PARIS, October 27,2015 /PRNewswire/ --
MAUNA KEA TECHNOLOGIES AWARDED U.S. FDA CLEARANCE
FOR USE OF CELLVIZIO IN MINIMALLY INVASIVE SURGERY
510(k) clearance supports use of Cellvizio endomicroscopy platform during a range of surgical procedures to treat many types of cancer
New cleared indications reinforce Cellvizio in the new strategic partnership framework
Mauna Kea Technologies (Euronext: MKEA, FR0010609263, PEA-PME eligible), inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy platform, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use of Cellvizio® in surgery. Using Cellvizio, surgeons can have a real time microscopic image of tissue during a surgical procedure to be able to identify cancerous tissue and guide treatment during surgery. The clearance positions Cellvizio for potential use in millions of cancer surgeries performed each year.
"This is a historic regulatory and business milestone for Mauna Kea Technologies that will have a strong impact on the value of our proprietary endomicroscopy technology," declared Sacha Loiseau, founder and CEO of Mauna Kea Technologies. "This is the first clearance for this technology in surgery in the United-States, making it possible for surgeries to be performed with real-time visualization of tissues at the microscopic level, enabling a new level of precision and confirmation for surgeons."
In image guided cancer surgery, the Celioflex® probe can be delivered endoscopically or laparoscopically through a trocar and manipulated in the surgical field with standard laparoscopic hand-held instruments. With precise real-time visualization of tissue during surgery, surgeons may be better able to confirm the absence or presence of metastasis that may not be visible using preoperative imaging. Cellvizio also could make it easier to identify the extent of tumor margins and evaluate appropriate responses to treatment. In resection surgery, Cellvizio could enhance the ability to define the safety margin and improved surgical planning. In addition, pathologists could also benefit from improved frozen section sampling by better targeting of malignant lesions.
"Earlier in October we announced our marketing strategy based on development of new partnerships positioned to incorporate Cellvizio into their established platforms. This FDA clearance positions our imaging technology for use with potentially millions of new patients each year, representing a significant value proposition for our partners in the years ahead," Sacha Loiseau added.
Cellvizio is currently being studied in several major clinical studies in surgical treatment of cancer.
About Mauna Kea Technologies
Mauna Kea Technologies is a global medical device company focused on protecting patients' lives while enabling physicians and surgeons to make better decisions thanks to direct visualization at the cellular level. 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 http://www.maunakeatech.com
Mauna Kea Technologies France and Europe United States
Eric Cohen NewCap - Investor Relations Berry & Company
Vice President Finance Florent Alba/Pierre Laurent Public Relations
Tel: +33(0)1-70-08-09-70 Tel: +33(0)1-44-71-94-94 Bill Berry
investor-vpf@maunakeatech.com maunakea@newcap.fr Tel: +1-212-253-8881 bberry@berrypr.com
This is a disclosure announcement from PR Newswire.