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Mauna Kea Technologies Announces the Publication of a Study Confirming the Value of the Cellvizio(R) System in Colorectal Cancer Follow-Up


December 13, 2011 - PARIS

Mauna Kea Technologies (EURONEXT PARIS: MKEA), the leader in the endomicroscopy market, announced today the publication of a new study on Colorectal cancer in a leading medical journal, Gastrointestinal Endoscopy (GIE). The study results underline the value of Cellvizio®'s probe-based confocal laser endomicroscopy (pCLE) technology in the detection of residual neoplasia after colorectal endoscopic mucosal resection (EMR).

"The study adds to the growing body of clinical evidence demonstrating once again, the value of Cellvizio as an advanced imaging system which facilitates real-time diagnosis, follow-up and treatment," said Dr. Emmanuel Coron, Department of Gastroenterology and Hepatology, University Hospital of Nantes, France. "As physicians continue to advance the use of Cellvizio in the field of gastroenterology, growing numbers of investigators are using the system to provide enhanced visualization of potentially diseased tissue in the digestive and pulmonary systems including lungs, urinary tract and pancreas. Studies of the technology in various applications have already been featured in many publications of high-profile scientific journals -- including 30 in recent months."

In comparison to endoscopy alone, final study results demonstrate that the combination of Cellvizio's pCLE with virtual chromoendoscopy (VCE) following an EMR in the colon, can help:

  • physicians to decide during endoscopy procedures whether a patient requires re-treatment or not;
  • reduce the need for repeat follow-up colonoscopies and additional procedures;
  • reduce the need for additional histologic examinations (analysis of tissues taken from a biopsy, under a microscope).

The multicenter study was initiated by the Mayo Clinic in Jacksonville (FL, USA) and was conducted at three centers, including Nantes University Medical Center (Nantes, France). High-resolution colonoscopies were performed using pCLE and VCE to detect residual neoplasia in 129 previous EMR scars in 92 patients. The study results have now been published in GIE under the title "Diagnostic accuracy of probe-based Confocal Laser Endomicroscopy (pCLE) in detecting residual colorectal neoplasia after endoscopic mucosal resection (EMR)". (1)

Colorectal cancer
Colorectal cancer is a malignant tumor of the colonic or rectal mucosa. The colon and the rectum constitute the last section of the digestive tract (also referred to as the large intestine). It has been estimated that 60 to 80% of colorectal tumors develop from a benign tumors called polyps or adenomas. Out of 1,000 adenomas, an average of 100 will grow to a size of 1 cm and 25 will become cancerous. The adenoma-cancer transition takes place over a period of around ten years, on average. Colorectal is often initially asymptomatic and is sometimes diagnosed late - requiring the subsequent use of aggressive treatments. According to GLOBCAN, around 60% of cases were diagnosed in the developed world. It is estimated that, in 2008, 1.24 million new cases of colorectal cancer were clinically diagnosed, and that this type of cancer killed 610,000 people.

Cancer is a leading cause of death worldwide and accounted for 7.6 million deaths (around 13% of all deaths) in 2008 (2). The main types of cancer are: lung (1.4 million deaths); stomach (740 000 deaths); liver (700 000 deaths); colorectal (610 000 deaths) and breast (460 000 deaths). About 70% of all cancer deaths occurred in low- and middle-income countries. Deaths from cancer worldwide are projected to continue to rise to over 11 million in 2030.

About Mauna Kea Technologies
Mauna Kea Technologies is a global medical device company and a leader in endomicroscopic innovation. The company designs, develops and markets innovative tools to visualize and help detect abnormalities in the gastrointestinal and pulmonary tracts. Its flagship product (Cellvizio®, a probe-based confocal laser endomicroscopy (pCLE) system) provides physicians and researchers with 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 hospital costs, 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 gastrointestinal and pulmonary tracts.
For more information on Mauna Kea Technologies, visit www.maunakeatech.com

Disclaimer
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.

(1) Shahid, M. W., et al. (2011). Diagnostic accuracy of probe-based confocal laser endomicroscopy in detecting residual colorectal neoplasia after EMR: a prospective study. Gastrointest Endosc, Epub ahead of print. http://www.giejournal.org/article/S0016-5107%2811%2902106-7/abstract

(2) Latest worldwide number given by the World Health Organization

United States
Erich Sandoval
Lazar Partners Ltd.
Tel: +1 917 497 2867
esandoval@lazarpartners.com

France and Europe
ALIZE RP
Caroline Carmagnol
Tel: + 33 1 42 68 86 43 / + 33 6 64 18 99 59
caroline@alizerp.com
Anne-Sophie Cosquéric
Tel: + 33 1 42 68 86 41 / Anne-sophie@alizerp.com

Mauna Kea Technologies
Alexander Bryson
Marketing Communications and Brand Manager
Tel: +33 (0) 1 70 08 09 92
alexander@maunakeatech.com

NewCap
Investor Relations and Financial Communication
Pierre Laurent / Florent Alba
Tel: +33 1 44 71 94 94 / maunakea@newcap.fr

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