Advanced NanoTherapies (ANT) has announced the closing of an oversubscribed Series B financing totalling more than US$31 million. The round was co-led by an undisclosed strategic investor and S3 Ventures, with participation from the T45 Fund and new and existing investors.
ANT states in a press release that it is “redefining the vascular intervention paradigm” with a next-generation dual-drug (paclitaxel and sirolimus) nanoparticle on a percutaneous balloon platform. The company notes that this approach aims to maximise therapeutic effects while promoting a more predictable, sustained vascular response compared with first-generation drug-coated balloons (DCBs) with a crystalline single drug.
“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 functionalised nanoparticles, enabling sustained local drug retention at lower doses,” said Rishi Puri (Cleveland Clinic, Cleveland, USA).
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 programme, has received US 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,” said Azeem Latib (Montefiore Einstein, New York, USA). “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 addition, in Spain, investigators are conducting an ongoing 30-patient study designed to mirror the US pivotal protocol, which is currently in follow-up. Together, ANT notes, these datasets are expected to create a strong foundation for US pivotal execution.
ANT shares that next steps include scaling up manufacturing to meet FDA investigational deveice exemption (IDE) requirements for devices across both coronary and peripheral programmes. US 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 US below-the-knee (BTK) early feasibility study, pursuing a pivotal clinical trial agreement with the FDA, and identifying clinical sites outside the USA as early pivotal enrolment centres.
