About

Making Neuromodulation Accessible for Bladder Dysfunction

Calm Medical is developing minimally invasive neuromodulation for bladder dysfunction that requires only a needle, not surgery. As a wholly owned subsidiary of Neuronoff Inc., we utilize the Injectrode® platform to deliver tibial nerve stimulation through a simple injection procedure.

Our mission

We exist to lower the barriers of neuromodulation treatments for patients, physicians, providers, and payers by transforming invasive surgical procedures into elegant needle-based interventions. Our goal is to make neuromodulation an early choice in bladder dysfunction treatment, not a last resort reserved for the most severe cases.

We believe every patient with bladder dysfunction deserves:

  • Access to effective, minimally invasive treatment options

  • Freedom from the side effects and limitations of chronic medication use

  • Treatment that fits into their life rather than disrupting it

  • Hope for genuine improvement in their quality of life

Regulatory Pathway & Development

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.

Development Timeline:

  • 2026: FDA Pre-Submission meetings and regulatory guidance

  • 2027: Formal FDA submission and review process

  • Ongoing: Clinical research and evidence generation

Partnership & Collaboration

Calm Medical actively seeks partnerships with healthcare providers, research institutions, and advocacy organizations who share our vision of transforming bladder care. Together, we can ensure that breakthrough neuromodulation technology reaches the patients who need it most.