Irish startup raises $18.3M for bioabsorbable vascular closure device

Medical device procedures are increasingly going the minimally invasive route.

You have transcatheter aortic valve replacement emerging as a superior alternative to open-heart surgery for people with diseased heart valves. And efforts are being made to offer minimally invasive options for side procedures related to TAVR and others including endovascular abdominal aortic aneurysm repair.

One such is the closure of the hole in the artery wall in the groin — arteriotomy — that needs to be created for TAVR and other catheter-based procedures. Vivasure Medical, based in Galway, Ireland, announced Thursday that it has raised €16.2 million  ($18.3 million) in a Series C funding round to commercialize the company’s bioabsorbable vascular closure device based on its PerQSeal technology platform.

The lead investor in the round is LSP (Life Sciences Partners) of The Netherlands that forked over money from its LSP Health Economics Fund. The co-leads were Evonik Venture Capital, out of Germany and Italy-based Panakes Partners. Existing investor Fountain Healthcare Partners of Ireland also participated.

The Vivasure Closure Device has CE Mark for being the “only approved fully bioabsorbable, sutureless and entirely synthetic option to close large-bore arteriotomies that result from percutaneous transcatheter procedures,” according to a news release.

The Irish startup is taking inspiration from the success of companies like St. Jude Medical whose Angioseal biosbsorbable device has cornered a portio of the market for closing smaller holes, noted Vivasure’s CEO.

“As the market leader, with more than 40% of the small closure market, Angioseal demonstrates clinical acceptance of easy to use bioabsorbable closure solutions,” wrote Gerard Brett, also the company’s co-founder, in an email forwarded by a representative of the company.

For a TAVR or EVAR procedure, physicians need to make a large cut in the groin to expose the femoral artery. After the procedure, when that arteriotomy needs to be closed, the blood vessel and overlying tissue have to be manually stitched together using surgical sutures. Now, for large-hole closures, physicians have the option to use Vivasure’s bioabsorbable fully synthetic implant, that does not leave a permanent implant or exogenous tissue in the patient, he noted.

By offering a closure option through the skin, or percutaneously, the Vivasure closure device also stands to benefit many, Brett believes.

“Providing fully percutaneous access and closure avoids the need for a groin incision and manual suturing of the arteriotomy and access wound, offers several advantages for the patients, physicians and payors, including local anesthesia, less pain, shorter procedure times and reduced costs,” he said.

While St. Jude Medical’s device is targeted toward small-hole closures, another company has developed two femoral artery closure devices, one for large-bore arteriotomies called Manta. That device is made by Essential Medical, based in Malvern, Pennsylvania, and like the Vivasure Closure Device, Manta is not commercially approved in the U.S. However, Essential Medical is a step ahead of its Irish counterpart by already having regulatory permission to launch a pivotal trial to win approval for the device.

Meanwhile , Vivasure is hoping to launch its own pivotal trial in 2017. To date, the company has raised €34.7 million (nearly $39 million based on today’s exchange rates) through three rounds of funding. The money from the current round will be used to commercialize the Vivasure device in Europe as well as to support the pivotal trial for a premarket approval in the U.S.

 

“We are excited to support this innovative company and its vision of improving outcomes for patients as it moves into commercialization in the European Union and enters the United States,” said Anne Portwich, partner, LSP, in a statement.

[Photo Credit: Vivasure Medical]