Mauna Kea Technologies : 2025 Annual Financial Report (free translation)

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1 Table of Contents CHAPTER 1: OVERVIEW OF ACTIVITIES 4 General Overview of Activities 4 Executive Summary 4 A Disruptive Technology Offering 8 Clinical, Regulatory, and Reimbursement Validation 17 Marketing and market 29 A dual commercialization strategy also based on partnerships 38 Operations 40 Innovation, Patents, Licenses, Trademarks, and Domain Names 44 Innovation Policy 44 Patents and Patent Applications 44 Other Intellectual Property Assets 50 CHAPTER 2: RISK AND INTERNAL CONTROL 51 Risk factors 51 Risks related to the markets in which the Group operates 52 Risks related to the Group's business and organization 55 Financial risks 59 Legal risks 61 Risk Management 66 General Principles of Risk Management 66 Link Between Risk Management and Internal Control 67 General Principles of Internal Control 67 Stakeholders in Risk Management and Internal Control 69 Limitations of Risk Management and Internal Control and Areas for Improvement 69 Insurance and Coverage 69 CHAPTER 3: REPORT ON CORPORATE GOVERNANCE 71 Composition of the Board of Directors, Committees, and Executive Management 71 Composition of the Board of Directors and Executive Management 71 Conflicts of Interest at the Board and Management Levels 76 Functioning of the Board of Directors, Committees, and Executive Management 77 Company Management 77 Specialized Committees 77 Granting of bonus shares and stock options to corporate officers 80 Corporate Governance Statement 81 Transactions with Related Parties 83 Agreements between a corporate officer or a shareholder holding more than 10% of the voting rights and a controlled company 83 Regulated agreements entered into by the Company 83 Special Report of the Statutory Auditors on Regulated Agreements 83 CHAPTER 4: INFORMATION ON THE COMPANY AND ITS CAPITAL 85 Corporate Information 85 Company Name 85 Place and registration number of the Company 85 Date of Incorporation and Term 85 Company headquarters, legal form, and applicable laws 85 Description of the main provisions of the Articles of Incorporation 85 Corporate purpose 85 Mechanisms to delay, postpone, or prevent a change of control 86 Share capital 86 Amount of share capital 86 Securities not representing capital 86 Changes in the Company's Capital 86 Acquisition by the Company of its own shares 87 Securities Entitling the Holder to a Share of the Capital 87 Shareholder Structure 96 Breakdown of capital and theoretical voting rights as of March 31, 2026 96 Significant shareholders not represented on the Board of Directors 96 Voting rights of major shareholders 96 Control of the Company 97 Statement of Pledges 97 Transactions with Related Parties 97 Shareholder Participation in the Annual General Meeting 98 CHAPTER 5: FINANCIAL AND ACCOUNTING INFORMATION 100 Financial information regarding results and financial position 100 Business Review 100 Analysis of Consolidated Earnings 102 Analysis of the Consolidated Balance Sheet 107 Consolidated Cash Flow and Financing 109 Recent Developments and Outlook 113 Consolidated Annual Financial Statements 115 Consolidated Financial Statements Prepared in Accordance with IFRS for the Year Ended December 31, 2025 . 115 Statutory Auditors' Reports on the Consolidated Financial Statements 151 Parent Company Financial Statements 155 Parent Company Financial Statements for the fiscal year ended December 31, 2025 155 Information Regarding the Balance Sheet Assets 163 Information regarding the balance sheet liabilities 167 Information Regarding the Income Statement 174 Miscellaneous Information 178 Auditors' Reports on the Annual Financial Statements 182 CHAPTER 6: RESPONSIBLE PERSONS 186 Person Responsible for the Document 186 Certification by the Responsible Person 186 Person Responsible for Financial Reporting 186 Auditors 186 Statutory Auditors 186 Alternate auditors 187 Expert statements and declaration of interest 187 Information from third parties 187 Statement by the competent authority regarding approval of the Document 187 Documents available to the public 187 CHAPTER 7: CROSS-REFERENCE TABLES 188 Cross-reference table for the annual financial report 188 Reconciliation Table for the Management Report 188 Reconciliation table for the items in Annexes 1 and 2 of European Regulation 2019/980 191 ‌CHAPTER 1: OVERVIEW OF ACTIVITIES ‌General Overview of Activities ‌Executive Summary Founded in 2000, Mauna Kea Technologies is a global medical device company that develops, manufactures, and markets an innovative imaging platform enabling real-time visualization of tissue at the cellular level during standard procedures, with a mission to improve patients' lives by empowering physicians through cellular vision.The Group's flagship product, Cellvizio®, is the world's smallest microscope, designed for direct use during minimally invasive procedures. The Cellvizio consists of a central unit that includes the visualization system, to which a minisonde is connected; the design of the minisonde is specific to each medical indication. Thanks to the extreme miniaturization of the minisondes, the Cellvizio® can be positioned directly within the patient's body. In vivo visualization allows the practitioner to obtain real-time information about the tissue, and thus perform a more targeted tissue sample collection, improve diagnostic yield by performing biopsies on tissues with previously identified abnormalities-thereby avoiding many biopsies on healthy cells-monitor disease progression over time, assess reactions as they occur, classify areas of uncertainty, and guide surgical interventions. Cellvizio® has received marketing approvals for a wide range of medical applications (with gastroenterology being the first among them) in more than 40 countries, including the United States, Europe, Japan, China, South Korea, and several Latin American countries. Cellvizio® has substantial clinical validation based on numerous international multicenter clinical trials demonstrating that Cellvizio® can help physicians more accurately characterize or detect early forms of mucosal changes and make therapeutic decisions earlier. This validation has notably contributed to the acquisition of several reimbursement codes from public and private payers, primarily in the United States and France, for upper endoscopy procedures, thereby facilitating the adoption of Cellvizio® by numerous hospitals and clinics. With four codes obtained in the United States, the U.S. market has quickly become the Group's priority market, where it has focused a large part of its commercial efforts while seeking to expand directly into many other countries, particularly in Europe, as well as indirectly through distributors in other regions, including Asia-notably in China and Japan. Building on this technological platform, the Group positions itself as a key player in the digital transformation of medicine and surgery. The Group's ambition is thus to shift diagnostic practices from an analog paradigm-inefficient and costly-to a fully digital, instantaneous paradigm that provides physicians and surgeons with the full power of real-time cellular visualization combined with the best machine learning algorithms. Cellvizio® benefits from numerous achievements 0 A breakthrough innovation protected by an intellectual property portfolio of 266 patents Cellvizio® is the world's smallest microscope, capable of producing real-time (9 to 12 images per second) microscopic images of the inside of the human body with exceptional stability. The images are magnified up to 1,000 times compared to a traditional camera. They are obtained by simply pressing the Cellvizio®'s mini-probe against the wall of the mucosa or the target organ. The procedure is minimally invasive, and the images are perfectly reproducible. As of December 31, 2025, Mauna Kea Technologies' intellectual property portfolio consists of 271 issued national and international patents protecting its technologies and methods. This policy of innovation and intellectual property protection constitutes a significant barrier to entry for potential competitors. The Company continues to invest in R&D and will continue to maintain an active patent filing policy. 0 Cellvizio®, a benefit for patients, physicians, and healthcare systems Cellvizio® was designed to help physicians reduce diagnostic uncertainty, provide better patient care, and lower hospital costs. Cellvizio® provides physicians with real-time, in vivo cellular information during procedures. This information is obtained in a minimally invasive manner, without damaging the patient's tissue. Cellvizio® was designed with the goal of causing minimal disruption to clinical practices. Consequently, there is a range of probes compatible with existing procedures. For example, in the field of gastrointestinal endoscopy, the Confocal Mini-Probes for this category of applications are compatible with nearly all endoscopes on the market and are used naturally as an endoscopic tool. Cellvizio® enables the improvement of clinical practices without radically altering them. The medical benefit of Cellvizio® has been demonstrated by numerous clinical studies covering each of the indications for which it is routinely used today. For patients, the benefit is significant on several levels. In addition to not having to wait for the results of a physical biopsy-which can sometimes take several weeks-the procedure is non-invasive, repeatable (since it does not damage the areas being examined), and painless. Above all, it enables faster characterization of precancerous and cancerous lesions. For healthcare systems, real-time in vivo microscopic visualization helps reduce the number of unnecessary physical biopsies-since the vast majority of physical biopsies are negative (e.g., prostate: 75% 1 , Barrett's esophagus: 58% 2 )-and reduces the number of endoscopic procedures through better characterization of precancerous or cancerous lesions. Cellvizio® also prevents unnecessary surgeries, particularly of the pancreas. 0 Cellvizio®, a multi-indication platform Cellvizio® was designed as a platform capable of providing solutions for a wide range of medical and surgical fields where tissue characterization is routinely required, thanks to mini-probes tailored to each medical indication. Among these, gastroenterology, urology, interventional pulmonology, and surgery are priority candidates. With the introduction of its minisensor, which has a diameter of less than 1 mm and can fit inside a biopsy needle, Cellvizio® can now access the interior of human organs, thereby opening up new possibilities for improved diagnosis of major diseases such as pancreatic cancer and lung cancer. To date, the Group offers a range of 10 reusable mini-probes, which can be reused 10 or 20 times depending on the model (see section 1.1.2 of this Document). 1 "Presence Of High-risk Prostate Cancer Can Be Predicted Without A Biopsy, New Study Says." ScienceDaily. ScienceDaily, May 22, 2005. 2 Bertani H. et al. Improved Detection of Incident Dysplasia by probe-based confocal laser endomicroscopy in a Barrett's esophagus Surveillance Program. Dig Dis Sci 2013; 58(1):188-93. 0 Numerous marketing authorizations To date, Cellvizio® has received marketing approvals for a wide range of applications in numerous countries, including the United States, Europe, and China. The status and details of marketing and reimbursement approvals are outlined in Section 1.1.3 of this Document. 0 Several reimbursement codes already obtained The adoption of Cellvizio® technology also depends largely on obtaining reimbursement codes from payers (public health systems and private insurers) to enable patients to receive full or partial coverage for a procedure performed using Cellvizio®. As of the date of this Document, the Group has obtained primarily 4 reimbursement codes in the United States and additional codes in France, South Korea, and Croatia (see the details in Section 1.1.3 of this Document). Through these marketing authorizations and reimbursement codes, the Group has demonstrated its ability to successfully navigate regulatory processes that are often lengthy, evolving, and specific to each geographic region. It continues its efforts in this area with the goal of obtaining codes in the fields of pulmonology and urology, in particular. 