Mauna Kea Technologies Receives FDA Clearance For Next-Generation Cellvizio® System
The New Cellvizio® 100 Series Is Now Available in the US; The Cellvizio 100 Series Includes Significant Improvements and New Features
Paris --(Marketwire) - Mauna Kea Technologies (EURONEXT PARIS: MKEA), leader in the endomicroscopy market, announced today that it has just obtained 510(k) clearance (N° K111047) from the U.S. Food and Drug Administration (FDA) to market the next-generation endomicroscopy system for the GI and pulmonary tracts, called the Cellvizio® 100 Series. Launched in Europe after obtaining the CE mark in April 2011, the Cellvizio 100 Series is now ready to be released in the United States.
"We are proud to announce the market release of the Cellvizio 100 Series in the USA," said Sacha Loiseau, CEO and Founder of Mauna Kea Technologies. "Based on the feedback from our current user base, we have made significant improvements to help physicians integrate Cellvizio into their endoscopy suites. These new features greatly improve endomicroscopic image acquisition and interpretation. As announced during our Initial Public Offering in July 2011, this market release is a major milestone and achievement for us and demonstrates our continued commitment to innovation in the endomicroscopy market."
Used mainly in gastroenterology applications, Cellvizio provides physicians with real-time microscopic images of tissue inside the body. The images facilitate the diagnosis and surveillance of patients, improving the detection of pre-cancerous lesions and helping physicians make immediate treatment decisions for their patients.
The Cellvizio 100 Series incorporates key upgrades including enhanced image quality and a "Cine Review" feature that allows physicians to focus on a single frame of clinical evidence for as long as necessary. Other features include an improved user interface, faster start up and shut down times, and data exchange allowing images to be exported to patient's medical files with ease.
About Mauna Kea Technologies
Mauna Kea Technologies is a global medical device company and leader in the endomicroscopy market. The company researches, develops and markets innovative tools to visualize and detect abnormalities in the gastro-intestinal and pulmonary tracts. 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, multi-center 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 in the GI and pulmonary tracts.
For more information about Mauna Kea Technologies visit www.maunakeatech.com
This press release and the information contained herein do not constitute an offer to sell or subscribe to, or a solicitation of an offer to buy or subscribe to, shares in Mauna Kea Technologies ("the Company") in any country. This press release contains forward-looking statements that relate to the Company's objectives. Such forward-looking statements are based solely on the current expectations and assumptions of the Company's management and involve risk and uncertainties. Potential risks and uncertainties include, without limitation, whether the Company will be successful in implementing its strategies, whether there will be continued growth in the relevant market and demand for the Company's products, new products or technological developments introduced by competitors, and risks associated with managing growth. Unfavorable developments in connection with these and other risks and uncertainties described, in particular, in the Company's prospectus prepared in connection with its IPO and on which the French Autorité des marches financiers ("AMF") granted its visa number 11-236 on June 230, 2011, could cause the Company to fail to achieve the objectives expressed by the forward-looking statements above.
SOURCE: Mauna Kea Technologies