Final qualification testing for myoelectric implant to control prostheses

The goal of this DARPA Phase II SBIR program is to evaluate an implantable system for recording myoelectric signals from residual muscles of individuals with forearm amputations. The signals will be wirelessly coupled to an external receiver for controlling prostheses. Compared to surface electrodes, this system will provide: more channels for prosthesis control from a larger number of muscles in the limb, improved specificity and repeatability for recording from individual muscles and muscle groups, higher reliability and quality for the recorded signals under different socket conditions, and selective, consistent signals from deep muscles. These multichannel recordings will also enable users to generate simultaneous multi-axis movements with a more natural feel of control than existing myocontrollers. In this DARPA Phase II SBIR, we will complete pre-clinical validation qualification testing, including: six-month GLP in vivo study, implant chemical characterization, and algorithm integration into the external transceiver. We will compile these results into a Master File for use in IDE submissions by future clinical teams. As an Option, we will further develop a smaller, wearable data acquisition system for animal subject researchers to provide near-term revenue to help cover costs of future clinical studies.