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Mauna Kea Technologies Announces Major Step Forward for Reimbursement of Cellvizio Optical Biopsies Performed in Ambulatory Surgery Centers
Optical Biopsies Added to U.S. Centers for Medicare and Medicaid Services Approved Procedures List
By: Marketwired .
Jan. 7, 2013 01:20 AM
PARIS -- (Marketwire) -- 01/07/13 -- Mauna Kea Technologies (NYSE Euronext: MKEA), leader in the optical biopsy market and developer of Cellvizio®, the fastest way to see cancer, announced today that Cellvizio procedures in the upper GI tract have been added to the Ambulatory Surgical Center (ASC) approved procedure list. Ambulatory Surgical Centers are health care facilities focused on providing same-day surgical care, including diagnostic and preventative services, often times found to be more convenient than hospital-based outpatient procedures. The U.S. Centers for Medicare and Medicaid Services (CMS) has approved the payment rate of $520 per previously-awarded Category 1 Current Procedural Terminology (CPT®) codes for the use of Cellvizio® during endoscopy procedures in the upper gastrointestinal tract.
GI related procedures make up 24% of all specialties served at ambulatory surgical centers(i). There are approximately 5,000 ambulatory surgical centers(ii) across the United States, each one performing more than 3,700(iii) GI endoscopy procedures each year, representing a total of about 18 million GI procedures.
Cellvizio is used at hospitals throughout the United States and the rest of the world to provide physicians live-cellular level views of the GI tract to help identify and rule out cancer and guide treatment decisions in real-time.
"We're pleased with the addition of Cellvizio optical biopsies to the list of approved procedures performed in ambulatory surgical centers across the country and believe this opens a much larger market segment for Cellvizio in the United States, our largest clinical market," said Sacha Loiseau, PhD, Founder and CEO of Mauna Kea Technologies. "This is a major milestone in our efforts to make optical biopsies available to a majority of patients with suspected GI diseases, in order to grant them access to a streamlined diagnostic work-up and to a faster treatment decision."
The Category I CPT codes issued by the American Medical Association (AMA) include 43206 for the Cellvizio esophageal optical endomicroscopy and 43252 for esogastroduodenoscopy with optical endomicroscopy. The CPT codes went into effect on January 1, 2013.
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.
(i) Koenig, Lane. (2009) An Analysis of Recent Growth of Ambulatory Surgical Centers. KNG Health Consulting.
(ii) Taparia, Vivek. (2010) The ASC Industry in the United States: Evolution, Landscape and Future. Regent Surgical Health.
(iii) Fields, Rachel. (2010) 35 Statistics About GI/Endoscopy. ASC Communications.
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