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June 2, 2026
Advanced NanoTherapies Secures Financing for SirPlux Duo DCB Therapy
KEY TAKEAWAYS
- Advanced NanoTherapies closed a Series B round totaling more than $31 million.
- The funding will support FDA IDE activities for SirPlux Duo in coronary and BTK peripheral applications.
- The investigational SirPlux Duo features a dual drug (paclitaxel and sirolimus) nanoparticle on a percutaneous balloon platform.
June 2, 2026—Advanced NanoTherapies, Inc. (ANT), which is developing the SirPlux Duo drug-coated balloon therapy for coronary and peripheral applications, announced the closing of a Series B financing totaling more than $31 million. The financing round was led by an undisclosed strategic investor and S3 Ventures, with participation from the T45 Fund and new and existing investors.
The company stated that the funding will be used to support the approval of an FDA investigational device exemption (IDE) for the SirPlux Duo; the device’s coronary clinical advancement; and its expansion into below-the-knee (BTK) peripheral applications. SirPlux Duo has received FDA Breakthrough Device designation and is an investigational device that has not yet been approved for commercial use.
As noted in the press release, ANT’s SirPlux Duo features a dual drug (paclitaxel and sirolimus) nanoparticle on a percutaneous balloon platform. The company’s nanoparticle delivery system drives active cellular uptake within the vessel wall. The technology is built as a drug-agnostic, fully biodegradable platform for coronary, peripheral, and future vascular applications.
The technology is exclusively licensed from Cleveland Clinic in Cleveland, Ohio, and is under clinical evaluation in the ADVANCE-DUO study.
Additionally, ANT stated that clinical experience with SirPlux Duo includes a first-in-human study of 28 patients in Australia, the Dominican Republic, and New Zealand, with 2-year follow-up showing no new treatment failures. Investigators in Spain are conducting a 30-patient study designed to mirror the United States pivotal protocol, which is currently in follow-up. These data sets are expected to create a foundation for the United States pivotal execution.
The company advised that the next steps include scaling up manufacturing to meet FDA IDE requirements for devices across both coronary and peripheral programs. The IDE submissions will advance two coronary indications: in-stent restenosis and small-vessel de novo lesions.
Other priorities include completing the testing package and IDE submission for a United States BTK early feasibility study; pursuing a pivotal clinical trial agreement with the FDA; and identifying clinical sites outside the United States as early pivotal enrollment centers, noted the ANT press release.
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