Using audio-visual stimulation to help ease the brain through chronic nerve pain and improve sleep.
CEO: Richard Hanbury
Based: San Francisco and London
The scoop: Sana Health wants to move away from the use of potentially addictive opioids, a scourge on the U.S. healthcare system, with the use of not drugs, but tech—in the form of a smart pain relief mask. The piece of kit uses both audio and visual stimulation to place the brain in a relaxation state to treat chronic nerve pain while measuring variations in heart rate through a forehead sensor.
What makes Sana fierce: As the senior editor of FierceBiotech, I have spent many years writing and interviewing parents who have set up biotech companies to try and find a curative treatment for their children, who are suffering from a rare disease with few to no treatments. When speaking to Richard Hanbury, CEO of Sana Health, there’s a similar thread, but the need wasn’t for his children, but for him, following a serious, life-changing accident nearly 30 years ago.
“In 1992, I had to drive a Jeep off a bridge in Yemen, near the capital Sanaa, to avoid a head-on collision next to a gas truck,” he explains. “I sustained spinal injuries that resulted in a nerve damage pain problem so severe I was given a five-year life expectancy.”
As was the case with this type of injury, the more things change, the more they stay the same: He was given large doses of opioids. But they very quickly began to lose their effect.
“I was left with two choices: keep popping pills until they killed me, or else find a better way. This led me, via over 1,300 EEGs and a lot of trial and error, to discover what is now called Sana, a fundamentally new method of pain management—drug free, addiction free and no side effects.”
He says that Sana “wiped out” all of his nerve damage pain, and that he has been pain-free since 1993. Since then, he has been on a lifelong mission to get Sana to the millions of people it can help to reduce pain and improve sleep, all while reducing the need for opioids.
“This quest took me to Wharton where I did an MBA (healthcare) and to McKinsey London where I was in the healthcare practice. In 2015, advances in heart rate variability sensors allowed me to finally build the device I had always wanted to build. One that can be used anywhere by anyone. Since then, two rounds of funding early clinical trials, and our first meeting with the FDA, brings us to today.”
And how does it work? Hanbury says the core of the tech is a neuromodulation device—similar to electromagnetic neuromodulation, such as transcranial magnetic stimulation—using audio-visual stimulation to create specific, targeted patterns of activity in the brain.
“The advantages of AV stim are many, but include a higher safety profile, allowing at-home use. In addition, we have been able to create a feedback loop mechanism to provide personalized neuromodulation.
“The original idea came from my own experience under a five-year life expectancy from extreme levels of pain, watching a film in hospital that was alternately good and bad, and by the end of the film I realized my pain levels were lower when the film was good, and that was more effective for me than morphine.
“This film effect is similar to how VR pain relief works now with distraction therapy. But I wanted to solve the problem of having to find new content to distract me every time.
“So, I read all of the research I could find on brain entrainment, and started testing on myself. I had the immense advantage of being in extreme pain, so it made me highly sensitive to small improvements in the algorithms. This developed over time until I had my first day with a few minutes of being pain free after using the device, and that expanded to my first 24 hours of being pain-free by the end of three months. And since that day I have not had a single minute’s nerve damage pain.
“The device wiped out all of my neuropathic pain, and thus saved my life, by increasing neuoplasticity, and allowing my brain to rewire around the problem. So, in extreme cases like mine, we are hoping to be able to radically change underlying pain levels, and at the other end of the spectrum we are proving out the effects of the device to managing pain to a lower level.”
The company is currently focused on getting an FDA 510(k) clearance for insomnia, with the product under review. “We have had our pre-sub meeting, and are back with the FDA in February to discuss predicates and trial data required for our 510(k),” Hanbury says.
But there are, naturally, plans for more: “The company’s first study in opioid use disorder, which is aiming to help addicts in withdrawal, is underway at PRASA Health Sciences in Salt Lake City. Data is set to come in by the end of February.”
The plan is also to help current, non-addicted opioid users to decrease the amounts they are taking, through three upcoming trials: one focusing on neuropathic pain at Mount Sinai, starting this month; one in severe and chronic pain; and one in fibromyalgia.
Sana also wants to provide an alternative to people using opioids in the first place, with Hanbury saying he is currently planning a study with the Cleveland Clinic.
“Our anecdotal data in all three areas is good, now we need to prove these in robust RCT trials to confirm efficacy, and take us through FDA approval.”