Vascular Nanotransfer Technologies (VNT)has announced that large animal model in vivo tests of its paclitaxel nano-carrier based drug-coated balloon achieved tissue levels comparable to devices with proven clinical efficacy.
“VNT has achieved tissue levels of paclitaxel that are comparable to devices with proven clinical efficacy but has done so with a device that has superior coating characteristics along with a lower concentration of paclitaxel per surface area,” said John A Williams, president and CEO of VNT.
“We are very pleased with our proprietary balloon coating technology designed for enhanced drug delivery and superior coating characteristics. Now we have a high-performing paclitaxel nano-carrier based drug-coated balloon with strong in vivo test results,” said Williams.
VNT is focused on drug-coated balloons, which are emerging as the ideal therapeutic tool for patients with coronary in-stent restenosis and peripheral vascular disease. However, despite the success of first-generation drug-coated balloons in clinical trials, they exhibit significant limitations related to the precision in drug delivery and tissue retention, raising concerns about overall vascular safety. There is a need for the development of reliable coatings that allow for controlled drug delivery at a lower dose and minimal dislodgement of the coating into the distal vessel.
“There are as yet no drug-coated balloons approved for sale in the United States,” said Williams. “VNT’s paclitaxel-based drug-coated balloons for coronary and peripheral vascular applications are designed to have important competitive advantages over today’s European drug-coated balloon market leaders, such as lower balloon drug surface concentration and particulate counts. We expect to begin patient enrolment for VNT’s first-in-man clinical trial in early 2013.”