Crospon gets FDA approval for EndoFLIP
Medical devices firm Crospon has just secured €2million in a new funding round and has won Food and Drug Administration (FDA) approval for its main EndoFLIP product, clearing the way for the company to begin selling into the US market.
FDA approval follows on from the firm winning CE Mark certification from the National Standards Authority, which enabled it to start selling across Europe.
EndoFLIP is a an imaging device that can be used in the diagnosis of gastroesophageal disorders. Doctors can insert a probe into a patient’s oesophagus and it can relay information back to a screen. While the device was developed as a diagnostic tool, Crospon has since widened its applications to include bariatric surgery, which enables weight loss by reducing the size of the stomach. Its FDA approval is for the bariatric surgery application of the device.
Crospon chief executive John O’Dea explained that bariatric surgery involves the insertion of a gastric band to alter the capacity of the stomach.
Adjusting the band correctly can be difficult and EndoFLIP allows doctors to get a better view of what they are doing, he said. The company has already been gearing itself up for a launch in the US, opening an office in California and appointing a US-based vice president of sales last year.
O’Dea said that Crospon would initially target five or six of the major centres for such surgery in the country, to build up awareness of the product.
He declined to comment on what level of revenues the company was hoping to hit in its first full year of sales.
The latest €2 million funding round comes from a number of private investors and Enterprise Ireland and includes new investment from the Welcome Trust in the UK.
O’Dea said that the funding would be used for a variety of purposes including expanding the company’s research and development efforts. The funding from the Welcome trust was specifically for this purpose, he added.
The funding round follows on from €500,000 raised last year and €3 million raised in 2008.
Prior to that, Crospon raised €2.3 million in seed funding from the Western Development Commission, Australian firm Schwenty One and Enterprise Ireland.
O’Dea said that this was likely to be the last funding round the company undertook before it became self-financing.
The company has recently spun out its drug delivery business Janisys into a separate subsidiary, and O’Dea said that it was likely to embark on fund raising this year.
