SymPhysis Medical, the Galway MedTech company seeking to address the distressing condition of fluid in the chest in cancer patients, today announces that it has received €2.2M in funding as it prepares for regulatory clearance in the US. The funding consists of follow-on investments from Irrus Investments, the MedTech Syndicate and Boole Investments along with capital from Enterprise Ireland and a new private investor
SymPhysis Medical has been working with global leaders in cancer care to develop releaze, a device for cancer patients who are suffering from fluid in the chest. The condition impacts 50% of end-of-life cancer patients and can cause pain and shortness of breath1. It requires frequent hospital visits for treatment.
SymPhysis Medical’s founders, Tim Jones and Dr Michelle Tierney, identified the unmet clinical need for better treatment of the condition as part of the BioInnovate programme run by University of Galway. Their device offers a less invasive alternative to current treatments and can be managed from a patient’s home, giving patients the freedom and time to pursue the activities they enjoy and to spend time with loved ones.
The latest funding for SymPhysis Medical – which follows €1.5M announced in December 2023 – will help the company to launch in the US and reach its first patients. In total, SymPhysis Medical aims to raise €6.5M in 2024 to pursue these activities.
releaze is being manufactured in Letterkenny, Co. Donegal, by Phillips Medisize. Key to its launch in the US will be FDA (Food and Drug Administration) clearance, which SymPhysis Medical aims to receive at the end of 2025. In advance of this, the company seeks to carry out the necessary pre-clinical studies required by the FDA for the clearance of medical devices. Additionally, SymPhysis Medical aims to continue carrying out usability studies with the UK’s National Innovation Centre Ageing (NICA) and Mayo Clinic. The goal of these is to provide vital evidence that the device functions exactly as it is marketed.
Approval in the US would mean that SymPhysis Medical could reach its first 10 to 20 patients using the funding it has received. The target will be to treat those under the care of MD Anderson Cancer Center in Houston, Texas – the largest of its kind in the world – and Mayo Clinic in Rochester, Minnesota. SymPhysis Medical has been working alongside clinicians in both of these institutions for the last five and seven years respectively.
If granted FDA clearance, SymPhysis Medical’s next goal will be to seek the CE mark, which would enable it to market its device in Europe.
Tim Jones, CEO, SymPhysis Medical, said: “At SymPhysis Medical, our focus has always been on the patient and enhancing their quality of life as they receive palliative care. Despite the seriousness of their condition, these patients can still lead active lives; we have met patients who are still jogging, hiking and swimming. Regardless of how active their condition allows them to be, cancer patients receiving palliative care all have one thing in common: they are determined to ensure that the time they have remaining is enriched and fulfilling – and that requires as little time in hospital as possible.
“That has been the driving force behind SymPhysis Medical and six years on from our foundation, we are excited to be getting to the point when we can finally see our device benefiting patients. This would not have been possible without the support of our investors, who have seen that this is an unmet clinical need with global market potential. We have also been able to demonstrate to them that this is a device with the support of global leaders in cancer care, so there is no question about the appetite for it – it is all about getting it to our first patients as soon as possible.”
Dr Horiana Grosu, Director of Pleural Service in MD Anderson, said: “The insertion process for this device is straightforward and the drainage system is user-friendly, offering patients greater independence. This is particularly significant for patients who lack family support or assistance, as we often avoid placing catheters in such cases. This new system could be a game-changer.
“Once the catheter is available for use, we will aim to gather real-time clinical data to compare its performance with the currently available systems. Based on the preliminary data, I am quite confident that the device will be widely adopted soon, as it appears to offer clear advantages.”
SymPhysis Medical’s next round of funding will close in late 2024. To find out more, or to enquire about investing, please email invest@symphysismedical.com.
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