MAUNA KEA TECHNOLOGIES (EPA:MKEA) Mauna Kea Technologies receives additional CPT® reimbursement code in the U.S supporting key application of endomicroscopy with Cellvizio in the biliary tract

Transparency directive : regulatory news

17/03/2015 17:45

PRESS RELEASE

MAUNA KEA TECHNOLOGIES RECEIVES ADDITIONAL CPT(r) REIMBURSEMENT CODE IN THE
U.S SUPPORTING KEY APPLICATION OF ENDOMICROSCOPY WITH CELLVIZIO IN THE BILIARY
                                    TRACT

New code reflects rapidly expanding recognition of positive clinical results
  involving use of endomicroscopy to enhance diagnostic accuracy during ERCP
                                  procedures.

PARIS, March 17th 2015-Mauna Kea Technologies (Euronext: MKEA, FR0010609263),
inventor of Cellvizio(r), the multidisciplinary confocal laser endomicroscopy
platform, today announced that the American Medical Association (AMA) Editorial
Panel has awarded a new CPT Code related to the use of endomicroscopy during
endoscopic retrograde cholangiopancreatography (ERCP) procedures to enable
physicians to diagnose health problems in the biliary tract including diagnosis
of biliary strictures and the presence of biliary cancer. More than 500,000
ECRPs are completed annually in the United States.

"The creation of a new CPT code for biliary tract endomicroscopy is excellent
news for patients with biliary strictures, representing a significant level of
recognition for its applications in this area," said David L. Carr-Locke, MD,
Director, GI Services, Continuum Cancer Centers of New York, Co-Director,
Comprehensive Digestive Diseases Center of New York at Mount Sinai Beth Israel
and former President of the American Society for Gastrointestinal Endoscopy
(ASGE). "This achievement recognizes years of carefully designed clinical trials
that have demonstrated the value of endomicroscopy in enhancing the diagnostic
accuracy of ERCP. It will also continue to foster the acceptance of a technology
that has proven benefit in many other fields of medicine."

In January 2015, Mauna Kea announced publication of final results from a
multi-center international prospective clinical trial (the FOCUS trial)
assessing the use of probe-based confocal laser endomicroscopy (pCLE) in the
diagnosis of biliary cancer during ERCP. Among the 112 patients enrolled in this
study, pCLE correctly diagnosed 88% of patients (accuracy: 88%, Sensitivity:
89%, specificity: 88%, positive predictive value: 93%, negative predictive
value: 82%) when combined with ERCP. Results were published in the peer-reviewed
journal Gastrointestinal Endoscopy.

"The advantage that Cellvizio can deliver in terms of more rapid and accurate
diagnosis of biliary strictures has been well established in both the clinical
literature and in medical practice. We are very encouraged by both the
designation of a new CPT code covering this procedure and the continuing
adoption of this technology by gastroenterologists in the U.S. and around the
world," said Sacha Loiseau, CEO and Founder of Mauna Kea Technologies. "These
important developments provide strong support for our continuing efforts to help
physicians provide improved care to more patients."

The designation of CPT coding for medical procedures supports more accurate
physician communication to payers for specific coding and payment guidelines
about the procedure. Physician use of optical endomicroscopy with ERCP enables
more appropriate treatment decisions and improved access to care for patients.
This new Category III CPT Code 039X7T for ERCP with optical endomicroscopy using
Cellvizio, was announced in the Summary of Panel Actions of the AMA Editorial
Panel, will be released July 1st, 2015 and go into effect on January 1st, 2016.
The Category III code is applicable for all Third Party payers, including
Medicare.

About Current Procedural Terminology (CPT(r))
CPT codes are a listing of descriptive terms and identifying codes for reporting
medical services and procedures. The purpose of CPT is to provide a uniform
language that accurately describes medical, surgical, and diagnostic services,
and thereby serves as an effective means for reliable nationwide communication
among physicians and other healthcare providers, patients, and third parties.
CPT(r) is registered trademark of the American Medical Association. For more
information on CPT codes, see:
http://www.ama-assn.org/ama/pub/physician-resources/solutions-managing-your-
practice/coding-billing-insurance/cpt/cpt-process-faq/code-becomes-cpt.page

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(r), 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 more information on Mauna Kea Technologies, visit www.maunakeatech.com

Mauna Kea Technologies            France and Europe
Eric Cohen                        NewCap
Vice President Finance            Investor Relations & Financial Communication
Tel: +33 (0)1 70 08 09 70         Florent Alba / Pierre Laurent
investor-vpf@maunakeatech.com     Tel: +33 (0)1 44 71 94 94
                                  maunakea@newcap.fr

United States
Berry & Company Public Relations
US - Public Relations Bill Berry
Tel: +1 212 253 8881
bberry@berrypr.com

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