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Vivasure has also received FDA approval to begin a pivotal study for its synthetic PerQseal implant, which seals blood vessels from the inside.
Galway medtech Vivasure Medical has received a €30m strategic investment from Haemonetics to help develop its vessel closure technology.
The company has built a device called PerQseal, which seals blood vessels from the inside, returning the artery or vein to its natural state without leaving behind the remains of any materials.
Vivasure says this device is the first sutureless and fully absorbable synthetic implant for large-bore arterial vessel punctures. The medtech also said the market for PerQseal is estimated at more than €300m annually.
The €30m investment is part of Vivasure’s Series D funding round, which raised €22m last May to fund the clinical development and regulatory approval of its technology.
US-based Haemonetics is a global supplier of blood and plasma supplies and services. The company joins existing investors Fountain Healthcare Partners, Orchestra BioMed, LSP Health Economics Fund, Panakès Partners and Evonik Venture Capital, which all previously participated in the round.
“We are delighted to now be partnered with Haemonetics, which has quickly established itself as a market leader in advanced vessel closure,” said Vivasure Medical CEO Andrew Glass.
“We strongly believe in the potential of our fully absorbable patch-based approach to large hole closure, and these steps mark important progress toward fulfilling our mission of enabling safe and effective advanced structural and percutaneous cardiovascular therapies.”
Meanwhile, Vivasure has also received approval by the US Food and Drug Administration (FDA) to undertake a pivotal study for its PerQSeal system.
The FDA has granted the medtech an investigational device exemption, which will allow Vivasure to advance its patch study to evaluate the safety and effectiveness of the device.
This clinical study will involve 188 patients across the US and Europe. Vivasure plans to use the results of this study to support an FDA pre-market approval submission and commercially launch the PerQseal system.
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