Advanced NanoTherapies Raises $31M Series B to Advance SirPlux Duo and FDA IDE Programs

Advanced NanoTherapies has raised more than $31M in an oversubscribed Series B financing round co-led by S3 Ventures and an undisclosed strategic investor, with participation from T45 Fund and existing investors. The funding will support FDA Investigational Device Exemption (IDE) activities, expansion of coronary artery disease (CAD) and peripheral artery disease (PAD) clinical programs, and development of below-the-knee vascular applications for the company's lead product, SirPlux Duo.

Advanced NanoTherapies, led by Founder and CEO Marwan Berrada, is developing a dual-drug coated balloon that delivers both paclitaxel and sirolimus using biodegradable nanoparticle technology. The company has also received FDA Breakthrough Device Designation for SirPlux Duo, a milestone that can help accelerate regulatory interactions and development. The financing reflects a broader trend across cardiovascular medtech: investors are increasingly backing technologies that combine proven treatment pathways with novel delivery mechanisms capable of producing better clinical outcomes.

What Happened

Medical technology financing tends to follow a familiar script. A company raises money. Investors issue supportive statements. Everyone talks about opportunity. The reality is usually much less glamorous. Cardiovascular devices live in one of healthcare's most unforgiving environments, where products face years of development, complex regulatory pathways, demanding physicians, and patients whose arteries do not care about investor presentations. That reality makes Advanced NanoTherapies' latest financing noteworthy.

The Santa Clara, California-based clinical-stage medtech company announced an oversubscribed Series B round exceeding $31M. The financing was co-led by S3 Ventures and an undisclosed strategic investor, with participation from T45 Fund and other investors. For Advanced NanoTherapies, this isn't the beginning of the story. It's another checkpoint in a capital formation journey that has steadily expanded since the company raised a $5.3M seed round in 2020, followed by a $7.2M Series A in 2022 and a $4M strategic investment in 2023. Collectively, the company has now secured more than $47.5M in confirmed funding.

That number matters less than what investors are funding. They're funding a regulatory roadmap. They're funding clinical evidence. They're funding the possibility that SirPlux Duo becomes something more than another entrant in the drug-coated balloon market.

Why This Matters

Advanced NanoTherapies is targeting a problem physicians have been wrestling with for years. When treating coronary artery disease (CAD) and peripheral artery disease (PAD), clinicians often face a difficult balancing act. Permanent implants can be effective, but they also introduce long-term considerations. Drug-coated balloons offer a leave-nothing-behind approach, but performance remains the critical question.

SirPlux Duo attempts to address that challenge through a dual-drug strategy. The platform combines paclitaxel and sirolimus, delivered through biodegradable functionalized nanoparticles designed to improve drug uptake and retention at the treatment site. The concept sounds straightforward. The execution is anything but. Medical history is filled with products that looked elegant in scientific theory but struggled under real-world clinical scrutiny. Investors understand that. Regulators certainly understand that.

That's why the funding is significant. The Series B proceeds are being directed toward FDA Investigational Device Exemption (IDE) activities, coronary clinical advancement, and below-the-knee peripheral programs. An FDA IDE allows a medical device to be studied in clinical trials before commercial approval. Those milestones represent the difference between an interesting technology and a validated medical product.

Market Context

Cardiovascular disease remains one of the largest healthcare markets in the world. At the same time, interventional cardiology continues searching for approaches that reduce complications, improve vessel healing, and provide durable outcomes without unnecessary procedural complexity. That search has created sustained interest in drug-coated balloon technology.

The broader market has already demonstrated demand for alternatives to permanent implants in specific clinical settings. What remains uncertain is which technologies can consistently deliver superior outcomes while navigating increasingly rigorous regulatory expectations. Advanced NanoTherapies is entering that conversation with a differentiated position.

Rather than relying on a single-drug coating strategy, the company is pursuing a dual-drug approach supported by nanoparticle-enabled delivery technology originating from intellectual property licensed through Cleveland Clinic Innovations. Investors are not simply betting on another balloon. They're betting on the possibility that drug delivery itself becomes the differentiator.

