Access Vascular said today that it raised $6 million from new and existing investors for the HyrdoPICC device it developed, earmarking the proceeds for the launch of.
HydroPICC, a peripherally inserted central catheter, is made of a proprietary material that’s designed to inhibit the formation of blood clots. It won 510(k) clearance from the FDA in February 2018.
Bedford, Mass.-based Access Vascular said it plans to use the proceeds for launching a next-generation product, a post-market registry study and R&D. Founder & CEO Jim Biggins told MassDevice.com that the bulk of the round will be used to generate early-use clinical data and to fund further commercialization. Longer-term, the company is eyeing unmet needs in the vascular access space, Biggins told us.
“We had great feedback from our early clinical supporters in January, when we did the first couple of patients. That information was used to make some changes to the kit itself,” he said. “We’ll roll out some smaller clinical studies in the very beginning part of next year.
“In the PICC space, we think it’s much more important to show the attributes of thrombosis reduction or near elimination to be the standard of care. And that’s sort of where we’re going to put our funds to use,” he told us. “We think it’s important to be that clinical think tank for all of these clinicians, to have that data and offer it not necessarily a service, but as the expert on venous access devices.”
Access Vascular also plans to seek FDA clearance for a second product next year and has its eye on potential targets, including catheters with active bloodstream infection-fighting properties or that could allow insertion through difficult or stenosed vessels.
“We’re looking to address other, very large unmet needs across the entire sweep of venous access products,” Biggins said. “They can all benefit from our type of material.”
On the sales side, Access is looking to build on a breakthrough technology contract with group purchasing organization Premier.
“We signed a great agreement with Premier and plan to leverage that to start our commercial use,” he explained. “We’re going to build that sales team to help penetrate the markets that we’re in.
“It’s a $3.5 billion venous access market with lots of global international players that haven’t innovated. Eighty percent to 90% of all patients entering the hospital system require some sort of intravenous access. That’s a huge number. From our estimates, about 30% of all those patients are going to have some sort of complication,” Biggins said.
The round was led by an international family office that Biggins declined to identify, saying only that the fund “has sort of found a niche in medical device.”
“We’re very happy to have that sort of support moving forward. I think it’s also great that a lot of our existing investors participated in in this round. It shows that they’re very supportive of the company,” he said.
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