Galway medtech business SymPhysis Medical prepares to reach first patients with device.
SymPhysis Medical has raised €2.2m out of a targeted €6.5m funding target for this year.
As it prepared to bring its breakthrough device to the first patients, the company will seek FDA clearance for its device treating end-of-life cancer patients at the end of 2025.
“Despite the seriousness of their condition, these patients can still lead active lives; we have met patients who are still jogging, hiking and swimming.”
The Galway medtech is seeking to address the distressing condition of fluid in the chest in cancer patients.
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.
Better treatment for cancer patients
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 breath.
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.
“At SymPhysis Medical, our focus has always been on the patient and enhancing their quality of life as they receive palliative care,” said CEO Tim Jones. “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.”
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.
“The insertion process for this device is straightforward and the drainage system is user-friendly, offering patients greater independence,” said Dr Horiana Grosu, Director of Pleural Service in MD Anderson.
“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.
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