The United States is currently struggling with one of its worst-ever drug crises. It is reported that approximately 100 million American adults live with chronic pain, most of which are treated with opioids but they are hampered by side effects, abuse, and addiction. 4 out of 5 addictions begin with prescription opioid use and in 2017 alone, there were over 72,000 opioid-related deaths reported – that’s nearly 200 people per day dying from opioid abuse. The Centers for Disease Control and Prevention estimates that the total “economic burden” of prescription opioid misuse alone in the United States is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement.

That’s where Sana Health comes in.

Pain relief without pharmaceuticals

In 1992, Richard Hanbury, Sana Health’s Founder and CEO, was forced to crash his Jeep off a bridge in Yemen. He was pronounced clinically dead for 8 minutes and then in a coma for 6 weeks. After waking up, he spent the next 14 months in the hospital.

The doctors gave Richard five years to live due to the extreme chronic nerve damage pain.

Richard tried everything that was available at the time to treat his pain. After trying opioids and building a resistance to the drugs, he experimented with many internal and external medical devices, such as electrical stimulators and TENS devices. Nothing worked for Richard until he discovered research on brainwave entrainment (BWE.)

Brainwave entrainment stimulates the brain into entering a specific state by using a pulsing sound, light, or electromagnetic field. The pulses elicit the brain’s “frequency following” response causing the brain to adopt the given frequency. However, magnetic or electronic methods have not shown much efficacy for chronic pain.

After a lightbulb moment, while watching a film in the hospital, Richard began to explore the impact of audio-visual stimulation or “distraction therapy.” To produce the most lasting pain relief, he experimented with different neuromodulation patterns and biometric sensors which normalized how his brain processed pain signals. Using this system, Richard was able to save his own life.

FlowState Technology

Sana has since developed a unique mask that utilizes an intervention lasting 16 minutes to restore balance in the brain and induce a therapeutic “flow state.” The device uses a complex pattern of light and sound, plus a closed loop biofeedback system to increase relaxation, reduce pain, and promote healthy sleep.

Using an embedded Valencell Benchmark sensor placed on the forehead, the device is able to accurately monitor biometrics such as heart rate and heart rate variability (HRV). The HRV sensor triggers specific patterns of light and sound to maximize relaxation and pain relief based on the user’s reaction to the therapy. Monitoring HRV allows the device to determine whether the person is being effectively moved from a “fight or flight” status to a “rest and recovery” state. In addition, Valencell’s signal quality indicator advises the device whether to employ the data coming in or if additional time and data collection is needed.

Clinical Trials

In medical device development, validated data is key. Data and data credibility are like steps on a ladder. It is important in the trial process to take each step on the ladder in order versus jumping right to the top. Racing to the final step often equals wasted time and money due to the difficulty in convincing clinicians to run long-term trials without data to support the device from the start.

After many anecdotal successes, Sana teamed with third parties like Stanford School of Medicine and US Special Operations Command for a 75 person sham-controlled study. This study showed a 2x increase in relaxation, 3x reduction in pain levels, and a 5x improvement in recovery and sleep, measured using HRV.

From there, the Sana device was tested in an opioid use clinical trial conducted at the PRA Salt Lake Inpatient Clinic by Dr. Lynn Webster. The trial included long-term Methadone (a narcotic pain medication) users. These patients are required to take breaks from using Methadone for the drug to remain effective. These breaks are the most stress-inducing situation a patient can undergo in a clinical setting.

In the trial, the Sana system proved a statistically significant lowering of anxiety and pain scores, a reduced need for opioids, a reduced desire for opioids, and more.

FDA Approval

The Sana device is undergoing the FDA approval process in several areas shown below.

External wearable devices tend to have a higher chance of qualifying as non-significant risks (NSR) by independent review boards. Having an NSR rating allows clinical trials to be completed more easily.

As a device, there are two components considered in the FDA approval process. A majority of consideration rests in the design history files where it’s crucial to show you’re making exactly what you’ve stated you’re making and that the device does, in fact, do what you intended it to. There is also a need to prove the device produces clinical efficacy in a safe way.

So, while the FDA approval process can be lengthy, it should not be considered a roadblock.

For more information on this topic, check out the presentation below and if you have any questions, please contact us at info@valencell.com