Innovator’s Pitch Challenge

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Interested in Connecting? Please contact:
Richard Hanbury

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FDA Breakthrough device designation for fibromyalgia (class II), Sana is an audiovisual neuormodulation device that gives anxiety relief on demand, giving it applications across pain, mental health and long covid. We have recently completed a pivotal study in Fibromyalgia with Duke, which will be submitted to the FDA as a Denovo in the next month. We also have a pivotal study underway in Neuropathic pain at Mount Sinai, and two more pivotals in Anxiety and PTSD due to start in Q1. We recently were awarded a DoD grant for PTSD. We are on market under a 513g Designation as a wellness device, allowing for speedy clinical trials and adoption. Future areas – depression, lower back pain and long covid. The user puts on the device, and pulses of light and sound induce deep relaxation or sleep within 16 minutes.

Pitch Video

Sana Company Video

Executive Summary