Mauna Kea Technologies Announces That Its CONTACT 2 Pivotal Trial in Pancreatic Cysts Has Met Primary and Secondary Endpoints Demonstrating Cellvizio’s Significantly Higher Diagnostic Performance Compared to the Current Standard of Care

Regulatory News:

Mauna Kea Technologies (Paris:MKEA) (OTCQX:MKEAY) inventor of Cellvizio, the multidisciplinary probe-based and needle-based confocal laser endomicroscopy (pCLE/nCLE) platform, today announced results from the large, prospective, multi-center validation CONTACT 2 study that met its primary and secondary endpoints, demonstrating significantly higher diagnostic performance of nCLE with Cellvizio compared to standard of care methods in patients with pancreatic cyst lesions (PCLs). The findings were published in the article Needle-based confocal laser endomicroscopy of pancreatic cystic lesions: a prospective multicenter validation study in patients with definite diagnosis in the peer-reviewed publication Endoscopy.

Bertrand Napoleon, M.D., Department of Gastroenterology at the Jean Mermoz Private Hospital in Lyon, France and first author of the study, commented, Current methods of EUS and CEA have limited diagnostic yield and accuracy and are often associated with unnecessary repeated follow-up procedures or surgery, which have important consequences both for patients and healthcare systems. Our study demonstrated very high sensitivity and specificity of nCLE criteria for accurately diagnosing single, non-communicating, pancreatic cystic tumors, concluding that the routine addition of nCLE to standard EUS-FNA procedures has the potential to positively impact patient management and provides significant economic benefits for patients and hospitals. We look forward to providing further results on Cellvizios patient management impact in the near future.

Robert L. Gershon, CEO of Mauna Kea Technologies, said, The results of this large prospective clinical trial illustrate our mission to eliminate diagnostic and treatment uncertainties for healthcare teams and patients. This study reinforces the growing body of evidence on the clinical advantages of Cellvizio in pancreatic cystic lesions to improve diagnostic yield and accuracy. We have now clearly demonstrated that Cellvizio surpasses the existing standard of care and is improving outcomes for patients while maintaining safety.

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The CONTACT 2 study enrolled 217 patients at five centers in France to evaluate Cellvizio diagnostic performance using surgical histopathology or endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) cytohistopathology as the gold standard. Of eligible participants, 206 patients underwent Cellvizio on single, noncommunicating PCLs as incidentally identified by CT or MRI scans.

Results exceed the previously reported performance of Cellvizio in PCLs, key results include:

  • Cellvizio nCLE was the most efficient method for determining the diagnosis of PCLs compared to CEA and EUS.
  • Sensitivities and specificities of Cellvizio for the diagnosis of serous cystadenoma, mucinous PCL, and premalignant PCL were all greater than 95%.
  • Perfect specificities (100%) were confirmed for benign serous cystadenomas and for the overall group of mucinous lesions.
  • 1.3 percent of patients suffered from acute pancreatitis which is similar to standard EUS-FNA procedures.
  • The mean Cellvizio procedure duration was decreased, likely due to the learning curve.
  • In a subgroup of 23 patients who had undergone an inconclusive EUS-FNA procedure in the past, Cellvizio was conclusive in 91% of patients (21 of 23) and established a correct diagnosis in 100% of them (21 of 21).
  • 4.5% of patients with confirmed serous cystadenomas (1 of 22) underwent surgical resection due to diagnostic uncertainty, compared to the 36% on average who undergo this unnecessary resection due to diagnostic uncertainty; confirming the cost-effectiveness of Cellvizio.

About Mauna Kea Technologies Mauna Kea Technologies is a global medical device company focused on eliminating uncertainties related to the diagnosis and treatment of cancer and other diseases thanks to real-time in vivo microscopic visualization. The Companys flagship product, Cellvizio, has received clearance to sell a wide range of applications in more than 40 countries, including the United States, Europe, Japan, China, South Korea, Canada, Brazil and Mexico. For more information on Mauna Kea Technologies, 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 statements are subject to numerous risks and uncertainties including the risks set forth in the registration document of Mauna Kea Technologies registered by the French Financial Markets Authority (Autorit des marchs financiers (AMF)) on April 27, 2018 under number R.18-0429 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.

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