#USA #Santa Clara #Vascular Health #Dual-Drug #NanoTherapies

Advanced NanoTherapies' Landmark Funding Boosts Vascular Treatments

Advanced NanoTherapies, Inc. (ANT), based in Santa Clara, California, has successfully closed an oversubscribed Series B financing round, raising over $31 million. This financing round marks a significant milestone for the clinical-stage medtech company, which specializes in improving patient outcomes for those suffering from coronary and peripheral artery disease. The funding was co-led by an undisclosed strategic investor and S3 Ventures, and also saw contributions from T45 Fund along with both new and existing investors.

Revolutionizing Vascular Therapy

The funding will be pivotal in advancing ANT's groundbreaking project, the SirPlux Duo, which represents a novel approach to drug-coated balloon (DCB) therapy. This innovative device utilizes a proprietary nanoparticle delivery system, which facilitates active cellular uptake within the vessel wall and combines the strengths of two well-known antiproliferative drugs: sirolimus and paclitaxel. By marrying these two agents, ANT aims to optimize therapeutic effects while ensuring a more predictable and sustained vascular response compared to existing first-generation drug-coated balloons.

ANT's CEO, Marwan Berrada-Sounni, emphasized the importance of this financing, stating, "This milestone arrives at a crucial time for vascular intervention. While first-generation single-drug DCBs are making inroads in the U.S. market, they still expose the significant limitations of passive crystalline drug delivery systems. Our nanoparticle-enabled approach is a much-needed advancement in local vascular therapy."

Targeting Restenosis

Restenosis, or the re-narrowing of blood vessels after procedures like percutaneous coronary intervention (PCI), remains a major clinical obstacle primarily driven by cell proliferation at treatment sites. The SirPlux Duo is designed to combat this challenge by delivering both drugs simultaneously to the lesion site using functionalized nanoparticles, which allows for sustained local retention of the drugs at lower doses.

Dr. Rishi Puri, an interventional cardiologist at Cleveland Clinic, underscored the significance of this dual-delivery method, noting its potential to generate more effective treatment outcomes, saying, "This novel platform aims to improve drug retention at the site while minimizing downstream particulate burden and preserving future treatment options."

Built on a fully biodegradable framework and implemented in clinical studies, SirPlux Duo has received FDA breakthrough designation, although it is currently still an investigational device not yet approved for commercial use.

Evidence and Clinical Trials

ANT's promising approach is backed by encouraging clinical experiences, including a first-in-human study conducted across Australia, the Dominican Republic, and New Zealand involving 28 patients, which demonstrated no new treatment failures over a two-year follow-up period. Furthermore, ongoing research in Spain encompasses a 30-patient study designed to align with U.S. regulatory protocols.

Brian R. Smith, Managing Director at S3 Ventures, commented on the financing, noting, "This investment reinforces the potential of ANT's differentiated platform and the progress achieved in science, clinical execution, and regulatory pathways. ANT is well-positioned for pivotal execution and to bring a transformative therapy to patients in need of better options."

Future Directions

As ANT gears up for the next phases of development, it is focused on scaling manufacturing operations to meet the FDA's Investigational Device Exemption (IDE) requirements for both coronary and peripheral applications. Plans include submission for two coronary indications aimed at in-stent restenosis and small-vessel de novo lesions, as well as completing their testing package for an early feasibility study in below-the-knee applications.

Conclusion

Advanced NanoTherapies stands on the brink of revolutionizing vascular treatments with its SirPlux Duo. With sufficient funding backing their innovative dual-drug technology, ANT is prepared to redefine vascular interventions while also addressing the significant challenges of restenosis, ensuring better clinical outcomes for patients worldwide. Their commitment to advancing medical technology holds promise for millions affected by arterial diseases.