Advanced NanoTherapies (ANT) has announced positive results from its first-in-human (FIH) trial of the SirPlux™ Duo Drug-Coated Balloon (DCB), a next-generation therapy for coronary artery disease. The company is moving forward with plans for a U.S. early feasibility study (EFS), named DYNAMIC DUO I, to assess the safety and efficacy of the SirPlux™ Duo DCB in de novo coronary lesions.
SirPlux Duo DCB: A Novel Approach to Coronary Artery Disease
The SirPlux Duo DCB is designed to deliver a synergistic combination of sirolimus and paclitaxel, aiming to improve vessel patency and prevent restenosis. This dual-drug approach is facilitated by ANT's novel nanoparticle drug encapsulation and delivery platform, which seeks to provide sustained, long-term in-tissue bioavailability without the need for a permanent stent.
Dr. Bernardo Cortese, Director of the Interventional Coronary Center at University Hospitals and Professor of Medicine at Case Western Reserve, stated, "The innovative drug delivery platform of the SirPlux Duo DCB is poised to redefine how coronary disease is treated. By combining two proven drugs with the novel nanoparticle technology, SirPlux Duo DCB aims to minimize drug flaking, deliver sustained drug therapy at therapeutic levels, and get the best characteristics of the two drugs, theoretically making it a strong front-line device alternative to current DCBs or drug-eluting stents."
DYNAMIC DUO I: Early Feasibility Study Design
The planned DYNAMIC DUO I EFS is a prospective, multi-center, non-randomized study. It will enroll patients presenting with symptomatic stable angina, unstable angina, or NSTEMI, all of whom have de novo coronary lesions with reference vessel diameters ranging from 2 to 4 mm. The study's outcomes will guide ANT in refining its clinical programs and inform broader commercialization strategies in the U.S. and worldwide.
Marwan Berrada-Sounni, Co-founder and CEO of ANT, commented, "We are thrilled to take this next step in further validating the clinical performance of SirPlux™ Duo DCB, a novel technology licensed from the Cleveland Clinic. Moving forward with our DYNAMIC DUO I EFS aligns with our vision of advancing nanotechnology-driven solutions that combine the power of sirolimus and paclitaxel to offer a safe and prolonged therapy without leaving a permanent implant behind."
About Advanced NanoTherapies
Advanced NanoTherapies (ANT), part of the T45 Labs portfolio, specializes in developing nanoparticle technology-based platforms for drug delivery. The company focuses on minimally invasive cardiovascular applications, aiming to provide safer therapeutic options for patients with arterial disease. Their lead product, the SirPlux Duo Drug-Coated Balloon (DCB), represents a next-generation approach to minimally invasive catheter interventions.
