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The new catheter devices will be released to select US stroke treatment centres.
Perfuze, a medtech based in Galway Business Park, has successfully raised €22m in a follow-on funding round led by existing investors including Earlybird, EQT Life Sciences, Seroba and SV Health.
The medtech start-up develops innovative catheter-based aspiration technology to treat acute ischemic stroke which occurs when a blockage cuts off blood supply to parts of the brain, killing brain cells.
The additional funding will support a limited market release of its two catheters, the Zipline and Millipede models, in select comprehensive stroke centres in the US, the start-up said.
The funding will also advance Perfuze’s ongoing research and development into new stroke treatment capabilities.
Alongside raising millions, Perfuze has also received clearance from the US Food and Drugs Administration (FDA) for its Zipline Access Catheter.
According to the start-up, the new device is “engineered to enhance” the trackability and delivery of its large and superbore aspiration catheters. By providing increased support and navigational ease, Zipline aims to optimise the efficiency of clot removal.
Millipede, meanwhile, received the EU CE Mark of approval in 2021 and FDA clearance back in 2023.
“The FDA clearance of our Zipline Access Catheter is a testament to Perfuze’s commitment to developing best-in-class stroke solutions,” said Wayne Allen, the CEO of Perfuze.
“This regulatory approval strengthens our growing presence in the US market and supports our vision of delivering novel, effective and easy-to-use technologies that can make a real difference in stroke care.”
While Perfuze chairperson Hooman Hakami said that with the funding, the company is “well-positioned” to initiate a limited market release and drive the adoption of its devices in “select centres”.
In 2022, the company raised €22.5m in a Series A funding round to push forward with US clinical studies into Millipede and secure regulatory clearance.
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