Access Vascular raised more than $3 million from a consortium of new and existing investors that CEO Jim Biggins said should be sufficient to carry the company through a post-market clinical evaluation of its HydroPICC catheter and into the regulatory process for its next iteration.

Biggins told MassDevice.com yesterday that the $3.4 million round was led by a “family office in the Boston area” that’s backed Access since its 2015 inception.

“They’ve been supporting us since the beginning of the company and they helped price and lead this most recent round,” he told us, adding that half of the funding came from existing backers and the rest from new domestic and international investors.

“I’m very grateful for the support of our existing and new investors. I think it says a lot about what we’re building here, great technology and a great team,” Biggins said during a telephone interview. “I think we’re really just scratching the surface with what the technology can do.

“That money will be used to fund a rollout of the initial post-market use of the device,” he added, essentially “a limited commercial launch.”

Biggins

A veteran of medtech giants Boston Scientific (NYSE:BSX) and Medtronic (NYSE:MDT), and later Ocular Therapeutix (NSDQ:OCUL) under serial entrepreneur and hydrogel pioneer Amar Sawhney, Biggins formed the Bedford, Mass.-based company after spending 18 months seeking medtech’s Holy Grail: an addressable unmet need.

Under the auspices of MassMEDIC’s now-defunct MedTech Ignite program, Biggins trailed physicians at Boston Medical Center for 18 months and realized that venous access might fit the bill.

“It was almost overwhelming, the clinicians who would comment on issues with venous access, the thrombosis rates, the frustration that the nurses had with not being able to provide the therapy, whatever that may be, on a consistent basis, and the challenges associated with that, kind of stuck out like a sore thumb, really. That’s really where I knew that that was something that was worth solving,” he told us.

Thanks to his experience at Ocular Therapeutics, Biggins knew about the possibilities of hydrogels; his stints elsewhere in medtech gave him insight into the limitations posed by more materials already approved for use in medical devices.

“We took a fundamentally different approach, which was change the material to one that has a reduced thrombogenic response. Not coating or adding something to the polyurethane, which was pretty much the way everyone else was doing it,” he said.

That involves an extremely hydrophilic material and Access Vascular’s proprietary formulation method, Biggins explained.

“Essentially, it’s the high water content of our material that’s the primary mode of how we’re preventing thrombosis. Having water closely associated with the molecules of the polymer is what gives us the advantage,” he said.

Having won FDA clearance earlier this year, the next step is post-market clinical work in real-world settings, alongside a bid for 510(k) clearance for the anti-microbial-eluting product.

“We’re in active conversations with the FDA, making use of FDA’s pre-submission program, and plan to submit in the very near future on an anti-thrombogenic, antimicrobial version of our device,” Biggins said. “We’re looking at controlled release of a drug over extended periods of time to actively kill bacteria over the lifespan of the device. The goal is to offer a single solution to the two major complications plaguing venous access, something no one else has done.”

Looking farther ahead, the technology has nearly “an endless amount of applications” on top of the already considerable roster in venous access, Biggins noted, especially when it comes to longer-term implantables.

“Any time you want to put something in the body that is more accepted, less recognized, then you need some sort of load-bearing material. Our material provides us the ability to solve a lot of those problems,” he said.

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