Advanced NanoTherapies, Inc., a privately-held medical device company committed to solving vascular disease’s most significant challenges through the creative applications of nanotechnology, today announced the closing of its oversubscribed $7.2 million Series A equity financing, marking a total of $12.5 million raised since September 2020.
Funds will be used to complete the first-in-human clinical study in Australia of the SirPlux Duo drug-coated balloon (DCB) in de-novo coronary artery disease (CAD) lesions. Funding comes from various sources in the U.S., Canada, Europe, and Asia.
“Interventional therapies have historically advanced in big steps – angioplasty, bare-metal stenting, drug-eluting stenting,” says Reggie Groves, Board of Directors Member at Advanced NanoTherapies. “We believe the interventional cardiology space is poised for the next disruption in the treatment of coronary artery disease with the unique offering of the SirPlux Duo DCB. We are pleased to initiate the next phase of Advanced NanoTherapies’ clinical program.”
“With the advent of cutting-edge drug delivery platforms, it is no longer acceptable to deliver drugs to arterial tissue using a haphazard, undirected approach,” stated Dr. Aloke Finn, MD, Medical Director and Chief Scientific Officer at CVPath and Associate Professor of Medicine at the University of Maryland. “SirPlux Duo will be the first dual Active Pharmaceutical Ingredient (API) solution to provide a fully targeted, safe, and potent drug delivery option for preventing neointimal growth after coronary and peripheral interventions.”
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. SirPlux Duo DCB delivers low-dose, long-term release of both compounds to inhibit cell growth, resulting in maximum potency exceeding any other DCB or drug-eluting stent.1 The Advanced NanoTherapies nanoparticle drug-encapsulation and delivery platform provides safe, reliable, and sustained bioavailability of the two synergistic drugs in tissue.
The global interventional device market is estimated to be $6.1B for CAD and $4.5B for PAD, with CAGRs of 8.5% and 8.7%, respectively. As the market grows and treated patients live longer lives, the medical community increasingly calls to leave nothing behind in de-novo coronary lesions to eliminate the risk of late stent thrombosis.2,3
“Sirolimus and paclitaxel are both proven drugs in the vascular space, each with unique benefits, limitations, and mechanisms of action,” commented Dr. Mehdi Shishehbor, President, Harrington Heart and Vascular Institute, University Hospitals Health System, Professor of Medicine, Case Western Reserve University School of Medicine, Cleveland, Ohio, and Chief Medical Officer of Advanced NanoTherapies. “Pre-clinical data has shown that using both drugs in combination results in higher antiproliferative potency at lower doses than using each drug independently. The synergistic effects of eluting them simultaneously over long periods may be the key to sustaining patency following interventions.”
“We are excited to close this round as we prepare for clinical testing of the SirPlux Duo DCB in de novo CAD patients,” said Marwan Berrada, Co-Founder and CEO of Advanced NanoTherapies. “Thank you to everyone involved in helping us reach this important milestone. The Series A funding will allow us to gather first-in-human clinical data before the end of 2022, a key step to accelerating the paradigm shift of leaving nothing behind in coronary arteries.”