Advanced Nanotherapies Reports Positive First Human Trial Results, Plans US Feasibility Study for Sirplux Duo

Advanced NanoTherapies (ANT), a clinical-stage medical device company in Santa Clara, Calif., has announced promising results from its first-in-human trial of the SirPlux™ Duo Drug-Coated Balloon (DCB). The company plans to advance to a U.S. early feasibility study, named DYNAMIC DUO I, to assess the SirPlux™ Duo DCB's safety and effectiveness in treating de novo coronary lesions. This innovative device utilizes a dual-drug therapy with sirolimus and paclitaxel, specifically designed to maintain vessel patency and prevent restenosis.

Dr. Bernardo Cortese, Director of the Interventional Coronary Center at University Hospitals, emphasized that the SirPlux Duo DCB's unique drug delivery system could revolutionize coronary disease treatment. By integrating two established drugs with advanced nanoparticle technology, the device aims to minimize drug flaking and deliver sustained therapeutic levels, potentially making it a superior alternative to current drug-coated balloons or drug-eluting stents.

The SirPlux Duo DCB is distinguished by its ability to simultaneously administer sirolimus and paclitaxel, enhancing its potency and dosing efficiency. ANT's novel nanoparticle encapsulation and delivery platform ensures these drugs remain bioavailable within the tissue over the long term, avoiding the complications associated with permanent stent implants.

Marwan Berrada-Sounni, Co-founder and CEO of ANT, expressed enthusiasm for the upcoming DYNAMIC DUO I EFS study, which continues the validation of SirPlux™ Duo DCB’s performance. This study aligns with ANT's mission to advance nanotechnology-based solutions, leveraging the combined efficacy of sirolimus and paclitaxel for sustained, safe therapy without permanent implants.

The DYNAMIC DUO I EFS study is a prospective, multi-center, non-randomized trial that will enroll patients with symptomatic stable angina, unstable angina, or NSTEMI, all having de novo coronary lesions with vessel diameters between 2 and 4 mm. The outcomes of this study will guide ANT in expanding its clinical programs towards broader commercialization in both U.S. and global markets.

Advanced NanoTherapies, part of the T45 Labs portfolio, specializes in developing nanoparticle technology-based platforms for drug delivery, focusing on minimally invasive cardiovascular applications. The SirPlux Duo DCB, ANT’s first product, represents a next-generation therapy for minimally invasive catheter procedures, offering a safer option for patients with arterial disease.