Mauna Kea Technologies - Corporate Presentation - November 2018
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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
Cellvizio®: cellular vision at your fingertips First miniaturized confocal microscope designed to provide physicians and surgeons with digital cellular visualization at the bedside
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
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
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
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
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
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