Mauna Kea Technologies : CE Mark for a Complete Range of Probes Dedicated to Urology

Regulatory News :

Mauna Kea Technologies (Paris:MKEA) (NYSE Euronext: MKEA, FR0010609263), leader in the optical biopsy market and maker of Cellvizio, the fastest way to see cancer, today announced the granting of the CE Mark and the pre-launch of a comprehensive range of probes aimed at endourological applications, to coincide with its first participation in the 107^th French annual congress of Urology, that brings together more than 2,000 practitioners.

This range of probes will provide access to the flexible cystoscopy, rigid cystoscopy and ureteroscopy (CystoFlex™, CystoFlex UHD™ and UroFlex™ probes respectively) procedures market. Mauna Kea Technologies will focus its development on tumors of the bladder and the upper urinary tract, accessible by endoscopy and mainly affecting people over 50. The conventional procedure to treat these types of tumor involves an initial endoscopic examination to detect bladder lesions (flexible cystoscopy procedure) and resection them (rigid cystoscopy procedure), before sending analyses to a laboratory, to gauge their aggressiveness and to distinguish superficial forms and infiltrating tumors requiring surgical resection.

"The introduction of this new technique in France raises significant interest in our specialty. Indeed, bladder cancer has a recurrence rate of about 70%, which requires patients to be monitored throughout the rest of their lives and undergo frequent further treatments, making it the most expensive cancer to manage”, comments Dr. Patrick Coloby, President of the Association Française d'Urologie. "Optical biopsy would enable us to better guide and control our interventions during these procedures.”

Sacha Loiseau, Founder and CEO of Mauna Kea Technologies, declares: "This announcement follows the recent presentation of further major clinical results in the United States concerning the use of Cellvizio in urology. Given the proven medical need and a substantial demand from the medical community for an improvement in urology procedures, we are confident in the clinical value that these new probes will provide in the treatment of bladder cancer and several new clinical studies will be conducted to provide supporting data. The market opportunity in urology is considerable and the Cellvizio Optical Biopsy platform, which now includes the EVA operating system and a range of miniprobes specifically designed for urology applications, is ideally positioned to address it.”

Prof. Young Deuk Choi, Director of the Severance Robot & MIS Center at Severance Hospital of Yonsei University, Korea, has just launched a study on some one hundred patients aimed at assessing the efficiency of optical biopsy by Cellvizio in characterizing bladder tumors and said: "We are delighted to be among the pioneers to validate Cellvizio for urology applications".

Cellvizio is the only Optical Biopsy system that can be used for numerous indications and that allows medical staff to assess tissue microscopically with no invasiveness and no limit on the number of optical "examinations” carried out. Use of the Cellvizio in urology is already authorized in Europe and is pending FDA clearance in the United States. The CystoFlex UHD™ mini probe that has just been granted CE Mark completes the existing range of probes and opens the way for urological use in operating theaters.

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 in the GI tract, biliary and pancreatic ducts and lungs and during fine needle aspiration procedures.

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