0 Extensive and statistically significant clinical validation Establishing a disruptive technology in the medical field today requires, as a prerequisite, scientific and medical evidence of the value of the proposed innovation. A comprehensive program of international multicenter clinical trials has been underway since 2005, focusing on applications in gastroenterology, pulmonology, and urology. The studies completed to date have yielded compelling results regarding the benefits of Cellvizio® compared to traditional endoscopies, particularly in terms of the quality of diagnosis it provides. There are over 1,000 published references on endomicroscopy in the PubMed database, searched using the keyword "endomicoscopy." The results of the clinical study programs conducted by the Company are described in sections 1.1.3 and 1.2.3 of this Document. 0 An agile business model designed to adapt to local conditions The Company's business model is based on the sale of equipment (or systems) and consumables (known as minisondes) tailored to each procedure according to the specific indication and reusable a limited number of times, as well as a range of services, including maintenance contracts that help generate recurring revenue. In certain cases in Europe, the systems may also be offered for rent. In the United States, the Company also offers a specific business model consisting of a program to provide systems on a "pay-per-use" basis. This program is particularly relevant due to U.S. reimbursement rates, which make the use of endomicroscopy a highly profitable clinical practice for hospitals. Revenue from fee-for-service payments billed by the Group is recognized as "consumables" revenue, while the systems provided are capitalized as property, plant, and equipment and depreciated. To fully leverage its technology platform in indications or markets where the Company does not wish to, or cannot, invest directly, it enters into licensing agreements with other parties. In line with this strategy, a strategic partnership was signed in July 2022 with the Chinese company Tasly Pharmaceuticals, leading to the creation of a joint venture in China (see section 1.2.3 of this document). These partnerships generate additional revenue, notably in the form of milestone payments and future royalties. 0 An operational equipment base of approximately 250 units capable of generating recurring revenue Since its inception, the Group has installed more than 700 systems, a total that includes both those sold and those made available. However, the Group estimates that to date the truly operational installed base is approximately 250 systems, with nearly 60% in the United States, 40% in Europe, and the remainder in the rest of the world. In fact, a number of systems were sold to academic centers that used them on an ad hoc basis during clinical trials, for example, as well as to small-animal research and imaging centers from which the Group withdrew in 2021. 0 Market Size The existing range of probes opens up significant commercial opportunities for the Group in multiple medical fields, in addition to its traditional gastroenterology market. The number of facilities with endoscopy suites is estimated at approximately 60,000 in the three main target regions: 14,700 in the United States, 15,000 in Europe, and approximately 30,000 in China and Japan (see section 1.1.4 below on the market). Given its financial resources, the Group has so far focused a large part of its efforts on the U.S. market to identify and specifically target approximately 1,100 hospitals (1,500 physicians) specializing in gastrointestinal endoscopy, whether community hospitals with a very high volume of gastroesophageal reflux cases, or Ambulatory Surgery Centers (ASCs) that treat a very large number of these patients. This represents a total equipment market of approximately $200 million in the United States alone, to which is added a potential recurring market estimated at over $220 million per year, given the number of procedures performed on the upper gastrointestinal tract alone, for which Cellvizio® is particularly well-suited and has reimbursement codes and coverage. In addition to chronic gastroesophageal reflux disease (GERD), the Group is also targeting interventional endoscopy centers for the characterization of pancreatic cysts. The Group estimates that there are more than 1,000 such centers in the United States, representing an equipment market of approximately $200 million and recurring revenue of $100 million based on 100,000 procedures. Since 2024, the Group has been rolling out CellTolerance®, a program dedicated to the in vivo assessment of intestinal barrier permeability during food challenge tests performed during a standard gastroscopy. This approach addresses a major medical need, as food intolerances are believed to be involved in nearly 50% of cases of irritable bowel syndrome (IBS), a condition affecting 10-15% of the global population. Furthermore, the Group believes it could benefit from numerous other potential opportunities, given the wide range of fields in which Cellvizio® could be used, such as: interventional pulmonology, with a total of nearly 60,000 healthcare facilities worldwide and a very large number of procedures performed (500,000 bronchoscopies per year in the United States alone, including more than 240,000 diagnostic bronchoscopies with biopsies); endourology, where the continuous, lifelong monitoring of patients with bladder cancer results in a multitude of rigid and flexible endoscopic cystoscopy procedures (both diagnostic and therapeutic), totaling more than 420,000 procedures per year in the United States alone; and neurosurgery, a field that the joint venture in China intends to develop and market globally. 0 A team of 59 employees with diverse expertise By the end of 2025, the Group will have a multidisciplinary team of 59 employees led by an experienced senior management team, including Alexandre (Sacha) Loiseau, the Company's founder and current Chairman and CEO. The sales team also benefits from the support of an international network of distributors. A strategic repositioning focused on a hybrid sales approach primarily based on partnerships with leading industry players Building on a decade of experience and particularly capital-intensive sales investments, the Company has decided to reduce the size of its sales teams and combine its sales efforts with strategic partnerships with leading pharmaceutical and medtech companies. These partnerships aim to commercialize oncology-focused solutions, for which the advanced imaging technology offered by Cellvizio® serves as a key differentiator. This strategic repositioning offers several advantages: ✔ Optimization of financial resources through a more capital-efficient business model based on upfront and/or milestone payments as well as royalties; ✔ A robust and stable gross margin profile; ✔ Access to vast markets at a pace the Group could not achieve on its own; ✔ An accelerated pace of intellectual property monetization; ✔ Greater visibility into financial results. An initial partnership was established with the Chinese group Tasly Pharmaceutical through the creation of a joint venture in 2022. In December 2025, an exclusive commercial partnership in North America was established with TaeWoong Medical USA, allowing the latter to market Cellvizio® for the characterization of pancreatic cysts (see the details presented in section 1.2.3 of this Document). ‌A breakthrough technological offering Integrated technological expertise 0 Strong innovation capabilities All innovation begins with an analysis of the application's needs, and in the case of medical devices, with an analysis of clinical needs and the constraints associated with medical practices. Building on this approach, in late 2003, the first Cellvizio® was launched after a team of experts, through an iterative process, successfully addressed challenges as varied as: The design of a high-resolution "plug-and-play" confocal microscope-one that requires no adjustment during installation or use, Extreme miniaturization of this microscope and its objectives, the mini-probes, Image processing optimized to compensate for the physical limitations of the optical components, High integration capability with standard equipment, Designing each component to make future manufacturing as straightforward as possible. The quality of the planning carried out prior to the design of the Cellvizio® now enables Mauna Kea Technologies to have a technical platform adaptable to multiple applications with only minimal additional research and development investment. This approach has been repeated in recent years and has led to the development of the next-generation Cellvizio® platform, known as "GEN 3," which was commercially launched in the United States and Europe on October 1, 2021, and which enables: A mobile, lightweight, space-saving system with accelerated and optimized setup in procedure rooms, To offer a touchscreen interface and redesigned ergonomics, based on user feedback The introduction of new products and services, including decision-support tools and new clinical features, Deliver functional and ergonomic improvements more quickly, in the form of software or hardware updates, To integrate intraoperative images into hospital information systems and video capture systems for clinical reports and patient follow-up, Leverage internal modularity to easily integrate with laparoscopic, advanced navigation, and robotic systems, enabling the development of potential new market access channels, Leverage internal computing power and scalability to develop advanced visualization tools in the future. 0 A highly qualified multidisciplinary team As of the end of December 2025, the Research and Development team consisted of 15 employees (doctors, engineers, and technicians) covering the areas of expertise necessary for the development of the Group's products and technologies, namely: Optics and opto-mechatronics, Applied mathematics for image processing, Digital and analog electronics, Software development, Systems engineering, Biomechanics and instrumentation, Micromechanics, materials, and precision assembly processes. The R&D team shares medical and biological knowledge regarding product applications and usage with specialists from the Clinical Affairs team and Product Managers. 0 Upstream R&D: Innovation The Company has organized itself to acquire the necessary resources to directly drive the technological innovations that will enable it to expand its market and capture new ones by exploring all proposals likely to facilitate the development of innovative solutions capable of improving patient care. Scientific and technological monitoring is conducted on an ongoing basis under the leadership of the Innovation Department. It aims to identify and validate the value of emerging technologies or components to remain at the cutting edge of technology while minimizing the risk of key components becoming obsolete by identifying alternative technical solutions early on. The preliminary studies resulting from this monitoring are conducted by teams in the R&D departments, either internally or through external collaborations. They may constitute the preliminary feasibility assessment phase used to decide whether to launch a product development project. On the clinical front, the Company conducts research in collaboration with various hospitals to assess the potential value and practicality of Cellvizio® technology in new indications. Upstream studies conducted in collaboration with academic laboratories are often co-funded to optimize research costs through grants or doctoral thesis fellowships. Product Development The product development process combines traditional "V-model" techniques with more modern and proven "Agile" approaches. The R&D, Marketing, Clinical, and Regulatory teams coordinate during each iteration to achieve the set objective. The implementation of development cycles-or iterations-enables the device to be updated twice a year, in compliance with medical standards, device safety, and performance requirements; Structuring the starting point of these iterations around requests from the Product team, the Customer Support team, and the Regulatory team; The continuous integration of technical debt management for the system and probes: improving maintainability, optimizing manufacturing costs, and increasing robustness