Breakthrough designation reinforces a significant unmet need in the treatment of small vessel coronary arteries
LOS GATOS, CA., September 19, 2022 /PRNewswire/ — Advanced nanotherapies, Inc., a privately-held medical device company committed to solving the world’s most significant challenges in vascular disease through the creative applications of nanotechnology, today announced that the U.S. Food and Drug Administration (FDA) has granted the company a breakthrough device designation for its SirPlux Duo Drug-Coated Balloon (DCB) for coronary artery disease in vessels less than 3.0 mm. This achievement comes just weeks after the company received two more Critical Breakthrough Device designations for its SirPlux Duo DCB in in-stent coronary restenosis (ISR) and peripheral below the knee lesions (BTK).
“Despite decades of advances in drug-eluting stents, treatment of small coronary vessels continues to be challenging due to the unacceptable incidence of restenosis and target lesion failure,” commented Dr. Rishi Puri MD, Ph.D., coronary and structural interventional cardiologist. in the Tomsich Family Department of Cardiovascular Medicine at the Cleveland Clinic and co-principal investigator of the company’s ADVANCE-DCB clinical trial. “Advanced NanoTherapies is championing a new stentless option to address this clinical gap. I look forward to seeing how this technology can advance the field of coronary interventions by improving long-term clinical outcomes and avoiding the need for repeat revascularizations.
SirPlux Duo Drug Coated Balloon (DCB)
Small vessel disease (SVD), defined as atherosclerosis in small coronary vessels (3
SirPlux Duo DCB combines the synergistic power of sirolimus and paclitaxel to create a next-generation, first-line therapy designed to provide stent-like patency and restenosis prevention without leaving an implant behind. SirPlux Duo DCB delivers low-dose, long-term release of both compounds to inhibit cell growth, resulting in peak potency surpassing any other DCB or drug-eluting stent.4 The company’s proprietary nanoparticle encapsulation and drug delivery platform provides safe, reliable and sustained bioavailability of the two synergistic drugs in tissues for long-term results.
“Our third breakthrough designation underscores the urgent need for new coronary and peripheral therapies with a no-leaves-not approach,” said Marwan Berrada-Sounni, co-founder and CEO of Advanced NanoTherapies. “We appreciate the collaborative approach the FDA has taken to review our technology and the novelty of combining two synergistic drugs. Over the next few months, we will build on this positive momentum by generating first-in-human clinical data using the SirPlux Duo DCB. .”
1Cardiol J. 2021;28(5):767-778. doi: 10.5603/CJ.a2020.0127. Published online September 28, 2020. PMID: 32986235; PMC ID: PMC8428937
2Cassese S, Byrne RA, Tada T, et al. Incidence and predictive factors of restenosis after coronary stenting in 10,004 patients with surveillance angiography. Heart. 2014;100(2):153–159. doi: 10.1136/heartjnl-2013-304933.
3Cardiol J. 2021;28(5):767-778. doi: 10.5603/CJ.a2020.0127. Published online September 28, 2020. PMID: 32986235; PMC ID: PMC8428937
4Data archived at ANT.
About advanced nanotherapies
Advanced NanoTherapies, Inc. is a highly specialized medical device company developing a proprietary nanoparticle technology-based platform for drug delivery. The company is focused on minimally invasive cardiovascular applications to provide a safer treatment option for patients with coronary artery disease (CAD) or peripheral arterial disease (PAD). The company’s first product is SirPlux Duo DCB, a next-generation first-line CAD and PAD therapy. To learn more about advanced nanotherapies, visit www.advancednanotherapies.com.
SOURCE Advanced nanotherapies / SPRIG Consulting