Advanced NanoTherapies Secures Over $31 Million for Dual-Drug Treatment Development

Advanced NanoTherapies' Funding Breakthrough

In an exciting development for the medical technology sector, Advanced NanoTherapies, Inc. (ANT) has successfully raised over $31 million in a Series B funding round. This funding is earmarked for the development of an innovative platform that utilizes a nanoparticle-coated balloon for vascular treatments, designed to improve outcomes for patients suffering from coronary artery disease and peripheral artery disease.

The latest financing round was led by an undisclosed strategic investor along with S3 Ventures, with participation from the T45 Fund and several new and existing investors. The funding will further advance the company’s clinical development and is specifically directed towards obtaining the U.S. Investigational Device Exemption (IDE) for their product. This exemption is critical for pushing forward with clinical trials in coronary surgeries and extending its applications to below-the-knee (BTK) peripheral vascular treatments.

ANT is paving the way in the drug-coated balloon (DCB) therapeutic category with its flagship product, SirPlux Duo. This dual-drug device employs a unique nanoparticle delivery system that enhances the uptake of its components into the vessel walls. By utilizing the combined strengths of sirolimus and paclitaxel, both well-established antiproliferative agents, the aim is to provide a more effective and longer-lasting therapeutic solution compared to current first-generation DCBs that typically deliver a single crystalline drug.

Chief Executive Officer Marwan Berrada-Sounni emphasizes that this funding milestone arrives at a crucial juncture for vascular interventions. While first-generation DCBs are gaining traction in the U.S. market, they still exhibit limitations regarding the passive release of crystalline drugs. ANT’s strategy, which leverages a nanoparticle-based approach to local vascular therapy, aims to overcome these limitations significantly.

Dr. Rishi Puri, an interventional cardiologist at the Cleveland Clinic, outlined the concerning clinical challenge of restenosis following percutaneous coronary interventions (PCI). This issue is primarily attributed to cell proliferation at treatment sites. ANT's innovative platform aspires to deliver two drugs simultaneously to the lesion site via functionalized nanoparticles, allowing for sustained local drug retention at reduced dosages.

The technology has been exclusively licensed from the Cleveland Clinic and is designed as a drug-independent fully biodegradable platform for a range of vascular applications including coronary, peripheral, and future uses. SirPlux Duo has received FDA Breakthrough Device designation and is not yet approved for commercial use.

The dual-drug mechanism of SirPlux Duo facilitates controlled cellular uptake and sustained tissue retention, aiming to enhance efficacy while decreasing off-target particle load. Dr. Azeem Latib, medical director for structural heart interventions at Montefiore Einstein, added that introducing a new DCB category utilizing two pharmacological agents represents a significant leap in vascular intervention. The technology promises sustainable clinical outcomes that hold potential equivalence to drug-eluting stents while retaining a strategy that leaves no residues behind following treatment.

Initial clinical experiences have bolstered this approach, including a human study involving 28 patients across Australia, the Dominican Republic, and New Zealand. After two years of follow-up, no new treatment failures were reported. Researchers in Spain are currently conducting a study with 30 patients designed to reflect U.S. approval protocols, now in its observational phase. Collectively, these datasets will establish a robust foundation for conducting the pivotal U.S. clinical trial.

This funding marks not only a validation of ANT's unique platform but also underscores the momentum built in the areas of scientific research, clinical execution, and regulatory readiness, as noted by Brian R. Smith, Managing Director at S3 Ventures. With clinical experience from two coronary trials and a clear regulatory pathway in the U.S., ANT is well-equipped to progress towards its IDE submissions, offering a truly differentiated therapeutic option to patients in need.

Advancing production to meet FDA IDE requirements for both coronary and peripheral programs is the next step. The IDE submissions in the U.S. will advance two coronary indications: in-stent restenosis and de novo lesions in small vessels. Remaining priorities include completing the testing package and IDE submission for an early feasibility study in BTK in the U.S. and negotiating a pivotal clinical trial agreement with the FDA.

In summary, the advancements being made by Advanced NanoTherapies promise not only to redefine treatment methods for vascular diseases but also to enhance patient care overall. The innovative dual-drug delivery system is poised to make significant strides in therapeutic effectiveness, creating a new standard in vascular therapy.