and reliability. Technological Pillars of Innovation The R&D team has also implemented a technology strategy focused on four key areas to enhance its technological value and foster partnerships, enabling the integration of its technology with that of partners: "XPLore": agnostic instrumentation compatible with the widest range of minimally invasive devices on the market (endoscopes, needles, etc.); - "AI": physician assistance integrated into the system, helping to make the practice more accessible; "Multimodal Vision": the provision of multi-wavelength imaging on the new platform, particularly to address the molecular imaging market; "Core Components": the provision of a "Cellvizio® Development Kit" enabling the integration of CLE technology in vivo into third-party devices such as surgical robots, endoscopes, and any minimally invasive device used for monitoring, diagnosis, or treatment. The package includes technology and services designed to open up an OEM integration market. How the technology works and its benefits 0 The principles of biopsy Based on a minimally invasive visual approach using the body's natural passages, endoscopy is a recognized method of screening and treatment. Since 90% of cancers develop in mucous membranes (source: Year 2000 Surveillance Research from the American Cancer Society), endoscopic access to these membranes (located in hollow organs, such as the esophagus or colon) has led to a major improvement in patient comfort and diagnosis in general. If everyone aged 50 and older followed screening recommendations, particularly for colonoscopy, 60% of deaths from colorectal cancer could be prevented. Diagram showing the progression of cancer cells from the depth of the mucosa toward the surface (progression invisible via endoscopy) Using a camera mounted on a flexible, articulated tube-the endoscope-the physician can identify lesions from which samples (biopsies) can be taken to obtain histological confirmation of the macroscopic diagnostic impression. Microscopic analysis of the cellular architecture of the samples is then entrusted to the pathology department, which differentiates and characterizes any abnormalities. Always performed at a later time-often several weeks later-and on dead cells, this sampling and examination procedure does not allow the doctor to intervene in real time during the same endoscopic procedure. Furthermore, to perform the biopsy, the physician relies on the images received from the endoscope; the selection of sampling sites is therefore limited by the microscopic size of the cells and their location beneath the tissue surface-or even in areas inaccessible to biopsy forceps. Biopsies, when they can be performed, are therefore done "blindly" in areas where the physician can only estimate the likelihood of suspicious lesions. The quality of the sample is therefore not always sufficient for diagnostic purposes and often requires one or more additional endoscopic procedures, thereby delaying diagnosis and the initiation of therapy for conditions where early intervention is a key factor in the cure rate. In light of this, over the past two decades, players in the endoscopy market have advanced their equipment to improve macroscopic visualization of tissues. However, these advances have contributed only marginally to improving the localization of suspicious lesions, and still do not allow access to the microscopic level, which remains the sole domain of the pathologist. The diagram below illustrates the key difference between a standard or advanced endoscope and the Cellvizio®. The image on the left shows the macroscopic view of the esophageal mucosa via standard endoscopy, which corresponds to actual size magnified 4x; then, in the lower left, via contrast enhancement (narrow-band imaging or NBI) but which does not change the size of the image, whereas the images on the right present a real-time in situ microscopic view obtained by Cellvizio® and allowing for immediate characterization. The scale is 1,000x relative to normal size, corresponding to visualization at the cellular level. 0 Benefits of the technology By bringing the microscope to the patient, rather than taking a sample (biopsy) from the patient to examine under a microscope, Cellvizio® allows all key diagnostic steps to be performed during the endoscopy procedure. Indeed, for the first time, the clinician has access to relevant cellular information in real time: For optimized diagnosis and improved diagnostic yield compared to traditional biopsies, For hard-to-reach or inaccessible areas where biopsies are difficult to perform, Cellvizio® can provide key microscopic information for diagnosis, To decide, if necessary, whether to perform immediate endoscopic therapeutic intervention, refer the patient for surgery, or, conversely, confirm the absence of disease and limit unnecessary interventions. Insertion of a confocal miniprobe into the working channel of a standard endoscope. Confocal miniprobe emerging from the tip of an endoscope's working channel. All endoscopes have such a channel, which is used to pass instruments. Cellvizio® procedure in an endoscopy suite: the physician simultaneously views the endoscopic image (macroscopic, on the left of the image) and the Cellvizio® image (microscopic, in the center of the image) Beyond the in vivo cellular imaging provided by Cellvizio, its confocal video mode-which captures 8 to 12 images per second-allows it to record dynamic sequences that reveal pathophysiological processes at the cellular level in real time. This high frame rate enables visualization of capillary microcirculation, leukocyte migration, epithelial junction permeability, or the extravasation of fluorescent dye-key parameters for assessing inflammation and food hypersensitivity reactions. In the CellTolerance® protocol, the clinician thus observes, within seconds of applying a test food, the immediate reaction of the duodenal mucosa: vascular leakage, intercellular dilation, reversibility after rinsing, etc. All video sequences are automatically archived in mp4/DICOM format and can be reviewed frame by frame for precise longitudinal monitoring of intestinal barrier integrity, facilitating instant and personalized therapeutic decisions. Mauna Kea Technologies' value proposition is significant in that it benefits all stakeholders in the healthcare chain. Clinical studies conducted with Cellvizio® have thus demonstrated the following benefits: 0 For patients Real-time clinical information, A less invasive procedure than biopsy, For certain indications, a reduction in unnecessary endoscopic and surgical procedures. 0 For physicians Enables real-time microscopic visualization of tissue and reduces diagnostic uncertainty, Avoids unnecessary treatments and anticipates those that are necessary, 0 For healthcare facilities Position the facility as an expert center equipped with state-of-the-art technology, Offer an advanced program in endoscopy of the digestive, pulmonary, and urinary tracts, as well as in laparoscopic surgery and interventional radiology, Optimize the efficiency of diagnostic care, Reduce the number of unnecessary endoscopic and surgical procedures. Each of these factors contributes to a significant reduction in healthcare costs for both public and private entities. Images obtained in vivo with Cellvizio® during a colonoscopy (top) compared to images obtained ex vivo in the laboratory. Note the similarity of the images. Major advantage Clinical impact Dynamic confocal video imaging (8-12 fps) The clinician monitors in real time the microcirculation, the permeability of epithelial junctions, leukocyte migration, or, in the CellTolerance® protocol, dye leakage a few seconds after the application of a test food Ultra-precise targeting of biopsies Samples are no longer taken "blindly": this reduces the need for repeat procedures and improves diagnostic yield. Access to difficult-to-reach areas Cellvizio® provides microscopic information even where a biopsy forceps cannot be placed (stenoses, subepithelial areas, pancreatic cysts, etc.). Immediate therapeutic decision Based on visual characterization, the physician can: perform endoscopic treatment, refer the patient for surgery, or, conversely, avoid an unnecessary procedure. 0 Current applications Cellvizio® is potentially applicable to all medical fields in which physicians need to assess tissue characteristics to make decisions regarding patient care. These include gastroenterology, urology, pulmonology, as well as surgery and interventional radiology. Lacking the necessary resources to tackle all of these opportunities head-on, the Company identified gastroenterology as a priority market as early as 2005, given Cellvizio®'s contributions to various pathologies that are particularly difficult to diagnose: Endo-Brachy-Esophagus, precancerous lesions of the stomach, and later, biliary strictures, chronic inflammatory bowel diseases, and pancreatic cysts. To date, digestive conditions accessible via endoscopy remain the indications in which Cellvizio® is most widely used and sold. The Company has obtained regulatory approvals and high-level clinical evidence for other applications and is currently investigating their potential in bronchial exploration and the targeting of potentially malignant peripheral lung nodules, as well as in urology and neurosurgery applications. The Cellvizio® system 0 Product Description The Group has developed several generations of Cellvizio® systems. The model shown below is the third generation, launched in 2021, and offers easier handling through system miniaturization, an improved user interface, enhanced overall ergonomics, and faster startup time. Regardless of its application, the Cellvizio® system consists of four main components: A central base that includes the display screen and the optoelectronic Laser Scanning Unit (LSU), The computer processor, Confocal minisondes, specific to each indication, which are therefore consumable components, Proprietary software for real-time image processing and display. The exceptional quality of the images delivered by the minisondes reflects one of the Group's core areas of expertise: image processing, without which the images captured by the tens of thousands of fibers in the minisensor would simply be unreadable by the physician. The minisondes can be reused between 10 and 20 times and are reprocessed using standard equipment, in the same way as endoscopic accessories. They constitute a source of recurring revenue for the Group. Confocal minisondes consist of a bundle of tens of thousands of optical fibers sequentially scanned by a laser beam emitted by the scanning unit. They carry the laser beam to the area to be observed, within human anatomical tracts. The fluorescence (exogenous or endogenous) emitted by the tissue upon laser excitation is collected by the minisensor and analyzed to form an image of the observed tissue. During use, the minisondes must be connected to the Laser Scanning Unit and then inserted into the endoscope's working channel-much like a biopsy forceps, for example-to provide in vivo microscopic fluorescence imaging during the endoscopy procedure. They are fully compatible with all standard equipment already present in endoscopy suites and, unlike conventional endoscopy, allow for in-depth observation of the mucosa (up to 70 µm), the primary site for the localization of cancerous tumors. The major advantage of the Cellvizio® design, in addition to being particularly suited for easy manufacturing, lies in the fact that it consists of a single, standardized microscopy platform offering guaranteed stability for several years, and that only the probes constitute the specific link between this standard platform and the relevant application (digestive tract, lungs, etc.), thereby allowing the platform to be shared by multiple hospital departments or physician users. ‌Clinical, Regulatory, and Reimbursement Validation Clinical applications 0 Clinical validation Mauna Kea Technologies is rolling out an ambitious clinical program that goes beyond mere regulatory requirements. The goal is not only to obtain marketing authorization but to establish Cellvizio® as a new standard of care. Integrating a disruptive technology into established medical practices requires the absolute trust of healthcare professionals. Our approach is therefore clear: Scientifically demonstrate the superiority of confocal endomicroscopy over existing methods. Convince Key Opinion Leaders (KOLs) and learned societies with these results. Secure reimbursement from national health authorities and insurers, based on these expert recommendations. The Clinical Affairs department collaborates with global centers of excellence to conduct high-quality studies. Each trial follows a strict sequential process aimed at establishing the device's clinical validity: Targeting: Selection of the therapeutic indication aligned with the company's strategy and definition of the value proposition. Selection: Rigorous recruitment of the highest-performing partner hospitals. Execution: Protocol development, management of patient recruitment, and study monitoring. Validation: Data analysis, scientific communications, and publications in leading medical journals. Today, Cellvizio® technology is backed by an exceptional body of evidence, as evidenced by more than 1,000 scientific publications. These studies, primarily focused on gastroenterology, have demonstrated Cellvizio®'s ability to characterize tissue in real time with unmatched precision, enabling immediate therapeutic decisions. This accumulation of clinical evidence now enables the Group to take a decisive step forward: demonstrating medical-economic value, the cornerstone for securing reimbursement and accelerating large-scale commercialization. 