Vivasure picks up €30M from Haemonetics to fund arterial closure device trial

For Vivasure Medical, good things come in twos.

In tandem with its announcement this week that the FDA has greenlit a pivotal study of its PerQseal arterial closure device, the Irish devicemaker also confirmed that it has found an investor to fill in the 30-million-euro-sized hole left in the series D funding round it began last year.

The investor in question is Haemonetics, the Boston-based maker of a range of blood-focused products, from plasma collection systems to transfusion management software to vascular closure devices like Vivasure’s.

Haemonetics chipped in the 30 million euros (about $31.6 million) nearly a year after Vivasure closed the first 22 million euro tranche of its series D financing—backed by Orchestra BioMed, Fountain Healthcare Partners and several others—and promised that the round could one day stretch to reach 52 million euros.

In helping Vivasure keep that promise, Haemonetics also made a deal with the company that gives it the option to acquire Vivasure if it reaches certain unspecified milestones.

“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,” Stew Strong, president of Haemonetics’ global hospital business, said in this week’s announcement.

The funding will go toward the continued development of Vivasure’s products. That includes supporting the newly FDA-cleared pivotal trial of the PerQseal technology, the results of which will help back up an application for full FDA approval of the device.

The PerQseal system is designed for use in large-hole arterial closure procedures—that is, to seal up the punctures in the artery made during transcatheter aortic valve replacement, thoracic endovascular aneurysm repair, the placement of heart pumps and other operations conducted via the blood vessels.

Vivasure’s technology centers on an implanted patch that’s placed inside the artery to cover the puncture hole. Its synthetic material is meant to seal up the opening and then, once healed, be fully absorbed by the body, so it doesn’t leave behind the sutures, collagen or metal implant pieces associated with other arterial closure devices.

The original PerQseal device for arterial closure has been cleared for use in Europe since 2016. In clinical studies that led to the CE mark approval, the device achieved technical success in 97% of cases, with no major device-related complications, according to Vivasure.

An upgraded version of the system, PerQseal+, is the focus of the upcoming trial; it’s meant to expand the reach of the original technology, with the ability to address more complex patient anatomies. The company said it plans to recruit up to 188 patients in the U.S. and Europe for the trial. It’s aiming to wrap up the study by the end of this year, after which the results will be sent to the FDA for potential premarket approval of the device.

In addition to the artery-focused iterations of the technology, Vivasure is also in the process of developing PerQseal Blue, which would be used to close up holes in the venous vessels that are made during repairs or replacements of the mitral and tricuspid valves and during pacemaker implants, among other procedures.