ANACONDA Biomed Receives CE Mark for Its ANA5 Funnel Catheter to Treat Ischemic Stroke

BARCELONA, Spain--(BUSINESS WIRE)--ANACONDA Biomed, a medical technology company developing next-generation thrombectomy systems for the treatment of ischemic stroke, has announced that it has received CE Mark certification for its ANA5 Funnel Catheter. The CE marking confirms that the ANA5 device complies with the European Union's health, safety, and environmental protection standards, enabling its eventual commercial viability across the EU.

The CE Mark approval is supported by a comprehensive body of evidence, including preclinical bench and animal studies, and clinical data from the recently published ANAIS study demonstrating high reperfusion and first-pass success rates.

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The ANA5 Funnel Catheter is engineered to optimize mechanical thrombectomy by maximizing clot capture with its vessel-matching diameter funnel. Simultaneously, it enables antegrade flow arrest and offers the potential for flow reversal, enhancing aspiration-assisted clot retrieval. The ANA5 promotes improved clot capture and removal through its unique proprietary geometry.

The CE Mark approval is supported by a comprehensive body of evidence, including preclinical bench and animal studies, and clinical data from the recently published ANAIS study demonstrating high reperfusion and first-pass success rates. Further clinical validation is ongoing in the ATHENA trial, a prospective, multicenter randomized study systematically evaluating the impact of proximal flow arrest on reperfusion effectiveness, to support future regulatory submissions and commercialization efforts in the United States.

"Receiving CE Mark approval is a pivotal achievement for ANACONDA Biomed that advances our mission to innovate in the interventional management of acute ischemic stroke," said Trent Reutiman, chief executive officer. "This milestone reflects the strength of our science and the dedication of our team. We now have the capability of making ANA5 available to clinicians across Europe, bringing this innovative technology to broader stroke application."

Dr. Marc Ribo, the co-founder of Anaconda Biomed, added, "Receiving CE Mark approval for ANA5 is deeply meaningful, as it represents the culmination of years of research, iteration, and belief in an idea that began at the bench. This is more than a regulatory milestone; it's the moment where innovation becomes impact. We're now gearing up to capture real-world data by collecting more invaluable insight into how ANA5 performs across diverse stroke centers and clinical realities."

About ANA Funnel Catheter

ANA5 Advanced Neurovascular Access™ (ANA Funnel Catheter) is designed as an expandable and collapsable funnel catheter for interventional neurovascular procedures, requiring the retrieval of clot, and benefiting from limiting flow and/or flow reversal towards that goal. The device consists of a radiopaque nitinol braid funnel, covered with a polymeric coating enabling local flow arrest. The catheter is currently an investigational device and is not available for sale in the United States.

About Anaconda Biomed

Anaconda Biomed is an innovative medical technology company dedicated to developing next-generation thrombectomy systems for the treatment of ischemic stroke. At the heart of its product portfolio is the ANA Funnel Catheter. Anaconda Biomed has received funding from prominent life science investment firms, including Ysios Capital, Omega Funds, Innogest, Asabys Partners, Banco Sabadell, and private investors. Additionally, through public grants, the company has received significant public support from ENISA, CDTI (Innvierte and NEOTEC), the Ministry of Science & Innovation (Emplea and Retos), EIB, and EIT Health. For more information, please visit https://anaconda.bio and follow the company on LinkedIn.