PARIS--(Marketwired - June 13, 2013) - Mauna Kea Technologies (EURONEXT PARIS: MKEA), leader in the optical biopsy market and developer of Cellvizio®, the fastest way to see cancer, reported that it has entered an exclusive distribution agreement in Japan with AMCO Inc. for a five-year period. This partnership further strengthens Mauna Kea Technologies' ties with the Japanese market, and is a major step forward in the company's efforts to obtain regulatory approval in the world's second largest endoscopy device market after the US.
The Japanese Ministry of Health, Labor, and Welfare (MHLW) requires foreign medical device companies to have a physical presence within the country or define a partnering distributor prior to approving a device for commercial sale.(1)
A strong presence in Japan with 8 regional offices
"We believe that, once approved in Japan, Cellvizio will have a significant impact on the prevention, early diagnosis and treatment of many of the most pervasive digestive diseases affecting the Japanese people, particularly stomach, colorectal, biliary and pancreatic cancers," said Akihiro Koshikawa, President & CEO, AMCO Inc. "There is a significant market for Cellvizio technology in Japan, as it corresponds very well to the advanced nature of the endoscopy practice in the country. We're excited to work with Mauna Kea Technologies and to make Cellvizio available to a wide array of physicians and patients in Japan once Cellvizio is approved."
AMCO has more than 60 years of experience as a medical device distributor and is deeply rooted in Japan with eight regional offices across the country, and has nearly 150 employees, of which 85 are sales people. Furthermore, AMCO has a strong focus in Mauna Kea Technologies' main indications: gastroenterology, pulmonology and urology.
"After the first installations at two leading medical research institutions earlier this year, this is the second major milestone we have achieved in the Japanese endoscopy market," said Sacha Loiseau, Ph.D., CEO of Mauna Kea Technologies. "We are both happy and proud to establish a long-term partnership with a leading company such as AMCO in what should become a very important market in the world for Cellvizio."
About AMCO Incorporated
AMCO, incorporated in 1951 with its headquarters in Tokyo and seven sales/service offices in major cities throughout Japan, has been involved in importing, marketing and servicing medical and scientific products for over six decades. Company has 160 employees with deep experience in the sale of therapeutic and diagnostic medical products used in surgical and endoscopic suites, as well as outpatient surgery centers. The company is dedicated to actively introducing advanced and innovative medical products that help medical professionals better serve their patients. For more information: http://www.amco.co.jp/english/index.html
About Mauna Kea Technologies
Mauna Kea Technologies is a global medical device company dedicated to the advent of optical biopsy. The company researches, develops and markets innovative tools to visualize and detect cellular abnormalities during endoscopic procedures. 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, multicenter 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 tract, biliary and pancreatic ducts and lungs.
For more information on Mauna Kea Technologies, visit www.maunakeatech.com
This press release and the information contained herein do not constitute an offer to sell or subscribe to, or a solicitation of an offer to buy or subscribe to, shares in Mauna Kea Technologies ("the Company") in any country. This press release contains forward-looking statements that relate to the Company's objectives. Such forward-looking statements are based solely on the current expectations and assumptions of the Company's management and involve risk and uncertainties. Potential risks and uncertainties include, without limitation, whether the Company will be successful in implementing its strategies, whether there will be continued growth in the relevant market and demand for the Company's products, new products or technological developments introduced by competitors, and risks associated with managing growth. Unfavorable developments in connection with these and other risks and uncertainties described, in particular, in the Company's prospectus prepared in connection with its IPO and on which the French Autorité des marches financiers ("AMF") granted its visa number 11-236 on June 20, 2011, could cause the Company to fail to achieve the objectives expressed by the forward-looking statements above.