0 Barrett's Esophagus (BE) Barrett's esophagus (BE) is an abnormal transformation of the lower esophageal lining (metaplasia) resulting from chronic gastroesophageal reflux. Although initially benign, this lesion can progress to esophageal cancer if left untreated. The limitation of the current standard (Seattle Protocol): Conventional monitoring relies on "blind" (random) biopsies performed according to a cumbersome and time-consuming protocol. This "trial-and-error" approach poses a major risk: missing a cancerous or dysplastic area located between two samples. Unlike physical biopsies, which test only a tiny fraction of the tissue, confocal laser endomicroscopy (pCLE) allows the mucosa to be scanned in real time. It transforms the surveillance strategy: we move from random samples to targeted samples of visually identified suspicious areas. Enhanced Detection: Cellvizio® detects 97% of patients with dysplasia, significantly outperforming traditional techniques. Reliable exclusion: With a Negative Predictive Value of 98%, the technology allows the physician to confirm with near certainty the absence of disease in a given area, thereby avoiding unnecessary biopsies. Proven effectiveness, even for non-experts (2018 Study) 3 . A major U.S. multicenter study ( Surgical Endoscopy , 2018) compared the effectiveness of novice physicians using Cellvizio® against the standard protocol. The results are telling: Cellvizio® users identified more than twice as many patients with metaplasia (99 vs. 46) compared to the standard method. The study demonstrated that the disease was indeed present in patients who had been declared "healthy" by conventional biopsies. Conclusion: The technology drastically reduces the risk of "false negatives" (missed disease). Confirmation by Meta-analysis (2022) 4 : A recent meta-analysis involving 688 patients confirmed these results on a large scale. The addition of Cellvizio® increases the relative detection rate of neoplasia by 243% compared to random biopsies, demonstrating that image-guided biopsy is far superior to random sampling. Support from Professional Societies: The technology enjoys strong recognition in the United States: 3 "Real-time diagnosis of Barrett's esophagus: a prospective, multicenter study comparing confocal laser endomicroscopy with conventional histology for the identification of intestinal metaplasia in new users" 4 2022 : "High definition probe-based confocal laser endomicroscopy review and meta-analysis for neoplasia detection in Barrett's esophagus" - Meta-analysis of 9 studies (688 patients) The AGA (Gastroenterologists) and the CAP (Pathologists) endorse the replacement of random biopsies with targeted biopsies. The SAGES (Endoscopic Surgeons) and the ASGS recommend its use, highlighting in a 2020 report its excellent safety profile and its ability to improve lesion classification 5 . The impact of adopting Cellvizio® extends beyond simple diagnosis: Optimization of the care pathway: The reliability of the immediate diagnosis often allows the patient to be treated during the same procedure (endoscopic treatment), avoiding multiple trips to the hospital. Resource savings: A retrospective study shows that the use of Cellvizio® reduces overall healthcare utilization: fewer anesthetics, fewer repeat procedures, and a significant reduction in the number of biopsy vials (approximately 7.5 fewer per patient). In the surveillance of Barrett's esophagus, Cellvizio® addresses the limitations of random biopsies. By allowing the disease to be "seen" in real time, it offers increased patient safety and earlier detection of precancerous conditions, while streamlining costs for healthcare facilities. 0 Cystic pancreatic tumors: an application with high potential Pancreatic cysts, fluid-filled cavities that develop on the pancreas, are most often discovered incidentally via CT or MRI. While the majority are benign, some have the potential to degenerate into pancreatic cancer. The current challenge: The standard diagnosis relies on the analysis of intra-cystic fluid (ACE, cytology) obtained via aspiration. This method is inherently limited: more than 50 % of cysts remain without a formal diagnosis ("indeterminate") due to a lack of cells in the fluid. This "gray area" leads to suboptimal management: major surgeries for cysts that turn out to be benign or anxiety-inducing lifelong monitoring. Needle-based confocal endomicroscopy (nCLE) is transforming the procedure. By inserting a microscopic probe into the aspiration needle, the practitioner no longer relies solely on the fluid but visualizes the cyst's inner wall and its vascularization in real time (optical biopsy). 2015-2021: A Decade of Clinical and Economic Validation The technology has built its credibility on a series of robust clinical studies: Characterization of benign lesions (CONTACT studies): The results (published in Endoscopy and Surgical Endoscopy ) demonstrated that visualization of the superficial vascular network enabled the identification of serous cystadenomas (benign) with 100% specificity. Impact: This accuracy led to a change in diagnosis in 30% of cases and avoided follow-up for 42% of patients with benign lesions. Diagnostic Performance (INDEX Study & Meta-analyses) 6 : A major 2020 meta-analysis ( Eur J Gastroenterol Hepatol ) involving 536 patients concluded that nCLE outperformed standard aspiration with 99% accuracy in differentiating mucinous cysts (high-risk). International Consensus (Delphi 2020) 7 : A panel of global experts officially recommended the routine use of nCLE, describing it as a safe method for reducing diagnostic errors. 5 SAGES TAVAC safety and efficacy analysis of confocal laser endomicroscopy 6 "Needle-based Confocal Laser Endomicroscopy in Pancreatic Cysts: A Meta-Analysis" - Published in the European Journal of Gastroenterology & Hepatology (DOI: 10.1097/MEG.0000000000001728) 7 "Confocal Endomicroscopy for the Evaluation of Pancreatic Cystic Lesions: A Systematic Review and an International Delphi Consensus Report" Cost-Effectiveness: A cost-benefit analysis (2021) 8 demonstrated that the integration of Cellvizio generated a net savings of $4,757 per patient, primarily by avoiding unnecessary surgeries. 2025: The CLIMB Study - A Historic Large-Scale Validation The year 2025 marks a turning point with the results of the CLIMB study, the largest and most rigorous ever conducted in this therapeutic field. It definitively establishes Cellvizio® as the new gold standard. Major Institutional Support: The study enjoys exceptional scientific credibility, being co-funded by the NIH (National Institutes of Health). Academic Excellence: It was conducted at 14 U.S. centers of excellence, including leading institutions such as the Mayo Clinic , Johns Hopkins , Stanford University, and NYU Langone . Statistical Power: With over 500 patients enrolled, CLIMB is the largest study ever conducted on endomicroscopy of pancreatic cysts. CLIMB data confirm on a large scale the superiority of Cellvizio® over the current standard of care. The study demonstrates that the diagnostic accuracy observed in previous studies is reproducible in a multicenter setting, validating the technology's ability to: Accurately diagnose precancerous lesions. Significantly reduce unnecessary surgeries. Standardize patient care at the national level. 0 Irritable Bowel Syndrome (IBS) and Food Intolerance Irritable Bowel Syndrome (IBS) affects millions of people and is characterized by chronic abdominal pain with no apparent cause on standard tests. The current limitation: Management is essentially empirical. Patients often wander from one elimination diet to another (gluten-free, lactose-free, FODMAPs) without knowing precisely which food triggers their symptoms. Until now, there has been no reliable biomarker to identify these atypical food intolerances in real time. Mauna Kea Technologies has developed a unique approach: the "in vivo food challenge" under endomicroscopy (CLE). Specifically, during an endoscopy, food extracts (wheat, milk, soy, etc.) are applied directly to the intestinal mucosa. Thanks to Cellvizio®, the physician immediately visualizes the physiological reaction: a "leak" between cells (hyperpermeability) and local inflammation, indicating the patient's specific intolerance. The Proof of Concept (Fritscher-Ravens Study, 2014) 9 . This seminal study paved the way by demonstrating that in 61% of patients with IBS, exposure to allergens triggered a visible reaction in the mucosa. The targeted exclusion of foods identified by Cellvizio® led to a more than 50% improvement in symptoms in all patients diagnosed as positive. One year later, 74% of these patients maintained this clinical benefit. 8 "Cost-Benefit Analysis and Resource Implications of Endoscopy Ultrasound-guided Confocal Endomicroscopy in Pancreatic Cysts" - Published in Techniques and Innovations in Gastrointestinal Endoscopy (TIGE) (DOI: 10.1016/j.tige.2021.10.002) 9 "Confocal endomicroscopy shows food-associated changes in the intestinal mucosa of patients with irritable bowel syndrome" - Fritscher-Ravens et al., published in Gastroenterology. Multicenter Validation (2nd Fritscher-Ravens Study, 2019) 10 . Published in the prestigious journal *Gastroenterology* , this double-blind study of 147 patients confirmed the reliability of the method. Cellvizio® successfully predicted the response to the elimination diet in 83% of susceptible patients. Confirmation (Bamberg Study - UEGW 2024) 11 . Recently presented, this prospective study involving 119 patients evaluated the complete CellTolerance® protocol (diagnosis using Cellvizio + nutritional management). Beyond simple elimination, the study shows that 71% of patients restored their intestinal barrier after six months of targeted management (including 46% with complete normalization), correlated with a significant reduction in disease severity and a major improvement in quality of life. These results confirm that approximately one in two IBS patients actually suffers from an atypical food intolerance, which can now be objectively identified using Cellvizio®. By transforming a diagnosis of exclusion into a personalized etiological approach, Mauna Kea Technologies is addressing a market estimated at over $6 billion annually, finally offering a sustainable solution to the millions of patients who have failed conventional treatments. 