Mauna Kea Technologies: Major Success for Cellvizio at the EUS 2014 Conference

Regulatory News:

Mauna Kea Technologies (Paris:MKEA) (NYSE Euronext: MKEA, FR0010609263), inventor of Cellvizio^®, the only trans-disciplinary optical biopsy platform, today announced that Cellvizio's clinical value for the management of patients with pancreatic cysts was widely disseminated to the international medical community during the EUS 2014 conference that took place in Chennai, India, from September 18 to 20^th.

During this conference focused on the use of endoscopic ultra-sound, several world experts – Dr Bertrand Napoléon (Hôpital Privé Jean Mermoz, France), Dr Laurent Palazzo (Clinique du Trocadero, France), Dr Pierre Deprez (Cliniques Universitaires St Luc, Belgium), Dr Kenneth Chang (University of California Irvine, USA) – each presented how using Cellvizio optical biopsy during fine-needle aspiration procedures can represent a breakthrough for the management of patients with pancreatic cysts.

The use of Cellvizio's AQ-Flex 19 miniprobe was then demonstrated during two live medical cases, performed by Dr Napoléon and Dr Chang. During the second case performed on a patient with an indeterminate pancreatic cyst, images now proven to predict the benign nature of a cyst, according to clinical study results about to be published, immediately appeared when the probe was positioned inside the cyst. Physicians could then confidently determine that the cyst was benign, thus potentially avoiding an unnecessary surgical resection.

"Thanks to high quality clinical data obtained from several centers in France and the United-States, we now feel confident that images obtained with Cellvizio in certain pancreatic cysts provide us with the key missing information we needed to make the right therapeutic decision,” declared Dr Bertrand Napoléon, Chief of Gastro-intestinal Endoscopy at Hôpital Jean Mermoz and member of the Program Committee of the EUS 2014 conference. "We have already modified our management for patients with these types of cysts and have considerably reduced the number of associated unnecessary surgeries, which means more efficient patient care and a reduction of surgical comorbidities for our patients.”

About Mauna Kea Technologies

Mauna Kea Technologies is a global medical device company focused on leading innovation in endomicroscopy and optical biopsy. The company designs, develops and markets innovative tools to visualize and detect cell abnormalities in real time during standard gastrointestinal and pulmonary endoscopy procedures. The company’s flagship product, Cellvizio®, a probe-based Confocal Laser Endomicroscopy (pCLE) system, provides physicians and researchers with high-resolution cellular imaging of internal tissues. Large-scale, international, multi-center clinical trials have demonstrated Cellvizio's ability to help physicians to more accurately detect early forms of diseases and make immediate treatment decisions. Designed to help physicians in their diagnoses, provide patients with better treatment and reduce hospital costs, the Cellvizio system can be used with practically all endoscopes. Cellvizio has 510(k) clearance from the United States Food and Drug Administration and CE Marking in the European Union for use in the gastrointestinal tract and the urinary and respiratory systems, for endoscopic exploration of the biliary and pancreatic ducts, and for fine-needle aspiration procedures. Cellvizio also obtained SFDA regulatory approval in China and MHLW approval in Japan. For further information on Mauna Kea Technologies, visit www.maunakeatech.com