mkea apr 2017 corporate presentation 11 5 2017€¦ · gi market growth opportunities 13 gerd /...

©2017 Mauna Kea Technologies1

May 2017


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 June 13, 2016 under number R. 16-054.

• 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.

3

Our mission is to eliminate diagnostic

and treatment uncertainties

4

We help surgeons & physicians secure their decisions and reach better outcomes with real time digital

cellular and molecular information

©2017 Mauna Kea Technologies

Cellvizio® poised to become standard of care

•131% increase in Medicare hospital outpatient and 86% in ASC reimbursement for multiple key clinical applications starting January 2017

• Cellvizio procedures are reimbursable with category 1 CPT codes

•Endorsements and recommendations from key U.S. medical societies

• Strong and ever growing clinical evidence for multiple GI applications including GERD and Barrett’s Esophagus

•U.S. business transitioning to per procedure business model in order to quickly address demand and opportunity

• U.S. annual recurring procedural revenue opportunity estimated at $2.8 billion*

Major changes in 2016 created multiple growth drivers for 2017 and beyond

* see slide 11 for details5


Standard HD imaging

X 30 Macroscopic analysis

Cellvizio X 1000

Endomicroscopic analysis

Biopsy X 1000

Histology: microscopic analysis

Cellvizio is a breakthrough imaging platform

Cellvizio provides real-time microscopic views of tissues, in a minimally invasive way that is compatible with most access technologies

Observation plane with Cellvizio


Cellvizio® Systems

Cellvizio system and confocal miniprobes offering

nCLE (needle)

pCLE (scope/catheter)

pCLE (rigid scopes, trocars)

Limited Use Miniprobes (consumables)

10 uses.

Significant system opportunity and procedural volumes drive revenue

growth

Confocal Miniprobes

20 uses.

10 uses.

Clinical grade CellvizioCellvizio Dual Band for

preclinical imaging


A recognized clinical solution in 40+ countries

Americas

150+ units

APAC

150+ units

EMEA

250+ units

Regulatory clearances for probe and needle-based

CLE in 40+ countries

12 510(k) from U.S. FDA (GI, Lung, Urology, Surgery) CE Mark (GI, Lung, Urology, Surgery, Interventional Radiology)

SFDA in China, MHLW in Japan ANVISA in Brazil, Cofepris in Mexico

Turkey, Russia, Canada, KSA...

More than 550 systems installed worldwide


Year-on-year growth in peer-reviewed research

9

•Recent release of clinical studies outcomes e.g CONTACT II, PERSEE...

•High level of evidence for key applications in gastroenterology has driven the publication of recommendation and statement papers

•Level of evidence is rising for other key applications in urology, pulmonology, surgery and others

See appendix for references

Num

ber

of

pub

licat

ions

20042005

20062007

20082009

2010 20112012

20132014

20152016

100

50

150

930+ references on PubMed for endomicroscopy across

multiple applications


World leaders in endomicroscopy innovation and products

10

200+ issued patents in optics, optronics, image processing on

Confocal Laser Endomicroscopy (CLE)

OptoelectronicsImage ProcessingCognitive ComputingImage Processing

Three key pillars of our technical roadmap

U.S. Gastroenterology Market Opportunity


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


GI market growth opportunities

13

GERD / Barrett’s Esophagus Pancreatic Cysts

Goblet cells

Procedure is upper GI endoscopy (EGD) + endomicroscopy

Estimated market opportunity is 3.6 million procedures per year in the U.S.

At least 20% of the U.S. adult population has weekly GERD symptoms1

Procedure is Endoscopic Ultra-Sound Fine Needle Aspiration (EUSFNA) + endomicroscopy

About 3.5 million U.S. adults have a pancreatic cyst: estimated market opportunity is 50,000 to 100,000 procedures per year in the U.S.2

1. El-Serag HB, Petersen NJ, Carter J, et al. Gastroesophageal reflux among different racial groups in the United States. Gastroenterology. 2004;126:1692–1699. 2. Pancreatic cyst prevalence and the risk of mucin-producing adenocarcinoma in U.S. adults. Am J Gastroenterol. 2013 Oct;108(10):1546-50. doi: 10.1038/ajg.2013.103.


