Advanced NanoTherapies Attracts More Than $31 Million From Investors

Advanced NanoTherapies Inc. (ANT) has closed an oversubscribed Series B financing totaling more than $31 million co-led by an undisclosed strategic investor and S3 Ventures, with participation from the T45 Fund and new and existing supporters.

ANT is striving to redefine the vascular intervention paradigm with a next-generation dual-drug (paclitaxel and sirolimus) nanoparticle on a percutaneous balloon platform. This approach attempts to maximize therapeutic effects while promoting a more predictable, sustained vascular response compared with first-generation drug-coated balloons (DCBs) with a crystalline single drug.

“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 CEO Marwan Berrada-Sounni said. “ANT is positioned to advance the field through a differentiated nanoparticle-enabled approach to local vascular therapy, which is long overdue.”

“Restenosis after PCI (percutaneous coronary intervention) continues to be a meaningful clinical challenge, largely driven by cell proliferation at the treatment site. This platform aims to deliver two drugs simultaneously to the lesion site using functionalized nanoparticles, enabling sustained local drug retention at lower doses,” stated Rishi Puri, M.D., an interventional cardiologist at the Cleveland Clinic.

The technology is exclusively licensed from Cleveland Clinic and built as a drug-agnostic, fully biodegradable platform for coronary, peripheral, and future vascular applications. SirPlux Duo, ANT’s lead program, has received U.S. Food and Drug Administration (FDA) breakthrough designation and is not yet approved for commercial use.

“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,” commented Azeem Latib, M.D., medical director, Structural Heart Intervention, Montefiore Einstein. “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.”

Clinical experience supports this approach, including a first-in-human study of 28 patients across Australia, the Dominican Republic, and New Zealand, with a two-year follow-up showing no new treatment failures. In Spain, investigators are conducting an ongoing 30-patient study designed to mirror the U.S. pivotal protocol, which is currently in follow-up. Together, these data sets are expected to create a strong foundation for U.S. pivotal execution.

“This financing validates the strength of ANT’s platform and the momentum built across science, clinical execution, and regulatory readiness,” S3 Ventures Managing Director Brian R. Smith commented. “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.”

Next steps include scaling up manufacturing to meet FDA Investigational Device Exemption (IDE) requirements for devices across both coronary and peripheral programs. U.S. IDE submissions will advance two coronary indications: in-stent restenosis and small-vessel de novo lesions. Additional priorities include completing the testing package and IDE submission for a U.S. BTK early feasibility study, pursuing a pivotal clinical trial agreement with the FDA, and identifying clinical sites outside the U.S. as early pivotal enrollment centers.

A T45 Labs portfolio company, Advanced NanoTherapieis developing a differentiated functionalized nanoparticle platform for local, dual-drug delivery during catheter-based interventions. The company’s lead program, SirPlux Duo, establishes a new category in drug-coated balloon (DCB) therapy by actively delivering two synergistic drugs simultaneously to vascular cells, enabling controlled, sustained dual-drug delivery at the lesion site. The technology is exclusively licensed from Cleveland Clinic and is under clinical evaluation in the ADVANCE-DUO study. SirPlux Duo received FDA breakthrough designation and is an investigational device that has not yet been approved for commercial use.

Founded in 2005, S3 Ventures is one of the largest and longest-serving venture capital firms in Texas. Backed by a philanthropic family with a multi-billion-dollar foundation, it empowers visionary founders with the patient capital and proper resources required to grow high-impact companies in business and healthcare technology. With more than $1 billion in assets under management, S3 Ventures leads investments in Seed, Series A, and Series B rounds, ranging from $500,000 to $10 million, with the capacity to invest more than $20 million in a company’s lifetime.