February 21, 2020
Cerus Endovascular Receives FDA Approval for Its First Microcatheter
February 21, 2020—Cerus Endovascular Ltd. announced it has received FDA approval for its first microcatheter. Commercial sales are expected to begin during the second quarter of 2020.
Cerus’ 021 microcatheter will be offered with three different distal configurations. Going forward, the company will be developing additional microcatheters of various dimensions to offer a comprehensive selection of instrumentation for the needs of interventional neuroradiologists.
Additionally, the company advised it has successfully completed its Series B financing that has raised a total of $19 million from current and new institutional investors since the commencement of the round in July 2018. Completion of the Series B financing will allow the company to execute on its go-to-market strategy and to complete the planned expansion of its product portfolio.
The expanded portfolio will include a smaller delivery platform for its recently CE Mark–approved lead product, the Contour neurovascular system for the treatment of intracranial aneurysms.
The company’s second implant device, the Neqstent aneurysm bridging device, is advancing through the regulatory process, with a clinical trial currently enrolling, aimed at providing additional safety and efficacy data. The Neqstent is designed to be used in conjunction with conventional embolic coils for endovascular embolization of bifurcated saccular intracranial aneurysms.
On February 18, Cerus announced that it has received European CE Mark approval for the Contour neurovascular system in the treatment of intracranial aneurysms. The Contour system is a fine-mesh braid that is deployed across the neck of the aneurysm sac and provides a combination of flow diversion and flow disruption through a single device implant. Cerus expects to begin commercial sales via a controlled market release across the European Union during the second quarter of 2020.