SymPhysis Medical raises more than €2m as it prepares device for release
Galway medtech company SymPhysis Medical has received €2.2 million 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 private investor.
SymPhysis Medical has been working on a device for cancer patients suffering from fluid in the chest. The condition impacts 50% of end-of-life cancer patients and can cause pain and shortness of breath. It requires frequent hospital visits for treatment.
SymPhysis’ 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, releaze, has been developed in collaboration with some of the world’s leading experts in cancer care offers a less invasive alternative to current treatments and can be managed from a patient’s home.
The latest funding for SymPhysis Medical – which follows €1.5 million announced in December 2023 – will help the company to launch in the US and reach its first patients. SymPhysis Medical aims to raise €6.5 million in 2024.
Releaze is being manufactured in Letterkenny, Co. Donegal, by Phillips Medisize. Key to its launch in the US will be Food and Drug Administration (FDA) 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 already 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.
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.”
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