Proof of Concept Study
In order to establish proof of concept, the Company recently conducted a small study at the University of Maastricht in the Netherlands. The study was designed to establish the safety of the ThinAir™ system, as well as obtain preliminary efficacy data to show proof of concept. The following were the key parameters of the study:
The Maastricht proof of concept study was completed in November 2005. The study tested the system for two weeks in 11 subjects, with four of the subjects (and two spouses) volunteering for an additional six weeks in the ThinAir™ system. Subjects were healthy males, aged 35 to 55 and moderately obese, with BMIs between 28 and 38. Subjects were not allowed to exercise during the study. For the primary study, each subject spent two weeks in the ThinAir™ system at normoxia (sea level) and two weeks at a simulated altitude of 4,200 meters (13,780 feet). Subjects were acclimatized in a stair-step fashion, bringing them to 4,200 meters in a period of five days. Subjects spent an average of seven hours per night in the ThinAir™ system. Biochemical analysis and echocardiogram data were used to evaluate potential health risks.
Data from the study answered several important questions:
Results from the study are being used to design preclinical trials. The preclinical trials will be blinded, will include more subjects, and incorporate a longer hypoxic exposure time (number of successive nights) than the Maastricht study.
Upon successful completion of the preclinical trials, Aestis will apply for an Investigational Device Exemption for clinical trials in the U.S.