Vivasure wins FDA IDE approval, receives €30M from Haemonetics

Vivasure Medical announced today that it received FDA investigational device exemption (IDE) to advance a clinical study of its PerQseal device.

Additionally, Galway, Ireland-based Vivasure announced a €30 million ($32.2 million) investment from Haemonetics. It marks part of the company’s Series D financing, for which the initial $23 million tranche closed in May 2022. The agreement includes an option for Haemonetics to acquire Vivasure.

Vivasure Medical develops a portfolio of fully absorbable, patch-based, large-bore percutaneous vessel closure devices. Uses for the devices include transcatheter endovascular and cardiovascular procedures.

About the Vivasure Patch pivotal study

Vivasure’s Patch clinical study evaluates the safety and effectiveness of the Vivasure PerQseal closure device system. The multi-center, single-arm, pivotal study will enroll up to 188 patients across the U.S. and Europe. Vivasure intends to use clinical results to su…

Read more
  • 0

Vivasure raises $23M initial Series D tranche; could reach up to $54M

Vivasure Medical announced today that it closed the first tranche — worth $23 million — of its Series D financing round.

Galway, Ireland-based Vivasure’s $23 million (€22 million) fundraising tranche could make up a chunk of the Series D that could reach up to $54 million (€52 million) in total.

According to a news release, an unnamed multi-national strategic corporation led the financing, which includes an option to buy the company upon certain milestones. Other participants included a second unnamed strategic corporate investor and existing investors Fountain Healthcare Partners, Orchestra BioMed, LSP Health Economics Fund managed by the EQT Life Sciences team, Panakès Partners and Evonik Venture Capital.

The funds will be used to support the U.S. and European clinical development and regulatory processes for the company’s portfolio of fully absorbable, patch-based, large-bore percutaneous vessel closure devices for transcatheter endovascul…

Read more
  • 0

Vivasure treats first patient in U.S. study for next-gen PerQseal+ in TAVR procedures

Vivasure Medical announced today that the first patient was treated in a U.S. early feasibility study of its next-generation PerQseal+ device.

Galway, Ireland-based Vivasure’s study will evaluate PerQseal+ in percutaneous transcatheter aortic valve replacement (TAVR) procedures. The first patient was treated by Dr. Robert Pyo at Stony Brook University Hospital in Stony Brook, New York.

The company designed PerQseal+ to provide physicians with an option for managing challenges and bleeding complications associated with large-bore arterial vessel closure, according to a news release.

Vivasure’s first-generation PerQseal device, a sutureless and fully absorbable synthetic implant for large-bore arterial vessel punctures, is available in Europe. That version has an intravascular patch that seals the vessel from the inside, while the PerQseal+ has an enhanced bioabsorbable patch designed to address more complex patient anatomies. The next-generati…

Read more
  • 0