Confirming the Role and added value of Cellvizio for the Identification and Management of IBS Patients with Atypical Food Allergies

Regulatory News:

Mauna Kea Technologies (Paris:MKEA) (OTCQX:MKEAY) (Euronext: MKEA) inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, continues to expand its European customer base in healthcare centers treating patients with Irritable Bowel Syndrome (IBS), a chronic functional disorder of the gastrointestinal system which affects approximately 7.1% of the European population1. To date, more than 15 centers in Europe, including prominent groups such as the Helios group in Germany and the group Hexagon Santé in France, have adopted Cellvizio to address the unmet need of assessing atypical food allergies in real time with a higher degree of accuracy compared to standard of care diagnostic methods.

In a study published in 2019, Annette Fritscher-Ravens, M.D., Ph.D., Head of Experimental Endoscopy Unit at the University Hospital Schleswig-Holstein in Kiel, Germany, confirmed with Cellvizio that more than 50% of patients with IBS could have a nonclassical food allergy (Gastroenterology 2019; 157:109–118, DOI: https://doi.org/10.1053/j.gastro.2019.03.046). Despite negative results from skin tests and serologic analysis of immunoglobulin E, the current standard of care for diagnosis, 70 % of patients in this study showed an immediate visible disruption of the intestinal mucosal barrier upon exposure to food antigens using pCLE. Two-thirds of those patients with IBS who had abnormal mucosal reactions to certain foods using Cellvizio, experienced significative improvement of IBS symptoms after a 12-month exclusion diet, confirming the atypical food allergy diagnosis.

“Many patients suffer from symptoms typical of IBS. Often there is an underlying atypical food allergy or allergy-like reaction limited to the intestine, which can not be detected by standard allergy testing. Cellvizio allows to more accurately differentiate patients with atypical food hypersensitivity from IBS patients, allowing physician to provide tailored treatment for each patient and to develop new therapeutic approaches,” said Christian Sina, M.D., Gastroenterologist & Director, Fresenius Kabi Professor of Nutritional Medicine.

“The growing adoption of Cellvizio for this novel application combined with the large population suffering from IBS symptoms represent a compelling market size and business opportunity for the company,” said Robert L. Gershon, Chief Executive Officer of Mauna Kea Technologies. “ Mauna Kea will continue to expand its business in Europe with the aim of establishing Cellvizio as the leading technique in identifying atypical food allergies providing patients with a long-awaited answer to their condition. IBS represents 25% to 50% of all referrals to gastroenterologists and is second only to the common cold for the number of days of work missed2. Using Cellvizio to identify those patients with an atypical food allergy can significantly relieve the health economic burden in Europe, reducing direct medical costs to healthcare systems and indirect costs related to work absenteeism or work impairment while improving many patients’ quality of life”.

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 revolutionizing the way physicians diagnose and treat patients — making a transformative change in medicine. For more information, visit www.maunakeatech.com.

Disclaimer

This press release contains forward-looking statements concerning Mauna Kea Technologies and its activities. Such forward looking statements are based on assumptions that Mauna Kea Technologies considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward- looking statements are subject to numerous risks and uncertainties including the risks set forth in the Universal Registration Document of Mauna Kea Technologies registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on August 7, 2020 under number 926346434_20200807 and available on the Company's website (www.maunakeatech.com), and to the development of economic situation, financial markets, and the markets in which Mauna Kea Technologies operates. The forward-looking statements contained in this release are also subject to risks unknown to Mauna Kea Technologies or that Mauna Kea Technologies does not consider material at this time. The realization of all or part of these risks could lead to actual results, financial conditions, performances or achievements by Mauna Kea Technologies that differ significantly from the results, financial conditions, performances or achievements expressed in such forward-looking statements. This press release and the information it contains do not constitute an offer to sell or to subscribe for, or a solicitation of an order to purchase or subscribe for, Mauna Kea Technologies shares in any country.

1 Sperber AD, Dumitrascu D, Fukudo S, et al The global prevalence of IBS in adults remains elusive due to the heterogeneity of studies: a Rome Foundation working team literature review Gut 2017;66:1075-1082. 2 American College of Gastroenterology Task Force on Irritable Bowel Syndrome, Brandt LJ, Chey WD, Foxx-Orenstein AE, Schiller LR, Schoenfeld PS, Spiegel BM, Talley NJ, Quigley EM. An evidence-based position statement on the management of irritable bowel syndrome. Am J Gastroenterol. 2009 Jan;104 Suppl 1:S1-35.

United States Mike Piccinino, CFA Westwicke, an ICR Company 443-213-0500

France and Europe NewCap - Investor Relations Thomas Grojean +33 (0)1 44 71 94 94 maunakea@newcap.eu