0 Chronic Inflammatory Bowel Diseases (IBD) Managing IBD (Crohn's disease, ulcerative colitis) is complex because clinical symptoms do not always reflect the reality of internal inflammation. The problem: current methods (standard endoscopy and random biopsies) assess healing "on the surface" (endoscopic remission). However, many patients considered to be in remission eventually relapse because inflammation persists at a microscopic level invisible to the naked eye. Confocal endomicroscopy (pCLE) allows us to look beyond the appearance of the mucosa to assess its microscopic and functional integrity in real time. This cellular analysis enables us to: Optimize treatment: Identify patients who actually respond to costly therapies (biotherapies) and adjust treatment doses or duration. Anticipate relapses: Detect persistent microscopic inflammation in a patient who appears to be cured, allowing for intervention before symptoms appear. Prevent cancer: Accurately distinguish benign inflammatory lesions (ALMs) from precancerous lesions (DALMs), thereby refining the surgical strategy. The year 2022 marked a major breakthrough with the publication of the final results of the prospective ERIca study, led by Prof. Timo Rath (Ludwig Demling Center of Excellence, Erlangen) 12 . Published in Gastroenterology , the field's most prestigious journal, this study compared the ability of different methods to predict long-term disease progression. The study demonstrates that "intestinal barrier healing," observable only through the dynamic visualization provided by Cellvizio®, is a far more powerful indicator than simple endoscopic or histological (biopsy) remission. Cellvizio® proves superior to current standards in predicting major adverse events (hospitalization, surgery, severe relapse). 10 "Many Patients With Irritable Bowel Syndrome Have Atypical Food Allergies Not Associated With Immunoglobulin E" - Fritscher-Ravens et al., published in Gastroenterology, vol. 157 11 "Restoration of intestinal barrier function in IBS patients using the CellTolerance® program" - Langhorst et al., presented at UEGW 2024 12 "Intestinal barrier healing is superior to endoscopic and histologic remission for predicting major adverse outcomes in IBD: the prospective ERIca trial" - Rath et al., This scientific validation positions Cellvizio® as an essential tool for redefining the ultimate therapeutic goal in IBD: no longer merely aiming for the disappearance of visible lesions, but achieving complete restoration of the intestinal barrier , the only guarantee of lasting remission for the patient. 0 Biliary tract strictures Biliary strictures are narrowings of the ducts that carry bile from the liver to the intestines. The diagnostic challenge is critical: these narrowings may be benign or caused by cholangiocarcinoma , an aggressive cancer with a poor prognosis and rapid progression. The current limitation: Traditional tissue sampling methods (brushing, forceps) are severely lacking in sensitivity. They fail to detect cancer in nearly 40% of cases , delaying vital treatment or necessitating the repetition of invasive and anxiety-inducing procedures. Mini-probe confocal endomicroscopy (pCLE) allows an optical fiber to be inserted directly into the bile ducts during an endoscopy (ERCP). It provides real-time microscopic visualization of the stricture, enabling immediate differentiation between healthy and tumorous tissues. The pivotal FOCUS study (2015) 13 and other research involving 252 patients revealed a significant performance gap between the technologies: Cancer Detection (Sensitivity): Cellvizio® detects 88% of cancerous strictures, compared to only 59% for traditional methods. Cancer Exclusion (Negative Predictive Value): With a rate of 78% (compared to 57% for standard methods), Cellvizio® allows for the exclusion of a cancer diagnosis with a high degree of confidence, quickly reassuring patients. A recent large-scale meta-analysis 14 , based on 18 scientific publications, has definitively confirmed these results. It confirms that Cellvizio® maintains a sensitivity of 88% (compared to 54% for conventional biopsies). Confocal endomicroscopy is a superior approach for the diagnosis of indeterminate biliary strictures. 0 Pulmonology Lung cancer remains the leading cause of cancer death worldwide. Early detection relies on the analysis of pulmonary nodules (small lesions). The problem: While current technologies (robots, electromagnetic navigation) can guide a needle to the periphery of the lung, they do not allow the physician to see what the needle is penetrating. Consequence: The rate of "missed biopsies" (samples taken away from the target) remains high, delaying a vital diagnosis. Cellvizio® (nCLE) provides real-time microscopic vision at the tip of the needle. It acts as the robot's eye, allowing the physician to immediately confirm that the tool is indeed within the tumor lesion ("Tool-in-Lesion") before taking a sample, thereby maximizing diagnostic yield. To meet future standards, Mauna Kea has conducted feasibility trials with the two leaders in robotics: Monarch™ (Auris/Johnson & Johnson) and Ion™ (Intuitive Surgical). These tests overcame technological barriers, confirming that the probes (AQ-Flex™ 19) withstand the bending forces of the robots without disrupting their electromagnetic navigation system. 13 "Digital cholangioscopy and probe-based confocal laser endomicroscopy for the diagnosis of indeterminate biliary strictures (FOCUS study)" 14 "Probe-based confocal laser endomicroscopy for the diagnosis of indeterminate biliary strictures: a systematic review and meta-analysis" J&J / Fox Chase Clinical Study (2020-2021) . Co-funded by the Johnson & Johnson Lung Cancer Initiative , this pilot study marked a world first: the combined use of Cellvizio® and the Monarch™ robot on 25 patients. The results, published in Respirology ( DOI: 10.1111/resp.14438 ), are conclusive: Confirmation of Targeting ("Tool-in-Lesion"): Cellvizio® confirmed that the needle was correctly positioned within the lesion in 95% of patients (19/20), compared to only 45% for the standard method (ROSE). Decision-Making Impact: The visual information led to needle repositioning in 45% of patients, ensuring optimal diagnostic yield. Performance: In malignant cases, the diagnosis was confirmed in 94% of cases by nCLE imaging. Amsterdam UMC Studies (2019-2021) 15 . The work of Prof. Annema's team established the accuracy standards for nCLE: A pilot study (2019, European Respiratory Journal ) demonstrated 89% accuracy in detecting tumors and lymph node metastases. A second prospective study (2021, Thorax ), involving 26 patients, confirmed that the technique is safe and can detect malignancy at the needle tip with 95% accuracy and excellent inter-observer reproducibility (k=0.78). Mayo Clinic / Intuitive Surgical Study (launched in 2023). To validate these results on a large scale, a major study began in 2023 at the Mayo Clinic campuses (Florida and Minnesota). Including 118 patients, it combines Cellvizio® with the Ion™ robotic platform to demonstrate improved diagnostic yield and targeting accuracy in peripheral nodules. 0 Urology Bladder cancer poses a major public health challenge. Its distinctiveness lies in its extremely high recurrence rate ( 75% ), the highest among all cancers. This high recurrence rate requires patients to undergo lifelong monitoring (regular cystoscopies), making this cancer very burdensome to live with on a daily basis and particularly costly for healthcare systems due to repeated examinations. Confocal endomicroscopy (pCLE) integrates with standard cystoscopy procedures. Using a mini-probe inserted into the endoscope channel, the physician obtains a dynamic visualization of the urothelium (bladder wall) at the cellular level. The goal: to immediately identify aggressive lesions and avoid unnecessary biopsies of healthy or inflamed tissue. Since the initial feasibility studies in 2009, more than 10 publications have validated the technique, enabling the creation of a reference image atlas for the bladder and adjacent organs. Diagnostic Performance (Stanford Study, 2012) 16 . A landmark study led by Dr. J. Liao's team (Stanford, USA) compared the benefits of Cellvizio® versus traditional white light in 57 patients. The combination of white light and Cellvizio® achieved 100% diagnostic accuracy and sensitivity for high-grade lesions (the most dangerous). Extension to the Upper Tract (Tenon Study, 2015) 17 . Prof. Traxer (Tenon Hospital, Paris) demonstrated the utility of Cellvizio® for tumors of the upper urinary tract. These tumors (5% of cases) are located in 15 "Bronchoscopic nCLE as a real-time detection tool for peripheral lung cancer" 16 "Interobserver Agreement of Confocal Laser Endomicroscopy for Bladder Cancer" - Published in The Journal of Urology (DOI: 10.1089/end.2012.0549) 17 "Upper Urinary Tract Application" - Results from Prof. Traxer's team (Paris in areas that are very difficult to access, where conventional diagnosis is complex. The study confirms that the mini-probe allows for inspection of these narrow areas, offering a new solution for the diagnosis of these rare but serious lesions. The technology is now so mature that confocal endomicroscopy is mentioned in the recommendations of the European Association of Urology (EAU), highlighting its promising potential for the diagnosis of urothelial tumors. Larger-scale studies are underway to transform these preliminary results into a new standard of care. 0 Surgery Supported by Bpifrance, the PERSEE collaborative project aims for a major breakthrough: integrating real-time microscopic imaging into the heart of robotic surgery. The challenge: To provide the surgeon with a "microscopic eye" to guide their movements during complex procedures (tumor resection), in order to choose the best therapeutic strategy (conservative vs. radical surgery) and to verify in real time the absence of contraindications. The "PERSEE II" pilot phase focused on urology, through a multicenter trial involving centers of excellence (Institut Mutualiste Montsouris, Hôpital des Diaconesses, Hôpital Tenon). Step 1: Tissue Mapping (Ex Vivo) . A preliminary study enabled the creation of a reference "atlas" of prostate tissue. Correlations between Cellvizio® images and histology validated the technology's ability to identify structures critical to the patient's quality of life: Cancer Detection: Distinction between healthy and tumorous glands (correlated with the Gleason score). Functional preservation: Visualization of nerve bundles (for erectile function) and sphincter muscle fibers (for continence). Step 2: Validation in the Operating Room (In Vivo). Based on these results, a prospective study was conducted on 31 patients who underwent radical prostatectomy assisted by the Da Vinci robot. Analysis of the data from this in vivo study confirms the viability of the Mauna Kea solution in a state-of-the-art surgical environment: Feasibility and Safety: The use of the CelioFlex™ UHD 5 probe is safe and compatible with robotic laparoscopic surgery, with a very short learning curve for the surgeon. Contrast Innovation: The study validated a method for applying the contrast agent (fluorescein) directly to the organ's surface (topically). This technique offers excellent image quality while reducing the allergic risks associated with intravenous injection. Telemedicine: The device has proven its reliability for inter-center telepathology, allowing an expert to interpret images remotely. This work, presented at the European Association of Urology (EAU) Congress, demonstrates that Cellvizio® can be seamlessly integrated into the robotic surgery workflow, providing critical microscopic information without slowing down the procedure. 