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Press Release

Mauna Kea Technologies: New CONTACT Study Analysis Demonstrates Cellvizio’s Ability to Improve the Management of Patients with Pancreatic Cysts

Mauna Kea Technologies
Posted on: 30 Oct 17

Regulatory News:

Mauna Kea Technologies (Paris:MKEA) (OTCQX:MKEAY) (Euronext: MKEA, OTCQX: MKEAY) inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy platform, today announced that Cellvizio was featured in several presentations at the United European Gastroenterology Week (UEGW) 2017 meeting, including a late-breaking presentation of new data from the CONTACT study of Cellvizio for the diagnosis of pancreatic cysts. The UEGW meeting takes place from October 28 to November 1, 2017 in Barcelona, Spain, and is hosted by the United European Gastroenterology (UEG), a professional non-profit organization combining all the leading European societies concerned with digestive health, with a cumulative membership of over 22,000 specialists working across medicine, surgery, pediatrics, GI oncology and endoscopy.

In the late-breaking session, Dr. Bertrand Napoleon presented today additional analysis from the CONTACT Study, entitled “Needle-based confocal laser endomicroscopy: the impact on diagnosis and management of pancreatic cystic lesions,” which enrolled 217 patients at 5 hospitals and clinics in France. This analysis builds on results published two years ago in Endoscopy and which was among the 3 most cited articles of the journal in 2016. Key highlights from the presentation showed that the use of Cellvizio:

  • Changed 30% of diagnoses, while significantly improving diagnostic inter-observer agreement from 0.45 to 0.76, increasing high confidence diagnoses from 57% to 79%.
  • Changed 28% of the patient management strategies, while significantly improving inter-observer agreement on these strategies from 0.36 to 0.64.
  • Prevented 42% of the patients with benign cysts from any surveillance and reversed the choice between surveillance and surgery in 15% of the pre-malignant lesions.

Dr. Napoleon, commenting on the new CONTACT Study analysis, said, “Previous results from the CONTACT study already validated the very high sensitivity and specificity of endomicroscopy for the diagnosis pancreatic cystic lesions, which remained until now a major diagnostic issue for clinicians. With these new data from the CONTACT study, we have shown that the use of Cellvizio allows clinicians to alter, with a high confidence level, their treatment decisions. Overall, these results from the CONTACT study continue to support the recognition of endomicroscopy as an integral part of the standard of care in patients with pancreatic cystic lesions.”

In addition, Cellvizio was highlighted in two podium presentations at UEGW 2017 (all times are CEST):

  • Monday, October 30 from 11:36 – 11:48 am – C. Robles-Medranda and H. Pitanga-Lukashok made an oral presentation titled “In vivo detection of colonic mucosa micro-inflammation by confocal laser endomicroscopy probe (p-CLE) in patients with Irritable Bowel Syndrome.”
  • Monday, October 30 from 2:24 – 2:36 pm – G.E. Tontini and H. Neumann gave an oral presentation entitled “Prediction of clinical outcomes in Crohn’s disease by using confocal laser endomicroscopy: a prospective multicenter study.”

Sacha Loiseau, Ph.D., Founder and Chief Executive Officer of Mauna Kea Technologies, commented, “This year at UEGW we are highlighting the ability of needle-based confocal laser endomicroscopy with Cellvizio to address diagnostic uncertainties in pancreatic cysts, which is a well-known and hard-to-achieve medical challenge. This study demonstrates the potential benefit of using Cellvizio as a standard of care for this major application.”

Cellvizio will also be highlighted in two poster presentations at UEGW 2017:

  • Poster P0848 from 9:00 am – 5:00 pm on Tuesday, October 31 – “The role of probe confocal laser endomicroscopy with image enhanced endoscopy in characterisation and endoscopic resection of dysplastic lesions in inflammatory bowel disease patients.” Poster authors: M. Iacucci and S. Gosh.
  • Poster P1555 from 9:00 am – 5:00 pm on Wednesday, November 1 – “A pilot study of probe-based confocal laser endomicroscopy for computer-aided diagnosis of bile duct cancer by using the deep learning technology.” Poster authors: K. Furukawa and H. Hashidate.

Mauna Kea Technologies is exhibiting at Booth #89 at UEGW 2017 in Barcelona.

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 Company’s 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, 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. Forward- looking 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 (Autorité des marchés financiers (AMF)) on May 31, 2017 under number D.17-0574 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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20171030005847/en/

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Last updated on: 30/10/2017

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