transition to Support New Phase of Growth

!25October 22, 2018 Proprietary and Confidential. Not to be distributed or reproduced without permission

Rob Gershon

• Most recently CEO of Bovie Medical (NYSE: BVX), where he oversaw the successful repositioning of the Company’s product portfolio and commercial operations

• 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

Mr. Rob Gershon Chief Executive Officer (CEO)

• Brings 30 years of commercial leadership experience

• Joins Mauna Kea’s board of directors

"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


Unrivaled regulatory foundations create high barriers to entry

!26

“Cellvizio® 100 Series Systems with 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” —

FDA clearance December 2017

Above images are not FDA cleared and are shown as

illustrative examples15 510(k) Clearances

CE mark Clearances in China, Korea and Japan


A growing installed base worldwide

Preclinical

30+ units

Clinical

100+ units

Clinical

130+ units

Approx. 645 systems installed worldwide

Clinical

160+ units

Preclinical

70+ units

Preclinical

60+ units

!27


Strong clinical evidence and intellectual property

!28 See appendix for references

Nu

mb

er

of

pu

blicati

on

s

2004

2005

20062007

2008

20092010

20112012

20132014

20152016

20172018

100

50

150

1,100+ Articles on PubMed for endomicroscopy across

multiple applications

230+ issued patents in optics, optronics, image

processing on probe-based Confocal Laser

Endomicroscopy (CLE)

Optoelectronics

Image Processing

Machine Learning


H1 Key figures

!29

Contacts

€ 2,7m

Down

-18%

Net Sales Gross margin

Opex Ebitda Cash

€ 1,7m

64% Vs 68%

€ -7,7m

Up

3,4%

€ -5,5m

down

-0,7m

€ 15,1 m

Vs

€ 9,4 m

• Q1 Sales 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


• U.S. commercial focus gaining traction with 16 systems placed under consignment (compared to 8 systems in 1H17)

• APAC sales +8% above last year,

• EMEA and LATAM still low.

H1 2018 Sales

System Sales & Consignment Sales

0

8

15

23

30

1H17 1H18

914

16

8

New Consignments Placed NewSystem Straight Sales

1H18 vs. 1H17 Sales

'- 0

875

1 750

2 625

3 500

'- 0

825

1 650

2 475

3 300

1H17 1H18

Sales Systems (LTM*) Consumables (LTM*)

2 707

3 285

1H18 Sales by Product

1H18 Sales by Category

18,4%

81,6%

Pre Clinical Clinical

990

1 197

520

Systems Probes Services

!30


Opex under control

• Opex (excluding COGS & Depreciation) up 3,4% :

▪ Marketing and sales expenses under control and down 20%.

▪ Payroll in the US up 34%, in line with the strategy.

▪ G&A expenses increase : US recruitment fees and HR staffing.

€ 2,0 m€ 1,6 m

€ 3,9 m€ 4,0 m

€ 1,9 m€ 1,9m

0,0

1,0

2,0

3,0

4,0

5,0

6,0

7,0

8,0

9,0

1H 2018 1H 2017

G&A M&S R&D

G&A

R&D

M&S


Balance sheet

• PPE increases due to PPU model deployment, with 16 new LSU installed in 1H 2018

• Inventories mainly increase due to anticipated purchases.

!32

• Swap of 4M€ from LT debts to Short term due to IPF covenants renegotiation.

• Other short term debt includes Coface advance (150 K€), fully reimbursed as of sept 2018.

1

ASSETS (in K€) 30/06/2018 31/12/2017

Intangible assets 1 873 2 100

Property, plant, and equipment 1 813 1 466

Non-current financial assets 140 138

Total of non-current assets 3 825 3 704

Inventories & Work in progress 2 251 1 969

Trade receivables 1 618 2 034

Other current assets 2 333 2 462

Current financial assets 40 125

Cash and cash equivalents 15 132 17 453

Total of current asets 21 374 24 043

TOTAL OF ASSETS 25 199 27 747

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

Equity 13 738 16 744

Long-term loans and borrowings 2 749 6 567

Non-current provisions 379 283

Total of non-current liabilities 3 128 6 850

Short-term loans and borrowings 4 333 386

Trade payables 1 910 1 663

Other current liabilities 2 091 2 104

Total of current liabilities 8 334 4 153

TOTAL OF EQUITY AND LIABILITIES 25 199 27 747


Liquidity Update : a strong cash position at the end ofJune

17 453

-5 638 - 248

3 625 15 193

BoP Cash Operating CF Investing CF Financing CF EoP Cash

0

2 000

4 000

6 000

8 000

10 000

12 000

14 000

16 000

18 000

20 000

HY 2018 Cash variation - in K€

Hausse Baisse Total

Key drivers to Cash burn

• Change in EBITDA drives the change in cash (€ 0,7m

• Change in working capital

- Increase in inventories due to sales gap.-

- Positive impact on trade payables

•Capex

- New web sites, PLM software development

•Cash flow from financing

- Paceo capital raise for 3.8 M€


Re-orders & Pay-Per-Use Probe Units

0

55

110

165

220

Q1 Q2 Q3

215

146

101

161

108107

20172018

Q3 2018 Highlights • 20 U.S. consignment 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%

Continued Momentum of U.S. Sales Team

!34

Placed more PPU systems in 3Q18 than 1H18 and FY17

0

5

10

15

20

Q1 Q2 Q3

20

11

5 42

6


Total Float > 80%

Shareholding Profile

!35

Investor Relations U.S.