0 Molecular Imaging In a decade, molecular imaging has transformed clinical practice: operating rooms are being extensively equipped with increasingly advanced intraoperative detection systems. The principle: Injecting a fluorescent agent that specifically "illuminates" cancer cells, thereby guiding the surgeon's hand for more precise resection. While current dyes (fluorescein, ICG) are useful, they remain non-specific. For precision oncology, surgeons need targeted contrast agents that operate in the near-infrared (NIR, 650-900 nm). These new tracers, whether permanent (antibodies, peptides) or activatable (reacting to the tumor environment), must meet strict physical criteria to be effective: High antigen density: The target must be abundant on the tumor to compensate for the lower sensitivity of fluorescence compared to nuclear medicine. High affinity: The marker must remain bound to the tumor even as its concentration in the blood decreases. High yield: The light signal must be strong to be detected through tissue. Macroscopic imaging (operating room cameras) has a major physical limitation: it cannot see through more than 10 to 15 mm of tissue. It therefore struggles to detect deep nodules. This is where endomicroscopy comes in: Depth and Precision: Using a confocal needle, Cellvizio® allows for in situ , in-depth verification of tissue characteristics in areas where light can no longer penetrate. Cellular Specificity: It provides the surgeon with real-time microscopic confirmation, validating that the fluorescent signal corresponds to cancer cells and not a false positive-information invisible to the naked eye. To address this need, Mauna Kea Technologies has developed a specialized version of its technology: the Cellvizio® F800. Capable of exciting fluorophores at a wavelength of 785 nm (the emerging standard for optimal penetration), this system allows users to: Visualize the cellular organization of labeled tissues intraoperatively. Dramatically improve the precision of surgery. Enable ultra-precise resection by defining tumor margins at the microscopic level. The implementation of this "molecular surgery" requires careful management of pharmacokinetics. Studies show that an injection window of 1 to 5 days prior to surgery is often necessary for the marker to perfectly target the tumor. The future likely lies in the combination of targeted tracers (around 700 nm) and vascular markers (around 800 nm), a multimodal approach in which endomicroscopy will play a central role in immediate validation. Marketing Authorizations The tables below present the regulatory approvals for the third-generation Cellvizio I.V.E., known as "Gen3," and probes designed to meet the specific needs of each medical specialty, as well as the countries where marketing is authorized. Territory Licensing Status Products Austria Extended until December 31, December 2028 Cellvizio I.V.E. Catheters: AlveoFlex N; GastroFlex N; ColoFlex N; CholangioFlex N AQ-Flex 19 N; UroFlex N; CystoFlex R N; CystoFlex F N; CelioFlex 5 N Belgium Extended until December 31, December 2028 Cellvizio I.V.E. Catheters: AlveoFlex N; GastroFlex N; ColoFlex N; CholangioFlex N; AQ-Flex 19 N; UroFlex N; CystoFlex R N; CystoFlex F N; CelioFlex 5 N Czech Republic Extension until December 31, December 2028 Cellvizio I.V.E. Catheters: AlveoFlex N; AQ-Flex 19 N France Extension until December 31, December 2028 Cellvizio I.V.E. Probes: AlveoFlex N; GastroFlex N; ColoFlex N; CholangioFlex N; AQ-Flex 19 N; UroFlex N; CystoFlex R N; CystoFlex F N; CelioFlex 5 N Germany Extension until December 31, December 2028 Cellvizio I.V.E. Catheters: AlveoFlex N; GastroFlex N; ColoFlex N; CholangioFlex N; AQ-Flex 19 N; UroFlex N; CystoFlex R N; CystoFlex F N; CelioFlex 5 N Ireland Extension until December 31, December 2028 Cellvizio I.V.E. Catheters: AlveoFlex N; GastroFlex N; ColoFlex N; CholangioFlex N; AQ-Flex 19 N; UroFlex N; CystoFlex R N; CystoFlex F N Italy Extension until December 31, December 2028 Cellvizio I.V.E. Catheters: AlveoFlex N; GastroFlex N; ColoFlex N; CholangioFlex N; AQ-Flex 19 N; CelioFlex 5 N Slovakia Extension until December 31, December 2028 Cellvizio I.V.E. Catheters: AlveoFlex N; AQ-Flex 19 N Sweden Extension until December 31, December 2028 Cellvizio I.V.E. Catheters: GastroFlex N; ColoFlex N; CholangioFlex N United States Cellvizio I.V.E. Probes: AlveoFlex N; GastroFlex N; ColoFlex N; CholangioFlex N; AQ-Flex 19 N; UroFlex N; CystoFlex R N; CystoFlex F N Ecuador Expires in December 2027 Cellvizio I.V.E. Catheters: AlveoFlex N; GastroFlex N; ColoFlex N; CholangioFlex N; AQ-Flex 19 N Australia Cellvizio I.V.E. Catheters: AlveoFlex N; GastroFlex N; ColoFlex N; CholangioFlex N; AQ-Flex 19 N 0 Relationships with Healthcare Professionals The Group has had a code of ethics governing these relationships since 2009, which was revised and expanded in 2018. Relations with healthcare professionals are governed in France by the provisions of Article L. 4113-6 of the Public Health Code concerning benefits granted to healthcare professionals (the so-called "anti-gifts" law). As such, the Company has implemented ethical rules in compliance with these provisions. Furthermore, since 2013, the Company has disclosed agreements entered into and benefits granted to healthcare professionals in accordance with the requirements of transparency laws in France and the United States (Sunshine Act). 0 Environment The Group has taken into account European environmental regulations (e.g., REACH, ROHS, WEEE, etc.) aimed at: Limit waste and its hazardous nature, Promote reuse and recycling, Improve disposal conditions and their monitoring, Limit or prohibit the use of certain materials. These regulations and their requirements are taken into account both in product design (eco-design and restrictions on certain substances under REACH and ROHS) and in end-of-life disposal (Directive 2012/19/EU on waste electrical and electronic equipment, or WEEE). Market Access and Reimbursement Reimbursement for the medical procedure involving the use of Cellvizio® is a critical factor in the widespread adoption of the technology. In every country, and even every region, public and/or private insurers provide reimbursement for medical procedures for their patients. Mauna Kea Technologies aims to secure reimbursement for Cellvizio® in its primary clinical indications. To achieve this, the Reimbursement and Market Access team works closely with Clinical and Regulatory Affairs, Marketing and Sales (and, if necessary, local distributors), as well as dedicated external resources in the United States, to develop and execute the reimbursement access plan in the countries that are most strategically important from a commercial standpoint for the Company and for the indications in which the Company has the largest number of users. Access to reimbursement generally involves the creation of a procedure (recognition of a new procedure and inclusion in the reimbursement list), obtaining "coverage" for that procedure, and setting its fee; these three steps may be carried out in parallel or sequentially, depending on the country and insurer in question. It also requires the support of learned societies and experts who contribute to the development of best practice guidelines. 0 In the United States As of the date of this Document, the Company has four primary reimbursement codes (43206, 43252, 0397T, 88375) in the United States, three of which are Category I codes with no expiration date. For the Category III code, CPT advisors from the AGA, ACG, and ASGE issue a recommendation every five years. Mauna Kea Technologies has simultaneously taken steps to defend this existing coverage and extend it to private insurers, with the help of specialized consultants. The results achieved are promising, as several insurers have announced that they will cover Cellvizio® procedures. Increasing private insurance coverage, and ensuring that the most recent clinical data is taken into account when determining coverage, is the Company's long-term challenge in the United States. Demonstrating the value of Cellvizio®, based on data from the available scientific literature, has therefore become a major priority. It is essential to understand the following points to assess the significance of reimbursement in the United States: CPT codes are used for outpatient procedures and therefore do not apply to surgical procedures requiring an overnight hospital stay or longer; Obtaining a CPT code is one of three steps required to secure reimbursement for a procedure. A fee schedule must also be established, and payment must be secured from government insurers (including Medicare and Medicaid) and private insurers; Obtaining a CPT code is very difficult, but securing payment from insurers-especially private ones-is even more challenging. Mauna Kea Technologies has successfully completed most of these three steps: obtaining multiple reimbursement codes, securing a fee schedule, and achieving nearly complete national coverage through Medicare/Medicaid and partial coverage through private insurers. The Company has shifted its approach toward private insurers and has achieved very good results since the final months of 2015. It is continuing this approach today to secure not only local coverage but also national coverage from one of the major private insurers. The success of these initiatives is a key factor in the growth of gastroenterology applications. The use of Cellvizio® in the treatment of Barrett's esophagus and in the management of patients with gastroesophageal reflux disease has been recommended by several recognized professional societies in this field, namely the American Gastroenterological Association (AGA), the American Society of General Surgeons (ASGS), and the American Pharyngo-Esophageal Society (AFS). The College of American Pathologists (CAP) has also established a division dedicated to in vivo microscopy (IVM). In 2024, the hospital reimbursement for CPT 43252 was downgraded from APC 5303 "Upper-GI Level 3" to APC 5302 "Upper-GI Level 2" in the Medicare OPPS rule, causing the technical fee to drop by approximately 40%. CMS relied on median costs reported by hospitals; however, professional societies (AGA, ACG, ASGE) believe these reports underestimate the actual cost of the Cellvizio® procedure, which explains the decrease. Mauna Kea Technologies is working with these societies and specialized consultants to have the cost data corrected, document clinical savings (reduction in biopsies and repeat procedures), and request, during the next OPPS cycle, the reclassification of the code-while securing coverage from private insurers. 0 In France An application to create a procedure code for the main gastrointestinal indications was submitted in September 2010 to the Haute Autorité de Santé (HAS). The admissibility of the application was notified in January 2011. The procedure's evaluation program finally began in late 2013 and concluded for the first indication evaluated-monitoring of endobrachial esophagitis-with the HAS issuing a favorable opinion in late 2014 for the inclusion of a new procedure on the list of reimbursable procedures. Subsequently, the Union of Gastroenterologists referred the matter to the National Union of Health Insurance Funds (UNCAM), the body responsible for reviewing the scope of services eligible for reimbursement and the reimbursement rates for medical care. In 2016, representatives of the National Council of Hepato-Gastroenterology and the French Society of Digestive Endoscopy also met with the General Directorate of Healthcare Provision to discuss the conditions for implementing this new procedure in public and private healthcare facilities. In June 2019, the UNCAM published its decision to add a new reimbursable procedure to the nomenclature, described as follows: "Esophageal endoscopy with biopsy guided by confocal laser endomicroscopy-pre-therapeutic esophageal mapping with biopsy guided by confocal laser endomicroscopy." The reimbursement rates are as follows: 150 euros for the endoscopist (Activity 1) and 69 euros for the anesthesiologist (Activity 4). In September 2015, the HAS issued an unfavorable opinion regarding the use of Cellvizio® for the characterization of biliary tract strictures. Subsequently, the dossier on the use of Cellvizio® in the colon (pending evaluation since 2011) was removed from the HAS's work program in the first quarter of 2017. In 2020, the HAS scheduled the evaluation of confocal endomicroscopy via a biopsy needle for the characterization of cystic pancreatic tumors, with a view to its inclusion in the Common Classification of Medical Procedures (CCAM). A multidisciplinary working group was formed to assess the technique's value within the French healthcare context. The HAS initially issued an unfavorable opinion in 2023 due to a lack of clinical evidence. Following the publication of new clinical data and the inclusion of Cellvizio in the guidelines of the European Society of Gastroenterology, the HAS ultimately decided to re-evaluate the case in the fourth quarter of 2025. The HAS opinion is expected in the first half of 2026. 