In addition to the FDA approval, Cerus Endovascular has also closed a Series B financing for a total of $19m from current and new institutional investors
US-based medical device firm Cerus Endovascular has secured the US Food and Drug Administration (FDA) approval for 021 microcatheter, which is the company’s first microcatheter.
In addition to the FDA approval, the company has also closed a Series B financing for a total of $19m from current and new institutional investors.
Cerus Endovascular chairman Sam Milstein said: “We are grateful to our new and existing investors for their confidence in the company, as well as to our remarkable and dedicated team of skilled professionals, led by company President, Dr. Stephen Griffin, all of whom have been instrumental in bringing us to this important inflection point.
“As a result, we are now in a position to execute on our commercial and product development programs and have ample working capital to see us well into 2021.
“As reported earlier this week, during the upcoming second quarter, our European Union sales and marketing team will begin rolling out the Contour Neurovascular System in carefully selected target markets, where we have regulatory approval.”
Cerus has patented Contour Neurovascular System and Neqstent for intrasaccular embolization
Cerus said that the proceeds from Series B financing will facilitate the implementation of its marketing strategy and support its planned product portfolio expansion, which includes the development of a smaller delivery platform for the recently CE Mark approved Contour Neurovascular System.
In addition, the company has a second implant device in its pipeline, the Neqstent Aneurysm Bridging Device, intended for use in combination with conventional embolic coils for endovascular embolisation of bifurcated saccular intracranial aneurysms.
The device is advancing through the regulatory process, with a clinical trial aimed at providing additional safety and efficacy data.
Griffin said: “Receipt of FDA approval for our 021 microcatheter, offered with three different distal configurations, represents the achievement of yet another key milestone for the company.
“Going forward, we will be developing additional microcatheters of various dimensions in order to ensure that we offer interventional neuroradiologists a comprehensive selection of instrumentation to meet their needs.”
The Contour Neurovascular System has been designed to comprise fine mesh braid, and target the neck of the aneurysm, away from the vulnerable aneurysm dome. The device is said to provide a combination of flow diversion and flow disruption through a single device implant.
In addition, the design of the system allows it to be self-anchored to provide stability, re-sheathable for precise placement, and offers less restrictive sizing criteria compared to other available intrasaccular devices.