• First-of-its-kind Dual-Drug Therapy for Coronary De Novo Disease Moves Toward U.S. Clinical Phase
• Novel Nanoparticle Technology Platform Aims to Deliver Two Proven Drugs for Vessel Patency and Restenosis Prevention

SANTA CLARA, Calif., Oct. 26, 2024 — Advanced NanoTherapies (ANT), a clinical-stage medical device company focused on innovative nanotechnology solutions for vascular disease, has announced positive results from its first-in-human (FIH) trial of the SirPlux™ Duo Drug-Coated Balloon (DCB). The company also announced plans to advance to its U.S. early feasibility study (EFS), known as DYNAMIC DUO I, to assess the safety and efficacy of the SirPlux™ Duo DCB in de novo coronary lesions. The SirPlux™ Duo DCB delivers a combined therapy of sirolimus and paclitaxel, designed for vessel patency and restenosis prevention.

“The innovative drug delivery platform of the SirPlux Duo DCB has the potential to change the way coronary disease is treated,” said Dr. Bernardo Cortese, MD, FESC, FSCAI, Director, Interventional Coronary Center, University Hospitals and Professor of Medicine, Case Western Reserve. “By combining two established drugs with this novel nanoparticle technology, the SirPlux Duo DCB aims to minimize drug flaking, provide sustained drug therapy at therapeutic levels, and benefit from the best aspects of both drugs, potentially making it a strong front-line device alternative to existing DCBs or drug-eluting stents.”

The SirPlux Duo DCB is the only therapy designed to concurrently deliver sirolimus and paclitaxel to inhibit cell growth with greater potency and an efficient dose. ANT’s advanced nanoparticle drug encapsulation and delivery platform is designed to ensure safe, reliable, and sustained long-term drug bioavailability in the tissue without the need for a stent.

“We are excited to take this next step in further validating the clinical performance of SirPlux™ Duo DCB, a novel technology licensed from the Cleveland Clinic,” said Marwan Berrada-Sounni, Co-founder and CEO of ANT. “Moving forward with our DYNAMIC DUO I EFS aligns with our vision of advancing nanotechnology-driven solutions that leverage the combined power of sirolimus and paclitaxel to offer a safe and prolonged therapy without leaving a permanent implant behind.”

The planned DYNAMIC DUO I EFS study is a prospective, multi-center, non-randomized study that will enroll and treat patients with symptomatic stable angina, unstable angina, or NSTEMI who have de novo coronary lesions with reference vessel diameters of 2 to 4 mm. The results from this study will guide the Company in advancing its clinical programs towards broader commercialization plans in the U.S. and international markets.

About Advanced NanoTherapies (ANT)
Advanced NanoTherapies, Inc., a member of the T45 Labs portfolio, is a highly specialized medical device company developing a nanoparticle technology-based platform for drug delivery. The Company focuses on minimally invasive cardiovascular applications to bring a safer therapeutic option to patients with arterial disease. The company’s first product is the SirPlux Duo Drug-Coated Balloon (DCB), a next-generation front-line therapy for minimally invasive catheter interventions.

To learn more about Advanced NanoTherapies, visit .

Caution: Products are currently in development and are not available for sale.

SOURCE Advanced NanoTherapies