SensPD · SensPD: Early Diagnosis of Autism

About 1 in 45 babies born today will be diagnosed later in life with Autism Spectrum Disorder (ASD). But final diagnosis will come only at age four, too late for early interventions that would allow them to markedly improve their level of functionality, enabling them to acquire needed social skills to be integrated in society. When interventions are applied before the age of two the outcome is an over 90% success rate of social integration, as compared to after the age of five, where the success rate drops below 11%.People with ASD in all its forms have Sensory Processing (SP) issues, SensPD monitors SP performance by measuring the Oto-Acoustic Emissions (OAE). This procedure is objective, short, non-invasive and can be performed hours after birth. SensPD aims to include this procedure in the standard battery of tests performed on every new-born, enabling early interventions, and realizing the cost savings associated with this improved functionality. During Phase I, SensPD will complete the technological and economic feasibility of the device and the service. SensPD will conduct three small scale clinical studies, each with 30 diagnosed subjects between the ages of two to five and 30 controls. The readings will be compared with results of the current diagnoses, thus establishing the technological feasibility. SensPD’s economic viability will be tested from the perspective of using the device as an add-on to an already existing OAE measuring device (and not as a stand-alone device). We will negotiate with an OAE device company as a strategic partner and complete the approval of the patent in Europe and USA.In Phase II, SensPD will conduct widened multi-site clinical studies (~250 subjects per site), will start the regulatory process and the establishment of a cloud global data base. By the completion of the clinical trials, the process for obtaining the needed regulatory approvals, as well for obtaining the insurance reimbursement code, will be underway.