Intestinal Metaplasia

HistologyDelayed information

CELLVIZIO®Real-time information

High Grade Dysplasia

Squamous Esophagus

Enhancing Barrett’s Esophagus 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.

DONT BIOPCE trial multi-center, randomized controlled

trial, 101 patients, 2 arms 4

68%

pCLE or WLEWLE

WLE : White Light Endoscopy NBI : Narrow Band Imaging

34%

Major improvement of sensitivity for neoplasia detection x2 - Improved treatment plan in 36% patients - Diagnostic yield tripled x3 - Diagnostic and therapy in one procedure

x 2

Sensitivity


In vivo pancreatic cyst assessment with Cellvizio

40% of patients with benign pancreatic cysts undergo unnecessary

surgery(1)

specific feature of benign pancreatic cysts

as seen on Cellvizio

➡Avoiding unnecessary surgeries and repeat procedures*Napoleon B, et al, 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

Unique solution to characterize pancreatic lesions with 100% specificity *

indeterminate pancreatic cyst as seen on endoscopic ultra-sound


Strong endorsements from medical societies

AGA white paper “Why should practice change?”

December 2015

Sharma P et al. White Paper AGA: Advanced Imaging in Barrett's Esophagus. Clin 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” 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

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

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 Òwhite lightÓ 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 BarrettÕs 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. ThatÕs 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 !mÐ2 !m resolution at a depth of 10 !m.


A shifting paradigm with in vivo microscopy

17

“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

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


Reimbursement : a game changer

Setting 2016 Rate 2017 Rate 2017 Change ($)

2017 Change (%)

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

ASC $608.39 $1,134.02 $525.63 86%

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

18


Reimbursement for upper GI endomicroscopy 2017

19

Treating without Endomicroscopy via

traditional biopsy (Seattle Protocol) in

2017

Medicare payment for CPT 43239 (EGD only):

$699 in hospital setting

$378 in ASC

Treating with Endomicroscopy

targeted biopsy protocol as per recommendations

EGD procedure for GERD / Barrett’s Esophagus

*Multi-Procedure Rule

Medicare payment CPT 43239 + CPT 43252* (EGD + endomicroscopy):

$2,860 in hospital setting (+$2,161‡)

$1,323 in ASC (+$945‡)

Hospital and ASC Reimbursement

‡ was $673 in 2016

‡ was $400 in 2016


Reimbursement for needle-based CLE in 2017

20

EUSFNA$1,319 medicare payment

(CPT 43238 or 43242)

Adding endomicroscopy (nCLE) to EUSFNA

*Multi-Procedure Rule

$3,169* medicare payment (+$1,850)

(CPT 43238/43242 + CPT 43252)

Pancreatic lesion procedure Hospital and ASC Reimbursement


Large untapped U.S. market in EGDs

From 120+ Cellvizio in U.S. hospitals to a 3,000+ center market opportunity Strong references in anti-reflux centers

Upper GI endoscopies (EGDs) performed 60% in hospital outpatient setting and 40% in the 1,200 GI-focused ASCs

21

Potential U.S. Customers

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. U.S. census; Medicare website.

# o

f ce

ntre

s

ASC Gov't Hospitals

Community Hospitals

Academic Hospitals

Total

3,313

400

1,500

2132913

14131200

1200

1,200

# o

f p

roce

dur

es in

tho

usan

ds

Hospital Hospital ASC ASC Total

3,608

284

398

810

2,116

3,324

2,514

2,116

Medicare Private Payor Total


U.S. sales team scale-up to address opportunity2017 U.S. Sales Force Objectives

• Strong focus on anti-reflux centers, large volume GI centers and GI-focused ASC organizations

• Use of a per-procedure business model to accelerate adoption

•Agility to quickly place high-utilization systems in well targeted centers

• Leveraging current customer revenue via Clinical Account Managers (CAMs) who assist with case support, probe sales and usage increase.

