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Applying heart rate data to optimize pain relief: A conversation with Sana Health

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Sana is a non-invasive solution for those with severe pain problems. Learn how Sana measures and tracks users' overall state of health over time, and uses this measure to help achieve deep relaxation and pain reduction. Following clinical trials in late 2018 and early 2019 with Mount Sinai Hospital, data analysis with Stanford Sleep Labs and PTSD with the UK military, the device will be made available to the general public following FDA certification.

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Applying heart rate data to optimize pain relief: A conversation with Sana Health

  1. 1. Neuromodulation technology to end prolonged severe pain © 2019 Valencell, Inc Richard Hanbury CEO Sana Health
  2. 2. Our mission is deliver FREEDOM from pain, and FREEDOM from the anxiety that pain creates.
  3. 3. 100 millionAMERICANS CURRENTLY SUFFER FROM SEVERE PAIN Today, opioids are still the gold standard.
  4. 4. There were 72,000+ opioid deaths in 2017. addictions start with prescription opioids 4 in 5
  5. 5. Opioids just mask pain Rest & Recovery Fight or Flight Rest & Recovery Fight or Flight Severe Pain After Opioids 5
  6. 6. In 1992, the jeep I was driving rolled off a bridge and I was pronounced dead. The nerve damage was so bad I was given 5 years to live.
  7. 7. In my search for pain relief I tried everything first opioids, then devices. 7
  8. 8. Magnetic Electronic Audio- Visual Nothing worked until I discovered the research on brainwave entrainment (BWE).
  9. 9. Magneti c In 1993, I started experimenting with thousands of audio-visual stimulation patterns. I wiped out my pain and saved my life. Since then I have been pain-free.
  10. 10. Measures individual biometrics via HRV Patterns change based on FlowState algorithm Neurowave stimulation is activated via light in front of the eyelids and sound via headphones A unique mask that uses pulsed light and sound to guide users into a deep state of relaxation. increases relaxation Induces Sleep in 10-min Reduces pain
  11. 11. EEG of traumatic brain patient with severe pain EEG after using Sana Relief for 4 hours The Sana device restores hemispheric balance in the brain. 30 29 28 27 26 25 24 23 22 21 20 19 18 17 16 15 14 13 12 11 10 9 8 7 6 5 4 3 2 1 30 29 28 27 26 25 24 23 22 21 20 19 18 17 16 15 14 13 12 11 10 9 8 7 6 5 4 3 2 1 Back to homeostasis.
  12. 12. Rest & Recovery Fight or Flight Rest & Recovery Fight or Flight Before Sana After Sana Then induces deep drug-free relaxation and strong pain relief.
  13. 13. Patent 1 Filed 2015 Patent 2 Filed 2016 Patent 3,4 &5 Filed 2018/19 13 We’ve secured strong and broad IP
  14. 14. We’ve piloted studies with collaborators to validate efficacy. Completed Studies 14 14
  15. 15. Hattie, age 13 Severe Regional Pain Syndrome "I cut my opioids in half, and could touch my arm without pain for the first time in 3 years. And in one week went back to school." 50% opioid reduction* Achieved early success in the most severe cases. *Based on four hours daily usage for first week and one hour ongoing daily maintenance
  16. 16. We completed a 75-person sham-controlled study with Stanford and SOCOM. in relaxation 2x increase in recovery and sleep* 5x improvement in pain levels 3x reduction united states Special Operations Command *Measures using heart rate variability
