A Galway-based medical device company, focused on developing new products which reduce the risk of catheter related infections, began its First in Man clinical study of its NexSite vascular access catheter at University Hospital Galway recently.
The initiative by Marvao Medical, which was set up in 2006 and employs five people, began in late February. Its first patient was enrolled on April 7.
Catheters equipped with NexSite technology enable the patient’s skin to fully heal into the device at its exit site.
The company says this has a unique advantage because it prevents germs from entering the body though the skin. In addition to its anticipated safety benefits, NexSite catheters should be easier for care givers to maintain and result in significantly reduced healthcare cost.
Dr Gerry O’Sullivan, consultant radiologist at UHG and principal investigator of the study, says Marvao Medical’s vascular access catheter is an innovative device designed to overcome a critical unmet medical need in patients who required long-term venous access.
“It should reduce the incidence of catheter related blood stream infection which is a serious and potentially fatal condition. We are proud that a patient from Galway University Hospital has been chosen to be the first in the world to receive this ground-breaking device.”
Chris Davey, the chief executive of Marvao Medical says a key element in Marvao Medical’s strategy has always been to conduct its First in Man studies in Ireland.
“We are delighted to have worked so successfully with the Irish Medicines Board, University Hospital Galway, NSAI, and the HRB clinical research facility Galway to reach this critical milestone.
“Oncology patients receiving intravenous chemotherapy are particularly vulnerable to infection and results from this study will set the stage for additional studies of our novel medical devices in other vulnerable patient populations. The resulting data will provide the basis on which to establish a better standard of care for patients who require long term vascular access.”
Professor Frank Giles, the director of the HRB clinical research facility at NUI Galway, says it supports all aspects of Irish health research.
“The conduct of First in Man studies is the most demanding and complex clinical aspect of bringing innovative improvements into our local community. We are delighted to be working with Marvao Medical on this important study. The CRF is a resource that benefits our community in many ways, including being a partner to our thriving local medical devices industry."
NUI Galway president Dr James Browne welcomed this important development.
“This clinical study highlights NUI Galway’s role in translating biomedical research into better clinical outcomes for patients. Our researchers are working with industrial partners and with clinicians to bring new therapies to patients.”
Marvao Medical is based at the Innovation in Business Centre on the GMIT campus and is supported by investments from Enterprise Ireland, the Western Development Commission, Enterprise Equity and private investors.
