Cellvizio Food Intolerance Test (C-FIT) delivers real-time, in vivo visibility to accurately identify food intolerance in patients suffering from Irritable Bowel Syndrome (IBS)
Metrodora will serve as Center of Excellence for patient care and physician training to enable broad access to this breakthrough procedure
Regulatory News:
Mauna Kea Technologies (Euronext Growth: ALMKT), inventor of Cellvizio, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, and Metrodora Institute, a leading multispecialty healthcare institute, today announced the formation of a new partnership. This collaboration aims to establish Metrodora Institute as the first U.S. Center of Excellence that will serve as the model of patient care and physician training on the use of Cellvizio for identifying and treating food intolerances in patients suffering from Irritable Bowel Syndrome (IBS). The Cellvizio Food Intolerance Test (C-FIT) offers a groundbreaking approach to diagnosing food intolerances, providing a real-time visualization of the intestinal barrier during a food challenge.
In the United States, about 10-15%1 of the general adult population suffers from IBS, a condition reportedly linked to atypical food intolerance in the majority of cases, characterized by a group of symptoms including abdominal pain, bloating, and changes in bowel habits (diarrhea, constipation, or both). This condition significantly affects the quality of life of those affected 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.
"This partnership is perfectly aligned with our strategic ambition and represents a significant step forward in expanding the use of Cellvizio in the food intolerance markets. The Cellvizio U.S. Center of Excellence at the Metrodora Institute serves as a key driver in increasing awareness among the medical and patient communities about C-FIT, positioning it as a benchmark method for food intolerance detection", said Sacha Loiseau, Ph.D., Founder, Chairman and Chief Executive Officer of Mauna Kea Technologies. "There is an urgent, unmet need for the immense pool of IBS patients who endure debilitating daily complications. It is crucial to swiftly extend the C-FIT procedure to as broad an audience as possible."
Metrodora was established in 2021 as a multidisciplinary care and research center for people with neuroimmune disorders, including neurogastrointestinal disorders. Metrodora's state-of-the-art ambulatory surgery center in Salt Lake City, Utah, offers advanced diagnostic and therapeutic procedures to evaluate and treat a range of complex and routine conditions.
"We couldn't be more excited about being named the first U.S. Center of Excellence for implementing and serving as a healthcare model for the C-FIT procedure," said John Wirthlin, CEO, Metrodora Institute. "Many patients live with undiagnosed food intolerances, simply because existing testing methods cannot identify the underlying issues. Our vision is that Metrodora Institute will adopt novel technologies like Cellvizio to improve the lives of the patients we serve."
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.
About Metrodora Institute
Located in Salt Lake City, Utah, the Metrodora Institute was founded in 2021 with the vision of reimagining care for patients with complex multisystem disorders. Metrodora is uniquely positioned to advance the latest clinical care and develop and commercialize new diagnostic tests and therapeutics for patients living with these often-debilitating conditions. Metrodora Institute has created an innovative offering with a collaborative multidisciplinary approach to medicine. Metrodora currently treats neurological, gastrointestinal, immunological, autoimmune, pain and metabolic disorders.
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 Techonologies' 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 3 of Mauna Kea Technologies' 2022 Universal Registration Document filed with the Autorité des marchés financiers (AMF) on June 28, 2023 under number D-23-0545, 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.
1 Hungin APS, Tack J, Mearin F, Whorwell PJ, Dennis E, Barghoui V. Irritable bowel syndrome (IBS): prevalence and impact in the USA the truth about IBS (T-IBS) survey. Am J Gastroenterol. 2002; 97:242. (Poster #460)
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Aurélie Manavarere Thomas Grojean
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