NEST-1

PhotoThera, Inc. completed an initial evaluation of the NeuroThera® Laser System (NTS) in the treatment of Subjects diagnosed with acute ischemic stroke within 24 hours of onset.  The study was entitled NeuroThera Efficacy and Safety Trial-1(NEST-1).

NEST-1 evaluated the safety and preliminary effectiveness of the NeuroThera Laser System (NTS) in improving 90-day outcomes in ischemic stroke patients treated within 24 hours of stroke onset.  The NTS is an investigational device that seeks to improve neurological outcome via non-invasive delivery of near-infrared (NIR) energy transcranially into the brain.

NEST-1 was a prospective, intention-to-treat, multicenter, international, double-blind trial involving 120 ischemic stroke patients randomized in a 2:1 ratio, with 79 patients in the active treatment group and 41 in the sham (placebo) control group. The Study included patients with baseline stroke severity measured by National Institutes of Health Stroke Scale (NIHSS) scores of 7 to 22.

Significantly more patients (70%) in the active treatment group had successful outcomes than did controls (51%), as measured prospectively on the binary NIHSS (P<0.05). The median time to treatment was 18 hours for the active group and 17 hours for the control group.  There were no statistically significant differences between the treatment and control groups with respect to Serious Adverse Events, and there were no adverse outcomes attributed to the therapeutic procedure.

The results of the NeuroThera Effectiveness and Safety Trial-1 (NEST-1) were published in the June 2007 issue of the journal Stroke (Stroke. 2007;38(6):1843-9).