ADVANCED NANOTHERAPIES ANNOUNCES POSITIVE RESULTS IN ITS FIRST HUMAN TRIAL AND PLANS AN EARLY FEASIBILITY STUDY OF THE SIRPLUX™ DUO ENGINE-COATED BALLOON IN THE US

• The first-of-its-kind dual drug therapy for de novo coronary disease enters clinical phase in the US
• Novel nanoparticle technology platform aims to deliver two proven drugs for vascular patency and restenosis prevention

SANTA CLARA, California., Oct 26, 2024 /PRNewswire/ — Advanced Nanotherapies (ANT), a clinical-stage medical device company committed to solving the biggest challenges in vascular diseases through innovative applications of nanotechnology, announced positive results from its first-in-human study (FIH ) to evaluate the next generation SirPlux™ Duo Drug-Coated Balloon (DCB). The company also announced plans to proceed with conducting its early feasibility study (EFS) in the United States, known as DYNAMIC DUO I, to evaluate the safety and performance of the SirPlux™ Duo DCB in de novo coronary lesions. SirPlux™ Duo DCB provides a synergistic dual therapy of sirolimus and paclitaxel and is designed for vascular patency and prevention of restenosis.

“SirPlux Duo DCB’s innovative drug delivery platform is poised to redefine the treatment of coronary disease,” stated Dr. Bernardo CorteseMD, FESC, FSCAI, Director, Interventional Coronary Center, University Hospitals and Professor of Medicine, Western Reserve case. “By combining two proven drugs with novel nanoparticle technology, SirPlux Duo DCB aims to minimize drug flaking, provide sustained therapeutic-level drug therapy and achieve the best properties of the two drugs, theoretically making it a strong alternative to Frontline devices make current DCBs or drug-eluting stents.

SirPlux Duo DCB is the only therapy designed to co-administer sirolimus and paclitaxel 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 sustainable long-term tissue bioavailability without stent loading.

“We are pleased to take this next step to further validate the clinical performance of SirPlux™ Duo DCB, a novel technology licensed from Cleveland Clinic,” said Marwan Berrada SounniCo-founder and CEO of ANT. “The further development of our DYNAMIC DUO I EFS is in line with our vision to advance nanotechnology-based solutions that combine the power of sirolimus and paclitaxel to offer safe and prolonged therapy without leaving a permanent implant behind.”

The planned DYNAMIC DUO I EFS study is a prospective, multicenter, non-randomized study that includes patients with symptomatic stable angina, unstable angina or NSTEMI with de novo coronary lesions with reference vessel diameters of 2 to 4 mm and treated. The results of this study will provide the Company with insight into how it can advance its clinical programs into more comprehensive commercialization plans in the U.S. and global markets.

About Advanced Nano Therapies (ANT)
Advanced Nanotherapies, Inc., a member of the T45 Labs portfolio, is a highly specialized medical device company developing a drug delivery platform based on nanoparticle technology. The company focuses on minimally invasive cardiovascular applications to provide patients with arterial diseases a safer therapeutic option. The company's first product is the SirPlux Duo Drug-Coated Balloon (DCB), a next-generation, cutting-edge therapy for minimally invasive catheter procedures.

To learn more about Advanced Nanotherapies, visit www.advancednanotherapies.com.

Attention: The products are currently in development and are not available for sale.

SOURCE Advanced Nano Therapies

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