Advanced NanoTherapies (ANT) Secures $4M Strategic Investment to Accelerate Clinical Development of SirPlux Duo Drug-Coated Balloon (DCB) for Treating de novo Coronary Artery Disease (CAD)

Milestone achieved as company announces successful enrollment of ten patients in its First-In-Human (FIH) Trial, ADVANCE-DCB

LOS GATOS, CA – August 22nd, 2023 – Advanced NanoTherapies Inc. (ANT), a clinical-stage medical device company committed to solving the most significant challenges in vascular disease through the creative applications of nanotechnology, today announced a $4M Series A extension from a prominent undisclosed strategic medical device company. Additionally, ANT successfully treated the first cohort of study participants in its ADVANCE-DCB first-in-human (FIH) trial, demonstrating initial short-term safety data for the next-generation SirPlux Duo Drug-Coated Balloon (DCB). The trial is evaluating the safety and performance of the SirPlux Duo DCB in de novo coronary artery disease (CAD).

“Today, we celebrate two remarkable accomplishments for ANT and SirPlux Duo DCB,” said Marwan Berrada, Co-Founder and CEO of ANT. “I welcome the participation of a new strategic partner as this additional investment will bolster ANT’s clinical programs and accelerate the path toward U.S. IDE approval for the SirPlux Duo DCB. I also thank the entire clinical team and ANT’s scientific advisory board for their efforts and expertise to reach these important milestones for the company.”

The SirPlux Duo DCB combines the synergistic power of sirolimus and paclitaxel to create a next-generation, front-line therapy engineered to provide stent-like patency and restenosis prevention while leaving no implant behind. The DCB delivers low-dose, long-term release of both compounds to inhibit cell growth, resulting in maximum potency exceeding other DCBs or drug-eluting stents.1 The ANT nanoparticle drug-encapsulation and delivery platform is designed to provide safe, reliable, and sustained bioavailability of the two synergistic drugs in tissue.

“I am pleased to be part of the initial cases of ANT’s novel technology,” says Investigator Rishi Puri MD, PhD, a Coronary and Structural Heart Interventional Cardiologist at the Cleveland Clinic’s Heart, Vascular and Thoracic Institute. “This technology will allow me to offer a safe and prolonged therapy for preventing coronary restenosis without leaving a permanent implant behind.”

“The SirPlux Duo DCB could have an immense impact on how we approach coronary interventions,” commented Investigator Dr. Jith Somaratne, Interventional Cardiologist at Auckland City Hospital and The Heart Group in Auckland, New Zealand. “Combining two potent antiproliferative drugs in a reliable nanoparticle platform may be the key to simultaneously reducing adverse events and maintaining patency. This study provides a critical step in proving the safety and clinical performance of next-generation DCBs.”

The Company plans to share angiographic data from its ADVANCE-DCB FIH trial in early 2024.

1. Data on file at ANT.