  17. 17. • Double Blind randomized controlled trial, conducted by Dr. Lynn Webster at the PRA Salt Lake inpatient clinic. • 8 patient cross-over study (16 patient experiences) methadone addicts going into withdrawal • Subjects had their usual methadone dose (60-80mg/day) withdrawn, and the trial was run to compare their withdrawal symptoms on an active Sana device, versus a sham. • The Sana device cut subjects’ Subjective Opioid Withdrawal Symptoms (SOWS) by ~30% compared to sham. Clinical Opioid withdrawal symptoms (COWS) were also markedly reduced at 7 out of 10 time points. • The Sana device demonstrated a dramatic effect on reducing nicotine cravings. One multi-decade smoker reported he’d never smoke again, after one device use. This further validates that the device reduces cravings and addictions. • The Sana device proved superior to placebo on all other measures studied. These included statistical significance in Anxiety, Pain, NEED for Methadone (craving), and Desire for Methadone. Key Findings External Clinical trial -Opioid Use Disorder.
  18. 18. *The Subjective Opiate Withdrawal Scale (SOWS) is a self-administered scale for grading opioid withdrawal symptoms created 0 1 2 3 4 5 6 7 8 9 Baseline (AM) Treatment (AM) Treatment (PM) SOWSScores Active Sham Active lower at all time points. Subjective Opioid Withdrawal Symptoms* mean scores By Period
  19. 19. Clinical Opioid Withdrawal Symptoms* mean scores across subjects *The Clinical Opiate Withdrawal Score (COWS) score quantifies severity of opiate withdrawal and can be serially administered to track changes in the severity of withdrawal symptoms over time or in response to treatment 0 1.5 3 4.5 1 2 3 4 5 6 7 8 9 10 COWSMeanScores Day 1 Scores by Period Active Sham Active lower at all time points except 2. Mean reduction of other 8 timepoints 20%.
  20. 20. VAS-a Anxiety Scores* *Measure of anxiety is an emotional state characterized by apprehension and fear resulting from anticipation of a threatening event using a Visual Analogue Scale for Anxiety (VAS-A) 0 5 10 15 20 25 30 1 2 3 4 5 6 7 8 9 10 VAS-AScores Day 1 Scores by Period Active Sham Anxiety scores across study period – active lowered anxiety by 36% P=.047 Rising to 45% on average at end of study period P=.043 when withdrawal symptoms were most severe.
  21. 21. *The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations 0 8 16 24 VAS-PScores Day 1 Scores Combined Across All Observations Active Sham Pain scores, showing a 39% drop on active v sham. For those who were treated Actively in the first session, controlling for Sequence; P=.001 VAS-p Pain Scores*Across Subjects
  22. 22. VAS-n NEED Scores* *The need VAS is a unidimensional measure of the feeling of need, which has been widely used in buprenorphine trials 0 5 10 15 20 25 1 2 3 4 5 6 7 8 9 10 VAS-NeedTotalScore Day 1 Scores by Period Active Sham VAS Methadone NEED scores across day 1 study period. NEED reduced on average 39% in active group P=.041.
  23. 23. Our clinical roadmap is clear. Condition Trial Site Funded Opioid Use Disorder (Trial Complete) ✓ Fibromyalgia ✓ Severe Pain ✗ Neuropathic Pain ✓ Oncology Pain CU Denver Anschutz (TBC) ✗ FDA FDA FDA FDA Q1 2019 Q2 2019 Q3 2019 Q4 2019 Q1 2020 FDA
  24. 24. CEO & Founder Chief Operating Officer Chief Commercial Officer Chief Financial Officer Richard Hanbury Tasha Bond Steve SandersGeoff Birkett Team Leadership Inventor and developer 25 years with this technology 20 years in med-tech 4 successful exits Launched Nicorette Led merger of Zeneca/Astra 10 years in med-tech $2.5B in M&A experience 24
  25. 25. Neuromodulation technology to end prolonged severe pain. Richard Hanbury CEO richard@sana.io +1 415 630 0467

Sana is a non-invasive solution for those with severe pain problems. Learn how Sana measures and tracks users' overall state of health over time, and uses this measure to help achieve deep relaxation and pain reduction. Following clinical trials in late 2018 and early 2019 with Mount Sinai Hospital, data analysis with Stanford Sleep Labs and PTSD with the UK military, the device will be made available to the general public following FDA certification.

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