EndoFLIP system on track for First Quarter release to European Market
January 2009 – Crospon, a medical device developer based in Galway, Ireland today announced that its EndoFLIP® systemhas received CE Mark certification from the NSAI (National Standards Authority of Ireland), the Irish Notified Body, in accordance with the European Medical Device Directive.
Crospon Limited develops leading edge minimally invasive medical devices for monitoring, diagnosis and therapy in the gastroenterology area.
Commenting on the certification, John O’Dea, CEO Crospon Ltd, said, “Today’s announcement is an important step in the company’s development and ensures Crospon remains on schedule to release the EndoFLIP® system into the European market by the end of the first quarter of 2009.”
In December 2008, Crospon announced that it had completed an additional €500,000 funding round, following on from the completion of a €3m round of financing earlier that year. This additional funding will be primarily used for the completion of development, manufacturing startup and preparation to market of the EndoFLIP® system. EndoFLIP® is used to enhance diagnosis and assist in the surgical treatment of gastroesophageal reflux disorder (GERD). For further information please view www.endoflip.com. The EndoFLIP® system is the first is a range of products the company plans to bring to market.
CE Marking on a product is a manufacturer’s declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation. The Medical Devices Directives set out essential requirements to ensure that a medical device will not compromise the health and safety of the patient, user of any other person and that any risks associated with the device are compatible with patient health and protection.
Speaking at the launch of NSAI’s new two-year strategy document earlier this month, Maurice Buckley, Chief Executive of the NSAI emphasised the importance of recognised standards. “Gaining international certifications and standards such as the CE mark, can give Irish businesses a competitive advantage by providing assurance to global consumers that Irish goods or services are following the best international standards.”
For Further Information Please Contact
00353 1 498 0361 / 00353 87 6417451
Crospon, formed in 2006, is a medical device company focused on the monitoring and treatment of diabetes and 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.
Crospon recently won a 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.