Strategic FDA Approach

Our regulatory strategy leverages the established Injectrode platform to pursue a 510(k) and 510(k) de novo submission pathway for Class II device classification. This approach is designed to provide a clear, efficient path to market while ensuring patient safety and clinical efficacy.

Clinical Evidence Building

We are actively building clinical evidence through strategic partnerships with leading academic medical centers and targeted research initiatives, including our $1.73 million Department of Defense-funded neurogenic bladder study.