Cytori (CYTX), IDE Approval Initiates US Cardiac Cell Therapy, Athena Trial
Investigational Device Exemption (IDE) approval begins the ATHENA trial
ATHENA will investigate the use of the Celution(R) System, an innovative medical device to prepare adipose-derived stem and regenerative cells (ADRCs) to treat a form of coronary heart disease, chronic myocardial ischemia (CMI). The IDE application was originally submitted to the FDA in December 2011.
- ATHENA is a multi-center, randomized, double blind, placebo controlled, pilot trial to investigate the use of autologous, clinical-grade ADRCs, processed at the point-of-care with CYTX’s proprietary Celution(R) System;
- The trial will enroll up to 45 patients with no-option CMI who have limited therapeutic options;
- It will evaluate a variety of clinical and functional outcomes, including safety, peak oxygen consumption (mVO2), and clinical outcomes at 12-months.
The Bottom Line: This approval focuses the clinical strategy in the US.Previously, CYTX reported 6 and 18 month trial data from PRECISE, an EU clinical trial for this same indication showing improvement in mVO2. InEurope, CYTX has applied to expand its Celution(R) System CE Mark to include no-option CMI claims based on data from the PRECISE trial. CYTX is also enrolling ADVANCE, an EU pivotal trial investigating the Celution(R) System for acute myocardial infarction (heart attacks). This is a further confirmation of their device-based pathway and … a positive sign that approval by FDA was achieved so quickly. As an aside, for the investors who only value the US opportunity, this is the start of that process. Many investors have wanted to see this for some time and now they can begin to construct a timeline for when CYTX might achieve approval for its 1st heart indication in the US. Very positive development …
Market Size: In the US, it is estimated that 120,000 to 250,000 patients are diagnosed each year with chronic myocardial ischemia, a subset of the approximate 5.8 million patients who currently have some form of heart failure. CMI patients typically have undergone multiple revascularization procedures that have not improved their condition and are at a stage where they have few therapeutic options remaining.
