Advanced NanoTherapies Secures $31 Million Series B for Dual-Drug Nanoparticle Balloon Platform
Santa Clara, California-based Advanced NanoTherapies has announced the closing of an oversubscribed Series B financing totaling more than $31 million. The round was co-led by an undisclosed strategic investor and S3 Ventures, with participation from the T45 Fund and other new and existing investors. The financing supports the approval of a U.S. Investigational Device Exemption (IDE), coronary clinical advancement, and expansion into below-the-knee peripheral applications.
Advanced NanoTherapies is developing a next-generation dual-drug nanoparticle platform combining paclitaxel and sirolimus on a percutaneous balloon platform. The approach aims to maximize therapeutic effects while promoting a more predictable, sustained vascular response compared with first-generation drug-coated balloons that use a crystalline single-drug. SirPlux Duo, the company’s lead program, has received FDA Breakthrough Device Designation and is not yet approved for commercial use. The technology is exclusively licensed from Cleveland Clinic and built as a drug-agnostic, fully biodegradable platform for coronary, peripheral, and future vascular applications.
Marwan Berrada-Sounni, Chief Executive Officer of Advanced NanoTherapies, stated that first-generation single-drug drug-coated balloons are gaining traction in the U.S. market but continue to expose the limitations of passive crystalline drug delivery, adding that the company is uniquely positioned to advance the field through a differentiated nanoparticle-enabled approach. Dr. Rishi Puri, an interventional cardiologist at Cleveland Clinic, said restenosis after percutaneous coronary intervention continues to be a meaningful clinical challenge, and that this platform aims to deliver two drugs simultaneously to the lesion site using functionalized nanoparticles.
Clinical experience includes 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. An ongoing 30-patient study in Spain is designed to mirror the U.S. pivotal protocol. Next steps include scaling up manufacturing to meet FDA IDE requirements, submitting IDE applications for two coronary indications (in-stent restenosis and small-vessel de novo lesions), and pursuing a U.S. below-the-knee early feasibility study.