Leadership Behind the Platform

Technology rarely succeeds in isolation. Execution matters. Advanced NanoTherapies has assembled a leadership team that spans commercialization, clinical development, engineering, quality systems, and regulatory affairs.

Founder and CEO Marwan Berrada has guided the company since its early development. The broader leadership team includes Michael Mandel, Head of Corporate Development; Frank Proch, VP of R&D; Angela Mallery, VP of Regulatory Affairs & Quality Assurance; Joey Groszek, Director of Nanoparticle R&D; Mike Hogan, Sr. Director of Engineering; and Paul McFeely, Sr. Manager of Quality Assurance. The company's foundation also traces back to Co-Founder and former CMO Dr. Mehdi Shishehbor, whose clinical expertise helped shape the original vision behind the platform.

Scientific guidance is provided by Dr. Vinod Labhasetwar, Scientific Advisor to Advanced NanoTherapies and Professor and Endowed Chair of Nanomedicine at Cleveland Clinic Lerner Research Institute. In medtech, leadership teams do not get graded on vision statements. They get graded on regulatory submissions, clinical outcomes, manufacturing execution, and physician adoption. The next phase of growth will test all four.

What This Signals

The most interesting part of this financing may not be the size of the round. It's the type of company receiving it. Over the last several years, venture markets have frequently rewarded software businesses capable of scaling rapidly with relatively low regulatory friction. Advanced NanoTherapies represents the opposite model.

Clinical trials are expensive. Regulatory timelines are long. Evidence requirements are demanding. Yet investors continue funding companies capable of solving meaningful healthcare problems because successful outcomes create enormous clinical and economic value. The Series B financing suggests sophisticated investors still see opportunities in hard science, regulated innovation, and long-term product development. That matters far beyond a single company.

The Bigger Industry Shift

Healthcare innovation is entering a phase where the winning companies may not be those generating the most attention. They may be the companies generating the strongest evidence. Advanced NanoTherapies now moves into a period defined by FDA interactions, IDE activities, coronary studies, and below-the-knee clinical expansion.

The company has previously reported enrollment of 13 patients in its ADVANCE-DCB first-in-human study, with initial reports indicating 100% lesion and device success and no major adverse cardiac events in the early cohort. Capital opened the next door. Clinical data will decide what happens after it.

That dynamic is why investors, physicians, regulators, and medtech operators will be watching closely. The next chapter for Advanced NanoTherapies won't be written through financing announcements. It will be written through patient outcomes.

Frequently Asked Questions

What is Advanced NanoTherapies?

Advanced NanoTherapies is a clinical-stage medical device company developing nanoparticle-enabled drug-coated balloon technologies for coronary artery disease (CAD) and peripheral artery disease (PAD).

How much funding has Advanced NanoTherapies raised?

Advanced NanoTherapies has raised more than $47.5M in confirmed funding, including a $31M+ Series B announced in 2026.

What is SirPlux Duo?

SirPlux Duo is a dual-drug coated balloon that delivers paclitaxel and sirolimus through biodegradable nanoparticle technology to treat vascular disease.

What is an FDA Investigational Device Exemption (IDE)?

An FDA Investigational Device Exemption (IDE) allows a medical device to be studied in human clinical trials before receiving commercial approval.

What conditions is SirPlux Duo designed to treat?

SirPlux Duo is being developed for coronary artery disease, in-stent restenosis, small-vessel disease, and below-the-knee peripheral artery disease.

What is FDA Breakthrough Device Designation?

FDA Breakthrough Device Designation is a regulatory program designed to accelerate the development and review of technologies that address serious medical conditions.

Who leads Advanced NanoTherapies?

Advanced NanoTherapies is led by Founder and CEO Marwan Berrada.

Who invested in the Series B round?

The Series B was co-led by S3 Ventures and an undisclosed strategic investor, with participation from T45 Fund and additional investors.