EndoFLIP® Device receives FDA Approval - US market release in 2010
Sunday 10th January 2010 - Crospon, a medical device developer based in Galway has
announced the completion of a €2 million round of funding and that the Company's flagship
gastroenterology product, EndoFLIP® has received clearance from the US Food and Drugs
Obtaining FDA clearance for the EndoFLIP® device is another significant milestone in the
product's development. This clearance will permit the company to sell EndoFLIP® in the U.S.
market and assist Crospon in continuing to build the clinical evidence base to support wider
indications for use of EndoFLIP®, particularly in the bariatric surgery area. During 2009,
Crospon announced the establishment of a US operation in Carlsbad, California.
Crospon develops leading edge minimally invasive medical devices for monitoring, diagnosis and
therapy in the gastroenterology area. This latest funding round includes continued investment
from Enterprise Ireland and Private Investors as well as new investment from The Welcome
Trust in the UK. The Wellcome Trust is an independent charity funding research to improve human and animal health. Established in 1936 and with an endowment of around £13 billion, it is the UK's largest non-governmental source of funds for biomedical research. Each year, the Trust spends over
£600 million both in the UK and internationally.
Commenting on the funding, John O'Dea, CEO, Crospon said, “We are in a critical phase of our
development having recently established a US operation and launched the EndoFLIP® product
into the European market. Recognition and investment by The Wellcome Trust, after a rigorous
review procedure, is a significant endorsement for Crospon and our EndoFLIP® system”.
“Continuing, John O'Dea said, “This investment coupled with the FDA clearance in the US will
enable Crospon to continue to develop the EndoFLIP® technology. A particular short term focus
will be the development of products suited to measurements, which EndoFLIP® will enable,
during bariatric surgery. Looking forward, 2010 will also see the development of a broader
range of measurement catheters, and the investigation of additional applications for EndoFLIP®
in making measurements during interventional pulmonary and cardiology procedures.”
2009 was a landmark year for Crospon and its flagship gastroenterology product, EndoFLIP®. In
June, Crospon announced that it had agreed a worldwide distribution deal for the EndoFLIP®.
The agreement with Dutch company, Medical Measurement Systems, one of the world's leading
companies in the development and distribution of medical gastrodiagnostic systems resulted in
the first customer shipments into Europe taking place in July.
The EndoFLIP® tool was designed by Crospon to provide a more physiologically relevant
diagnostic test for gastroesophageal reflux disease (GERD). Chronic GERD is a prevalent
disorder reaching epidemic proportions worldwide that manifests itself as severe heartburn
caused by stomach acid refluxing up into the oesophagus. Crospon's development of the
EndoFLIP® system was recognised with the 2009 European Gastroenterology Technology Implementation of the Year Award by Frost & Sullivan and the Overall Medical Technology
Excellence Award and the Gold Award for Innovation and Research and Development at the
Irish Medical Device Association Awards.
Earlier in 2009, the Company received CE Mark certification for the EndoFLIP® product in
accordance with the European Medical Device Directive.