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Sana Health Clears a Major Milestone in the Fight Against Chronic Pain · StartUp Health NOW Podcast

• 0:00
  [chimes] Welcome. My name is Unity Stoakes, co-founder at Startup Health, and today I get to reconnect
• 0:12
  with longtime health transformer Richard Hanbury, who is the CEO and founder of Sana Health.
• 0:21
  Sana Health has actually been a member of Startup Health since 2020, and I believe the company was first founded in 2016.
• 0:32
  We're gonna learn all about the world's first approved audiovisual neuromodulation device that Sana is bringing to the world, and really get a full update on the moon shot progress that Sana is making in all the world of brain health, how they're helping people with pain, PTSD, and mental health issues.
• 0:54
  Stick around. We'll have a full conversation with Richard Hanbury from Sana Health. [upbeat music] Hello. Hello, Richard. How are you? I'm good. I'm good. How and where are you?
• 1:11
  I am in Berkeley, and I am great, and it's always a good day when I get to reconnect with you. [laughs] Because I feel like it's usually at a conference at, like, Stanford or in Boston or somewhere around the world.
• 1:27
  But it's always a pleasure when I get to reconnect and see you. How are you, and where are you? S- Sandy, Utah. And, yeah, it's... Winter is almost here.
• 1:38
  We were up in Yellowstone this weekend, and it was only the second time, or the fir- the first time since 2010 that I had to call 911 to get help. Whoa, what happened?
• 1:51
  My, my kid is nine, and he'd been very good about me taking pictures all morning of wolves and bear and stuff in Yellowstone. And he was... I was like, "What do you wanna do?"
• 2:02
  And he's, "I want you to drive me as close as you can to top of the mountain so I can walk the rest of the way up." I was like, "Okay." That ended up being a little too adventurous.
• 2:12
  And it turns out that when you have a pass, the snow's quite often deeper than it looks. So we were right out in the middle of nowhere, beyond northwest, northeast Yellowstone, like way out in the mountains. And- Wow...
• 2:28
  yeah, we got stuck. And I got out of the car, crawled around the car digging us out, but I could only dig us out so we could go backwards, not forwards, 'cause I couldn't get under the car to go forwards.
• 2:39
  And that left us with about a foot in which I had to get the car going in the right direction to get back onto the right path, and that didn't work. We ended up in a deeper...
• 2:50
  And then I had to call the cavalry, because there was no way we were getting out, and there was a winter storm coming in. And the person- I am, I'm so glad that everything worked out.
• 2:59
  It was- Those situations, you, you just... They're so challenging, and they turn on a dime. Sound like you acted quickly, and all is good now hopefully. It is. Have you...
• 3:09
  Uh, do you have an iPhone, or do you have a, an Android? I do. I do. So the satellite worked? Yeah. Yeah. I wouldn't have gone any- I wouldn't have gone up that road without it.
• 3:19
  'Cause I used to have a, an external one, but no, it worked perfectly. Yeah. It's... 'Cause I always make sure I have batteries and stuff in the car for just in case. But yeah, it's a good system.
• 3:30
  I feel like adventuring or dealing with the weather is a little bit similar to being an entrepreneur, because you... It's just constantly dynamic. It's constantly changing.
• 3:44
  You have to deal with the situation and, and it's such a powerful force to constantly be confronting something as powerful as weather. And in our case, it's the big industry that we're coming up against.
• 3:59
  [laughs] But maybe that's a good transition, because you have just been blazing away at Sana.
• 4:05
  And maybe just to level set, if we could just remind everyone the mission that you're on and the very important innovation that you're bringing to the world with Sana Health. Yeah.
• 4:19
  So it is still the same audiovisual neuromodulation. The... We're now in front of the FDA for neuropathic pain. We should have an approval on the 16th of January.
• 4:33
  We've probably about a 80% chance that's gonna go through. We have approval for Health Canada that came through early. Um- Congratulations. That is huge. So that is- Huge news. Yeah. Can you explain what that means?
• 4:47
  And just huge congratulations, 'cause you've worked very hard to get to that point. Thank you. Yes. It's the first regulatory approval anywhere in the world for any audiovisual neuromodulation ever.
• 5:03
  So first, first country to cross the line. It is neuropathic pain. It's Lyrica and gabapentinoids are the drug of choice. That's the gold standard. And they're awful.
• 5:16
  Gabapentin on average puts on 25 pounds of weight onto each person that uses it. And in America, that means usually adding on back pain as well as to other problems that people have, and brain fog, et cetera.
• 5:29
  So 90% of people who take gabapentinoids are not taking them at the two-year mark because of the side effects, which just leaves opioids.
• 5:38
  And yeah, so we are a standalone treatment, and hopefully when the FDA catches up with the Canadians, we'll have that approval as well. We've also got the DOD, I should say now, paying for the PTSD study.
• 5:56
  So we completed the pilot. The pilot went really well. The- And you've been working with the Department of Defense on that?Yes. Yes. Um, so they are our largest non-dilutive funder. Total of 5 million so far.
• 6:11
  And it goes through military operational medicine, and then the trials themselves are happening within the VA. So Charleston VA, and now we're about to do a pivotal, and that will be Charleston and San Francisco VA.
• 6:25
  And that is the pilot we did, device plus gold standard versus gold standard alone. And the device with gold standard got 3X the improvements in PTSD symptoms as gold standard alone.
• 6:43
  And gold standard in PTSD is pretty awful. It is prolonged exposure. Mm-hmm. It's, "Oh, you've been... You've had plenty of trauma. Let me sit and talk to you about your trauma until-" Mm. "...
