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Proven diagnostic accuracy of Cellvizio allows for successful downstaging of non-mucinous lesions and prevention of unnecessary surgeries, resulting in significant healthcare cost savings
PARIS & BOSTON, November 17, 2021--(BUSINESS WIRE)--Regulatory News:
Mauna Kea Technologies (Euronext: MKEA) (Paris:MKEA) (OTCQX:MKEAY) inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, today announces a new peer-reviewed publication showing the significant healthcare cost savings of using Cellvizio® as an adjunct to the standard of care for the management of pancreatic cystic lesions (PCLs).
The conventional management of PCLs involves a diagnostic workup that can be prone to errors with classifying mucinous versus non-mucinous cysts, thereby placing patients in an incorrect therapeutic or surveillance program, and potentially resulting in an unnecessary surgery on a benign cyst. The study, entitled "Cost-Benefit Analysis and Resource Implications of Endoscopy Ultrasound-guided Confocal Endomicroscopy in Pancreas Cysts" and published in Techniques and Innovations in Gastrointestinal Endoscopy (TIGE) (DOI: https://doi.org/10.1016/j.tige.2021.10.002), aims to assess the impact of the proven diagnostic accuracy of EUS-guided needle-based confocal laser endomicroscopy (EUS-nCLE) for PCLs on healthcare expenditure when added to the standard of care (SOC) management.
Via a post-hoc analysis of 93 patients enrolled in the INDEX study (NCT02516488), the authors conclude that the diagnostic accuracy of EUS-nCLE resulted in the successful downstaging from mucinous to non-mucinous of 12% of patients, sparing them an unnecessary surgery. As a result, the authors underscored that, "EUS-nCLE is potentially cost-beneficial in the management of PCLs by preventing at least one unnecessary pancreatic surgery for every ten subjects undergoing evaluation by current practices." In addition, EUS-nCLE was responsible for the successful upstaging of 1 patient, allowing earlier and more precise intervention compared to a long-term surveillance program. Across all concordant and discordant diagnoses, the addition of Cellvizio led to a fully burdened net savings of $442,438 for this cohort, or approximately $4,757 per patient.
The authors further concluded that, "when combined with favorable data regarding higher diagnostic accuracy, potential to risk stratify the most common precancerous cystic neoplasms, intraductal papillary mucinous neoplasms (IPMNs), and no higher-than-expected risk of postprocedural adverse events, the current economic analysis favors the application of EUS-nCLE in diagnostic algorithms."
"As we recognize Pancreatic Cancer Awareness Month and the need to provide better diagnostic tools for physicians and their patients for the management of pancreatic cysts, it is important that we also understand the cost burden on the healthcare system of accurately classifying these lesions." said Robert L. Gershon, Chief Executive Officer of Mauna Kea Technologies. "This additional evidence demonstrates that real-time in vivo cellular imaging with Cellvizio has a material impact on patient management while providing significant healthcare cost savings. We look forward to broadening the access to Cellvizio in PCL centers to meet this critical clinical and economic need."
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.
This press release contains forward-looking statements concerning Mauna Kea Technologies and its activities. All statements other than statements of historical fact included in this press release, including, without limitation, those regarding Mauna Kea Technologies’ financial condition, business, strategies, plans and objectives of management for future operations are forward-looking statements. 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 Chapter 3 of the 2020 Universal Registration Document of Mauna Kea Technologies registered by the French Financial Markets Authority (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, which are both available on the Company's website (www.maunakeatech.com), and risks relating the 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 jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. The distribution of this document may, in certain jurisdictions, be restricted by local regulations. Persons who come into possession of this document are required to observe all applicable local regulations relating to this document.
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