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TMCNet:  Mauna Kea Technologies Installs First Three Cellvizio Systems and Obtains Key Regulatory Clearances in Brazil

[March 31, 2014]

Mauna Kea Technologies Installs First Three Cellvizio Systems and Obtains Key Regulatory Clearances in Brazil

PARIS --(Business Wire)--

Regulatory News:

Mauna Kea Technologies (Euronext: MKEA, FR0010609263), leader in the Optical Biopsy market, announced today that its flagship Cellvizio system is or will soon be available at three leading hospitals in Brazil: ICESP (Cancer Institute of the São Paulo University), INCA (National Cancer Institute in Rio de Janeiro), and FUGAST (Gastroenterology Institute of Rio Grande do Sul). In addition, ANVISA, the National Health Surveillance Agency in Brazil, has cleared the company to sell its flagship miniprobe for direct pancreatic cyst imaging, the AQ-Flex 19, as well as its first miniprobe for urology, the UroFlex and its latest Optical Biopsy software platform, EVA, the Endomicroscopy Virtual Assistant.

"Cellvizio is a critical addition to our endoscopy unit", said Dr Fauze Maluf-Filho, Chief of Endoscopy at the Cancer Institute of the São Paulo University, "We are very pleased to be one of the first hospitals in Brazil to offer Optical Biopsy procedures to our patients who suffer from a range of digestive diseases, including very hard to diagnose pancreatic cysts".

Brazil is a fast-growing market for medical devices, and there is a significant need for advanced technologies improving patient care. The Cellvizio technology platform supports the efforts of state-of-the-art hospitals across Brazil to offer best practice solutions in the treatment of a wide range of pathologies and associated procedures.

"We were the first t demonstrate Cellvizio in Brazil at our 2012 ENEO/ENDOINCA international training course", commented Dr Simone Guaraldi from the National Cancer Institute in Rio de Janeiro, "and we are very excited to continue to be at the forefront of patient care with the addition of Cellvizio to our state-of-the-art endoscopy unit".


"I am convinced that Cellvizio will bring a major value to our Gastroenterology Center - and I am particularly pleased to offer Optical Biopsy to our patients in Rio Grande do Sul in the same timing as Rio de Janeiro and Sao Paulo" said Dr Claudio Rolim Teixeira, from the Gastroenterology Institute of Rio Grande do Sul - FUGAST.

Sacha Loiseau, CEO and founder of Mauna Kea Technologies, added: "With three centers of excellence providing care with Cellvizio and our full range of products now cleared, we are continuing to make significant progress in bringing the advantages of our technology to patients in the fast-growing Brazil and in other markets throughout Latin America."

Mauna Kea Technologies confirms that it is eligible for the new PEA-PME SME equity savings plan setup whose implementing decree was published in the Journal Officiel (official journal) on 4 March 2014 (decree n°2014-283). This new savings device, which benefits from the same fiscal advantages as the PEA equity savings plan, must consist of at least 75% of SME and VSE securities, including 50% in shares, and has a ceiling of €75,000.

About Mauna Kea Technologies

Mauna Kea Technologies is a global medical device company dedicated to the advent of optical biopsy. The company researches, develops and markets innovative tools to visualize and detect cellular abnormalities during endoscopic procedures. Its flagship product, Cellvizio®, a probe-based Confocal Laser Endomicroscopy (pCLE) system, provides physicians and researchers high-resolution cellular views of tissue inside the body. Large, international, multicenter clinical trials have demonstrated Cellvizio's ability to help physicians more accurately detect early forms of disease and make treatment decisions immediately. Designed to improve patient outcomes and reduce costs within a hospital, Cellvizio can be used with almost any endoscope. Cellvizio has 510(k) clearance from the U.S. Food and Drug Administration and the European CE-Mark for use during digestive, pulmonary and urologic endoscopy procedures, including pancreatic and biliary endoscopic explorations as well as fine needle aspiration procedures.

For more information on Mauna Kea Technologies, visit www.maunakeatech.com


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