MIPS Project Challenge:
The goal of this MIPS project is to develop sensitive, quantitative and objective clinical endpoints for the use of ART101 in clinical trials. The addition of such objective clinical measurements, along with standard of care determinations, will enable the company to design cost-effective and accelerated time points to measure ART101’s efficacy. Successful completion of this project will facilitate the company’s IND and subsequent regulatory approval pathway and timeline to commercialization.

Project Scope:
Aim 1 of this MIPS project is to develop imaging methods to quantify perfusion and arterial anatomy in target tissues impacted by PAD and to assess their relationship with functional outcomes such as peak walking distance, claudication onset distance, calf muscle strength per unit cross-sectional area, modified physical performance test and six-minute walking distance. Aim 2 is to refine and standardize imaging measures of arterial anatomy and perfusion to identify those most sensitive and specific to diagnose the presence and severity of PAD.