PRESS RELEASE

Vesalio Initiates FDA IDE Stroke Study

May 12, 2021

Nashville, TN, May 11, 2021 Vesalio announces another key milestone to support entry into the US neurovascular thrombectomy market. Enrollment has commenced in the Vesalio CLEAR(1) acute ischemic stroke FDA IDE clinical trial utilizing the NeVaTM thrombectomy technology platform. With twenty participating stroke treatment centers, enrollment is expected to be completed in early 2022.

Ischemic stroke is caused when a blood clot blocks an artery in the brain causing an area of the brain to die. It is one of the leading causes of death and long-term disability globally. In the U.S. 800,000 patients are estimated to suffer from a stroke each year. Although the risk increases with age, a stroke can occur at any age.

“There have been over 3,200 stroke patients treated with the NeVa thrombectomy platform in Europe and other global markets. The recanalization results have been impressive with high first-pass efficacy across the entire spectrum of clot types. We are excited to more definitively demonstrate the excellent performance and first-pass success of NeVa in the FDA IDE CLEAR study,” commented Steve Rybka, Vesalio’s CEO.

(1) CLEAR refers to “A prospective, open-label, multi-center, single-arm trial designed to assess the safety, performance, and efficacy of the NeVa ™ stent retriever in the treatment of Large Vessel Occlusion Stroke”

Founded in 2013, Vesalio is a privately held medical device company focused on advancing patient care in vascular occlusion by providing physicians superior technology designed to improve clinical outcomes. The Company’s proprietary NeVa™ platform was designed to consistently achieve first-pass recanalization in acute ischemic stroke by effectively removing all types of neurovascular clots from patient anatomy.

For further information, visit www.vesalio.com  or email info@vesalio.com . NeVa trademark and patents are the property of Vesalio.

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