Vivasure Medical of Galway raises €30 million for its vessel closing technology.
Vivasure has also received FDA clearance to begin a pivotal study for its synthetic PerQseal implant, which seals blood vessels from the inside has invested €30 million in Galway’s Vivasure Medical to support the development of its vessel closing technology.
The business has created a tool called PerQseal that seals blood vessels from the inside and restores the artery or vein to its original form without leaving any material residues behind.
According to Vivasure, this is the first synthetic implant that is completely absorbable and sutureless for large-bore arterial vessel punctures. The medtech company added that PerQseal’s market is thought to be worth more than €300 million yearly.
The €30 million investment was made as a part of the Series D funding round for Vivasure, which collected €22 million in May to pay for the technology’s clinical development and regulatory approval.
US-based Haemonetics is a worldwide supplier of blood and plasma supplies and services. The company joins current investors Fountain Healthcare Partners, Orchestra BioMed, LSP Health Economics Fund, Panakès Partners and Evonik Venture Capital, which all previously invested in the round.
The US Food and Drug Administration (FDA) has also given Vivasure permission to conduct a pivotal trial for its PerQSeal system.
The FDA has given the medtech an investigational device exemption, enabling Vivasure to move forward with its patch study to assess the device’s safety and efficacy.
There will be 188 patients in this clinical trial from the US and Europe. In order to introduce the PerQseal system commercially, Vivasure intends to use the findings of this research to support a pre-market approval application to the FDA.