Introducing the Next Generation of Drug-Coated Balloons
Engineered to deliver stent-like patency and restenosis prevention with long-term release of two synergistic drugs.
Higher potency. Lower dose. Nothing left behind.
Two Drugs Working Together
Dual API
SirPlux Duo DCB is the only coronary and peripheral therapy designed to deliver Sirolimus and Paclitaxel simultaneously to inhibit cell growth at a higher potency and lower dosage.
Powered by the Advanced NanoTherapies (A.N.T.) nanoparticle drug delivery platform, the two synergistic drugs are released in-tissue long term.
Sustained Drug Release & Retention
Our functionalized nanoparticles provide safe, reliable, and sustained bioavailability of two antiproliferative drugs at the lesion site. Pre-clinical data shows higher cellular uptake, more efficient tissue transfer, and greater drug retention compared to competitive solutions.
SirPlux Duo relies on a drug-agnostic nanparticle platform. The same excipient can be used with any single or multiple drug combination.
Better Outcomes, Safer Treatments
SirPlux Duo offers a next-generation front-line therapy for coronary artery disease (CAD) and peripheral artery disease (PAD). Our DCB is intended to demonstrate stent-like performance with no stent burden.
Endovascular and cardiovascular applications are just the beginning. Our drug delivery platform can provide new treatment approaches for neurology, ENT, orthopedics, and more.
Our journey so far
Achievements to Date
Exclusive license from the Cleveland Clinic for proprietary nanoparticle technology
Nanoparticle formulation and infrastructure completed, resulting in excellent manufacturing repeatability in preparation for First-in-Human trials
Completed single drug DCB platforms (Paclitaxel and Sirolimus) with positive pre-clinical performance
Favorable FDA feedback regarding dual-drug regulatory pathway; granted Breakthrough Designation for dual-drug DCB for BTK
Several strategic partnerships in place to assess A.N.T. technology
What lies ahead
Future Plans
First-in-Human Study in Australia (Q3, 2022)
U.S. EFS Study for Below-the-Knee indication, IDE application (2023)
U.S. de novo Coronary, IDE application (2023)
EU de novo Coronary commercialization (2023)
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