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 it has received U.S. Food and Drug Administration (FDA) 510(k) clearance of the Cellvizio® 100 series F400 and F800 with a new Confocal Miniprobe™, the CranioFlex™, to be used during neurosurgical procedures. This marks the 15th U.S. FDA 510(k) clearance of Cellvizio® and the first-ever FDA clearance for CLE applications in neurosurgery.
The Cellvizio® 100 with the CranioFlex™ provides imaging of tissue internal microstructures and allows the identification of cells and vessels and their organization within the central nervous system during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection. The Cellvizio 100 series F400 model operates at 488 nm and the F800 model at 800 nm, two highly relevant wavelengths commonly used during brain surgery for imaging and navigation.
“This is an important regulatory and business milestone for the Company, opening new avenues for market development and strategic partnerships,” said Sacha Loiseau, Ph.D., Founder and Chief Executive Officer of Mauna Kea Technologies. “It also unlocks a new era in neurosurgery, paving the way toward more precise resection of brain and spinal tumors. Cellvizio® is now the first to market endomicroscopic visualization platform providing neurosurgeons for the first time the ability to perform real-time optical biopsies to help determine, for instance, if the tumor is completely excised. This clearance builds on many years of clinical development and is happening at a time when the neurosurgery community recognizes the potential benefits of real-time digital visualization of nervous system tissue microstructures.”
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/approval in 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 April 27, 2018 under number R.18-0429 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.