Lee Roth The Ruth Group +1 (646) 536-7012 [email protected]

Investor Relations Europe

Newcap Pierre Laurent +33 (0) 1 44 71 94 94 [email protected]

Contacts

Contacts

Market Cap (1)Shares

outstandingCoverage

• Goetz Partners-M.Brunninger

• Kepler Chevreux- A.Guekam

• Gilbert Dupont - X.Regnard25,2 MM66 M€

Liquidity (2)

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

Mauna kea Technologies

Directors & Management

Other registered

Institutional investors

Free Floating

Shareholders

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

Japan

Benelux

Germany

Switz.

France

Shareholders by Region

(1) As of Oct. 12, 2018

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

92 K / day

Applications pipeline


Major improvement in pancreatic cystic lesions management

!37

(9)

1Mucinous cystic lesions can be confirmed with very high specificity in about 7 cases out of 10 (1, 2)

0 % 25 % 50 % 75 % 100 %

Sensitivity: 59 - 77%

Specificity: 100%

INSPECT study, 65 patients, multi-centric (9) DETECT study, 30 patients, mono-centric (10)

2Serous cystadenomas can be confirmed with very high specificity in 9 cases out of 10 (3)

CONTACT 2 study, 78 patients, multi-centric (11)0 % 25 % 50 % 75 % 100 %

Sensitivity: 95%

Specificity: 100%

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 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

Addressing a fast growing interventional market (3-10% prevalence) with unique solution


Robotic Assisted Radical Prostatectomy

!38

Lopez et al, “Intraoperative Optical Biopsy during Robotic Assisted Radical Prostatectomy Using Confocal Endomicroscopy”. Journal of Urology, April 2016 * source Intuitive Surgical investor presentation

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


Peripheral Nodules / Lymph Nodes / Mediastinal Nodules

!39

Unique through-the-scope access to the lungs now through needles for direct access to the inside of

peripheral and mediastinal lesions

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

0.8 mm AQ-Flex probe

compatible with 19 gauge needles

On target Target missed * CE marked, not yet FDA cleared


Inflammatory Bowel Disease / Syndrome

!40

Clinical evidence has shown that functional

mucosal healing is key to predict disease course

➡ Cell shedding and barrier loss detected by Cellvizio predict relapse of IBD

➡ Direct visualisation can provide immediate assessment of food allergies / IBS

•Liu J. et al, GIE, 2011. Increased epithelial gaps in the small intestines of patients with inflammatory bowel disease: density matters

• Turcotte A et al, Clinical and Translational Gastroenterology (2012). Increased Epithelial Gaps in the Small Intestine Are Predictive of Hospitalization and Surgery in Patients With Inflammatory Bowel Disease

Random biopsies - or even

targeted biopsies - fail to

provide the information

needed to assess

functional healing, while

Cellvizio does exactly that

• Neumann, H. Et al, Inflamm Bowel Dis, 2012. Assessment of Crohn’s Disease Activity by Confocal Laser Endomicroscopy

• Fritscher-Ravens A et al, Gastroenterology. 2014, Confocal endomicroscopy shows food-associated changes in the intestinal mucosa of patients with irritable bowel syndrome


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 liste in very short list of very promising technologies in EAU guidelines

!41


AI: Taking endomicroscopy to the next level

!42

Diagnostic Accuracy of Cellvizio in Bladder

0 %

20 %

40 %

60 %

80 %

100 %

Accuracy Sensitivity Specificity

Machine Urologists (n=8)

87%90%

79%79%77%

82%

Chang et al. EUS 2017 Szegedy C, et al. Proceedings of the IEEE Conference on Computer Vision and Pattern Recognition, 2015:1-9

Work performed by the Stanford Bioinformatics program on a dataset of 81 subjects (458 Cellvizio videos, 171,000 images, 21 layer CNN)


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.

!43

Cellvizio and its future generations are unparalleled products for in vivo optical biopsy applications


In vivo microscopic molecular imaging roadmap

!44 * Not cleared by FDA for human use

Molecular markers +

wide-field fluorescence +

in vivo microscopy =

precision surgery

Mauna Kea is the unique provider

of in vivo molecular

microscopic dual-band imaging*

Fluorescence-guided surgery (open, laparoscopic, robotic) is now the

norm with wide-field imaging systems from a dozen players

(Stryker+Novadaq, Olympus, Intuitive Surgical, Bracco, Fluoptics,

SurgVision…)


Unlimited discoveries with Cellvizio

!45

March 27th, 2018


Cellvizio is at the core of key trends in medicine and surgery

!46

Real time microscopic imaging &

characterization

Data-driven digital surgery

Endoluminal therapies

Minimally invasive interventions

Our technologies are key to the future of image-guided and data-driven interventions

Robotic

Surgery

Appendix

©2016 Mauna Kea Technologies 48

Beating uncertainty with CLE

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

(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


References - Clinical Evidence

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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

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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



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



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

!51



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

4. K. Wu, J.J. Liu, W. Adams, G.A. Sonn, K.E. Mach, Y. Pan, A.H. Beck, K.C. Jensen, and J.C. Liao Dynamic real-time microscopy of the urinary tract using confocal laser endomicroscopy. The Journal of Urology, 2011.

