Advanced NanoTherapies Secures $31M+ Series B Funding to Advance First-in-Class Dual-Drug (Paclitaxel + Sirolimus) Nanoparticle-Coated Balloon Platform

Jun 08, 2026 08:00 CST Updated 08:00

Advanced NanoTherapies

Medical Device Developer

Lead: A Major Transformation in the Era of Single-Drug Drug-Coated Balloons! Paclitaxel + Sirolimus Dual-Drug Nanoplatform Receives FDA Breakthrough Designation, Zero Treatment Failures in 2-Year Clinical Trials, $31 Million Oversubscribed Series B Financing, Full Steam Ahead for Pivotal Clinical Trials in China and the US

On June 3, 2026, Advanced NanoTherapies (ANT), an innovative vascular interventional device company, officially announced major financing news: the company has oversubscribed its $31 million Series B funding round.

This funding round was co-led by an undisclosed strategic investor and S3 Ventures, with participation from T45 Capital and both new and existing investors. The proceeds will be exclusively allocated to upgrading the production capacity of its core R&D platform—the dual-drug nanoparticle-coated balloon—as well as advancing U.S. clinical trial applications and global multicenter clinical trials, thereby accelerating the commercialization of next-generation vascular interventional technologies.

In the fields of interventional cardiology and peripheral vascular intervention, restenosis following percutaneous coronary intervention (PCI) remains a globally recognized core clinical challenge. Leveraging exclusively licensed technology from the Cleveland Clinic, Advanced NanoTherapies has developed a globally innovative dual-drug nanocoated drug-coated balloon platform, directly breaking through the technical bottlenecks of traditional single-drug drug-coated balloons (DCBs) and regarded by the industry as a leapfrog innovation in vascular intervention.

01.The Inherent Limitations of Traditional DCBs Are Becoming Prominent, Urgently Calling for Technological Breakthroughs in Clinical Practice

Currently, the mainstream first-generation drug-coated balloons in clinical practice all adopt a single-crystal, single-drug coating strategy, targeting a single therapeutic mechanism, and thus suffer from numerous unavoidable limitations.

Abnormal cellular proliferation at the lesion site following percutaneous coronary intervention (PCI) is the core driver of in-stent restenosis. Conventional single-drug drug-coated balloons fail to comprehensively and durably inhibit neointimal hyperplasia, resulting in limited therapeutic efficacy and unpredictable vascular repair outcomes. Issues such as short drug retention time and unstable efficacy are common, leaving a significant population of patients with in-stent restenosis or de novo lesions in small vessels with limited treatment options.

Addressing this critical clinical unmet need, Advanced NanoTherapies’ newly developed next-generation nanoballoon platform transcends traditional technical frameworks by innovatively enabling simultaneous targeted dual-drug delivery of paclitaxel and sirolimus, thereby fundamentally redefining the therapeutic paradigm of drug-coated balloons (DCBs).

02.Hardcore Technological Innovation: Dual-Drug Nano-Synergy Achieves Dual Upgrade in Efficacy and Safety

ANT’s core product, SirPlux Duo, is an innovative medical device built on a fully biodegradable, drug-agnostic nanoplatform, adaptable to various vascular intervention scenarios including coronary and peripheral arteries, with core advantages far surpassing those of traditional single-drug drug-coated balloons (DCBs).

Unlike the crystalline drug coating of traditional balloons, this technology encapsulates two core therapeutic agents within functional nanoparticles for precise delivery to vascular lesion targets, achieving multiple breakthroughs:

Low Dose, High Efficacy. The pharmacological complementarity and synergistic effects of the dual-drug regimen enable enhanced and more stable anti-proliferative efficacy at reduced dosages, thereby maximizing therapeutic effectiveness;
Prolonged Local Retention for More Stable Repair. Nano-carriers enable sustained drug retention in lesion tissues, providing long-term inhibition of abnormal cell proliferation and addressing the issues of rapid efficacy decay and uncontrollable vascular repair associated with traditional drug-coated balloons;
Reduce Particle Burden, Preserve Future Treatment Options. The optimized nano-delivery system significantly reduces residual particles in downstream vessels, mitigating the risk of distal embolization while preserving patients’ future options for endovascular intervention.

Professor Rishi Puri of the Cleveland Clinic in the United States stated that the core value of this innovative platform lies in achieving targeted, sustained release of dual drugs via nanocarriers, thereby delivering superior vascular repair outcomes at lower doses and fundamentally addressing the clinical challenge of restenosis following percutaneous coronary intervention (PCI).

Professor Azeem Latib of Montefiore Einstein Hospital in New York gave it high praise: the emergence of the new dual-drug DCB track represents a leapfrog breakthrough in the field of vascular intervention.

