GALWAY, Ireland--(BUSINESS WIRE)--Mar 13, 2025--
Perfuze, a leading medical device company dedicated to advancing stroke treatment, today announced that it has received FDA 510(k) clearance for its Zipline™ Access Catheters. This regulatory milestone strengthens Perfuze’s growing portfolio of innovative neurovascular devices, empowering physicians to treat acute ischemic strokes with greater speed, ease, and precision. In addition, Perfuze has secured €22 million in follow-on funding in a round led by existing investors including Earlybird, EQT Life Sciences, Seroba and SV Health.
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Transforming Stroke Care with Zipline ™
Every minute counts in stroke care. As a stroke progresses, human brain tissue is quickly and permanently lost, making urgent therapeutic intervention critical. The Zipline™ Access Catheters are engineered to enhance the trackability and delivery of large (070) and superbore (088) aspiration catheters, simplifying neurointerventional procedures and enabling faster, more efficient stroke treatment. By providing increased support and navigational ease, Zipline™ aims to optimize clot removal efficiency, ultimately improving procedural success rates and patient outcomes. The FDA clearance marks a significant step forward in Perfuze’s mission to simplify and improve stroke treatment and outcomes through technological innovation.
“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, CEO of Perfuze. “This regulatory approval strengthens our growing presence in the U.S. market and supports our vision of delivering novel, effective, and easy-to-use technologies that can make a real difference in stroke care.” Dr. Jay Dolia, Assistant Professor, Neurology, Emory University School of Medicine stated: “The Zipline catheters represent an innovative technology that I believe will simplify stroke intervention, reduce costs and accelerate reperfusion. In my initial experience, they have enabled rapid clot access and aspiration, even in complex anatomy."
Fueling Growth: €22 Million Investment to Drive Commercial Rollout
Perfuze has successfully closed a €22 million funding round, led by existing investors. This investment will support the Limited Market Release of the Zipline™ and Millipede™ catheters while advancing ongoing clinical and R&D initiatives to further enhance stroke treatment capabilities.
Perfuze has initiated a Limited Market Release in the U.S. in prestigious US Comprehensive Stroke Centres. The company’s growing portfolio is designed to provide physicians with highly effective tools to simplify stroke treatment and improve patient outcomes. “The continued support from our investors underscores the confidence in Perfuze’s technology and vision,” stated Perfuze Chairperson, Hooman Hakami. “With this funding, we are well-positioned to initiate our U.S. Limited Market Release and drive adoption in select centers of our transformative stroke treatment solutions.”
For more information about Perfuze and its innovative stroke treatment solutions, visit www.perfuze.com.
About Perfuze
Perfuze is a medical device company headquartered in Galway, Ireland, dedicated to developing next-generation catheter-based aspiration technology for the treatment of acute ischemic stroke. The company’s proprietary platform is designed to maximize clot removal efficiency, enhance procedural simplicity, and improve clinical outcomes.
Zipline Access Catheter (with coil) delivering the Millipede 088 catheter (Photo: Business Wire)
MELBOURNE, Australia (AP) — Mercedes team principal and chief executive Toto Wolff has denied rumors on the eve of the Australian Grand Prix weekend that he’s still seeking to sign reigning F1 world champion Max Verstappen for 2026.
Mercedes, which has a new driver lineup this year that sees rookie prospect Andrea Kimi Antonelli join George Russell, is hoping to emerge from its recent lean spell in F1 that has seen it score just five wins from the last three seasons, four of which came in 2024.
But while Verstappen was reportedly on Mercedes’ shopping list last year as a top-gun replacement for its then-outgoing star Lewis Hamilton, Silver Arrows’ team boss Wolff says extending Russell’s contract beyond 2025 is the priority.
“I think we’ve said it pretty clearly last year, and (Verstappen) said the same, we need to concentrate on our driver line-up, we need to do (the best with) that we have," Wolff said Thursday in Melbourne.
“I don’t flirt outside if I’m in a good relationship, and that is true for this year, too. So, at the moment that is not on any, let’s say, radar and I don’t plan to shift my concentration away from these guys and make sure that George has a contract (extension) pretty soon and we agree on the final things.”
Wolff’s future driver lineup came into focus this week after McLaren extended its deal with Australian Oscar Piastri, which puts him out of reach during the sport’s next big expected grid shuffle in 2027.
“We have had a chat (with Russell) a few weeks ago about what the right timing would be to liaise, and I’m — naively or not — someone that sticks to what he says,” Wolff said.
“These three (including reserve driver Valtteri Bottas) are the combination that I want to go forward with Mercedes, and I have no reasons to doubt that. We’re going to find some time, I guess, before the summer.”
Russell, a long-time Mercedes protégé who joined the works team in 2022 fresh from three years at Williams, is keen to stay in silver.
“We’ve had such a long-term relationship, and there’s so much trust,” Russell said. “We are focused on getting Mercedes back on top and trying to win races, and championships, and to be honest in this sport, the performance speaks.”
Hamilton made it clear in Melbourne that he’s moved on, following his record-breaking stint with Mercedes, with the seven-time F1 world champion enjoying life at Ferrari as he prepares for his maiden start with the Scuderia.
Hamilton, who’d been powered by Mercedes for his entire F1 career from 2007 to 2024, made a shock switch to Ferrari starting this year, following negotiations with Mercedes in 2023 that saw him offered a shorter tenure to future proof the operation.
Hamilton signed the one-plus-one (option year) deal in August 2023, but made a swift u-turn in January last year to join the Prancing Horse from 2025.
And the veteran Brit has been enjoying every moment spent at Maranello.
“You’re looking at things from a different perspective, and that makes it exciting and challenging,” Hamilton said Thursday. “This is definitely the most exciting period of my life. I’m really enjoying it, and I’m so excited to get in the car tomorrow.”
Hamilton is also working like he’s a rookie again, this time at age 40 — and with a record 105 wins and 104 pole positions.
“I’m back at kind of square one,” Hamilton said. “I’m really just putting all the time I have in. I’ve been at the factory, like four days a week. I’ve been given absolutely everything to training, to push my mind and my body further than I have before, trying to see if I can excel, and just squeeze more juice out of this."
AP Formula 1: https://apnews.com/hub/formula-one
Ferrari driver Lewis Hamilton of Britain reacts as he walks through the F1 paddock ahead of the Australian Formula One Grand Prix at Albert Park, in Melbourne, Australia, Thursday, March 13, 2025. (AP Photo/Heath McKinley)
Red Bull driver Max Verstappen of the Netherlands reacts following the drivers portrait photo session ahead of the Australian Formula One Grand Prix at Albert Park, in Melbourne, Australia, Thursday, March 13, 2025. (AP Photo/Asanka Brendon Ratnayake)
Red Bull driver Max Verstappen of the Netherlands walks through the paddock ahead of the Australian Formula One Grand Prix at Albert Park, in Melbourne, Australia, Thursday, March 13, 2025. (AP Photo/Heath McKinley)
Mercedes driver George Russell of Britain poses for the drivers portrait photo session ahead of the Australian Formula One Grand Prix at Albert Park, in Melbourne, Australia, Thursday, March 13, 2025. (AP Photo/Asanka Brendon Ratnayake)
Mercedes team principal Toto Wolff arrives at the track ahead of the Australian Formula One Grand Prix at Albert Park, in Melbourne, Australia, Thursday, March 13, 2025. (AP Photo/Asanka Brendon Ratnayake)
