VIVONICS INC — Department of Defense SBIR Phase II: DHP13-011

Description

Vivonics, Inc., together with clinical experts from the Mayo Clinic, are currently developing the Portable Multi-Modal Traumatic Brain Injury (PMT) monitor, a platform technology which will enable multiple neurological evaluations to be performed by a minimally trained person using a simple interface wired to a light-weight head-worn apparatus. During the Phase I period, the team successfully designed, fabricated, and tested a prototype with three subsystems on board to serve as a comprehensive diagnostic tool to detect and quantify mild brain injury (mTBI) in field applications using both visual evoked stimuli and non-invasive measurement of intracranial pressure (ICP). The combination of multiple test modalities is likely to provide additional information that can identify subtle injuries in the field, enabling early intervention and lessening or avoiding long-term sequelae. In the Phase II period, we will focus our efforts and drive to fully realized products: a medical device that will pass through the FDA process and a research device that will further the study of mTBI by clinicians and researchers, including our own team. Our complete plan makes full use of the broad expertise in our team, which includes deep understanding of mTBI and its sequelae, seminal expertise in use of VEP, along with the engineering and clinical leadership of the complementary ICP measurement technique that is currently being validated in clinical feasibility studies.