Inside Information / Other news releases

Mauna Kea Technologies Announces New Positive Clinical Results  for Cellvizio in Food Intolerance 

Major New Study Presented at the World's Largest Gastroenterology Congress 

Validation of Mauna Kea's Growth Strategy with CellTolerance® in a $6 Billion a Year Market Opportunity

Paris and Boston, October 17, 2024 – 08:00 a.m. CEST – Mauna Kea Technologies (Euronext Growth: ALMKT), inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, today announces that new clinical data demonstrating the value of Cellvizio® in the detection, understanding, and treatment of food intolerances leading to gut barrier dysfunction in patients suffering from Irritable Bowel Syndrome (IBS), were presented at UEG Week 2024, the world's largest gastroenterology congress.

Conducted by Prof. Jost Langhorst at Bamberg Hospital and the University of Duisburg-Essen in Germany, the study highlights the value of Confocal Laser Endomicroscopy (CLE) to guide personalized therapy and improve symptom management in patients suffering from IBS.

In this study, 119 patients suffering from IBS were screened using Cellvizio® during a food challenge to detect primary and food-induced gut barrier dysfunctions. Of these patients, 62% showed a response to a food challenge in the form of an impaired intestinal barrier. Patients with identified dysfunctions were treated with a multimodal approach, including an elimination diet of the problematic foods identified by the unique imaging provided by Cellvizio®.

After approximately six months, 71% of patients who returned for a follow-up procedure using Cellvizio® showed improvement in barrier integrity, with 46% achieving full stabilization. Clinical outcomes included significant improvements in IBS severity, quality of life, and psychological well-being, with particular relief from abdominal pain, cramping, and stool irregularities.

Prof. Jost Langhorst, gastroenterologist, Department for Internal and Integrative Medicine, Klinikum Bamberg, stated: "I am very pleased with the results of this study which represent a step forward in managing IBS, as Cellvizio® offers real-time assessment of gut barrier dysfunction, aiding in a more accurate diagnosis for patients with IBS. This technology could lead to more personalized and effective treatment options. Encouragingly, most patients show improvement in gut barrier integrity after treatment and food elimination, often accompanied by a notable reduction in symptoms. These findings suggest that Cellvizio® may serve as a valuable tool in improving IBS management for a large group of patients.”

Sacha Loiseau, Ph.D., Chairman and CEO of Mauna Kea Technologies, commented: “These results once again confirm the unique and unrivalled role of Cellvizio® in the identification and treatment of food intolerances. This is a major breakthrough for tens of millions of patients suffering from irritable bowel syndrome (IBS), desperately seeking treatments and solutions to relieve their symptoms. Every day, we are accumulating new positive data and seeing a very strong interest from doctors, nutritionists and patients, at a level never seen before. It's clear that we have an application here that could finally ensure Mauna Kea's success in an extremely attractive market, which is currently very accessible given the low barriers to entry, supported by a fully mature technology. As a result, starting in the fourth quarter, we will be stepping up the development of CellTolerance® and have already initiated active discussions with several centers to roll out this program.”

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About IBS

Irritable Bowel Syndrome (IBS) is a chronic gastrointestinal disorder, affecting 10 to 15% of the global population and characterized by a group of symptoms including abdominal pain, bloating, and changes in bowel habits (diarrhea, constipation, or both), without any underlying damage visible through standard diagnostics. IBS significantly affects the quality of life of sufferers who often face a protracted and distressing journey of medical consultation that could last 2 to 3 years on average with no guaranteed path to identifying the underlying cause of their symptoms. Its management often requires a multi-disciplinary approach, including dietary changes, medication, and psychological support, reflecting the complex interplay between the gut and the brain.

In several important clinical studies using Confocal Laser Endomicroscopy, it has been proven that more than 50% of IBS patients could suffer from atypical food intolerances that can only be characterized by the real-time visualization of the intestinal barrier with Cellvizio during a food challenge.

For more information on the use of Cellvizio in food intolerance and the unique CellTolerance® program, visit www.cell-tolerance.com.

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.