Clinical trials to take place at Hopital Europeen Georges Pompidou and Nouvel Hopital Civil de Strasbourg in France
PARIS, Nov. 4, 2014 /PRNewswire/ — Mauna Kea Technologies (Euronext: MKEA, FR0010609263), inventor of Cellvizio®, the unique trans-disciplinary optical biopsy platform, today announced a new collaboration with Siemens Healthcare to evaluate the clinical benefits of Cellvizio® in interventional radiology procedures. Cellvizio’s needle-based optical biopsy technology will be used in combination with Siemens Angiography & Interventional X-ray (AX) and Computed Tomography (CT) imaging systems in two clinical studies taking place at the Hopital Europeen Georges Pompidou (HEGP) in Paris and the University Hospital in Strasbourg, France.
Doctors will use the Cellvizio and Siemens AX and CT technologies combined in a range of interventional radiology procedures, which is a growing field in medicine, representing a potential multimillion procedure volume in the world each year. In this process, doctors insert a small needle, guided by X-ray, into tissue to perform biopsy or ablation. The two clinical trials will focus on procedures involving the lungs, liver and kidneys. Patients will receive a full examination using a combination of Cellvizio and Siemens imaging and guiding technologies.
"We strongly believe that real-time cellular information can enhance reliability and efficiency of biopsies and treatments by providing feedback on the adequacy of the location targeted, and streamline patient management," said Prof. Gangi, Interventional Radiologist and chairman of Radiology at University Hospital in Strasbourg.
"We are very interested in pioneering the evaluation of Optical Biopsy in Interventional Radiology procedures as the HEGP is a center of excellence in Interventional Oncology and has always been at the forefront of innovation," added Prof. Sapoval, Chairman of the Cardiovascular Radiology department at HEGP.
Both studies will provide quantitative and qualitative results on the feasibility and effectiveness of the device combination. Several additional teams around the world are also evaluating the benefits of Cellvizio in interventional radiology under their own study protocols.
"We are very pleased to initiate the evaluation of our technology in this new specialty in collaboration with Siemens, a recognized leader and expert in the field," commented Sacha Loiseau, CEO of Mauna Kea Technologies. "Our move into the field of Interventional Radiology represents yet another example of the expanding market opportunity for the Cellvizio platform."
Cellvizio is currently not approved for interventional radiology applications and is considered experimental in these protocols.
About Mauna Kea Technologies
Mauna Kea Technologies is a global medical device company focused on leading innovation in endomicroscopy and optical biopsy. The company designs, develops and markets innovative tools to visualize and detect cell abnormalities in real time during standard gastrointestinal and pulmonary endoscopy procedures. The company’s flagship product, Cellvizio®, a probe-based Confocal Laser Endomicroscopy (pCLE) system, provides physicians and researchers with high-resolution cellular imaging of internal tissues. Large-scale, international, multi-center clinical trials have demonstrated Cellvizio’s ability to help physicians to more accurately detect early forms of diseases and make immediate treatment decisions. Designed to help physicians in their diagnoses, provide patients with better treatment and reduce hospital costs, the Cellvizio system can be used with practically all endoscopes. Cellvizio has 510(k) clearance from the United States Food and Drug Administration and CE Marking in the European Union for use in the gastrointestinal tract and the urinary and respiratory systems, for endoscopic exploration of the biliary and pancreatic ducts, and for fine-needle aspiration procedures. Cellvizio also obtained SFDA regulatory approval in China and MHLW approval in Japan.
For further information on Mauna Kea Technologies, visit http://www.maunakeatech.com
Forward Looking Statements
This press release contains forward-looking statements which are based on current plans and forecasts of Mauna Kea Technologies’ management. Such forward-looking statements are, by their nature, subject to a number of important risks and uncertainties (such as those described in the company’s document de reference registered by the AMF on August 6, 2014 under Number R. 14-050) that could cause actual results to differ materially from the plans, objectives and expectations expressed or implied in such forward-looking statements. Forward-looking statements speak only as of the date on which they are made, and Mauna Kea Technologies undertakes no obligation to update or revise any of them, whether as a result of new information, future events or otherwise, except as required by law.
Europe – Investor Relations
Florent Alba / Pierre Laurent
United States – Investor Relations