SirPlux Duo Receives Breakthrough Designation

On May 28, 2021, the US Food and Drug Administration (FDA) granted Advanced NanoTherapies Breakthrough Designation for its SirPlux Duo device. SirPlux Duo is a drug-coated balloon (DCB) that leverages nanotechnology to safely and efficiently treat Peripheral Artery Disease (PAD).

ANT’s device is particularly needed in Below-the-Knee (BTK) applications, where there is no reliable interventional solution as of yet. Preclinical data shows SirPlux Duo is significantly better than current competitors in coronary and vascular applications as well.

The synergistic effect of delivering encapsulated Sirolimus and Paclitaxel directly into the tissue with the help of functionalized nanoparticles has exceeded all expectations. The overarching outcome is that ANT’s drug-coated balloon delivers better performance than regular and bioresorbable stents with fewer health risks.

SirPlux Duo demonstrated up to 5x lower neointimal growth and over 2x better retention with significantly smaller therapeutic doses. These improvements are the result of the device’s dual-drug API and innovative drug delivery platform.

ANT has exclusively licensed its nanoparticle technology (f-NP) from the Cleveland Clinic in 2019. At the time, Marwan Berrada-Sounni, ANT’s CEO hinted that:

“Safer therapeutic options for patients suffering from PAD is just the beginning. Our drug delivery platform can be adapted to address coronary and peripheral in-stent restenosis, dialysis, and much more.”

As part of the Breakthrough Devices Program, SirPlux Duo’s development, assessment, and review are greatly accelerated. ANT is now meeting with a designated FDA consultant on a bi-weekly basis.

ANT has raised $6.5m in its Series A financing, which will enable the group to achieve clinical readiness by the end of 2021, as well as further scale its operations throughout 2022.