PARIS & BOSTON--(BUSINESS WIRE)--Regulatory News:
Mauna Kea Technologies (Paris:MKEA) (OTCQX:MKEAY) (Euronext: MKEA, OTCQX: MKEAY) inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy (CLE) platform, today announced that Cook Medical’s Urology division has formally announced the global commercial launch of a private-labeled version of Cellvizio (click here) under a strategic partnership announced by the two companies in December 2015. Cook Medical is a world leader in medical devices and supplies.
Urology represents a significant new market opportunity for Cellvizio, which can be used in a variety of urological applications, including endoscopic procedures for the characterization of tissue microstructures, including urethra, bladder and ureter. The Cook commercial launch is expected to benefit from a June 2017 study published by the European Association of Urology evaluating the effectiveness of Cellvizio in the characterizing of upper tract urothelial carcinoma (UTUC) lesions and identifying Cellvizio as an effective tool for the real-time characterization upper urinary tract cancer.
This commercial launch is also expected to benefit from the recently announced FDA 510(k) clearance of the CelioFlex™ UHD Confocal Miniprobes™ for use of Cellvizio in robotic-assisted surgery procedures. An estimated 100,000 robotic-assisted, radical prostatectomy surgical procedures are performed annually in the U.S.
Sacha Loiseau, Ph.D., Founder and Chief Executive Officer of Mauna Kea Technologies, commented, “We are pleased that our partners at Cook Medical have continued to invest in this collaboration and welcome the opportunity to increase clinical awareness within the urology community of Cellvizio’s capacity to improve patient outcomes through real-time microscopic imaging. We view urology as an important illustration of Mauna Kea’s ongoing strategy to partner with leading healthcare organizations to accelerate the global commercialization of Cellvizio in a variety of clinical applications.”
About Mauna Kea Technologies
Mauna Kea Technologies is a global medical device company focused on eliminating uncertainties related to the diagnosis and treatment of cancer and other diseases thanks to real time in vivo microscopic visualization. The Company’s flagship product, Cellvizio, has received clearance to sell a wide range of applications in more than 40 countries, including the United States, Europe, Japan, China, Canada, Brazil and Mexico. For more information on Mauna Kea Technologies, visit www.maunakeatech.com
This press release contains forward-looking statements concerning Mauna Kea Technologies and its activities. Such forward looking statements are based on assumptions that Mauna Kea Technologies considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward- looking statements are subject to numerous risks and uncertainties including the risks set forth in the registration document of Mauna Kea Technologies registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on June 13, 2016 under number R.16-054 and available on the Company's website (www.maunakeatech.com), and to the development of economic situation, financial markets, and the markets in which Mauna Kea Technologies operates. The forward-looking statements contained in this release are also subject to risks unknown to Mauna Kea Technologies or that Mauna Kea Technologies does not consider material at this time. The realization of all or part of these risks could lead to actual results, financial conditions, performances or achievements by Mauna Kea Technologies that differ significantly from the results, financial conditions, performances or achievements expressed in such forward-looking statements. This press release and the information it contains do not constitute an offer to sell or to subscribe for, or a solicitation of an order to purchase or subscribe for, Mauna Kea Technologies shares in any country.