Irish medical device firm Ceroflo announced today that it has raised €6.4 million in investment-round funding, which will be used to advance development of the company’s SubMax device—a novel stent intended to “revolutionise” intracranial atherosclerotic disease (ICAD) treatments. In a press release, Ceroflo reports that these funds will help support first-in-human clinical trials of its innovative stroke technology across 30 patients.

Ceroflo engaged accounting firm DHKN to lead an Employment and Investment Incentive Scheme (EIIS) investment round. The round raised €5 million in a number of weeks, with the additional €1.4 million being raised from “highly respected Irish MedTech entrepreneurs and leading global stroke key opinion leaders”, according to the company’s recent release.

Some 10–15% of strokes are caused by ICAD, for which current treatment options including pharmaceutical therapies are “suboptimal” and thus leave patients burdened by an ongoing risk of suffering a stroke, Ceroflo claims.

The company says its SubMax stent represents a “gamechanger” in the treatment of ICAD, as its shape and structure have been developed to suit the unique challenges of this disease. It is designed to gently increase vital blood flow to the brain while reducing the risks associated with first-generation devices, including haemorrhage and stroke.

Last November, a consortium led by Ceroflo—including manufacturing firm Advant Medical and the Medical and Engineering Technologies Centre at Atlantic Technological University (Galway, Ireland)—secured €3.4 million from the Irish Department of Enterprise, Trade and Employment’s Disruptive Technologies Innovation Fund (DTIF).

Based in Galway City, Ireland, Ceroflo brings together a team from the Irish medical device industry that includes its co-founder and chairman Eamon Brady; co-founder John O’Dea; chief executive officer (CEO) Chloe Brown; chief technology officer Brendan Casey; and advisor John O’Shaughnessy. Other company co-founders include leading stroke interventionists Tommy Andersson (Karolinska University Hospital, Stockholm, Sweden), Leonard Yeo (National University of Health Singapore, Singapore) and Paul Bhogal (Royal London Hospital, London, UK).

“Ceroflo is developing an innovative stent device to address ICAD, the next frontier in the treatment and prevention of stroke,” said CEO Brown. “We are approaching the problem with a unique understanding of the challenges and are designing the technology with clinicians who have more than 50 years’ collective experience treating this disease. This is a very positive time for Ceroflo. Following our successful DTIF grant award and the incredible year since, we are excited about further development of the technology. This €6.4 million investment will enable Ceroflo to bring the SubMax stent to 30 patients in a first-in-human trial—a significant value inflection point. It will also allow us to provide a platform to support further US and Japanese regulatory studies.”

“Ceroflo [is] approaching a critical unmet clinical need for the millions of patients at risk of an acute stroke from ICAD,” Andersson added. “The technology and tools I have available to treat these patients today are not sufficient. They are not designed to address the specific challenges associated to plaque in the brain, therefore adding to the burden of this disease. Paul, Leonard and I identified a unique, novel technology solution and engaged a highly experienced team of industry professionals to create Ceroflo. I am excited to see the progress that this funding round will help bring to Ceroflo, and ultimately the patients in need.”