Sana Health

Summary: The Sana Sleep Mask is comprised of a mask with earbuds. The device is worn over the eyes (earbuds in ears) when the user is ready for bed and pulses specific algorithms of light and sound to effect neuromodulation, which is tailored to each individual by a skin contact heart rate variability (HRV) sensor built into the forehead area that measures HRV throughout its use. The HRV information allows the system to determine when a patient becomes more relaxed, and thus adjusts the algorithm to ensure that the patient remains in, or transitions to, the next section. This feedback loop, therefore, treats each patient according to their state of relaxation, efficiently placing them in a progressively more relaxed state, resulting in sleep. The device can be used temporarily when relaxing and falling asleep, or, with the use of the headband, worn throughout]] the night. The Sana device has been successfully used in the sports, military and medical arenas, including by the Virgin Global Challenger, Solar Impulse, Royal Marines, the US Air Force and US Navy, and the University of California, San Francisco (UCSF) Department of Psychiatry in the US, and in the MoD, Special Air Services, Special Boat Services, McClaren F1 and many others in the UK. We are now focused on our 510k for treatment of insomnia.

Need: 130 million Americans have sleep problems, 68 million of whom suffer from severe insomnia and the toughest sleepers are the 30 million with PTSD or chronic pain. This is a particularly acute problem among those whose sleep is disturbed by irregular sleep patterns, or exacerbated by extreme stress, chronic pain or injury (concussions, traumatic brain injury (TBI), or sub-concussive events). The existing therapies all have serious issues: drugs, ambience, etc. (side effects, risks, limited effectiveness); cognitive behavioral therapy (time, compliance, expense); and devices (not clinically) proven, not Food and Drug Administration (FDA) approved, low effect) – all resulting in no real solution

Value: The Sana Sleep Mask is comprised of a mask with earbuds. The device is worn over the eyes (earbuds in ears) when the user is ready for bed and pulses specific algorithms of light and sound to effect neuromodulation, which is tailored to each individual by a skin contact heart rate variability (HRV) sensor built into the forehead area that measures HRV throughout its use. The HRV information allows the system to determine when a patient becomes more relaxed, and thus adjusts the algorithm to ensure that the patient remains in, or transitions to, the next section. This feedback loop, therefore, treats each patient according to their state of relaxation, efficiently placing them in a progressively more relaxed state, resulting in sleep. The device can be used temporarily when relaxing and falling asleep, or, with the use of the headband, worn throughout the night.