Head Diagnostics, the medtech start-up developing a rapid assessment device for brain injuries and sports concussions, has raised €500,000 in seed funding.
The investment, from private sources, the National Digital Research Agency and Enterprise Ireland, will be used to complete the development of the handheld iTremor device ahead of plans to begin clinical trials next year.
“This funding will help us to move forward with the final stages of our product development,” David van Zuydam, chief executive at Head Diagnostics, said.
“The plan then is to open a €2.5 million Series A round early next year, so we can finance our pivotal investigations and get CE marking, hopefully, in 2022.”
Securing the CE Mark would allow Head Diagnostics to sell iTremor in EU countries. Van Zuydam said the company would apply for Food and Drug Administration (FDA) approval to sell the device in the US at a later date.
According to Van Zuydam, the iTremor device could be used to help diagnose a range of conditions, including mild traumatic brain injury (mTBI), Parkinson’s disease, stroke and other degenerative brain conditions.
“Where we see potential for iTremor in the first instance is in this big unmet need for better diagnostics in concussions and mTBI,” he said. “Currently, the diagnostic methods used in this area are very subjective [reliant on information provided by the patient], and they can be expensive.
“Ultimately, we want to help clinicians make faster and more accurate diagnoses at a lower cost.”
According to Van Zuydam, 3.8 million mTBI cases are diagnosed in the US every year and 2.5 million in Europe.
“These cases generally present at EDs and hospitals, which is, in itself, a big market. On top of that, there are the people walking around with brain injuries who have not been diagnosed because they don’t know they have them,” he said.
“ITremor could be used for objective point-of-care – or even the point-of-impact – diagnoses. That could be very helpful for individual patients and for the health system overall.”
Another early focus for Head Diagnostics will be the diagnosis of early-stage Parkinson’s disease.
“Next year will be about finalising our device and kicking off pivotal investigations in both mTBI and Parkinson’s,” Van Zuydam said.
“We would expect to continue these investigations into 2022 and then, hopefully, secure CE marking towards the end of the year, so we can launch the product in 2023, initially for mTBI and Parkinson’s diagnosis.”
Van Zuydam joined Head Diagnostics in the role of chief executive in 2018 through the Business Partners programme run by Enterprise Ireland.
The programme matches entrepreneurs with academic researchers to help establish third-level spin-offs with commercial potential. Head Diagnostics is a spin-off from Trinity College Dublin (TCD).
The development of the iTremor device is being led by Gerard Boyle, a principal physicist at St James’s Hospital in Dublin, and Mindaugas Norkus, a research fellow specialising in clinical medicine at TCD and medical physics and bioengineering at St James’s.
Originally from Durban in South Africa, Van Zuydam moved to Ireland two decades ago and has since worked as a senior finance manager at Microsoft and a senior management consultant at Accenture.
The 51-year-old is a voluntary rugby coach at Blackrock College RFC in Dublin. He took on the role of chief executive at Head Diagnostics following a meeting with Kevin Bourke, director of ICT commercialisation at Enterprise Ireland.
“I was looking for my next business opportunity when I met Kevin. Through my own interest in rugby, I was very aware of the impact of concussion and mTBI and the need for effective diagnoses,” he said.
“Head Diagnostics just seemed like a really great fit for me. My background is mainly in finance and I’ve built up a lot of business experience in the corporate world.
“The research into iTremor went back five or six years before I came in on the project. I believe we’re at the point now where we can commercialise this successfully and potentially make a real difference on a global level.”