5. JJ. Liu, TC. Chang, Y . Pan, et al Next generation of optical diagnostics for bladder cancer using probe-based confocal laser endomicroscopy. Proceedings of SPIE, 2012 6. JL. Bonnal, A. Rock, A. Gagnat, et al Confocal laser endomicroscopy of bladder tumors associated with photodynamic diagnosis : an ex vivo pilot study. Journal Urology, 2012 7. TC. Chang, JJ. Liu, ST Hsiao, et al Interobserver agreement of confocal laser endomicroscopy for bladder cancer.J Endourol, 2013 8. J. Liao Optical biopsy of upper tract urothelial carcinoma with confocal laser endomicroscopy (accepted at the congress of American Urological Association AUA, oral presentation

2013) 9. Stephanie P. Chen & Joseph C. Liao Confocal Laser Endomicroscopy of Bladder and Upper Tract Urothelial Carcinoma: A New Era of Optical Diagnosis? Curr Urol Rep (2014) 15:437 10. Aristeo Lopez & Joseph C. Liao Emerging Endoscopic Imaging Technologies for Bladder Cancer Detection Curr Urol Rep (2014) 15:406 11. Lopez A, Liao JC, Emerging endoscopic imaging technologies for bladder dancer detection, Curr Urol Rep, 2014 May ; 15(5):406 12. Chen, S. P., & Liao, J. C. (2014). Confocal laser endomicroscopy of bladder and upper tract urothelial carcinoma: a new era of optical diagnosis? Curr Urol Rep, 15(9), 437. 13. von Rundstedt, F. - C., & Lerner, S. P. (2014). New imaging techniques for nonmuscle invasive bladder cancer. Curr Opin Urol, 24(5), 532–539. 14. Bus, M. T. J., de Bruin, D. M., Faber, D. J., Kamphuis, G. M., Zondervan, P. J., Laguna Pes, M. P., de Reijke, T.M.; Traxer, O.; van Leeuwen, T.G.; de la Rosette, J.J.M.C.H. (2014). Optical

Diagnostics for Upper Urinary Tract Urothelial Cancer: Technology, Thresholds, and Clinical Applications. J Endourol, 15. Pan, Y., Volkmer, J. - P., Mach, K. E., Rouse, R. V., Liu, J. - J., Sahoo, D., Chang, T.C.; Metzner, T.J.; Kang, L.; van de Rijn, M.; Skinner, E.C.; Gambhir, S.S.; Weissman, I.L.; Liao, J.C.. (2014).

Endoscopic molecular imaging of human bladder cancer using a CD47 antibody. Sci Transl Med, 6(260), 260ra148. 16. Zlatev et al., Optical biopsy of bladder cancer using crowd sourced assessment, JAMA surgery, 2015 17. Seong Uk Jeh, Hae Do Jung*, Jong Kyou Kwon et al.,Diagnostic accuracy of probe based confocal laser endomicroscopy in bladder cancer, AUA, 2015 18. Zlatev, D. V., Altobelli, E., & Liao, J. C. (2015). Advances in imaging technologies in the evaluation of high-grade bladder cancer. Urol Clin North Am, 42(2), 147–57, vii. 19. Su LM, Kuo J, Allan RW, Liao JC, Ritari KL, Tomeny PE, Carter CM, Fiberoptic Confocal Laser Endomicroscopy of Small Renal Masses: Towards Real-time Optical Diagnostic Biopsy, The

Journal of Urology® (2015), 20. Bui D, Mach KE, Zlatev DV, Rouse RV, Leppert JT, Liao JC, A pilot study of in vivo confocal laser endomicroscopy of upper tract urothelial carcinoma, J Endourol. 2015 Oct 6 21. Lopez A, Zlatev DV, Mach KE, Bui D, Liu JJ, Rouse RV, Harris T, Leppert JT, Liao JC, Intraoperative optical biopsy during robotic-assisted radical prostatectomy usinf confocal

endomicroscopy. The Journal of Urology 2015, doi: 10.1016/j.juro.2015.10.182 22. Villa L, Cloutier J, Côté JF, Salonia A, Montorsi F, Traxer O, Confocal laser endomicroscopy (CLE) in the management of endoscopically treated upper urinary tract transitional cell

carcinoma (UUT-TCC) – preliminary data, J Endourol. 2015 Oct 16 (in press)

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