Advanced Nanotherapies Announces Positive Results in Its First-In-Human Trial and Plans for U.S. Early Feasibility Study for SirPlux™ Duo Drug-Coated Balloon

• 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 /PRNewswire/ -- Advanced NanoTherapies (ANT), a clinical-stage medical device company committed to solving the most significant challenges in vascular disease through innovative applications of nanotechnology, announced positive results from its first-in-human (FIH) trial evaluating the next-generation SirPlux™ Duo Drug-Coated Balloon (DCB). The Company also announced plans to proceed towards executing its U.S. early feasibility study (EFS), known as DYNAMIC DUO I, to evaluate the safety and performance of the SirPlux™ Duo DCB in de novo coronary lesions. SirPlux™ Duo DCB delivers a synergistic dual-drug therapy of sirolimus and paclitaxel and is engineered for vessel patency and restenosis prevention.

"The innovative drug delivery platform of the SirPlux Duo DCB is poised to redefine how coronary disease is treated," stated Dr. Bernardo Cortese, MD, FESC, FSCAI, Director, Interventional Coronary Center, University Hospitals and Professor of Medicine, Case Western Reserve. "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."

SirPlux Duo DCB is the only therapy designed to deliver sirolimus and paclitaxel simultaneously to inhibit cell growth at a higher potency and efficient dose. ANT's novel nanoparticle drug encapsulation and delivery platform is designed to provide the two drugs with safe, reliable, and sustained long-term in-tissue bioavailability with no stent burden.

"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," 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 combine the 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 symptomatic stable angina, unstable angina, or NSTEMI patients with de novo coronary lesions with reference vessel diameters of 2 to 4 mm. The results from this study will inform the Company on how to advance its clinical programs to broader commercialization plans in the U.S. and global 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 www.advancednanotherapies.com.

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