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 […]

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 support FDA pre-market approval submission. It also aims to work toward a multi-national commercial launch of the PerQseal system for large-hole vessel closure.

The company designed PerQseal as the first sutureless, fully absorbable synthetic implant for large-bore vessel punctures. With a low-profile patch, placement can occur from inside the vessel. Vivasure said this aims to make deployment simpler and more controlled than conventional closure techniques.

According to a news release, clinical studies to date showed a low complication rate and high technical success.

“We are excited to be moving forward with this multi-center pivotal study which we expect will affirm the safety and effectiveness of PerQseal for large hole arterial closure. Moreover, we are delighted to now be partnered with Haemonetics, which has quickly established itself as a market leader in advanced vessel closure,” said Andrew Glass, CEO of Vivasure Medical. “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.”

About Haemonetics’ investment

Haemonetics’  investment includes the option to acquire Vivasure upon the completion of certain milestones. Boston-based Haemonetics develops products and solutions for cardiology and electrophysiology procedures. It also has offerings for the surgical suite, transfusion services and blood and plasma component collection.

The company said large hole arterial closure represents a high-growth global market opportunity.

“Vascular closure is a key focus of Haemonetics’ growth strategy, and we are excited about the long-term potential of Vivasure’s innovative technology to advance large hole percutaneous procedures,” said Stew Strong, president, global hospital at Haemonetics.

Existing Vivasure investors include Fountain Healthcare Partners, Orchestra BioMed,, LSP Health Economics Fund managed by the EQT Life Sciences team, Panakès Partners and Evonik Venture Capital. Vivasure Medical also received support from Enterprise Ireland and the European Investment Bank.

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