Macon, Georgia, October 28, 2014. Mauna Kea Technologies (Euronext: MKEA, FR0010609263) and Coliseum Northside Hospital, an HCA hospital, today announced that surgeons at Coliseum Northside Hospital are among the first in the U.S. to use an advanced endomicroscopy technology called Cellvizio to identify pre-cancerous and cancerous cells in patients gastroesophageal reflux disease (GERD). According to guidelines established by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), it is important to take steps to identify and treat pre-cancerous or cancerous cells prior to anti-reflux surgery.
According to the US Department of Health and Human Services, approximately 20 percent of people in the United States experience reflux symptoms at least weekly. Severe GERD can occur when symptoms are not relieved by lifestyle modifications or acid-reducing medications known as proton-pump inhibitors (PPI). In addition, treatment with PPIs is associated with decreased quality of life and high costs, making surgery the only alternative for many patients.
In anti-reflux surgery, , surgeons strengthen the valve between the esophagus and stomach, which can help to stop naturally produced acid from backing up into the esophagus. Using Cellvizio’s endomicroscopic technology, surgeons at Coliseum Northside Hospital are able to perform an “optical biopsy” in the patient’s esophagus to detect the presence of cancerous or pre-cancerous cells prior to anti-reflux surgery, and can use Cellvizio to monitor for recurrence of disease after the procedure is completed.
“As we prepare patients for anti-reflux surgery, Cellvizio makes it possible for us to rule-out the presence of pre-cancerous cells with more diagnostic accuracy and gives us the ability to perform improved surgical intervention,” said Joseph J. Burnette M.D., surgeon at Coliseum Northside Hospital, adding “the technology also plays an important role in monitoring for the presence of cancerous cells after the procedure.”
Optical biopsy with Cellvizio enables the visualization of tissues at the cellular level during an endoscopic examination to determine the presence of diseases and conditions such as cancer. The procedure combines an advanced imaging technology, confocal laser endomicroscopy (CLE) with standard endoscopy. . The procedure produces images with microscopic precision that can provide physicians with real-time information to support faster and more accurate diagnosis, as shown by multiple randomized controlled trials involving hundreds of patients in leading institutions in the US and around the world.
“Instead of taking biopsy tissue to a microscope to identify cancer in patients with GERD, with Cellvizio we are taking the microscope to the tissue,” said V. John Bagnato, MD, surgeon at Coliseum Northside Hospital. “We can often identify cancer in real-time, which is a tremendous advantage for patients and for treatment outcomes.”. Dr. Burnette and Dr. Bagnato have completed over 100 endomicroscopic procedures in patients with GERD since they incorporated Cellvizio in their patient care paths in September.
“GERD continues to be a major health challenge in the U.S. and all around the world, affecting millions of patients.” said Sacha Loiseau, CEO and founder of Mauna Kea Technologies. “We are very pleased that Cellvizio is playing an important role in helping surgeons identify the right candidates for anti-reflux surgery.”
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®, a probe needlebased Confocal Laser Endomicroscopy (pCLE/nCLE) 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 virtually any endoscope. 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 has also obtained SFDA regulatory approval in China and MHLW approval in Japan.
For further information on Mauna Kea Technologies, visit www.maunakeatech.com
About Coliseum Northside Hospital
Coliseum Northside Hospital, affiliated with Coliseum Health System in Macon, Georgia, is a full-service, medical-surgical facility with 103 beds. Owned by Hospital Corporation of America, Coliseum Northside Hospital is recognized by the Joint Commission as a Top Performer on Key Quality Measures and for Total Joint Replacement Certification. The hospital operates a full-service 24-hour emergency room, has inpatient and outpatient surgery options, diagnostic services, an orthopedic and spine center, the Georgia Bariatric Center, an outpatient rehabilitation center, a sleep lab and a wound healing center. Learn more about Coliseum Northside Hospital at www.coliseumhealthsystem.com.