Irish MedTech Company Leads EU Breakthrough in Drug-Free Migraine Treatment – Platform Cleared for First-in-Human Trials

A Dublin-based medical device start-up has completed a major regulatory milestone in its bid to transform treatment for chronic migraine sufferers across Europe, advancing a minimally invasive implantable system that could reduce the cost of neurostimulation surgery.

Capri Medical, a smart medtech company founded in Dublin, is a lead partner in the EU-funded TARA consortium, which has announced completion of product development. The platform has now been cleared for First-in-Human clinical trials, a pivotal step in bringing the technology to patients.

The announcement comes during Migraine and Headache Awareness Month, a timely backdrop for a breakthrough that could meaningfully expand access to specialist care for a condition the World Health Organisation classifies among the most disabling illnesses — comparable to dementia and quadriplegia. Approximately 2% of the global population lives with chronic migraine.

What Capri Medical Has Built

At the heart of the platform is a delivery system, the LUNA-INJECT, developed by Capri Medical in Ireland. It reduces a procedure that has historically required a surgical theatre, a specialist surgeon, and three hours under general anaesthetic to a several minute outpatient intervention under local anaesthesia.

The significance is commercial as much as clinical. Conventional neurostimulation implantation costs in the region of €10,000 per procedure. The LUNA Platform is designed to significantly reduce costs by eliminating the need for surgical infrastructure and optimising manufacturing for scale.

Fergal Ward, CEO and founder of Capri Medical, said the company set out to disrupt a market that has long been out of reach for most patients and physicians alike.

“Neurostimulation is a last treatment option, despite often being more effective than pharmaceutical alternatives. The highest-penetrated neurostimulation market today serves only 10% of patients. We’re building a platform to disrupt that care continuum and enable more physicians to treat more patients.”

The LUNA-INJECT system is projected to unlock access for an estimated 90% of physicians who have been unable to offer neurostimulation therapy to date, with the potential to increase patient throughput sixfold.

The Platform in Full

The LUNA Platform comprises four proprietary components developed across the consortium:

• LUNA-AIR: A miniaturised implantable pulse generator that delivers targeted neural stimulation
• LUNA-INJECT: A single-handed delivery system, enabling outpatient implantation in minutes
• LUNA-CONTROL: A wearable device that wirelessly powers the implant
• LUNA-App: A patient-facing mobile application for biometric visualisation, and migraine diary tracking, developed by Ukrainian consortium partner Skein

The LUNA App uses AI to build a personalised diagnostic model based on each patient’s unique physiological profile. Participants in the diagnostic study reported that the app helped them better understand their condition, with many expressing a desire to continue using it after the trial period ended.

An Irish Company in a Growing European Bioelectronics Market

Capri Medical’s role in the TARA project is emblematic of the broader trajectory of Ireland’s medtech sector. Ireland is now the largest employer of medtech professionals per capita in Europe, with more than 48,000 people working directly in the sector and Irish life sciences and health tech companies raising a decade-high €491.3 million in venture capital in 2024.

The TARA project itself received €4.5 million in funding through the European Union’s Horizon Europe research programme, part of a wider effort to strengthen Europe’s position in the emerging bioelectronics market.

For the millions of migraine patients for whom medication has failed to deliver adequate relief — or who experience serious side effects from current treatments, the LUNA Platform represents a new clinical pathway: targeted, drug-free therapy delivered outside the hospital, at a fraction of current costs.

About Capri Medical

Capri Medical is a Dublin-based smart medtech company developing minimally invasive bioelectronic devices for neurological conditions. The company is a lead partner in the EU-funded TARA consortium and the developer of the LUNA-Air delivery system.

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