SymPhysis Medical, a Galway-based medical device company, has been awarded a $1.25 million (€1.1 million) grant by a state-backed incubator in Rhode Island that it says will support its push for US regulatory clearance and commercialisation.
The company, part of the BioInnovate programme at the University of Galway, has developed an at-home drainage device called Releaze to help treat fluid build-up in the chest, a common complication associated with advanced cancers.
SymPhysis is seeking clearance from the US Federal Drug Administration (FDA), which will allow it to commercialise the device on that side of the Atlantic.
On Monday, the company said it has now received a $1.25 million grant from the Rhode Island Life Science Hub to support the commercial development of Releaze in the US. The company intends to maintain its headquarters in Galway, it said, where it plans to add to its engineering and operations teams.
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Tasked with supporting the development of Rhode Island’s life sciences sector, the hub is a state-backed body. The grant is part of a $4.5 million fund, designed to help attract high-potential companies to the state.
Speaking to The Irish Times on Monday, SymPhysis co-founder and chief executive Tim Jones said the company has a small presence in Rhode Island, where its vice-president of sales and marketing, Joe Villanova, is based.
“One of our board members is from Rhode Island as well, so there’s a good link with us there,” he said.
“What we’re trying to do is slowly set up that operation and contribute to the Rhode Island ecosystem.”
SymPhysis also employs 12 people in the Republic and continues to build up its operations here with the support of Enterprise Ireland and other backers, Mr Jones said.
“Rhode Island gives us a bridge into the US market, not a replacement for what we are doing here,” he said.
The company raised some €4 million between 2022 and 2024 to support its drive for US regulatory clearance, from a range of investors including Furthr VC, Boole Investment Syndicate, Irrus Investments and HBAN’s MedTech Syndicate.
Mr Jones said SymPhysis is in the process of finishing its testing protocols for FDA submission, which will take roughly six months.
He said the company is aiming to submit its technical file to the regulator in the third quarter of next year. While it is unclear how long the review process will take, due in part to the recent US government shutdown, Mr Jones said the company hopes to receive clearance by the end of 2026.
