PARIS & CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Regulatory News:
Mauna Kea Technologies (Paris:MKEA) (Euronext: MKEA, OTCQX: MKEAY) inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy platform, today announced that the first results from the PERSEE Study examining the use of Cellvizio in digestive surgery were published in Surgical Endoscopy and European Journal of Gastroenterology & Hepatology.
The two scientific publications report on outcomes of 30 consecutive patients that underwent digestive surgery at the Institut Mutualiste Montsouris (IMM) in Paris, France between 2014 and 2015. During the surgeries, Cellvizio provided ex-vivo images of excised lesions that were analyzed by surgeons, pathologists and physicists and compared to histology standard of care. Diagnosis was complete using both traditional and new remote digital pathology methods.
To distinguish between normal and cancerous tissue, several factors were assessed including completeness of response to chemotherapy in the liver1 and the differentiation of peritoneal nodules2. Both studies demonstrate excellent sensitivity, specificity, and positive and negative predictive values to detect malignant lesions. Overall, sensitivity ranges from 75% to 100% and specificity ranges from 89% to 100%3.
“These results add to the growing evidence that the Cellvizio platform can help surgeons make appropriate real-time decisions and eliminate uncertainties during procedures,” said Brice Gayet, Professor of Digestive Surgery at Institut Mutualiste Montsouris. “In addition, for the first time my team used remote collaboration through live streaming techniques, enabling communication from multiple locations and better informed decision making.”
Sacha Loiseau, Ph.D., Founder and Chief Executive Officer of Mauna Kea Technologies, added, “The PERSEE study confirms that Cellvizio can add significant value in cancer surgeries, by bringing the same proven accuracy level in tissue characterization obtained in other indications and helping confirm surgical margins in real-time. As the body of clinical evidence grows in surgical procedures, we hope to see an acceleration of Cellvizio adoption, not only as a stand-alone technology but also integrated into other surgical platforms.”
Dr. Loiseau added, “These results represent a key step in the ongoing development of the PERSEE program. The milestone payment from BpiFrance will fund the fourth phase of the program, which will extend the clinical evidence and support technical innovation applied to surgical indications for the Cellvizio platform.”
About the PERSEE project
The PERSEE project was awarded 7.6 million euros in April 2010 from OSEO (now BpiFrance) in order to develop a robotized, miniature, flexible endomicroscope for the minimally invasive exploration of the abdominal cavity. Mauna Kea Technologies is the leader of this collaborative project along with EndoControl, a developer of robotic solutions to assist surgeons and physicians, the Institut des Systèmes Intelligents et de Robotique (ISIR) at the Université Pierre et Marie Curie, the digestive diseases department of the Institut Mutualiste Montsouris (IMM) and the departments of Cellular Imaging, Gastroenterology and Pathobiology of the Institut de Cancérologie Gustave Roussy (IGR).
1 Angelo Pierangelo, Pierre Validire, Ali Benali, David Fuks
and Brice Gayet - “Diagnostic accuracy of confocal laser endomicroscopy
for the characterization of liver nodules”, European Journal of
Gastroenterology & Hepatology, 2016.
2 Angelo
Pierangelo, David Fuks , Ali Benali, Pierre Validire and Brice Gayet -
“Diagnostic accuracy of confocal laser endomicroscopy for the ex vivo
characterization of peritoneal nodules during laparoscopic surgery”,
Surgical Endoscopy, 2016.
3 Full results included
overall sensitivity, specificity, and positive and negative predictive
values to detect malignant peritoneal nodules were 75%, 100%, 100% and
89 %, respectively. For the detection of malignant liver nodules, the
diagnostic performance of surgeon and the pathologist, Cellvizio
demonstrated, 78% and 100% sensitivity, 100% and 89% specificity, 90%
and 100% positive predictive value, and 90% and 100% negative predictive
value.
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 June 13, 2016 under number R.16-054 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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