0 In Germany An OPS code (Operationen- und Prozedurenschlüssel) was created in 2013 to document endomicroscopy procedures in the digestive tract, and confocal endomicroscopy with Cellvizio® was included on the final list of 2014 OPS codes for the reimbursement of associated medical and surgical procedures by the German Institute for Medical Documentation and Information (DIMDI). The assignment and implementation of an OPS code allows German authorities to measure procedure volumes as well as the costs of associated treatments, and then to set a reimbursement rate. Certain private clinics (part of the HELIOS hospital group) are piloting confocal laser endomicroscopy using a minisonde to aid in the diagnosis of atypical food allergies in patients with irritable bowel syndrome. Activity-based pricing (G-DRG) is then applied to ensure coverage by local health insurance providers. ‌Marketing and Market Marketing Strategy and Initiatives The marketing department is structured around several divisions: 0 Lead Generation It is essential to continuously provide sales representatives with new, pre-qualified sales opportunities. This is the objective of this group within the marketing team, which uses several methods to achieve this: purchasing relevant data for account targeting, inbound marketing, intensive use of LinkedIn Sales Navigator, presence at events, etc. 0 Application and Product Marketing The marketing department is responsible for marketing specific to Cellvizio® indications, primarily in gastroenterology and interventional pulmonology but also in other areas currently under study. This department acts as a liaison between the clinical affairs department and the sales forces-both direct and indirect-deployed in the field. In particular, the marketing teams provide ongoing training their sales force, the rollout of new products or offerings, local marketing initiatives, and participation in local events. This department is responsible for monitoring the market and customers in order to, first, select the best projects in terms of return on investment and, second, draft the corresponding functional specifications and oversee technical development efforts. Once products are developed, the product management team is responsible for their global launch and for providing the corresponding commercial support. It is also responsible for the educational and application aspects for each indication. This includes educating new and potential users through educational activities and fostering peer-to-peer learning among physicians. The product marketing department monitors user progress to ensure they learn quickly. 0 Event Communication and Digital Marketing The communications/digital marketing team aims to increase the visibility of the product and the Group's brands and to generate engagement that complements other commercial activities. More specifically, the communications team is responsible for disseminating marketing messages developed by the clinical and product teams and implementing them through marketing and communications materials. It organizes events for prospects and customers and participates in international conferences. Its expertise also extends to digital communication platforms (particularly websites) and public relations. The Hospital and Clinic Market Cellvizio® in its current configuration is intended for use exclusively by hospitals and private clinics that have an endoscopy suite and physicians trained in endoscopy. The Cellvizio® market must be defined by geography and by product based on the application. The Group's current focus is primarily on the United States and Europe, but also on Asia. In terms of applications, commercial development is concentrated in the field of gastroenterology, and in particular in upper gastrointestinal endoscopy. Other applications, such as pulmonology, are currently being evaluated and could represent future growth drivers. 0 United States Mauna Kea Technologies' primary target in the United States over the next few years includes mainly "Community Hospitals" and "Ambulatory Surgical Centers," as well as large academic hospitals, many of which are already Cellvizio users and are priority targets for upgrading to Cellvizio Gen3. The American Hospital Association has identified 6,093 hospitals, of which 5,139 are classified as "Community Hospitals ." "Community Hospitals" are non-governmental hospitals that provide short-term care to patients. In addition, there is a list of 207 government hospitals (Source: American Hospital Association - Fast facts on US hospitals 2020, https://www.aha.org/statistics/fast-facts-us-hospitals ). The Academic Medical Centers segment comprises 400 institutions according to the AAMC (Association of American Medical Colleges - https://www.aamc.org/members/coth ), which remains a secondary target. By limiting these numerous prospects to institutions involved in the field of gastrointestinal endoscopy, Mauna Kea estimates the total number of target centers in the United States at just over 3,000. Of this number, the Group is prioritizing 1,100 hospitals (1,500 physicians) specializing in gastrointestinal endoscopy, whether they are community hospitals with a very high volume of gastroesophageal reflux disease (GERD) cases or Ambulatory Surgical Centers (ASCs) that treat a very large number of these patients. This represents an equipment market of approximately $200 million, to which is added a recurring market linked to the sale of probes, which depends on the number of procedures performed and which the Company estimates at approximately $200 million per year. 0 Europe In 2009, the European Union had more than 15,000 hospitals providing advanced care (medicine, surgery, obstetrics) or other services (psychiatry, medium- or long-term care) (Source: Study "Hospitals " by Dexia in partnership with Hope, the European Federation of Hospitals and Healthcare Services - July 2008). Given their populations in particular, Germany and France are the two European countries with the highest number of hospitals, with nearly 3,500 and 3,000, respectively. Country Number of hospitals Germany 3,460 France 2,890 United Kingdom 1,300 Italy 1,295 Spain 740 Russia 18 9,000 Others 4,615 18 source http://dcc2.bumc.bu.edu/RussianLegalHealthReform/ProjectDocuments/n970.IIIE1.Analysis.pdf Total 23,300 In France, the Group targets a market of approximately 300 hospitals and clinics that perform interventional gastrointestinal endoscopy. This ratio applies to the other target countries, bringing the number of centers potentially equipped with Cellvizio® to approximately 2,000, for gastroenterology alone. 0 Asia Japan and China are the largest markets for Cellvizio® in Asia. The number of hospitals per country breaks down as follows: Country Number of Hospitals Japan 7,474 China 23,170 Total 30,644 In China, out of a total of more than 23,000 facilities, there are over 1,000 first-class hospitals, which are the Group's primary target today. In Japan, the Group is specifically seeking to penetrate the market for academic hospitals, which comprises between 200 and 300 hospitals. The potential market for probes: the number of targeted biopsy procedures This section will focus primarily on indications in gastrointestinal endoscopy, where Cellvizio® is most commonly used, noting that numerous other medical fields could utilize Cellvizio® technology (see section 1.1.4 below) Endomicroscopy is a medical procedure distinct from the endoscopy procedure during which it is performed. Because Cellvizio® is compatible with commercially available endoscopes and endoscopic instruments, endomicroscopy using a mini-probe (with Cellvizio®) can be performed during an endoscopy procedure to improve, for example, diagnostic reliability. It is therefore possible to estimate the endomicroscopy market in terms of the number of procedures, considering, for example, the indications for which the greatest number of validation studies have been conducted. 0 Barrett's esophagus and GERD In the United States, an estimated 1.6% of the adult population-or 3.6 million people-exhibit symptoms of Barrett's esophagus, and 20% of the adult population suffers from gastroesophageal reflux disease (GERD). The ability to monitor these patients endoscopically is directly linked to the detection of precancerous areas and their potential treatment. In 2016, the American Society of General Surgeons published a major recommendation, citing these compelling arguments, that surgeons evaluate their patients with Barrett's or reflux using Cellvizio® prior to any surgical treatment. The total number of upper gastrointestinal endoscopy procedures is close to 9 million per year in the United States. The Group's assessment shows that more than 3 million annual procedures could benefit from Cellvizio® and be reimbursed. This represents a potential annual recurring revenue of over $2 billion, considering that a probe is reusable approximately 10 times and that its average price is around $7,000. These procedures are distributed as follows by facility type. Sources: Burden of Gastrointestinal Disease in the United States: 2012 Update; Peery et al, Gastroenterology. November 2012; 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. 0 Pancreatic Cysts Between 3% and 10% of the U.S. population has a pancreatic cyst, representing several million patients. It is estimated that approximately 120,000 new cysts are identified each year. If we make a conservative estimate that 40% of patients with these cysts could benefit from an endoscopic diagnostic procedure in which Cellvizio® could be used (since some cysts can be characterized as benign or malignant based on endoscopic ultrasound imaging), we arrive at a figure of 50,000 procedures per year for which Cellvizio® could be indicated to characterize a pancreatic cyst. Furthermore, 1,000 U.S. hospitals offer an endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) procedure for cysts. The 500 largest departments are priority targets for the Company. 0 The Irritable Bowel Syndrome and Food Intolerance Market Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder that affects 9 to 15% of the population and is characterized by a set of symptoms including abdominal pain, bloating, and bowel movement disturbances (diarrhea, constipation, or both), without any underlying lesions being visible through standard diagnostic tests. IBS significantly impacts the quality of life of those who suffer from it, who often face a long and arduous medical consultation process that can last an average of 2 to 3 years, with no guarantee that the underlying cause of their symptoms will be identified. Its management often requires a multidisciplinary approach, including dietary changes, medication, and psychological support, reflecting the complex interaction between the gut and the brain. The market potential for the diagnosis of food intolerances associated with IBS is considerable. Although not all patients with IBS are affected-particularly due to the presence of symptoms that may be attributed to other causes such as celiac disease-it is estimated that the target market could reach nearly 8 million patients, representing an addressable market of approximately $6 billion. 0 Undetermined biliary stricture In the field of biliary tract diseases, an estimated 500,000 ERCP procedures are performed annually in the United States, and 10% of these are performed on patients with stenosis for whom endomicroscopy may be indicated, amounting to 50,000 procedures per year. Competition 0 Optiscan The Australian company Optiscan has developed a technical solution for confocal endomicroscopy that does not rely on the same technological choices as Cellvizio®. Optiscan markets a 6-mm-diameter rigid endomicroscope designed for tissue visualization during examinations of various organs, including the breast, brain, and gastrointestinal tract, among others. All of these applications are still undergoing clinical trials and are currently available only in research centers. Building on similar technology (same diameter and same frame rate) but this time in collaboration with Zeiss, Optiscan has developed a semi-rigid endomicroscope dedicated to neurosurgery called ConVivo. In 2018, Zeiss obtained marketing authorization for this product from U.S. authorities. 0 Olympus Olympus, a Japanese company and global leader in flexible endoscopy with a 71% market share (source: Endoscopy Devices Market to 2016, GBI Research, December 2010), does not offer any commercial solution for endomicroscopy in any form. A prototype known as an "endocytoscope" has been presented at a few congresses and conferences with very preliminary and highly mixed clinical results (source: American Gastroenterology Association http://www.asge.org/uploadedFiles/Publications_and_Products/Practice_Guidelines/endocytoscopy.pdf . Citation: "the diagnostic performance of EC for the differentiation of Barrett's epithelium has been suboptimal. In a recent study, the application of EC in Barrett's esophagus resulted in a high proportion of unusable images due to suboptimal image quality, fair interobserver agreement, and poor diagnostic specificity"). This prototype, which appears to be used today in only one center worldwide (in Japan), requires the use of several dyes (ibid.) and does not seem suitable for routine clinical practice. Furthermore, the few publications on this experimental device report significant difficulties in ensuring consistent image interpretation by physicians and making it reproducible (ibid.). 