Mauna Kea Technologies announces the publication of a meta-analysis demonstrating the significant role of Cellvizio in the detection of dysplasia and cancer of the esophagus

PARIS & BOSTON–(BUSINESS WIRE)–Regulatory news:

Mauna Kea Technologies (Euronext: MKEA, “Mauna Kea”) (Paris:MKEA) (OTCQX:MKEAY) inventor of Cellvizio®, the multidisciplinary probe and needle confocal laser endomicroscopy (p/nCLE) platform, today announced the peer-reviewed publication of a new meta-analysis in Techniques and Innovations in Gastrointestinal Endoscopy (TIGE) entitled “Review and meta-analysis of high-definition probe-based confocal laser endomicroscopy for the detection of neoplasias in Barrett’s esophagus1. Study demonstrates that adding Cellvizio as a supplement to guide biopsies provides significantly higher diagnostic yield for dysplasia and cancer and reduces sampling error compared to random four-quadrant biopsies alone, standard of care.

Existing endoscopic screening and surveillance methods are insufficient to detect Barrett’s esophagus or esophageal cancer, as use of the Seattle Protocol standard of care alone is prone to sampling errors and poor sensitivity and specificity. At Digestive Disease Week® (DDW) in May 2022, Dr. Bashar Qumseya presented data2 based on approximately 5 million people and showing that, among people aged 45 to 64, the rate of esophageal cancer (EAC) nearly doubled from 2012 to 2019. Additionally, the prevalence of esophageal Barrett – the only known precursor to EAC – has increased by about 50% in this age group over the same period.

In the STEM meta-analysis, the authors included 9 studies for a total of 688 patients and 1299 lesions and assessed the benefits of probe-based CLE (pCLE) as an adjunct to random 4-quadrant biopsies in monitoring patients with Barrett’s esophagus for dysplasia and early detection of EAC. The pooled sensitivity, specificity, and negative predictive value of pCLE per patient were 96%, 93%, and 98%, respectively. Compared to random biopsies, the increases in absolute and relative pooled per-patient detection rates of neoplasia with pCLE were significant and equal to 5% and 243%, respectively.

Separately, at the ENDO 2022 World Congress on Gastrointestinal Endoscopy in May 2022, the results of a retrospective multicenter chart review3 of 60 patients with Barrett’s esophagus who were referred for endoscopic monitoring or treatment were presented. The authors examined differences in the use of gastroenterology health services for eight items/services in patients treated with Cellvizio as an add-on compared to standard treatment alone. The Cellvizio cohort had 1.04 fewer endoscopy and anesthesia departments, 7.49 fewer biopsy vials, 1.30 fewer ablations, and 1.46 fewer brush cytology departments. Therefore, the researchers concluded that Cellvizio is associated with a lower overall burden on the healthcare system.

“The results of these studies demonstrate that there are better tools readily available to physicians who are striving to improve the detection rate of screening and surveillance programs, and ultimately to reverse the alarming increase in the prevalence of esophageal cancer,” said Nicolas Bouvier, Interim Chairman and CEO of Mauna Kea Technologies. “Better detection rates and lower healthcare utilization make the Cellvizio a valuable addition to the standard of care in hospitals and outpatient surgery centers.”

About Barrett’s Esophagus and Esophageal Cancer

Barrett’s esophagus, often abbreviated as BE, is a condition that results from chronic gastroesophageal reflux disease (GERD), where the lining of the esophagus at the junction of the stomach undergoes significant physiological changes that cannot often only be detected with thorough screening and monitoring. Chronic GERD affects around 5-10% of the world’s population and, if left untreated, can progress to EBO without proper monitoring. BE is the only known precursor to esophageal adenocarcinoma (EAC), one of the fastest growing causes of cancer death with very low 5-year survival rates.

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 provides in vivo cellular visualization that allows physicians to monitor disease progression over time, assess punctual reactions as they occur in real time, classify undetermined areas of concern and to guide surgical interventions. The Cellvizio platform is used globally in a wide range of medical specialties and is bringing a step change in the way doctors diagnose and treat patients. For more information, visit www.maunakeatech.com.

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Mauna Kea Technologies

This press release contains forward-looking statements regarding Mauna Kea Technologies and its business. All statements other than statements of historical fact included in this press release, including, without limitation, those regarding Mauna Kea Technologies’ financial condition, operations, strategies, plans and management objectives for future transactions, are forward-looking statements. These forward-looking statements are based on assumptions that Mauna Kea Technologies believes to be reasonable. However, there can be no assurance that the anticipated events contained in these forward-looking statements will occur. Forward-looking statements are subject to numerous risks and uncertainties, including the risks set out in Chapter 3 of Mauna Kea Technologies’ 2020 Universal Registration Document registered with the Autorité des marchés financiers (AMF) on June 17, 2021 under number D- 21-0566 and the amendment to the 2020 Universal Registration Document filed with the AMF on September 17, 2021, both available on the Company’s website (www.maunakeatech.com), and risks related to the economic environment economic, 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 unknown to Mauna Kea Technologies or that Mauna Kea Technologies does not currently consider material. The realization of all or part of these risks could lead to actual results, financial conditions, performance or achievements by Mauna Kea Technologies that differ materially from the results, financial conditions, performances or achievements expressed in these forward-looking statements. This press release and the information it contains do not constitute an offer to sell or subscribe, nor a solicitation of an order to buy or subscribe to Mauna Kea Technologies shares in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. The distribution of this document may, in some jurisdictions, be restricted by local regulations. Persons into whose possession this document comes are responsible for complying with all applicable local regulations relating to this document.

1 DOI: https://doi.org/10.1016/j.tige.2022.06.001

2 Qumseya, B. et al. Alarming increase in the prevalence of esophageal and Barrett’s esophageal cancer in middle-aged patients: results from a national database of more than five million patients https://news.ddw.org /wp-content/uploads/2022/05/671-Alarming- Augmentation-In-Prevalence-Of-Esophageal-Cancer-And-Barretts-Esophagus-In-Middle-Aged-Patients.pdf Accessed July 1, 2022.

3 Randhawa, N. et al. Health service utilization in patients with Barrett’s esophagus using confocal laser endomicroscopy versus standard of care. ENDO 2022.


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