Advanced NanoTherapies announced today that it received FDA breakthrough device designation for its SirPlux Duo drug-coated balloon (DCB).
Los Gatos, California-based Advanced NanoTherapies received the breakthrough nod for the use of the DCB in treating coronary artery disease in vessels less than 3.0mm. The regulatory win comes weeks after two previous breakthrough designations. SirPlux Duo already has a breakthrough designation for coronary in-stent restenosis (ISR) and peripheral below-the-knee (BTK) lesions.
SirPlux Duo combines sirolimus and paclitaxel to create a next-generation front-line therapy. It is designed to provide stent-like patency and restenosis prevention while leaving no implant behind. The DCB delivers low-dose, long-term release of both compounds to inhibit cell growth. This results in maximum potency exceeding any other DCB or drug-eluting stent, according to Advanced NanoTherapies.
“Despite decades of advances in drug-eluting stents, treating small coronary vessels continues to be challenging due to the unacceptable incidence of restenosis and target lesion failure,” said Dr. Rishi Puri coronary and structural heart interventional cardiologist in the Tomsich Family Department of Cardiovascular Medicine at Cleveland Clinic and co-principal investigator of the company’s ADVANCE-DCB clinical trial. “Advanced NanoTherapies is championing a novel stent-free option to address this clinical gap. I look forward to seeing how this technology can advance the field of coronary interventions by improving long-term clinical outcomes and preventing the need for repeat revascularizations.”
More about Advanced NanoTherapies and the SirPlux Duo
SirPlux Duo features a proprietary nanoparticle drug encapsulation and delivery platform. It provides safe and sustained bioavailability of sirolimus and paclitaxel in tissue for long-term outcomes.
Advanced NanoTherapies raised $7.2 million to support the technology earlier this year. The company has brought in $12.5 million in total since 2020.
“Our third breakthrough designation emphasizes the urgent need for new coronary and peripheral therapies with a leave nothing behind approach,” said Marwan Berrada-Sounni, co-founder and CEO of Advanced NanoTherapies. “We appreciate the collaborative approach the FDA has taken to reviewing our technology and the novelty of combining two synergistic drugs. Over the coming months, we will build on this positive momentum as we generate first-in-human clinical data using the SirPlux Duo DCB.”