PARIS--(BUSINESS WIRE)--Sep 18, 2012--Regulatory News: Mauna Kea Technologies (NYSE Euronext: MKEA, FR0010609263), leader in the endomicroscopy market and developer of Cellvizio® imaging, the fastest way to see cancer, today announced the expansion of its program to investigate surgical applications of the technology. The company is collaborating with Professor Guy-Bernard Cadière, M.D., Ph.D., and colleagues at the Saint Pierre University Hospital in Brussels on the first large-scale clinical trial of an optical biopsy modality in surgery.
“Having access to cellular-level views that amount to real-time pathology during surgery could have an enormous impact on patient outcomes and overall healthcare costs,” Prof. Cadière, Chief of Gastrointestinal Surgery of Saint Pierre University Hospital, said. “When removing cancerous tumors from any location in the body, the primary goal for a surgeon is to completely eliminate all the malignant tissue, but this can be difficult without a clear view of cellular structures. So, we often remove excess surrounding tissue to overcompensate. As gastroenterologists have been doing for years, we expect to be able to examine the margins around tumors to ensure that we’ve removed all the dangerous tissue, while preserving as much healthy tissue as possible to help improve the patient’s survival and quality of life following surgery.” Prof. Cadière is a pioneer of advanced laparoscopic procedures, including the laparoscopic Nissen fundoplication, a treatment for gastroesophageal reflux disease (GERD). In 1997, he and his team were the first in the world to perform robotic surgery and he led the world’s first laparoscopic bariatric surgery in 1992.
The study will investigate the benefits of offering surgeons instantaneous microscopic images of target tissue during open and laparoscopic procedures to remove cancerous tumors, while offering valuable feedback on the Cellvizio prototype probes developed for use in various procedures, including colorectal, ear, nose and throat (ENT) and gynecologic surgery.
With Prof. Cadière, Mauna Kea Technologies will explore complementary routes to those currently under investigation as part of the Persee project, a collaborative effort with a French start-up company specialized in robotic surgery solutions (Endocontrol), an academic laboratory (ISIR) and two leading French hospitals (Institut Mutualiste Montsouris and Institut Gustave Roussy). The Persee initiative has been funded by OSEO's Strategic Industrial Innovation program since its inception in 2010. To date, several prototypes for surgical Cellvizio probes have been developed and are being validated in preclinical conditions in preparation of a clinical trial in 2013.
“We are delighted that Prof. Cadière, a leading expert in minimally invasive surgery who has pioneered many different innovative procedures, will be leading this study in this extremely important new application for Cellvizio imaging,” said Sacha Loiseau, founder and Chief Executive of Mauna Kea Technologies. “The findings that emerge from his work will have deep impact on our strategy within the surgery market.” About Mauna Kea Technologies Mauna Kea Technologies is a global medical device company and leader in the endomicroscopy market. The company researches, develops and markets innovative tools to visualize and detect abnormalities in the gastro-intestinal and pulmonary tracts. Its flagship product, Cellvizio®, a probe-based Confocal Laser Endomicroscopy (pCLE) system, provides physicians and researchers high-resolution cellular views of tissue inside the body. Large, international, multi-center clinical trials have demonstrated Cellvizio’s ability to help physicians more accurately detect early forms of disease and make treatment decisions immediately. Designed to improve patient outcomes and reduce costs within a hospital, Cellvizio can be used with almost any endoscope. Cellvizio has 510(k) clearance from the U.S. Food and Drug Administration and the European CE-Mark for use in the GI and pulmonary tracts.
For more information on Mauna Kea Technologies, visit www.maunakeatech.comCONTACT: United States Lazar Partners Ltd.
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