Galway medtech SymPhysis Medical is preparing for US regulatory clearance for its device for cancer patients.
SymPhysis Medical is strengthening its management team ahead the US launch of its medical device for addressing the distressing condition of fluid in the chest in cancer patients.
With clearance from the US Food and Drug Administration (FDA) targeted by 2026, SymPhysis Medical aims to launch its device within the next 18 months and to reach €40M in revenue by 2030.
“This is an exciting time for our company. For six years, we have been laser-focused on our mission to help late-stage cancer patients – and, indirectly, their loved ones – to ease a very distressing condition at an extremely difficult time for them”
Founded by CEO Tim Jones and Chief Scientific Officer, Dr Michelle Tierney, SymPhysis Medical has developed a device Releaze, which can be used by cancer patients who are receiving palliative care to relieve the symptoms of fluid in the chest. These symptoms include shortness of breath, discomfort and pain.
Transforming medical care
The condition, experienced by approximately 50% of late-stage cancer patients, limits movements and activities, while necessitating regular medical appointments at a time when many wish to be at home and spending time with loved ones.
SymPhysis’ founders expect their device’s launch in the US to mark a transformation in the care, and quality of care, of these patients.
“This is an exciting time for our company. For six years, we have been laser-focused on our mission to help late-stage cancer patients – and, indirectly, their loved ones – to ease a very distressing condition at an extremely difficult time for them,” said Tim Jones, CEO of SymPhysis Medical.
“I am immensely proud of our team for their dedication to this mission and ensuring we are highly regarded as a compassionate, exciting innovator in our field. This has allowed us to attract top talent from Ireland and the US with individuals whose expertise stems from some of the world’s greatest medical device and pharmaceutical companies. Their appointments position us extremely well as we prepare for launch and rapid growth.
“Our ultimate goal of reaching patients with our device is now in sight. Helping us to achieve that is the backing from renowned industry investors, who have enabled us to get to this point and expand our footprint to the US in preparation of launching the Releaze there. Supporting the Employment and Investment Incentive Scheme (EIIS) has been an important differentiator for us and we look forward to taking on further investment as we enter this new chapter for our business – and the patients we will reach.”
In the most recent funding round, SymPhysis Medical has raised €2.8m and expects to close a further €3.7m from a combination of current and new investors by April 2025. Investors have been impressed by SymPhysis Medical’s ambitious growth plans and focus on a market, worth €860M in the US and Europe alone, which has lacked innovation over the last 25 years.
The company was endorsed by the European Innovation Council (EIC) in February 2025, receiving the Seal of Excellence, which highlights the value and impact of the innovation. SymPhysis Medical expects to represent 20% of the US market by 2030 and 10% of the European market in the same period. This will mean that 35,000 patients could be benefiting from Releaze by 2030.
Hiring medtech big guns
Joe Villanova, VP Sales and Marketing, will drive SymPhysis Medical’s penetration of the US market. He has more than 35 years of experience in commercialising medical devices, with 15 years of experience in those addressing fluid in the chest. He has held leadership roles in multinationals including Baxter Healthcare and Becton Dickinson.
Meanwhile, Niamh St John Lynch, Director of Quality Assurance and Regulatory Affairs, has 30 years of international experience in the pharmaceutical and medical device industries. Her knowledge of medical device regulations, FDA clearance and risk management, through previous work with Johnson & Johnson and Boston Scientific, among others, will help to drive global regulatory approval and adoption of Releaze.
The team will also benefit from a strengthened board of directors. David Uffer has almost 35 years of experience in the life sciences industry. His experience has seen him lead business development for multinationals including Boston Scientific, Abbott and Medtronic. With extensive experience in the commercialisation and launch of early stage medical device companies, he will be pivotal to SymPhysis Medical’s launch and success in the US.
Meanwhile, Gerard Ryan is a serial entrepreneur and experienced investor. Gerard founded Longboat Clinical (sold to Advarra in 2020 in a multimillion Euro deal) and Firecrest (sold in 2011 to ICON plc for €50M). One of SymPhysis Medical’s first investors, Ryan will help to drive SymPhysis Medical’s strategic direction.
“Chest drainage for cancer patients has changed little since the late 1990s,” said Joe Villanova, VP Sales and Marketing, SymPhysis Medical. “Since then, there have been numerous technological advancements that until now, have not been leveraged. I was immediately drawn to SymPhysis Medical’s patient-centred focus on technological transformation in this field and I am excited to help deliver our innovation to patients, their families and the clinicians who deal with the symptoms of fluid in the chest.
“Unfortunately, palliative care can lack investment – something that is distressing for patients and their families, as well as their medical practitioners. At SymPhysis Medical, we are directly addressing this clear need. I am excited to be a part of this groundbreaking journey and am confident that the market will respond quickly when Releaze is launched.”
Main image at top: Gerard Ryan, board member; Michelle Tierney, co-founder and chief scientific officer; and Tim Jones, co-founder and CEO, SymPhysis Medical
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