PARIS--(BUSINESS WIRE)--
Regulatory News:
Mauna Kea Technologies (Euronext: MKEA, OTCQX: MKEAY) (Paris:MKEA) (OTCQX:MKEAY) inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy (CLE) platform, today announced that it has received its 14th U.S. Food and Drug Administration (FDA) 510(k) clearance for the Cellvizio® 100 series and all of its Confocal Miniprobes™. FDA agreed that data from multiple peer-reviewed medical journals validate the technology’s ability to image the internal microstructure of tissues including, but not limited to, the identification of cells and vessels and their organization or architecture. The addition of the indications for: “identification of cells and vessels and their organization or architecture” to the previously cleared intended use (the fields of gastroenterology1, urology2 and pulmonology3 during endoscopic, laparoscopic manual and robot-assisted surgical, and image-guided percutaneous procedures), represents a pivotal milestone for in vivo real-time microscopic visualization technology.
“With this new clearance, Cellvizio is affirmed as the only platform for imaging and identification at the cellular and micro-vascular level during a wide variety of procedures in endoscopy and surgery,” said Sacha Loiseau, Ph.D., Founder and Chief Executive Officer of Mauna Kea Technologies. “This milestone enables us to formally shift from imaging to identification, providing us with strong leverage to broaden adoption by healthcare providers and payers.”
This new clearance builds on the recent executive summary published by the College of American Pathologists (CAP) which highlighted the potential value of in vivo microscopy (IVM). The summary noted that “the architectural and cellular patterns generated by IVM are interpretable by pathologists to make differential diagnoses and to identify areas for biopsy, improving diagnostic yield. Such directed biopsies decrease sampling errors resulting in fewer, less frequent biopsies, significantly decreased morbidity, and significant cost saving […]”4.
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
Disclaimer
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.
1 Wallace, M., Lauwers, G., Chen, Y., Dekker, E., Fockens,
P., Sharma, P., & Meining, A. (2011). Miami classification for
probe-based confocal laser endomicroscopy. Endoscopy, 43(10),
882–891. https://doi.org/10.1055/s-0030-1256632
2
Chen, S. P., & Liao, J. C. (2014). Confocal Laser Endomicroscopy of
Bladder and Upper Tract Urothelial Carcinoma: A New Era of Optical
Diagnosis? Current Urology Reports, 15(9). https://doi.org/10.1007/s11934-014-0437-y
3
Thiberville, L., Salaun, M., Lachkar, S., Dominique, S., Moreno-Swirc,
S., Vever-Bizet, C., & Bourg-Heckly, G. (2009). Human in vivo
fluorescence microimaging of the alveolar ducts and sacs during
bronchoscopy. European Respiratory Journal, 33(5),
974–985. https://doi.org/10.1183/09031936.00083708
4
http://www.cap.org/ShowProperty?nodePath=/UCMCon/Contribution%20Folders/WebContent/pdf/in-vivo-executive-summary.pdf
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