22

120+ equippedhospitals

1,200+ hospitals and

ASCsdirectly

prospected: larger

procedure volumes, anti-reflux centers

Over 3,000

targeted hospitals and ASCs

12+

Number of reps Jan 2017: 6 CAMs and

2 Area Sales Managers

8

Today 2017 2018+

Direct Sales Organization

20+


Competitive advantages of the Cellvizio platform

23

OCTAdvanced

Endoscopic Imaging

Endocytoscopy Traditionnal random biopsy

Commercially available ✓ ✓ ✓ x ✓

✓ x ✓ x x✓ x x x x✓ x x x x

Provides additional

reimbursement ✓ ✓* x x xRealtime

Microscopic resolution ✓ x x ✓ x

Platform with multiple apps ✓ x x x x

*To be confirmed

For NBI only

Corporate information and performance


Strong execution of company pivot for past 12 months

• Focus on new pay-per-use model

• 6 new consignment agreements in the U.S.

• Secured €7.0m senior debt financing

• EM Imaging collaboration

• 510(k) clearance for near-infrared surgical miniprobes

• 46% reduction of cash burn in H1

• Endorsement from ASGS

• New key Cellvizio installations

• €4.7m Private placement completed

Q2 2016

25

• Major reimbursement increase from CMS

• Key clinical data published

• Surgical milestone with PERSEE project

• Paediatric cardiac surgery funded by NIH

Q1 2017

Refocus on GERD / BE opportunity Partnership strategy for other applications

Reduction in cash burn - Improved cash position

Q4 2016

Q3 2016

FY 2015 FY 2016

8,7878,547


FY 2016 Global Revenue and split by category

26

0.88

2.47

5.19

SystemsProbesServices

1.63

2.94

4.22

FY 2015 FY 2016

Q1 Q2 Q3 Q42015 2016 2015 2016 2015 2016 2015 2016

2,2132,108

2,511

1,954

2,655

1,867

2,170

1,855

20152016

€ in Millions

+3%

+11%

+11%

+11%

+11%

(17%) +11%

+11%

Sales (€ in thousands) - IFRS

+11%

+11%

+11%

+11%

+11%

+11%

+13%+5%

+16%

Probes reorder +34%Services +84%

FY 2015 FY 2016

AmericasAsia-PacificEMA


FY 2016 Global Revenue and split by activity

27

€7.26

€6.08

Clinical Sales Pre-clinical Sales

FY 2015 FY 2016

€2.47

€1.53

+19%

(38%)

€2.88

€3.35+16%


Q1 2017 Sales

28

353

682

920

Q1 2016 Q1 2017

Q12016 2017

1,599

1,954

20162017

€ in thousands - IFRS

+11%

+11%

+11%

+11%

(18%)+11%

+11%

Sales (€ in thousands) - IFRS

+11%

+11%

+11%

+11%

+11%

+11%

380

535684

SystemsConsumableServices

Q1 2016 Q1 2017

AmericasAsia-PacificEMEA €1,478

€1,261

Clinical Sales Pre-clinical Sales

Q1 2016 Q1 2017

€476€338

(15%)(29%)

