Vesalio Raises Funding to Support Expansion of Vascular Occlusion Treatments to United States Market

May 18, 2022—Vesalio, a Tennessee-based company focused on treatments for cardiovascular and neurovascular occlusion, announced the completion of its oversubscribed Class A financing round.

Vesalio will use this funding to enter the United States market by executing FDA clearances, adding key personnel, developing support infrastructure, expanding its product portfolio, and completing its cardiology clinical study. The company has an established customer base in Europe.

Solas BioVentures led the investment with participation by new and existing investors, including the recent addition of Orlando Health Ventures, stated Vesalio.

According to the company, Vesalio’s NeVa thrombectomy platform is designed to achieve first-pass recanalization in acute ischemic stroke (AIS) by removing all types of neurovascular clots. The device was approved and initially launched in Europe in 2018. In September 2020, the company announced additional distribution agreements in Europe, Latin America, Asia, and the Middle East that expand market coverage in 53 countries.

On May 12, the company announced it completed patient enrollment for CLEAR, an FDA investigational device exemption study to assess the safety, performance, and efficacy of the NeVa platform in the treatment of AIS.

In December 2021, Vesalio announced commencement of enrollment for the randomized, multicenter NATURE clinical study of the company’s enVast thrombectomy system for patients with ST-segment elevation myocardial infarction (STEMI) who are undergoing percutaneous coronary intervention. NATURE will compare the safety and efficacy of the CE Mark–approved enVast system as an adjunctive measure to conventional intervention to the standard of care for patients with STEMI and large thrombus burden.