Monday 11th 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 Administration (FDA).
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 Wellcome 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. Ends.
About Crospon Established in 2006, Crospon is a medical device company focused on the monitoring and treatment of gastroesophageal reflux disorder (GERD). Company co-founder and CEO, John O’Dea, previously co-founded Caradyne, a respiratory products company which was acquired by Respironics Inc in 2004.
In 2008, Crospon announced that it had completed an additional funding round of €3.5m. This funding was primarily used for the completion of development, manufacturing start-up and preparation to market of the EndoFLIP® system.
Crospon received the Overall Medical Technology Excellence Award and the Gold Award for Innovation and Research and Development at the Irish Medical Device Association Awards and is currently shortlisted in the Innovator of the year category for the SFA National Business Awards 2010. The Irish Medical Devices Association (IMDA) is an IBEC group that represents the medical technology sector in Ireland, and the IMDA Industry Excellence Awards are supported by Enterprise Ireland and the IDA. Crospon was also awarded the Connaught Business Achievers Award for 2008 in the ‘Ones to Watch’ category and the company’s Smart Drug Delivery Patch in conjunction with HP was listed in Popular Science’s magazines annual ‘Best of What’s New’ for 2008.
For further information please contact: John McGuinness Murray Consultants jmcguinness@murrayconsult.ie 00353 1 498 0361 00353 87 6417451 www.endoflip.com
