Advanced NanoTherapies (ANT), a clinical-stage medtech company focused on improving outcomes for patients with coronary and peripheral artery disease, announced the closing of an oversubscribed Series B financing round totaling more than $31 million. The financing was co-led by an undisclosed strategic investor and S3 Ventures, with participation from the T45 Fund as well as new and existing investors.
The funding will support U.S. regulatory and clinical milestones for ANT’s lead product, SirPlux Duo, including approval of an Investigational Device Exemption (IDE), advancement of coronary clinical programs, and expansion into below-the-knee (BTK) peripheral artery disease applications.
ANT is developing a next-generation drug-coated balloon (DCB) platform that combines two antiproliferative drugs, paclitaxel and sirolimus, delivered through a proprietary nanoparticle-based system. The company believes the approach can improve drug uptake within vessel walls while providing a more predictable and sustained therapeutic effect compared with first-generation single-drug DCB technologies.
The technology, which is exclusively licensed from Cleveland Clinic, is designed as a fully biodegradable and drug-agnostic platform that can be applied across coronary, peripheral, and future vascular interventions. SirPlux Duo has received FDA Breakthrough Device designation but has not yet been approved for commercial use.
According to the company, clinical experience to date includes a first-in-human study involving 28 patients across Australia, the Dominican Republic, and New Zealand, with two-year follow-up data showing no new treatment failures. Investigators in Spain are also conducting a 30-patient study designed to mirror the planned U.S. pivotal protocol, with patient follow-up currently underway.
The company plans to use the new capital to expand manufacturing capabilities and prepare regulatory submissions for multiple programs. Planned milestones include U.S. IDE submissions for coronary indications involving in-stent restenosis and small-vessel de novo lesions, completion of testing and IDE submission for a BTK early feasibility study, pursuit of a pivotal clinical trial agreement with the FDA, and the establishment of international clinical sites to support early pivotal trial enrollment.
S3 Ventures Managing Director Brian R. Smith said the financing reflects confidence in ANT’s scientific foundation, clinical progress, and regulatory strategy. He noted that the company’s experience across multiple coronary studies and defined U.S. regulatory pathway position it well for pivotal clinical execution.
Founded as a portfolio company of T45 Labs, Advanced NanoTherapies is developing functionalized nanoparticle technologies for local dual-drug delivery during catheter-based vascular interventions. Its lead program, SirPlux Duo, is currently being evaluated in the ADVANCE-DUO clinical study.
KEY QUOTES:
“This financing milestone arrives at a pivotal moment in vascular intervention. First-generation single drug DCBs are gaining traction in the U.S. market, but they continue to expose the limitations of passive crystalline drug delivery. ANT is uniquely positioned to advance the field through a differentiated nanoparticle-enabled approach to local vascular therapy, which is long overdue.”
Marwan Berrada-Sounni, CEO, Advanced NanoTherapies
“Restenosis after PCI (percutaneous coronary intervention) continues to be a meaningful clinical challenge, largely driven by cell proliferation at the treatment site. This novel platform aims to deliver two drugs simultaneously to the lesion site using functionalized nanoparticles, enabling sustained local drug retention at lower doses.”
Rishi Puri, MD, Interventional Cardiologist, Cleveland Clinic
“SirPlux Duo enables dual-drug delivery with controlled cellular uptake and sustained tissue retention, generating higher potency at lower doses, reducing downstream particulate burden, and preserving future treatment options across coronary and peripheral vascular disease. The creation of a new DCB category using two rather than one drug is a leapfrogging moment in vascular intervention, providing sustainable clinical outcomes that are non-inferior to those of drug-eluting stents while maintaining the intervention strategy of leaving nothing behind.”
Azeem Latib, MD, Medical Director, Structural Heart Intervention, Montefiore Einstein
“This financing validates the strength of ANT’s platform and the momentum built across science, clinical execution, and regulatory readiness. With clinical experience across two coronary studies and a clear U.S. regulatory path, ANT is well positioned to move toward pivotal execution and to bring a truly differentiated therapy to patients needing better options.”
Brian R. Smith, Managing Director, S3 Ventures
