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.
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. 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. 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.
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Back to homeostasis.
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.
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. 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. • 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• Subjects had their usual methadone dose (60-80mg/day) withdrawn, and the trial was run to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. *The Subjective Opiate Withdrawal Scale (SOWS) is a self-administered scale for grading opioid withdrawal symptoms
created
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Baseline (AM) Treatment (AM) Treatment (PM)
SOWSScores
Active Sham
Active lower at all time points.
Subjective Opioid Withdrawal Symptoms* mean scores By Period
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. 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)
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5
10
15
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25
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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. *The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations
0
8
16
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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. 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. 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. 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
Need context. Opioids now kill more people than breast cancer. That’s 174 people per day. In the United States.
A Japanese television station broadcast a light and sound ‘strobe effect’ as part of a cartoon in 1997. In only 5 seconds, it put 700 children into hospital with seizures, and untold thousands more experienced headaches, dizziness, and nausea.
https://www.nytimes.com/1997/12/18/world/tv-cartoon-s-flashes-send-700-japanese-into-seizures.html
While I was in the hospital, my pain was so severe I couldn’t sleep. If we were conversing, I couldn’t concentrate on what you were saying.
I was watching Hudson Hawk, one of Bruce Willis early movies, and I was so transfixed that I forgot about my pain.
This is me in 1993 when I started recording a QEEG brain map. I could see that my brain was on high alert; the areas involved in pain reactivity and heart rate were running at triple the comfortable rate (I don’t know the actual rates). No wonder I was uncomfortable.
After careful analysis of my brain activity, I found that the underlying pain was affecting my ability to shift from an alert state to rest; the likely culprit on my severe pain and sleep troubles. The pain and anxiety were taking the majority of my brain’s resources, and there is little left for concentration, clear decision making let alone restful sleep and recovery.
Having identified the areas of concern, I created a neuro-feedback training plan and experimented with thousands of patterns. Hudson Hawk was the movie that put me in the flow state, so used that as the feedback for my training sessions.
During my neuro-feedback sessions, I monitored the areas involved in my pain and heart rate in real-time. When my brain would move towards a calmer position, I would change the sound patterns– positive signal letting my mind know I am heading the right way. When I was getting a bit more internally anxious, the lights would go darker, and the sound faded – a negative signal telling my brain that we were heading the wrong way.
I did this until I could continually shift further and further into a more and more balanced, non-anxious state. As I did this time and again, my brain was trained on how to return my mind to a calm position instantly.
As I tracked my progress, I noticed a corresponding shift on my brain map. It took me 6 months to finally realize that the pain was never coming back. Since 1993 I’ve been pain-free. This is why I founded Sana and why we’re going to end severe pain forever.
Send Away
Sana uses closed-loop-feedback and biosensors to personalize treatment based on physiologic systems.
Here is the EEG of an early patient with traumatic brain injury and severe pain. In the before graph you can see his EEG before using Sana, note the large hemispheric imbalance. In the after graph you can see his EEG after using Sana, his hemispheric balance has been restored, he was more relaxed and his pain levels were lower.
Send Away Version
Introducing Hattie
Hattie has this issues.
One day she found Sana.
She uses Sana for maintenance.
Now she uses Sana for Pain MGMT instead of opioids.