610 871

+43%Americas Clinical sales up

43% reflecting increase focus on new pay-per-use

model


2016 Income Statement IFRS

29

‘000 € 2016 2H 2016 1H 2016 Variation 2H16 / 1H16 2015 2H 2015 1H 2015 Variation

2H15 / 1H15

Sales 8 787 4 321 4 466 - 3% 8 547 4 522 4 025 +12%

Other revenues 883 407 476 - 14% 1 434 721 713 +1%

Total revenues 9 670 4 728 4 942 - 4% 9 981 5 243 4 738 +11%

Cost of goods sold -2 720 -1 283 -1 437 - 11% -2 534 -1 262 -1 272 - 1%

Gross margin rate % 69% 70% 68% 70% 72% 68%

R&D -4 445 -2 256 -2 189 +3% -4 648 -2 143 -2 505 - 14%

Sales & Marketing -8 366 -3 980 -4 386 - 9% -11 665 -5 171 -6 494 - 20%

General & Administrative -3 843 -1 808 -2 035 - 11% -3 642 -1 876 -1 766 +6%

Other -285 -413 128 - 423% -219 84 -303 - 128%

Operating expenses -19 660 -9 741 -9 919 - 2% -22 708 -10 367 -12 341 - 16%

Operating Profit -9 990 -5 013 -4 977 +1% -12 727 -5 124 -7 603 - 33%

Financial results 246 188 58 84 -27 111

Profit before tax -9 744 -4 824 -4 919 - 2% -12 643 -5 150 -7 493 - 31%

Tax 0 0 0 0 0 0 0

Profit / (Loss) -9 744 -4 824 -4 919 -2% -12 643 -5 150 -7 493 - 31%

Opex excluding COGS -16 940 -8 458 -8 482 - 0% -20 174 -9 105 -11 069 - 18%variation year-on-year - 16% - 7% - 23% - 10% - 21% +2%


Sales, Operating expenses & Net result in K€

30

-8,000

-3,000

2,000

7,000

12,000

1S 2011 2S 2011 1S 2012 2S 2012 1S 2013 2S 2013 1S 2014 2S 2014 1S 2015 2S 2015 1S 2016 2S 2016

-4,824-4,919-5,150

-7,493

-6,669

-7,324

-4,904

-6,612-6,116

-6,940

-4,758

-3,151

8,4588,4829,105

11,06911,528

10,903

9,4409,955

10,5579,980

7,831

4,6654,3214,4664,522

4,025

6,447

4,569

5,657

4,320

5,291

3,5193,196

1,820

Sales OPEX excl COGS Net Result


Operating expenses per functional area in K€

31

-1,750

0

1,750

3,500

5,250

7,000

1S 2011 2S 2011 1S 2012 2S 2012 1S 2013 2S 2013 1S 2014 2S 2014 1S 2015 2S 2015 1S 2016 2S 2016

3980

4386

5171

64946640

6113

5320

5854

6551

5976

3875

2406 22562189214325052499

2084175218591964

12971446

845

G&A R&D M&S share-based payments


FY 2016 Balance sheet summary

32

K€ 12/31/2016 12/31/2015Intangible assets 2,565 3,135Tangible assets 898 625Non-current financial assets 162 133Total of non-current assets 3,625 3,893Inventories and work in progress 2,331 2,644Trade receivables 2,116 3,458Other current assets 2,756 1,823Current financial assets 94 65Cash & Cash equivalents 9,053 10,620Total of current assets 16,349 18,610Total of assets 19,974 22,503K€ 12/31/2016 12/31/2015Equity 11,157 14,091

Long-term debts 2,640 2,182

Non-current provisions 261 246

Total of non-current liabilities 2,900 2,428Short-term borrowings and financial debts 404 719

Trade payables 3,131 2,453

Other current liabilities 2,382 2,812

Total of current liabilities 5,917 5,984

Total of Equity and liabilities 19,974 22,503


Summary of FY 2016 Cash Flow Statement

33

K€ 12/31/2016 12/31/2015

Net Result -9,744 -12,643

Self Financing capacity -8,635 -11,284

Change in working capital 799 -446

Net Cash From Operating activities -7,836 -11,729

Net Cash From Investing activities -573 -326

Net Cash From Financing activities 6,826 7,618

Cash Balance -1,567 -4,398

Cash & cash equivalents end of Period 9,053 10,620

• In 2016, the Company completed a capital increase of €4.4 million at an issue price of 1.49 euros per share for 2,980,131 new shares.

