Empower Neurosciences is an emerging spin-out of TheraNova, a San Francisco-based medical device start-up incubator. Empower Neurosciences is led by Michael Jaasma, PhD, and Daniel Burnett, MD, MBA, who collectively have over 25 years of experience in the medical device industry. We are developing the Empower Neuromodulation System, a portable, transcutaneous electrical nerve stimulation (TENS) device for non-invasive stimulation of nerves in the hand. Our first application is the treatment of anxiety. The Empower System is wearable and consists of standard, inexpensive TENS gel electrodes and a small, battery-powered signal generator. Empower is based on scientific literature showing that acupuncture-based stimulation of the ulnar and median nerves alters GABA signaling in the mid-brain, which can modulate key neuron activity associated with both anxiety and addiction. Thus, Empower offers a safe, effective, and convenient therapy to some of the biggest mental health challenges that our country faces. Through our NIH-NIAAA Phase I SBIR award, we conducted a pilot clinical study in patients with alcohol use disorder. Participants self-administered Empower treatment (30 minutes, twice daily). After only two weeks, the Empower treatment provided a 31% reduction in anxiety (p=0.001), a 29% reduction in alcoholic drinks consumed (p=0.026), and a 21% reduction in alcohol craving (p=0.001). Given these promising results, we are now looking to raise a $5M Series A round to fund: 1) development of a commercial-ready device and 2) a pivotal clinical study for anxiety treatment. This work will support FDA De Novo submission, enabling device commercialization within 2.5 years.