Its interview #3 of our St. Patrick's Day series, and we're heading to Copenhagen.

Jack O'Keeffe is the co-founder and CTO of Syntropic Medical, a company developing HAVEN, a wearable light therapy headset for treatment-resistant depression. It's a bold swing at one of healthcare's most stubborn unsolved problems.

A UCD Biomedical Engineering graduate who spent years at Johnson & Johnson and Baxter, Jack is now racing toward an FDA pivotal trial that could change how millions of people treat depression.

Stay tuned for the remaining interviews over the coming weeks and keep an eye out for our St. Patrick's Day newsletter, where we reveal the full results of our survey with over 120 Irish founders across the globe.

My name is Jack O’Keeffe and I'm a Biomedical Engineer with over 10 years working in the medical device industry, currently based in Copenhagen, Denmark. After graduating from University College Dublin with a Master’s in Biomedical Engineering, I started my career through global R&D roles at Johnson & Johnson and Baxter.

Before stepping into the startup world, I participated in a MedTech innovation program run by the Novo Nordisk Foundation in Denmark. That experience sparked my interest in building companies around healthcare technologies.

It ultimately led me to co-found Syntropic Medical in 2023, where I now serve as Chief Technical Officer (CTO). Syntropic is a Vienna-based medical device company developing HAVEN, a next-generation, non-invasive neuromodulation therapy for depression. Founded in 2023 as a spinout from the Institute of Science and Technology Austria (ISTA), the company was established with the goal of translating advances in neuroplasticity research into a practical, scalable therapy for patients who do not respond adequately to first-line antidepressants.

HAVEN delivers 60 Hz flickering white-light stimulation through a wearable headset, designed for at-home use under remote clinical supervision. By combining neuroscience, engineering, and digital health infrastructure, Syntropic aims to provide a safe, rapid-acting, and accessible alternative to existing pharmacological and clinic-based treatments.

We’re very excited about where Syntropic is headed. Mental health is still one of the biggest unmet needs in healthcare, and the demand for better solutions keeps growing.

At the same time, neuromodulation has really come into its own as a treatment option. Treatments like transcranial magnetic stimulation and deep brain stimulation in particular have paved the way and shown that stimulating the brain can be both safe and effective.

HAVEN builds on that momentum, but in a much simpler way: it’s completely non-invasive, uses light instead of electrical or magnetic stimulation, and can be used in the comfort of your own home. On top of that, we have a clear regulatory plan.

We’re preparing for an FDA De Novo Class II market approval backed by a large, multi-center, randomized, sham-controlled pivotal trial of around 300 patients. If we can show strong symptom improvement, remission rates comparable to antidepressants, and faster results, that’s not just clinically meaningful but commercially very powerful too.

Over the next year, we’re really focused on one big thing: getting our pivotal trial up and running and executing it well. That’s the major turning point for us. Strong clinical data is what unlocks everything, from regulatory approval to reimbursement conversations and serious commercial partnerships.

At the same time, we’re making sure we have the capital to get through those milestones. The MedTech funding environment right now is highly disciplined and expectations are high. Investors are backing companies with clear differentiation and tight execution plans, so for us that means having a clear regulatory roadmap, detailed clinical and operational plans, and experienced partners in place.

We’re also spending a lot of time thinking about reimbursement and health economics. In mental health, approval isn’t enough. You have to show real value to the system. One of HAVEN’s strengths is that it’s designed for at-home use, which could reduce clinic burden and make treatment much more convenient for patients.

If we can show that people improve faster, stay adherent, and potentially avoid medication switching or crisis visits, that has a meaningful economic impact. So alongside the clinical outcomes, building a strong health economic story is a big priority for us.

The biggest challenge we face today is financing and executing a large-scale psychiatric pivotal trial in a capital-constrained environment. Psychiatric RCTs are inherently complex. Placebo response is high, endpoints are subjective, and sample sizes must be sufficient to detect clinically meaningful differences.

At the same time, investors in the current medtech landscape demand rigorous evidence, disciplined spending, and clear milestone-driven progress. Hardware-based mental health solutions, in particular, are scrutinised closely due to the availability of low-cost generic medications. To succeed, our solution HAVEN must demonstrate not incremental but meaningful differentiation, especially in speed of onset, tolerability, and adherenc

MedTech fundraising in 2025 and 2026 reflects this reality. Capital is available, but it is concentrated in companies that can clearly articulate their regulatory pathway, intellectual property position, target market, and reimbursement strategy.

As an early-stage founder, I’ve learned that warm introductions only get you in the room. After that, you need to be ticking more boxes than you were even aware of before investors even talk about starting diligence.

Despite the challenges present in today’s fundraising climate, mental health remains attractive to investors due to its scale and societal impact, yet expectations are high. For us, having early human data showing positive clinical signals and good tolerability, a clearly defined pivotal trial design, and a large addressable market definitely helps. But investors today want to see near-term de-risking milestones.

For Syntropic, the critical step is securing the capital to initiate and meaningfully advance our pivotal trial. With a successfully executed pivotal trial, this would be the key step in unlocking broader institutional interest.

Being Irish has played a much bigger role in our journey than I initially expected. The MedTech ecosystem in Ireland, has an incredibly strong network of experienced founders, engineers, and operators. As first-time entrepreneurs, that community has been monumental for us. The guidance, honest advice, and encouragement from people who have already walked the path have made a real difference during some of the tougher moments.

Beyond the technical expertise in medical device design and R&D, it is the generosity of the entrepreneurial network, the willingness to share lessons learned, and the access to skilled talent and collaborative partnerships that have truly supported our growth so far.

Moreover, operating within Europe has facilitated access to grant funding and innovation support frameworks that have been instrumental in our early-stage development. At the same time, our commercial focus is firmly oriented toward the United States, given its market size, reimbursement potential, and regulatory clarity. Our Irish roots provide technical depth and support, while our strategic trajectory is globally focused. 

We are also hugely grateful to the Irish Insights group for creating a global platform that allows us to showcase what we’re building at Syntropic. It is not only a powerful way to share our story with the Irish Diaspora internationally, but also a constant source of inspiration for us. Seeing the ambition, resilience, and creativity of other Irish entrepreneurs featured in their newsletter and on their website reminds us that we are part of a much broader community pushing boundaries across industries and geographies. That shared momentum is incredibly motivating, and I’m excited to continue expanding our network and building meaningful connections through this growing community.

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