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News - Cellvizio - Nov 30, 2016

PERSEE Study demonstrates applicability of Cellvizio in surgical interventions for digestive cancers, triggering milestone payment from BpiFrance

Results from PERSEE Study Published in Surgical Endoscopy and European Journal of Gastroenterology & Hepatology

Mauna Kea Technologies receives milestone payment of €626,000 from BpiFrance

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.”