PARIS--(BUSINESS WIRE)--Sep 4, 2012--Regulatory News: Mauna Kea Technologies (NYSE Euronext: MKEA), leader in the endomicroscopy market and developer of Cellvizio® imaging, the fastest way to see cancer, today announced that the Cellvizio® 100 Series is now available throughout Brazil, the largest medical device market in South America. To coincide with the launch, physicians presented Brazil’s first four clinical cases utilizing real-time cellular imaging with Cellvizio at ENEO/ENDOINCA 2012, the Second International Course of Endoscopy Gastrointestinal Oncology, that took place in Rio de Janeiro August 31 to September 1.
“Gastrointestinal and lung cancers have the highest cancer mortality rates in Brazil, so a tool to help us detect and treat these cancers with greater efficiency could have an important impact on patients and healthcare throughout Brazil,” said course director Simone Guaraldi, MD, Section of Digestive Endoscopy at INCA (Instituto Nacional de Cáncer), the Brazilian National Institute of Cancer. “The technology and innovation that Cellvizio® offers will not only improve patient outcomes but will also have the potential to lower overall healthcare costs by reducing unnecessary procedures.” According to INCA, there were an estimated 27,000 new cases of lung cancer and 27,000 new cases of colorectal cancer in Brazil in 2008.
“Cellvizio is making an impact on how physicians diagnose and treat patients with digestive and bilio-pancreatic diseases,” said Marc Giovannini, M.D., Chief of Endoscopy Unit at Paoli-Calmettes Institute, Marseille, France. “The ability to access cellular-level views amounts to real-time pathology during endoscopy procedures and allows physicians to differentiate precisely between benign and malignant lesions so they can decide an optimum course of treatment and guide treatments in real time at the patient’s bedside.” Dr. Giovannini and Michel Kahaleh, MD, Chief of Advanced Endoscopy at Weill Cornell Medical College in New York, were both part of the course’s international faculty. The two physicians, who are authorities on the clinical use of Cellvizio® in the digestive tract, participated in three talks on Cellvizio during the course.
The Brazilian market accounts for approximately $5 billion in annual medical equipment sales and is expected to grow over 10% annually, according to the U.S. Department of Commerce (DOC) and International Trade Administration.
As announced in June 2012, ANVISA, the National Health Surveillance Agency in Brazil, has cleared the company to sell its Cellvizio® 100 Series endomicroscopic imaging system throughout the country. Mauna Kea Technologies has selected Labor-Med Aparelhagem de Precisão LTDA to distribute Cellvizio systems to hospitals throughout the country.
“The launch of Cellvizio® and the demonstration of these first four cases in the fast-growing Brazilian medical device market extends the Cellvizio® portfolio and offers gastroenterologists and pulmonologists additional options when choosing advanced imaging technologies for patients with suspected digestive and respiratory disease,” said Sacha Loiseau, CEO and Founder of Mauna Kea Technologies. “This demonstrates Mauna Kea Technologies’ ongoing commitment to broaden and deepen the market for cellular level, endoscopic imaging to help physicians around the world diagnose and treat their patients more effectively and efficiently.” ENEO/ENDOINCA 2012 was organized by the Encontro Nacional de Endoscopia Oncológica (ENEO) and INCA and endorsed by the American Society of Gastrointestinal Endoscopy (ASGE).
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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