Galway-based medtech firm SymPhysis Medical is preparing for a significant US market launch within the next 18 months, targeting a condition that affects approximately half of all late-stage cancer patients. The company has developed ReleazeTM, an innovative device designed to alleviate symptoms of malignant pleural effusion—a painful build-up of fluid between the chest wall and lung that causes shortness of breath and discomfort.
Founded by CEO Tim Jones and Chief Scientific Officer Dr. Michelle Tierney, SymPhysis Medical has successfully raised €2.8 million in its latest funding round and expects to secure an additional €3.7 million from current and new investors by April 2025. This capital will support the company's push toward US Food and Drug Administration (FDA) clearance, anticipated by 2026.
Addressing an Unmet Need in Palliative Care
Malignant pleural effusion represents a significant burden for late-stage cancer patients, limiting their mobility and quality of life during an already challenging time. Current treatment options are often invasive and require frequent hospital visits.
"Chest drainage for cancer patients has changed little since the late 1990s. Since then, there have been numerous technological advancements that until now, have not been leveraged," explained Joe Villanova, SymPhysis Medical's VP of Sales and Marketing. "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."
The ReleazeTM device offers a less invasive alternative to existing treatments and can be managed from a patient's home, providing greater independence and comfort. This home-based approach represents a significant advancement in palliative care technology.
Market Potential and Growth Strategy
SymPhysis is entering a substantial market valued at €860 million across the US and Europe alone. The company has ambitious plans to capture 20% of the US market and 10% of the European market by 2030, which would translate to reaching approximately 35,000 patients and generating revenue of €40 million.
"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. "Our ultimate goal of reaching patients with our device is now in sight."
The company's innovation has already received recognition from the European Innovation Council, which awarded SymPhysis its Seal of Excellence in February 2023, highlighting the value and impact of their technology. Additionally, SymPhysis won the MedTech Collaboration Award at the Irish MedTech Awards for its partnership with Britain's National Innovation Centre for Ageing, as well as the Excellence in Innovation Award at the Life Science Industry Awards in the same year.
Strengthened Leadership Team
To support its growth trajectory, SymPhysis has enhanced its leadership team with industry veterans who bring decades of experience in commercializing medical devices. Joe Villanova joined the company last year as VP of Sales and Marketing, bringing over 35 years of experience in commercializing medtech devices, including 15 years specifically focused on devices addressing fluid in the chest.
Niamh St John Lynch has also joined as the new Director of Quality Assurance and Regulatory Affairs, contributing 30 years of international experience in the pharmaceutical and medical device industries, having previously worked with major companies including Johnson & Johnson and Boston Scientific.
"This is an exciting time for our company," Jones added. "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."
The company's next funding round is scheduled to close in April 2025, with the capital raised expected to facilitate its entry into the US medtech market and support the continued development and commercialization of the ReleazeTM device.
