Relief made possible
Sana is helping in areas of the highest unmet need. We have secured DoD grants for Pain/Sleep and PTSD. In PTSD the remit is specifically to improve the standard of care to take people of waiting lists. We also have a DHS grant for PTSD prevention. We got Breakthrough Device Status from the FDA based on our clinical efficacy, in Fibromyalgia, an area of high unmet need. There are 3 approved drugs for Fibromyalgia, and only one is sold in any great quantity and that is Lyrica, We help 4x as many people as Lyrica for 4 times as long (at least). Lyrica has such severe side effects that 50% not using by 2 months, 90% of people are not using by 2 years. We are at 80% still using on average 6 times a week for 2 years (and counting). All of the data both subjective and objective HRV, being collected by the device goes into the cloud where it can be viewed by the treating physician to monitor progress and make changes to the protocol. We are able to work across all areas of pain and mental health where anxiety is a core driver. This is most of them. We are working centrally on autonomic nervous system dysregulation. This is something no drug or device has yet managed to do. Compared to CBT, we are the rescue med, which makes learning those new skills more possible, so we play well with all existing solutions.
The gap Sana fills is for an effective treatment for pain and anxiety which is drug-free and can be done without requiring a mental health professional. (and also augment that treatment) The Standard of care is Opioids, Benzos, and sleep drugs all have long-term efficacy, side effects, and addiction problems. Digital Therapeutics essentially falls into 3 tiers 1) apps that can reach people at scale, offer basic help, and give data on who needs more than an app. 2) telehealth therapeutic devices like Sana that can offer the next tier of help - remotely by device, but still in an automated fashion, and identify who also needs tier 3 3) the telehealth providers of medical professionals Digital Health in the mental health and pain area will not fulfill its overall promise until all 3 tiers are working together, so at Sana we are working to be the best solution in tier 2, and build cross-tier collaboration. Mental health professionals' numbers are declining (increased attrition from Covid) and if you took all practitioners, working at 95% capacity (telehealth and across state lines) they could still only reach 6% of the population. At any point in time, 25% of the adult population of the US is taking opioids, benzos, or zs. Sana helps fill this gap by offering much greater efficacy in remote care than the CBT apps, and thus reduces the numbers of people that need talk therapy, allowing resources to be focused at each tier where they are most needed.
In the Pilot study data1, Sana reduced overall pharmacy cost by approx. 30% (Avg total pharmacy cost per Fibromyalgia patient is - $9573/year2.) Sana is expected to lower the longer-term larger costs of FM - the doubling of oncology and cardiac risks, and the 2.77x3 risk of dementia. 2018 Pain/Recovery 3x lower pain over sham 5x better heart rate variability (a measure of recovery) n=75, 2019 Opioid Withdrawal 45% reduction in anxiety during peak opioid cold turkey withdrawal. n=16, 2019 Fatigue Mitigation (Hitlabs) 3x decrease in fatigue over sham n=20, 2020 Fibromyalgia 45% better quality of life, 30% reduction in opioid use n=20, pilot 2021 Fibromyalgia Evidence of mechanism of action n=10, EEG study on Fibromyalgia 2021 Fatigue Mitigation (Hungarian Armed Forces) 3x decrease in fatigue over sham, 3x reduction in anxiety. 2022 Fibromyalgia (pivotal) DeNovo Submission to FDA August 2022 2022 Chronic pain or sleep problems COMMERCIAL DATA ON MARKET 2 YEARS. - 80% retention at 2 years. average longterm use = 5x a week. n=200 2022 Fibromyalgia Strong improvements in Pain, Sleep, Anxiety and Depression n=353 (650 left to complete) 2022 DoD trial in PTSD 50 people starting August 2022 Mayo Clinic Trial on quantitive sensory testing (QST) in Fibromyalgia starting October. 2022 MainLine Health pilot in post op pain starting November.