• The Company opened also, in November 2016, an equity financing facility with Kepler Cheuvreux for a maximum number of 1,850,000 shares open for subscription over a maximum period of 24 months. At December 31, 2016, 845,000 shares were subscribed via the financing line with Kepler.


Total Float > 80%

Shareholding, financial calendar & coverageFinancial Calendar Shareholding structure as April 28st, 2017

2017 First-Half Sales July 25, 2017

2017 First-Half Results September 20, 2017

2017 Third-Quarter Sales October 24, 2017

• Market Cap as of 4/28/2017: €46m

• Analyst coverage

• Société Générale - Delphine Le Louët • ODDO - Sébastien Malafosse • Gilbert Dupont - Guillaume Cuvillier

34

2"%

85"%

3"%4"%6"%

Inocap AvivaFounders Other floatingSeventure

Investor Relations U.S.

Zack Kubow / Lee Roth The Ruth Group +1 (646)536-7020 / 7012 [email protected] [email protected]

Investor Relations Europe

Newcap Florent Alba +33 (0) 1 44 71 94 94 [email protected]

Contacts

mailto:[email protected]

mailto:[email protected]

Company vision and roadmap


A powerful vision: CLE integrated at the heart of each interventional platform

GI Endoscopy PulmonologyAnti-Reflux SurgeryInterventional Radiology Open Surgery

MIS EndourologyRobotic Surgery

36


Conquering the global urology market

37Sources : Urology Surgical Instruments Market by Product, Application - Global Forecast to 2021https://uromol.eu/background-and-objectives / NHSR, Number 11, 2009 “Number of ambulatory surgery procedures, U.S., 2006

About Cook Medical

11,000+ employees; Sales > $2B sales in 2013 World leader in urologic stone management 98% of urology disposable products available from Cook

2016: Readiness, awareness and promotion

• Cellvizio prominently presented at national / international urology trade shows

• Initial demo units shipped in Q2 2016

• Key target applications: Upper Tract and Bladder

• Dozens of members of global sales and marketing teams trained

• Hundreds of leads generated for 2017 in multiple regions

Market size and trend: a globally expanding market

Global urology surgical instruments market expected to reach $11.48 billion by 2021 (8.2% yoy growth)

2.5 million endo-urological procedures / yr U.S./EU

December 2015: Cook Medical becomes Mauna Kea’s global exclusive partner for urologic endomicroscopy applications with a private label Cellvizio product

https://uromol.eu/background-and-objectives


Robotic prostate surgery opportunity example

38

Journal of Urology, April 2016

Intraoperative Optical Biopsy during Robotic Assisted Radical Prostatectomy Using Confocal Endomicroscopy Lopez et al, 2016

Da Vinci installed base*:

2,431 United States

1,229 O.U.S.

~100,000 prostatectomies in the U.S per year

~100,000 prostatectomies O.U.S per year

Easy combination Cellvizio + Da Vinci:

Initial target market:

• 1,000 largest Da Vinci users

• Approx. 50,000 procedures per year with Cellvizio

• $25m to $50m recurring revenue opportunity

* source Intuitive Surgical investor presentation


Our technologies are key to the future of image-guided intervention

Digital Optical Biopsies with a unique

and proprietary Confocal Laser

Endomicroscopy (CLE) platform

Most similar images

Region descriptor

Region detectorIntensity Signature

Cloud-based deep learning services for

immediate image assessment

Increased applicability and

performance with smart molecular markers and

multicolor Cellvizio platform


Paving the way to advanced digital surgery

40

Operating Room

Pathology Lab

Real time visualization at cellular scale anywhere with Cellvizio + Cloud

Advanced image interpretation assistance with AI and computer vision technologies

Full duplex high quality video and

voice communication

between surgeon and pathologist

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


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


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


References - Clinical EvidenceCOLON/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

45


References - Clinical EvidenceUROLOGY

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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