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Mauna Kea Technologies Announces Major Step Forward for Reimbursement of Cellvizio Optical Biopsies Performed in Ambulatory Surgery Centers
PARIS, Jan 07, 2013 (MARKETWIRE via COMTEX) --
Mauna Kea Technologies (NYSE Euronext: MKEA), leader in the optical
biopsy market and developer of Cellvizio(R), 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(R)) codes for the use of Cellvizio(R)
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(R), 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
Disclaimer
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 Autorite 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.
United States
Erich Sandoval
Tel: +1 917 497 2867
esandoval@lazarpartners.com
Mauna Kea Technologies
Alexander Bryson
Marketing Communications and Brand Manager
Tel: +33 (0) 1 70 08 09 92
alexander@maunakeatech.com
France and Europe
NewCap.
Investor Relations and Financial Communication
Pierre Laurent / Florent Alba
Tel: +33(0)1 44 71 94 94
maunakea@newcap.fr
SOURCE: Mauna Kea Technologies
mailto:esandoval@lazarpartners.com
mailto:alexander@maunakeatech.com
mailto:maunakea@newcap.fr
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