Ireland's Neuravi is gearing up to take its device for removing blood clots in the brain to the U.S. market, and has just raised the funds to help make that happen.
The Galway-based company started rolling out its EmboTrap revascularization device in Europe last year and launched a second-generation version last month, taking on established rivals such as Medtronic's Solitaire product and Stryker's Trevo ProVue.
The so-called stent retriever devices are used to treat patients with acute ischemic stroke by trapping and removing clots from large blood vessels in the brain, restoring blood flow.
Neuravi's product has already been used in hundreds of patients in Europe, and now the Irish device company is ready to bring EmboTrap to the U.S. market. Its latest €15 million financing round from IPF Partners will help make that a reality, according to the company's CEO, Eamon Brady.
He said in a statement that patient recruitment is proceeding on schedule in its U.S. registration trial--called ARISE II--and the cash injection will allow it to build up commercial operations stateside, as well as bring forward other devices in its pipeline.
If it can get into the U.S. market quickly the rewards could be significant. The overall market for clot-clearing devices is estimated at a little under $1 billion a year at the moment, but should swell to $1.4 billion by 2022, according to Allied Market Research. Mechanical thrombectomy devices such as EmboTrap, Solitaire and Trevo are predicted to take the lion's share of the ischemic stroke end of the market.
Neuravi claims its product has an advantage over its competitors because it fully encloses the clot, preventing pieces escaping and potentially causing problems elsewhere, and allows blood flow to resume even before removal.
Meanwhile, Medtronic is fighting back by upgrading its device with a sleeve--acquired when it bought Lazarus Effect last year--that also prevents loss of clot particles during the revascularization process.
Ischemic strokes account for 87% of all strokes and are a leading cause of death and disability, affecting approximately one million Europeans and 700,000 Americans each year, and are estimated to cost around $65 billion in the U.S. alone.
There has been a general increase in the use of mechanical methods to clear blocked vessels, thanks to a positive assessment of the benefits of the approach published earlier this year by the European Network of Health Technology Assessment (EUnetHTA) and endorsement in the 2015 American Heart Association and American Stroke Association stroke treatment guidelines.