A Dublin-based medical device startup, Capri Medical, has reached a significant regulatory milestone by advancing its minimally invasive implantable system for treating chronic migraines to First-in-Human clinical trials. This development, part of the EU-funded TARA consortium, could expand access to specialist care and reduce the cost of neurostimulation surgery, offering a new option for millions suffering from the debilitating condition.
## What Capri Medical Has Built
Capri Medical, founded in Dublin, has developed the LUNA-INJECT delivery system, which simplifies a traditionally complex neurostimulation procedure. Previously requiring a surgical theatre and several hours under general anaesthesia, the procedure can now be completed in minutes as an outpatient service under local anaesthesia. This innovation not only promises clinical benefits but also aims to cut costs significantly. Current neurostimulation implantation procedures can cost around €10,000, but the LUNA Platform could lower these expenses by removing the need for extensive surgical infrastructure and leveraging scalable manufacturing processes.
CEO Fergal Ward noted the company’s ambition to disrupt a market largely inaccessible to many patients and physicians. Despite the effectiveness of neurostimulation, it’s often a last resort treatment. With the LUNA-INJECT system, Capri Medical aims to enable 90% of physicians to offer neurostimulation therapy, potentially increasing patient treatment throughput sixfold.
## The Platform in Full
The LUNA Platform, a collaborative effort within the TARA consortium, consists of four main components:
– **LUNA-AIR**: A miniaturised implantable pulse generator for targeted neural stimulation.
– **LUNA-INJECT**: A single-handed delivery system for quick outpatient implantation.
– **LUNA-CONTROL**: A wearable device that wirelessly powers the implant.
– **LUNA-App**: Developed by Ukrainian partner Skein, this mobile application offers biometric visualisation and migraine diary tracking using AI to personalise diagnostics.
The LUNA App stands out by leveraging AI to create a personalised diagnostic model based on each patient’s physiological profile. Participants in diagnostic studies have reported a better understanding of their migraines and have shown interest in continuing its use beyond trial periods.
## An Irish Company in a Growing European Bioelectronics Market
Capri Medical’s advancements reflect the burgeoning medtech sector in Ireland. The country now boasts the highest number of medtech professionals per capita in Europe, with over 48,000 employed directly in the sector. Irish life sciences and health tech companies have raised a decade-high €491.3 million in venture capital, underscoring the sector’s robust growth.
This growth in Ireland’s medtech scene is part of a larger trend across Europe, where bioelectronics and digital health are gaining momentum. The EU’s regulatory landscape, including the GDPR and the proposed AI Act, continues to shape the development and deployment of such technologies, ensuring patient safety and data privacy.
The successful completion of First-in-Human trials for Capri Medical’s platform could set a precedent for future innovations in the sector, highlighting Ireland’s role as a hub for medtech advancements.
As Capri Medical moves forward, the implications for Irish and European founders, engineers, and investors are significant. For founders, the success of the LUNA Platform underscores the potential for startups to innovate within highly regulated sectors. Engineers stand to gain from the cross-disciplinary collaboration opportunities that such complex projects entail. Investors might find promising opportunities in the growing bioelectronics market, particularly as demand for cost-effective, non-pharmaceutical treatments rises.
Next steps for Capri Medical involve the continuation and expansion of clinical trials, aiming to validate the efficacy and safety of the LUNA Platform. Irish and European stakeholders should watch closely as Capri Medical navigates this critical phase, potentially influencing medtech innovation strategies across the continent.