CLINICAL TRIALS, STUDIES, REGISTRIES, DATA

Cerapedics notes results from the study are intended to be used in a Premarket Approval (PMA) submission to the FDA.

The open-label, multicenter, Phase IIa study was designed to evaluate the minimum effective dose of the PA5108 Ocular Implant in patients with mild to moderate POAG across 3 dose cohorts (10 subjects per cohort). Primary and secondary efficacy endpoints include mean diurnal IOP at 12 and 26 weeks compared to baseline, and 8am IOP at 6, 18 and 21 weeks compared to baseline.

“This large cohort study provides encouraging evidence that the ‘implant free’ Phaco-ELIOS procedure causes minimal trauma, appears to show lasting IOP control with no serious intra- or post-operative complications, and low rate of incisional secondary surgical intervention over a period of at least 8 years,” said Thomas W. Samuelson, MD, founding partner of Minnesota Eye Consultants and an Adjunct Professor of Ophthalmology at the University of Minnesota.

The study will compare the Movano data to results captured with an FDA-cleared finger stick glucose tester, a subject’s existing CGM device, and/or a vital sign monitoring device.

The GIER feature is an audio-visual software module of guided imagery, relaxation and education, designed for optional use in conjunction with the REN treatments.

GenesisCare Chief Global Medical Officer, Dr. Wally Curran, adds: “GenesisCare’s participation in this clinical trial is one example of how we seek to increase access to innovative research that addresses each individual patient’s needs.