Mauna Kea Technologies Announces Another Milestone Year at Digestive Disease Week ® 2025 with 8 Presentations Demonstrating the Clinical Value of Cellvizio ® in Key Indications
Mauna Kea Technologies (Euronext Growth: ALMKT), inventor of Cellvizio ®, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, today announced another milestone year at the Digestive Disease Week ® (DDW) Conference, being held from May 3-6, 2025 in San Diego, California with the presentation of at least 8 abstracts supporting the clinical value of Cellvizio ® in key indications. These abstracts focus on pancreatic cystic lesions and pancreatic cancer, food intolerance, artificial intelligence, and other gastrointestinal disorders. Studies and presentations highlight how the use of Cellvizio ® directly impacts patient management and positive outcomes.
Members of Mauna Kea's executive team will be present at DDW and meeting with physicians, industry partners, and societies, and welcome the opportunity to discuss the Company's recent achievements and future opportunities as announced in recent press releases.
"Each year, DDW is a not-to-be-missed meeting bringing the entire gastroenterology healthcare community together, and we are proud yet again to have such a wide range of independent scientific abstracts and data about Cellvizio on display, especially in areas which have significant unmet patient needs,' said Sacha Loiseau, Ph.D., Chairman and Chief Executive Officer of Mauna Kea Technologies. 'Cellvizio's role in the accurate classification and risk stratification of pancreatic cysts is advancing the entire field forward for the management of patients at risk of pancreatic cancer. Moreover, the body of evidence for food intolerance identification and management has grown substantially, building a large opportunity for CellTolerance ® growth.'
Highlighted featured presentations:
Saturday, May 3
12:30pm-1:30pm
Artificial Intelligence Advances Digital Pathomics for Confocal Endomicroscopy-Guided Diagnosis of Pancreatic Cysts
12:30pm-1:30pm
Intracystic Capillary Morphology as a Novel Approach to Risk Stratification of Intraductal Papillary Mucinous Neoplasms In Confocal Endomicroscopy: Limitations of Human Performance and Insights from Artificial Intelligence
3:00pm-3:15pm
Confocal Laser Endomicroscopy Captures Local, Food-Induced Reactions at the Level of the Duodenal Mucosa in Functional Dyspepsia, That Cannot Be Translated into Permeability Alterations or Changes in Mast Cell Activation Ex Vivo
4:30pm-4:45pm
Targeted Elimination Diet in Eosinophilic Esophagitis Following Identification of Trigger Nutrients Using Confocal Laser Endomicroscopy: Results from a Pilot Trial
Sunday, May 4
8:12am-8:19am
Towards Automating Risk Stratification of Intraductal Papillary Mucinous Neoplasms: Artificial Intelligence Advances Beyond Human Expertise with Confocal Laser Endomicroscopy
Monday, May 5
8:42am-8:49am
Is It Time to Refine Our Standards? Insights From a Multicenter Prospective Study on Endoscopic Ultrasound-Guided Confocal Laser Endomicroscopy (EUS-nCLE) For Diagnosing Pancreatic Cystic Lesions
10:30am-10:45am
Effects of a Multimodal Treatment Approach in Patients with Longstanding Irritable Bowel Syndrome on Symptom Relief and Barriere Integrity Targeted by Confocal Laser Endomicroscopy: An Exploratory Prospective Observational Clinical Trial
12:30pm-1:30pm
Real-Time Intestinal Barrier Assessment by Endocytoscopy and Confocal Laser Endomicroscopy Uniquely Correlates with Multiple Barrier Protein Expression and Reflects the Gut-Brain Axis
About Digestive Disease Week ®
Digestive Disease Week ® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 3-6, 2025. The meeting showcases more than 5,600 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.
About Mauna Kea Technologies
Mauna Kea Technologies is a global medical device company that manufactures and sells Cellvizio ®, the real-time in vivo cellular imaging platform. This technology uniquely delivers in vivo cellular visualization which enables physicians to monitor the progression of disease over time, assess point-in-time reactions as they happen in real time, classify indeterminate areas of concern, and guide surgical interventions. The Cellvizio ® platform is used globally across a wide range of medical specialties and is making a transformative change in the way physicians diagnose and treat patients. For more information, visit www.maunakeatech.com.
Disclaimer
This press release contains forward-looking statements about Mauna Kea Technologies and its business. All statements other than statements of historical fact included in this press release, including, but not limited to, statements regarding Mauna Kea Technologies' financial condition, business, strategies, plans and objectives for future operations are forward-looking statements. Mauna Kea Technologies believes that these forward-looking statements are based on reasonable assumptions. However, no assurance can be given that the expectations expressed in these forward-looking statements will be achieved. These forward-looking statements are subject to numerous risks and uncertainties, including those described in Chapter 2 of Mauna Kea Technologies' 2023 Annual Report filed with the Autorité des marchés financiers (AMF) on April 30, 2024, which is available on the Company's website (www.maunakeatech.fr), as well as the risks associated with changes in economic conditions, financial markets and the markets in which Mauna Kea Technologies operates. The forward-looking statements contained in this press release are also subject to risks that are unknown to Mauna Kea Technologies or that Mauna Kea Technologies does not currently consider material. The occurrence of some or all of these risks could cause the actual results, financial condition, performance or achievements of Mauna Kea Technologies to differ materially from those expressed in the forward-looking statements. This press release and the information contained herein do not constitute an offer to sell or subscribe for, or the solicitation of an order to buy or subscribe for, shares of Mauna Kea Technologies in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The distribution of this press release may be restricted in certain jurisdictions by local law. Persons into whose possession this document comes are required to comply with all local regulations applicable to this document.
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U.S. Indication for Yeztugo® Yeztugo (lenacapavir) injection, 463.5 mg/1.5 mL, is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents (≥35kg) who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating Yeztugo. U.S. Important Safety Information for Yeztugo BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF YEZTUGO IN UNDIAGNOSED HIV-1 INFECTION Contraindications Warnings and precautions Adverse reactions Drug interactions Dosage and administration About Gilead HIV For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 13 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people. Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead was recognized as one of the leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead's ability to initiate, progress and complete clinical trials in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Yeztugo (lenacapavir) (such as PURPOSE 1 and PURPOSE 2); uncertainties relating to regulatory applications and related filing and approval timelines, including regulatory applications for lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir for indications currently under evaluation and, as a result, lenacapavir may never be successfully commercialized for such indications; Gilead's ability to effectively manage the access strategy relating to lenacapavir, subject to necessary regulatory approvals; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. U.S. full Prescribing Information for Truvada and Yeztugo, including Boxed Warning, are available Truvada, Truvada for PrEP, Yeztugo, Yeytuo, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. For more information about Gilead, please visit the company's website follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences). View source version on CONTACT: Ashleigh Koss, Media [email protected] Ross, Investors [email protected] KEYWORD: EUROPE UNITED STATES NORTH AMERICA CALIFORNIA INDUSTRY KEYWORD: AIDS HEALTH INFECTIOUS DISEASES HOSPITALS PHARMACEUTICAL BIOTECHNOLOGY SOURCE: Gilead Sciences, Inc. Copyright Business Wire 2025. PUB: 07/25/2025 03:00 AM/DISC: 07/25/2025 03:01 AM
