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Perfuze Receives FDA 510(k) Clearance for Zipline™ Access Catheters and Secures €22M in Additional Funding

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Perfuze Receives FDA 510(k) Clearance for Zipline™ Access Catheters and Secures €22M in Additional Funding
News

News

Perfuze Receives FDA 510(k) Clearance for Zipline™ Access Catheters and Secures €22M in Additional Funding

2025-03-13 15:59 Last Updated At:16:10

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.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250313532644/en/

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)

Zipline Access Catheter (with coil) delivering the Millipede 088 catheter (Photo: Business Wire)

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Former Olympic cyclist Rohan Dennis receives suspended sentence over wife's death

2025-05-14 10:52 Last Updated At:11:01

ADELAIDE, Australia (AP) — Former Olympic cyclist and world champion Rohan Dennis received a suspended sentence on Wednesday over what was termed a “tragic accident” that led to the death of his wife, fellow Olympian Melissa Hoskins.

The 34-year-old Dennis appeared in South Australia District Court after earlier pleading guilty to a charge of committing an aggravated act likely to cause harm.

Dennis was arrested after Hoskins, 32, was struck by his vehicle in front of their home at Medindie in Adelaide’s north on Dec. 30, 2023. Hoskins suffered serious injuries in the crash and died at Royal Adelaide Hospital.

The court was told that the couple had argued over kitchen renovations before Dennis left their home and drove away. The court also heard that Hoskins had jumped onto the hood of the car during the incident.

Dennis on Wednesday was sentenced to one year, four months and 28 days in jail, to be suspended for two years. The sentence was reduced from two years and two months because of his guilty plea and he’s been placed on a two-year good behavior bond.

His licence was also suspended for five years.

“I accept you have a sense of responsibility for all that occurred, I accept you have anguished over what could have been different if you had acted in some other way," Judge Ian Press said Wednesday.

Dennis showed little emotion when Press sentenced him.

“Given your plea of guilty, your remorse, that you are the sole carer for your young children, and given all your other personal circumstances and the circumstances of the offending, I am satisfied that good reason exists to suspend that sentence,” the judge said.

The offense carried a maximum sentence of seven years in jail but lawyer Jane Abbey asked that her client receive a suspended sentence, which was not opposed by the prosecution.

During sentencing submissions in in April, Amanda Hoskins said her daughter had loved Dennis “and I know that you would never intentionally hurt her."

“I believe this is a tragic accident. Your temper is your downfall and needs to be addressed,” she said.

Hoskins' funeral was held in her home city of Perth, Western Australia and a public memorial service was held in Adelaide in February 2024. Dennis attended the service with their two children.

Hoskins competed at the 2012 and 2016 Olympics on the track in the team pursuit and was in the squad that won the 2015 world title. Dennis won two world titles in the road time trial, as well as silver in the team pursuit at the 2012 Olympics and bronze in the road time trial at the Tokyo Olympics.

AP sports: https://apnews.com/sports

FILE - Gold medal winner Rohan Dennis of Australia poses with his medal after the men's cycling individual time trials at the Commonwealth Games in West Park, Wolverhampton, England, on Aug. 4, 2022. (AP Photo/Rui Vieira, File)

FILE - Gold medal winner Rohan Dennis of Australia poses with his medal after the men's cycling individual time trials at the Commonwealth Games in West Park, Wolverhampton, England, on Aug. 4, 2022. (AP Photo/Rui Vieira, File)

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