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News - Cellvizio - Jul 5, 2017

Cellvizio® endorsed by the American Society of General Surgeons as integral to the care of patients with Gastroesophageal Reflux Disease (GERD) and Barrett’s Esophagus

Mauna Kea Technologies (Euronext: MKEA, OTCQX: MKEAY) inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy platform, today announced that the American Society of General Surgeons (ASGS) endorsed Cellvizio® as integral to the comprehensive assessment and therapeutic decisions for the treatment of Barrett's esophagus and Gastroesophageal Reflux Disease (GERD). The Position Statement from the ASGS will be available on the ASGS website.

Commenting on the endorsement, Dr F. Paul (Tripp) Buckley III, Surgical Director, The Heartburn & Acid Reflux Center at Baylor Scott & White Health in Central Texas, and Member of the Board of Trustees of the ASGS, stated, "With esophageal cancer rates having increased by 600% since the introduction of powerful acid reducing medications, the accurate detection and determination of extent of Barrett's is greatly enhanced by Cellvizio®. We believe that physicians and surgeons who are fighting every day to relieve patients from GERD and to prevent them from later developing Barrett's Esophagus, a condition that could lead to esophageal cancer, need and deserve to have access to Cellvizio® in order to obtain a comprehensive assessment of the extent of disease and to make real-time therapeutic decisions."

Gastroesophageal Reflux Disease, or GERD, is a chronic form of heartburn, which according to a Harvard Medical School Report[1], affects 10% of Americans on a daily basis. Other sources[2] report that GERD affects 18% of U.S. adults weekly and almost 44% of U.S. adults monthly. In its statement, the ASGS highlights that patients with GERD have a 10-15% risk of developing Barrett's Esophagus, a condition associated with a 30-50% increased risk of developing cancer. GERD was responsible for 8.9 million hospital visits in the U.S. in 2012 and there was an estimated 6.9 million upper endoscopies performed that year, a number that is steadily growing[3].

Mauna Kea Technologies' internal estimates suggest that 5 million upper GI endoscopies performed annually in the U.S. could benefit from the use of Cellvizio®. These procedures are currently reimbursed with CPT codes 43206 and 43252.

"We are extremely gratified by the ASGS's position statement on Confocal Laser Endomicroscopy. Combined with the American Gastroenterological Association's 2015 white paper  which deemed the use of Confocal Laser Endomicroscopy to be appropriate for trained physicians as an alternative to random biopsies, we now have two important clinical endorsements for the use of Cellvizio® in the treatment of GERD and Barrett's Esophagus," declared Sacha Loiseau, Ph.D., Founder and Chief Executive Officer of Mauna Kea Technologies. "We are confident this additional position statement will be a catalyst for accelerated utilization of Cellvizio® in U.S. anti-reflux centers and hospitals, an application which has already proven to be very dynamic."

About the American Society for General Surgery 

The American Society of General Surgeons (ASGS) is the only national surgical specialty society exclusively representing General Surgeon Specialists. The ASGS represents the socioeconomic, political, scientific, ethical, and professional interests of General Surgeon Specialists. For more information, visit http://www.theasgs.org/index.html.

About Mauna Kea Technologies  

Mauna Kea Technologies is a global medical device company focused on eliminating uncertainties related to the diagnosis and treatment of cancer thanks to real time in vivo microscopic visualization. The Company's flagship product, Cellvizio®, has received clearance to sell a wide range of applications in more than 40 countries, including the United States, Europe, Japan, China, Canada, Brazil and Mexico.

For more information on Mauna Kea Technologies, visit http://www.maunakeatech.com

References 

1. Friedman L. The Sensitive Gut. A Harvard Medical School Special Health Report. 2010.

2. Shaheen N, Ransohoff DF. Gastroesophageal reflux, Barrett's esophagus and esophageal cancer. Journal of the American Medical Association. 2002; 287: 1972-1981.

3. Burden of Gastrointestinal Disease in the United States: 2012 Update. Doi: 10.1053/j.gastro.2012.08.002

4. AGA White Paper: Advanced Imaging in Barrett's Esophagus http://www.cghjournal.org/article/S1542-3565(15)01306-3/abstract