PARIS & CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Regulatory News:
Mauna Kea Technologies (Euronext:MKEA, OTCQX:MKEAY) inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy platform, announced today the launch of a ground-breaking new clinical study led by researchers at the University of Utah School of Medicine and Harvard Medical School called: “Evaluation of Fiberoptic Confocal Microscopy for Pediatric Cardiac Surgery.” This cardiac surgery study, funded by the National Institutes of Health (NIH), will explore a very important new application in the field of pediatric cardiac surgery, adding to the body of evidence on the use of Cellvizio in a growing variety of surgical procedures.
The NIH funding will advance pre-clinical research on the use of the Cellvizio system to help surgeons avoid damaging vital cardiac tissue during surgical procedures. Damage to the cardiac conduction system is currently a major risk in pediatric cardiac surgery that can result in electro-mechanical dysfunction and require pacemaker therapy. The project is being led by Robert Hitchcock, Ph.D., and Frank B. Sachse, both Associate Professors in the Department of Bioengineering at the University of Utah, along with Aditya Kaza, Assistant Professor of Surgery at Harvard Medical School and Director of the Neonatal Cardiac Surgery Program at Boston Children’s Hospital.
Dr. Kaza, commented, “As a surgeon I know the difference this technology will make in the smallest and most vulnerable patients. Intraoperative confocal microscopy is a powerful new tool for cardiac surgeons and I am anxious to continue working with my colleagues in Utah to bring this imaging technology into the operating room.”
Dr. Hitchcock, added, “This collaboration is a perfect example of a multidisciplinary approach to bringing new technology to the clinic. We’ve been working diligently on this new approach for pediatric congenital heart surgery since 2010. The project has been supported by the NIH, USTAR, The University of Utah and Boston Children’s Hospital. We are now beginning this preclinical research phase which should pave the way for our first human clinical trials in 2018.”
Congenital Heart Disease is one of the most common types of birth defect. It is estimated that at least 40,000 infants are expected to be affected by congenital heart defects each year in the U.S. Of these, approximately 25% require invasive treatment in the first year of life1. There are approximately 25,000 pediatric cardiac surgery procedures performed in the U.S. each year.
Sacha Loiseau, Ph.D., Founder and Chief Executive Officer of Mauna Kea Technologies, said, “Cellvizio’s unique ability to provide real-time, in-vivo microscopic imaging makes it well suited to add value to a wide range of surgical procedures where it is important to discriminate between tissue types. We are excited to be partnering with researchers from the University of Utah and Harvard to apply these capabilities in pediatric cardiac surgery to help surgeons avoid damaging important areas of the heart that could impact the health of these very young patients for the rest of their lives.”
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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 and other diseases 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 www.maunakeatech.com.
Disclaimer
This press release contains forward-looking statements concerning Mauna Kea Technologies and its activities. Such forward looking statements are based on assumptions that Mauna Kea Technologies considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward- looking statements are subject to numerous risks and uncertainties including the risks set forth in the registration document of Mauna Kea Technologies registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on June 13, 2016 under number R.16-054 and available on the Company's website (www.maunakeatech.com), and to the development of economic situation, financial markets, and the markets in which Mauna Kea Technologies operates. The forward-looking statements contained in this release are also subject to risks unknown to Mauna Kea Technologies or that Mauna Kea Technologies does not consider material at this time. The realization of all or part of these risks could lead to actual results, financial conditions, performances or achievements by Mauna Kea Technologies that differ significantly from the results, financial conditions, performances or achievements expressed in such forward-looking statements. This press release and the information it contains do not constitute an offer to sell or to subscribe for, or a solicitation of an order to purchase or subscribe for, Mauna Kea Technologies shares in any country.
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1 http://circ.ahajournals.org/content/133/4/e38
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