Los Gatos, California-based Advanced NanoTherapies received the investment from a medical device company. It also announced the successful treatment of the first cohort of study participants in its drug-coated balloon trial. The first-in-human trial evaluates initial short-term safety data for the next-generation SirPlux Duo drug-coated balloon. It looks at the balloon in treating de novo coronary artery disease (CAD).
SirPlux Duo combines sirolimus and paclitaxel to create a next-generation front-line therapy. It is designed 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. This results in maximum potency exceeding any other DCB or drug-eluting stent, Advanced NanoTherapies says.
The balloon received FDA breakthrough device designation for treating CAD in September 2022. It already had breakthrough designation for coronary in-stent restenosis (ISR) and peripheral below-the-knee (BTK) lesions.
“Today, we celebrate two remarkable accomplishments for ANT and SirPlux Duo DCB,” said Marwan Berrada, co-founder and CEO of Advanced NanoTherapies. “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.”
Dr. Rishi Puri of the Cleveland Clinic took part in the initial cases with the SirPlux Duo.
“This technology will allow me to offer a safe and prolonged therapy for preventing coronary restenosis without leaving a permanent implant behind,” Puri said.
Advanced NanoTherapies plans to share angiographic data from its ADVANCE-DCB FIH trial in early 2024.