0 Fujifilm Fujifilm is a major player in flexible endoscopy, under the Fujinon brand. Fujifilm offers advanced imaging systems on the high-end models of its flexible endoscopes under the names FICE (Fuji Intelligent Color Enhancement) and LASEREO, which was launched in late 2015. These are systems with electronic filters or a laser source that enhance certain colors in the image. Developed to aid in tissue characterization, the FICE system was shown to be inferior to Cellvizio® in an independent study conducted by the Mayo Clinic (reference: Comparison of Probe-Based Confocal Laser Endomicroscopy With Virtual Chromoendoscopy for Classification of Colon Polyps, Buchner et al, Gastroenterology, January 2010). Furthermore, the Company entered into a distribution partnership with Fujifilm in late 2012 for the Chinese market, which was renewed in 2016. Although the Group and Fujifilm operate in the same market, Fujifilm's endoscopes are not in direct competition with Cellvizio®. 0 Chinese Competitors Two Chinese companies (Viestar and HiSky) have developed and are marketing endomicroscopy systems that use technologies very similar to those of Cellvizio® in China The Company has undertaken an in-depth study of these products to determine whether action should be taken to protect its intellectual and industrial property rights. The platform's growth drivers, both internally and through partnerships While the Group initially launched sales in the gastroenterology and pulmonology sectors, it also secured marketing agreements for a range of mini-probes dedicated to urological applications in 2013, followed by laparoscopic applications in 2015. Thanks to its platform and wide range of probes, Mauna Kea Technologies is able to expand its commercial offering to the characterization or detection of non-cancerous conditions, or to other areas of endoscopy and surgery (see section 1.1.3 Clinical, Regulatory, and Reimbursement Validation). 0 The Interventional Pulmonology Market Lung cancer remains the leading cause of cancer in men, even though its incidence has stabilized ( source: American Cancer Society 2008 - stats) . Among women, the incidence is still rising slightly. Lung cancer is the leading cause of death in the Western world, for both men and women. The prognosis for lung cancer depends on several factors, one of the most important being the stage of the cancer at the time of diagnosis. Patients with peripheral lesions less than 3 centimeters in diameter (T1) are better candidates for surgical resection and have the best survival rates, with a 5-year survival rate of 60 to 80%. Less than 1% of patients with advanced-stage cancer are still alive 5 years after diagnosis. ( Source: World Health Organization ) When the patient is symptomatic, the disease is generally very advanced at the time of diagnosis and the prognosis is very poor. But more often than not, a peripheral nodule (a small mass, benign or malignant) is discovered in the lung during a routine examination, such as a CT scan. The challenge lies in characterizing this nodule to guide the choice of treatment in the most appropriate way. With improvements in wide-field imaging techniques such as CT scans, as well as the implementation of lung cancer screening programs , the number of nodules detected during these imaging exams has increased significantly, as has the need for characterization. American medical societies have recommended organized lung cancer screening since 2013, as it has been proven that such screening improves patient prognosis while reducing the cost of their care (source: Powell et al., Ann Surg. 2004 September; 240(3): 481-489, and CHEST / 142 / 2 /385-393 AUGUST 2012). In 2021, new recommendations from the USPSTF (U.S. Preventive Services Task Force) nearly doubled the number of people eligible for lung cancer screening in the United States and are expected to increase the number of lung cancer cases detected at an early stage through screening by 27%. Several techniques are used to characterize a lung mass. The most effective method, when feasible, involves physically obtaining a tissue sample from the nodule, either by taking a biopsy through a bronchoscope and/or a transbronchial needle-sometimes equipped with an electromagnetic navigation device within the bronchial tree-or by taking a biopsy via a transpleural approach, with external access. In the first case, the procedure carries little risk, but the current diagnostic yield of these procedures is low due to sampling errors. In the second case (transthoracic access), the procedure is burdensome for the patient, as it is highly invasive, and is consequently rarely performed. Despite the development of new technologies, the yield and accuracy of diagnosis via transbronchial biopsy remain low (between 30 and 65%), and it is impossible to confirm with a high degree of certainty that the biopsy needle is obtaining a sample from the targeted lesion. It is becoming increasingly clear that Cellvizio® imaging has the potential to significantly improve the yield and diagnostic accuracy of transbronchial biopsies. An AlveoFlex confocal miniprobe being inserted into a bronchoscope The bronchoscopy market is very similar to the gastrointestinal endoscopy market in terms of medical equipment: all healthcare facilities with an endoscopy unit have at least one bronchoscopy suite, which could be equipped with Cellvizio®. This represents more than 60,000 hospitals and clinics across Europe, the United States, and Asia. The number of bronchoscopy procedures is estimated at approximately 500,000 exams per year in the United States, with more than 240,000 biopsies taken annually. These figures are steadily increasing. Although this volume is lower than that of gastrointestinal endoscopy, it translates to a potential of several hundred thousand procedures for Cellvizio® in the field of pulmonology, and an associated replacement of tens of thousands of confocal minisondes per year. Source: Centers for Disease Control and Prevention, https://www.cdc.gov 0 The Endourology Market Example of Cellvizio® images obtained in the bladder and correlated with standard histology. Endourology is a branch of urology involving the endoscopic examination of the urinary tract to detect obstructions or cancers and, if necessary, to perform endoscopic treatment procedures. The most commonly performed procedure in endourology is cystoscopy, which involves examining the bladder. In 2010, there were approximately 71,000 new cases of bladder cancer in the United States, and 15,000 deaths from the disease. One in 27 men will develop this disease in his lifetime, compared to one in 85 women. Nearly 90% of patients with this cancer are over the age of 55. (Source: American Cancer Society, https://www.cancer.org/ ). The management of bladder cancer requires several cystoscopy procedures. The first is generally performed in the doctor's office using a flexible cystoscope and helps identify a lesion. The second, performed in the operating room using a rigid cystoscope, allows for the collection of biopsies from the lesion. The third procedure allows, when possible, for endoscopic resection of the tumor, which is not always feasible since too many cancers are diagnosed at an advanced stage. One-quarter of patients have cancer that has invaded the muscle layer and/or metastasized, while more than 20% of patients have less advanced but already high-grade cancer. The recurrence rate for bladder cancer is very high, ranging from 50% to 90%, which requires continuous, lifelong monitoring for patients who have survived bladder cancer. This monitoring is carried out through repeated cystoscopy procedures at regular intervals. The large number of diagnostic and follow-up endoscopic procedures makes the management of bladder cancer the most expensive among all cancers, costing approximately $3.7 billion in the United States in 2001. (Source: Jemal A, et al. CA Cancer J Clin, 2010. 60(5):277-300.) The cystoscopy market is estimated as follows: In France ( source: ATIH, 2008 ), the number of diagnostic cystoscopy procedures is estimated at 37,000 per year, while the number of therapeutic cystoscopy procedures is estimated at 52,000 per year. Based on this, it can be estimated that there are approximately 470,000 diagnostic cystoscopy procedures per year in Europe, and 670,000 therapeutic cystoscopy procedures; In the United States (source: NHSR, Number 11, 2009, "Number of ambulatory surgery procedures, US, 2006") , the number of diagnostic cystoscopy procedures is 750,000 per year, while the number of therapeutic cystoscopy procedures is approximately one million per year. As with bronchoscopy, all healthcare facilities with an endoscopy unit have at least one cystoscopy room, which could be equipped with Cellvizio®. Cellvizio® can be used during both diagnostic and therapeutic cystoscopy procedures, as demonstrated by several studies by Prof. Liao at the VA Hospital in Palo Alto ( source: Interobserver Agreement of Confocal Laser Endomicroscopy for Bladder Cancer, The Journal of Urology, doi: 10.1089/end.2012.0549, May 2012 ). Clinical studies are currently underway to confirm these U.S. data with European results. The use of Cellvizio in endourology appears to offer a critical benefit in optimizing the transurethral resection of precancerous and cancerous lesions, in identifying additional lesions not detected during the initial diagnostic examination (flexible cystoscopy), as well as in post-resection follow-up, which could ultimately lead to a reduction in recurrences. The volume of procedures represented by endourological applications is considerable. Finally, since urology is a specialty at the intersection of endoscopy and surgery, urological indications may serve as a gateway for Mauna Kea Technologies into surgical applications, which are a major focus for the company. 0 The surgical market Highly innovative and naturally taking over from endoscopists in the management of certain cancers (gastrointestinal, pulmonary, and urological), it was only natural that surgeons took an interest in Cellvizio®, seeing it as a tool that could help them refine their techniques, thereby better preserving the functions of resected organs while ensuring the complete eradication of cancer cells. In 2010, Mauna Kea Technologies and its partners in the PERSEE project (a collaborative project supported by the OSEO/ISI program, see 6.6.1.2) initiated the development of a robotic, minimally invasive endomicroscopic solution for the abdominal cavity designed to improve the care of cancer patients, with the goal of reducing the number of unnecessary and/or incomplete surgeries (up to 25% of pancreatectomies, for example). The prototype was tested in a clinical feasibility trial on patients, which was successfully completed in 2015. In 2016, at the American SAGES conference, two posters were presented and received very favorably. The PERSEE project is structured in four successive phases, the last of which was scheduled to end in May 2016. In practice, the third of these phases ended in July 2015, and the Phase 3 final report was submitted to BPI France in May 2016. In 2018, the fourth phase was initiated; in 2019, the Company obtained BPI France's approval to extend the duration of Phase 4 until October 31, 2020, at which point the project will be completed. Furthermore, Mauna Kea Technologies is devoting increasing efforts to the development of endomicroscopy solutions for surgical specialties, through: identifying this development as a core company initiative, recruiting dedicated personnel, incorporating operating room constraints into the design of its next-generation Cellvizio® systems, launching clinical trials specifically focused on surgical applications, whether these trials are initiated by...

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