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 platform, today announced that it has received CE Mark for its CelioFlex™ UHD Confocal Miniprobes™ for use with Cellvizio in robotic-assisted surgery procedures. The Company announced in August 2017 that it received United States Food and Drug Administration (FDA) 510(k) clearance for the same indication. The intended use of CelioFlex UHD Confocal Miniprobes is to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robotic-assisted procedures.
Robotic-assisted surgery allows doctors to perform many types of complex procedures with greater precision, flexibility and control than is possible with conventional techniques. There are more than 700 Da Vinci robotic surgical systems installed in Europe, with more than 100,000 robotic-assisted procedures performed on these systems in 20161.
Sacha Loiseau, Ph.D., Founder and Chief Executive Officer of Mauna Kea Technologies, added, “This new CE Mark is a key regulatory and product milestone for the company, building on years of development and efforts to adapt its unique endomicroscopy platform to a wide variety of clinical settings. This includes surgical robotics, which is the fastest growing segment in surgery. This demonstrates our ability to strengthening Cellvizio’s value proposition to expand its addressable market opportunity, such as with our worldwide commercial partner in urology, Cook Medical. Following the recent FDA clearance for the same robotic-assisted procedure indication in the U.S, we have received positive feedback from and we look forward to advancing Cellvizio in this application in Europe.”
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 May 31, 2017 under number D.17-0574 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.
1 Intuitive Surgical Q3 2017 investor presentation