Advanced NanoTherapies (ANT), a vascular disease-focused nanotechnology firm, has announced positive results from its first-in-human (FIH) trial for the SirPlux Duo Drug-Coated Balloon (DCB).  

Additionally, the California-based nanotechnology company has unveiled plans to advance its US early feasibility study (EFS), named DYNAMIC DUO I.

SirPlux Duo is an investigational next-generation, front-line therapy intended for minimally invasive catheter interventions.

It uses a dual-drug therapy of sirolimus and paclitaxel, designed to improve vessel patency and prevent restenosis. The therapy simultaneously delivers sirolimus and paclitaxel to inhibit cell growth at a higher potency.

Advanced NanoTherapies utilises a novel nanoparticle drug encapsulation and delivery platform. This design ensures the safe, reliable, and sustained long-term bioavailability of both drugs in tissue, eliminating the need for a stent.

The DCB received the US Food and Drug Administration (FDA) breakthrough device designation for treating coronary artery disease (CAD) in September 2022.

It also holds breakthrough designations for coronary in-stent restenosis (ISR) and peripheral below-the-knee (BTK) lesions.

Advanced NanoTherapies co-founder and CEO Marwan Berrada-Sounni said: “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.”

The DYNAMIC DUO I EFS study is a prospective, multi-centre, non-randomised trial. It will assess the safety and performance of the SirPlux Duo DCB in treating de novo coronary lesions.  

The trial will enrol patients with symptomatic stable angina, unstable angina, or NSTEMI who have de novo coronary lesions with reference vessel diameters of two to four mm.

Results from this study will guide Advanced NanoTherapies in advancing its clinical programmes and developing commercialisation plans in the US and global markets.

Last year, the nanotechnology company received a $4m Series A extension from an undisclosed medical device firm.