The FDA has granted investigational device exemption (IDE) approval to R3 Vascular to commence the ELITE-BTK trial of its MAGNITUDE drug-eluting bioresorbable scaffold. This scaffold is designed to treat below-the-knee (BTK) peripheral arterial disease (PAD). The trial is anticipated to commence in Q1 2025 and will enroll 264 subjects at up to 60 clinical sites across the globe.
MAGNITUDE Scaffold Design and Function
The MAGNITUDE scaffold is created using an ultra-high molecular weight polylactic acid polymer. This material, combined with R3 Vascular’s scaffold design and processing technology, results in a thinner, stronger, and more flexible scaffold. The scaffolds are designed to be absorbed gradually into the tissue without leaving any material behind, offering structural support akin to a stent while delivering the anti-inflammatory and anti-proliferative benefits of sirolimus.
Clinical Trial Details: ELITE-BTK
The ELITE-BTK trial will analyze MAGNITUDE's potential to treat patients with chronic limb-threatening ischemia caused by BTK PAD. R3 Vascular president and chief executive officer Christopher Owens stated that the trial will allow the company to follow up on positive first-in-human RESOLV1 study data, which demonstrated excellent and promising results with 96% patency by DUS at six months. Upon favorable conclusion of the ELITE-BTK trial, R3 Vascular intends to complete and pursue a PMA market application for MAGNITUDE with the FDA.
Financial Backing and Future Plans
In preparation for the ELITE-BTK trial, R3 Vascular secured $87 million in a Series B financing round in May 2024. These funds will also be used for conducting further research and development, regulatory submissions worldwide, scaling up manufacturing processes, and commercialization efforts. R3 Vascular is focused on developing fully bioresorbable, drug-eluting vascular scaffolds coated with sirolimus, aiming to improve the treatment of vascular diseases.
