Galway-based medical device company Ceroflo has announced the appointment of Galway’s Mairsíl Claffey as its new Chief Clinical and Regulatory Officer.
Ceroflo is developing next-generation solutions for the treatment of the world’s leading cause of stroke, intracranial atherosclerotic disease (ICAD ).
The appointment of Ms Claffey further strengthens Ceroflo’s leadership team as the company advances its clinical and regulatory strategy.
She brings deep expertise in ischemic stroke and neurovascular clinical development, with a proven track record of advancing breakthrough technologies from early feasibility studies through to pivotal trials and regulatory approval.
Ms Claffey has played key roles in clinical programs across acute ischemic stroke and complex cerebrovascular interventions, working closely with leading global key opinion leaders to design robust trials, define clinically meaningful endpoints, and deliver evidence packages aligned with regulatory expectations.
Her appointment comes as Ceroflo builds on early clinical experience and prepares for expanded clinical studies of its SubMax stent. Ceroflo’s SubMax stent is designed to address a major gap in stroke care by enabling treatment of patients with intracranial stenosis — which is a narrowing of arteries in the brain/inside the skull —for whom there are no safe and effective treatment options.
With ICAD representing one of the leading causes of stroke globally—and a key driver of mechanical thrombectomy failure—the SubMax platform is positioned to unlock a significant and rapidly growing market opportunity.
Ms Claffey will lead the company’s global clinical and regulatory strategy, including engagement with regulatory bodies, development of pivotal study designs, and execution of a pathway toward market approval.
Her appointment reinforces Ceroflo’s commitment to building a world-class team capable of delivering both clinical and commercial success, as the company advances toward pivotal trials and regulatory submissions.
CEO of Ceroflo Chloe Brown said that Mairsíl’s appointment is a key milestone in its business development.
“Her experience in ischemic stroke trials and regulatory strategy is exactly what we need to generate high-quality clinical evidence and execute a capital-efficient path to approval for our SubMax stent as we head into our Series A funding round.
“ICAD is one of the most undertreated conditions in stroke medicine – not because the clinical need isn’t recognised, but because existing limited stenting approaches carry procedural risks that have made physicians and patients hesitant. SubMax is designed to change that: a simpler implant procedure, a meaningfully safer periprocedural profile, and a platform that can realistically scale to the tens of thousands of patients who currently have no good option.”
Mairsíl Claffey, Chief Clinical & Regulatory Officer at Ceroflo, said that what excites her about SubMax is that it has been designed from first principles to make intracranial stenting simpler, safer, and scalable – qualities that have been missing from this space for too long.
“My focus will be on designing rigorous clinical studies that clearly demonstrate patient benefit, while navigating efficient regulatory pathways to bring SubMax to market and deliver enduring value for Ceroflo. I’m proud to join Ceroflo and to help build the clinical evidence that will put SubMax in the hands of the physicians who need it,” she concluded.
