Crospon, a Galway-based medical device developer, has received clearance from the FDA for its gastroenterology product, EndoFLIP. The company has also completed E2m round of additional funding.
Obtaining FDA clearance for the EndoFLIP device will permit the company to sell it in the US market and assist the company in continuing to build the clinical evidence base to support wider indications for use of EndoFLIP, particularly in the bariatric surgery area.
The funding round includes continued investment from Enterprise Ireland and private investors as well as new investment from The Welcome Trust in the UK, said the company.
In June, Crospon had agreed to a worldwide distribution deal for the EndoFLIP. The agreement with Dutch company, Medical Measurement Systems, resulted in the first customer shipments into Europe taking place in July.
The EndoFLIP tool was designed 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.
John O’Dea, CEO of 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.
“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.”