The therapeutic efficacy of this product is non-inferior to that of drug-eluting stents (DES), while perfectly preserving the core advantage of drug-coated balloons (DCB)—"no implant residue post-intervention." This approach not only avoids the long-term risk of thrombosis associated with multi-layer stent implantation but also provides superior long-term clinical outcomes for patients with various types of vascular lesions.

03.Robust Clinical Evidence from Multiple Countries: Zero Treatment Failures at Two-Year Follow-Up

This disruptive device is not merely a laboratory concept; it has already accumulated robust global early-stage clinical data, with its safety and efficacy preliminarily validated.

The world’s first-in-human study, previously conducted in Australia, the Dominican Republic, and New Zealand, enrolled a total of 28 patients. Two-year long-term follow-up results showed no new cases of treatment failure, demonstrating excellent clinical safety.

Meanwhile, Spain is conducting a prospective study involving 30 patients, with the trial protocol fully aligned with the U.S. pivotal clinical core standards. The trial is currently in the ongoing follow-up phase. These two sets of overseas clinical data will establish a robust evidence-based foundation for the subsequent U.S. pivotal clinical trials of the product.

With its differentiated innovative value and impressive early clinical results, SirPlux Duo has received the U.S. FDA Breakthrough Device Designation, granting it access to priority communication and an accelerated review pathway. It is a benchmark product with significant commercial potential in the next-generation drug-coated balloon (DCB) sector, although it has not yet been formally approved for market launch.

04.$10 Million Investment Fuels Accelerated Global Clinical Development

Following the closing of this oversubscribed $31 million Series B financing round, ANT has formally clarified its subsequent core development strategy, comprehensively accelerating the product commercialization process:

Production Capacity Standardization Upgrade: Expand production scale, optimize manufacturing processes, fully meet the production quality control standards for FDA Investigational Device Exemption (IDE), and accommodate the clinical trial requirements for both coronary and peripheral vascular pipelines;
Advance IDE submissions for core indications: Focus on tackling two major coronary core indications—in-stent restenosis and de novo lesions in small coronary vessels—complete US IDE submissions, and initiate key clinical development planning;
Optimize the peripheral vascular pipeline layout: Complete the full suite of testing and validation for below-the-knee (BTK) peripheral vascular disease, advance the submission of the Investigational Device Exemption (IDE) for early feasibility studies in the United States, and address gaps in the peripheral intervention portfolio.
Establish a Global Clinical Development System: Actively finalize key pivotal clinical trial collaboration plans with the FDA, while simultaneously deploying overseas clinical centers outside the United States to proactively build a reserve of global patient enrollment.

Notably, ANT’s nano-coating platform is characterized by drug independence, full biodegradability, and scalability, representing more than a single-product technology. It can be flexibly adapted to accommodate a broader range of therapeutic agents and expand into additional vascular intervention scenarios, offering substantial potential for long-term technological iteration. This constitutes the core rationale behind the oversubscription of capital in this financing round.

05.Industry Shift: Dual-Drug Nano-DCB Ushers in a New Era of Interventional Therapy

For years, the global drug-coated balloon (DCB) market has remained stuck in a phase of involution centered on single-drug technologies, with long-standing, unbroken barriers related to efficacy ceilings, safety concerns, and limited indications.

The advent of SirPlux Duo has directly defined the technical standards for next-generation dual-drug nano-DCBs, breaking the industry dilemma that “efficacy and implant-free treatment cannot be achieved simultaneously”: compared with traditional drug-coated balloons, it offers comprehensive efficacy upgrades; compared with stents, it retains the core advantages of being implant-free and facilitating repeat interventions.

From a clinical perspective, this technology offers a safer, more durable, and superior new treatment option for patients at high bleeding risk, those requiring multiple interventions, and those with complex vascular lesions; from an industry standpoint, it completely reshapes the competitive landscape of drug-coated balloon (DCB) technology, pioneering a new category distinct from traditional single-drug drug-coated balloons.

06.Conclusion

The era of single-drug drug-coated balloons (DCBs) has reached its peak. The combination of nanocarriers and dual-drug synergy has become the core direction for innovation in vascular interventional devices. With increased capital investment, FDA endorsement, and supportive clinical data from multiple countries, this innovative dual-drug nano-drug balloon is steadily advancing its commercialization process. It is poised to initiate a new global transformation in vascular interventional therapy, bringing new hope for treatment to millions of patients with cardiovascular diseases.

# Drug-Coated Balloon # Coronary Intervention # Medical Device Financing # FDA Breakthrough Device #Peripheral Vascular Intervention # Medical Innovation