• 6:53
  it's less traumatizing to talk to you about your trauma." So in Israel, we've also just started a pain and PTSD study combined. Approximately 30% of Israelis currently have PTSD. Obviously that number's higher in Gaza.
• 7:09
  And they said to us, "Okay, we don't care how this works.
• 7:13
  We only care can you replicate the results you got with the DOD in Israel with the most problematic PTSD people we can give you, which is PTSD and pain combined in combat-injured veterans?"
• 7:28
  So that study just started, and we had the first person complete yesterday, and they get, they got more than a 10-point drop, which means that they had a clinically important improvement.
• 7:38
  So we need 35 more of those out of 70, or 34, and then we've hit their 50% mark, and then they will start bulk ordering. Um, so sales-wise, we're more likely to have Israeli orders before we have many in the US.
• 7:56
  And CMS said, "You have breakthrough status, so we know we are supposed to care about breakthrough status and prioritize you." But the person basically told me,
• 8:09
  "We don't have the resources to take on, uh, breakthrough designation devices like in theory we would like to." He said- But- "... if you get sales to two sophisticated buyers,
• 8:25
  then we will prioritize you for coding and coverage, because at that point you will have reduced the work we have to do by 80%."
• 8:33
  So the aim is to get sales in Canada, get sales in Israel, or, and/or the VA, and that then gets us prioritization at CMS because it's two sophisticated buyers that set the price.
• 8:45
  It's a very interesting approach and strategy, and I hope more entrepreneurs and health transformers are listening here, because you're taking a very strategic and global approach.
• 8:57
  I know y- you've been working on this for what, it's, it's been a decade, better part of a decade at this point, or close to a decade. And- Uh, three. Three. Three decades. [laughs] Well, there we go. Okay.
• 9:09
  But I, I, I'm just- So the science- Yes, it is a decade now. You started with the science, right? Yeah. And the technology and the innovation.
• 9:16
  And then you've gone through the long journey to validate this and go through the pro- the various process there in different parts of the world.
• 9:27
  You've now got this approval and designation in health- with Health Canada, and I believe, does that open up potential for reimbursement in Canada? Yes.
• 9:38
  The reimbursement situation in Canada is it's even more complex than the, than, than the US.
• 9:44
  Uh, but it does start the ball rolling, especially in the, amongst indigenous communities, where the sort of the, that combination of PTSD plus chronic pain is very similar to the profile for veterans.
• 9:57
  And so hopefully that will start. It's... In terms of one thing I wish I could, I, I wish everyone who's starting in, in earlier stages than us would learn, and it took me a long time to, to learn this, is that
• 10:13
  the cre- credibility is not a bar when it comes to medical proof. It's a ladder. And the...
• 10:21
  If you treat it like a ladder and you treat it as what is the cheapest, simplest, easiest bit of data that I can grab, however crappy,
• 10:32
  and then grab the slightly less crappy, and the slightly less crappy, and the slightly less crappy, and eventually you get up to the full-blown RCT at a major institution that then gets you your FDA approval.
• 10:42
  But if you try and jump the ladder, it doesn't work. Uh, and e- all the time we spent going after grants was all wasted until we had enough early data.
• 10:54
  That was like, it was like once I understood it's not a bar, it's a ladder, and then we started just going after... And I guess it's the same of proof points in any area that's non-medical as well.
• 11:05
  It's, "Okay, what's the cheapest way we can prove or, or de-risk by getting the next bit of data in sales?" Whatever. It's, I guess it's the same construct. But in the medical area it's really easy to get it wrong.
• 11:16
  It's really easy to do what I did and go, "Oh, well, you really need the double blind RCT from a major institution. Let's jump to that." No. You get this. The...
• 11:25
  When I realized that first off, I stopped going after Stanford, Berkeley, and UCSF, who would all... Like Stanford was, "Not invented here. Go away."
• 11:35
  UCSF was, even though we had really helpful people inside it, they couldn't find the other people 'cause it was so disorganized. And Berkeley's first response was, "We really wanna help you.
• 11:47
  Really sorry, but the paperwork's gonna take 18 months, and we know you're a startup, so we know that's gonna be problematic for you." The day that someone made me get that it's a ladder, not a- Step... a bar,
• 12:00
  I hired a local meetup room,
• 12:03
  a local office in Berkeley-I rang a meetup group and said, "Hey, can you get some people to show up just to try a device and try a, a, a, one device and a sham, and we'll do a random crossover?"
• 12:15
  And I had 30 people show up. Within a week I had more data than I had from two years of trying to do it the wrong way around.
• 12:22
  What I love about this is you're saying one step in front of the other, one movement forward, one rung on the ladder up. Yeah. And you just persevere through all of that. Yeah.
• 12:35
  One institution says no, or they say no gently, but you go find another way to go get data and keep moving forward. And now you're doing this at...
• 12:45
  What's interesting, in different countries, in some cases for different indications it sounds like. There's pain, there's PTSD, there's anxiety. I believe you might be also helping with sleep, sleep disorders? Yeah.
• 13:01
  Yeah. So sleep is... Sleep probably underlies the clinical benefit probably across the board. But the consumer... But a- as a Brit, you can't advertise...
• 13:14
  There's the Advertising Standards Authority, you're not allowed to lie in advertising. In America it's your first- That's a good thing. This is good. Yeah. Everywhere in the world- This is good... this is good.
• 13:22
  In America, it's your First Amendment right to lie in advertising. [laughs] Unless you're covered by the FDA or the SEC. So if you have something that works,
• 13:34
  anything medical, uh, the consumer stuff, you've probably got really good data on this overall, of the success rates of people who try to go consumer versus go regulated and medical. It's a really...
• 13:49
  If you've got something that works, it's worth getting the evidence and proof points to go the medical route.
• 13:56
  If you're really good at marketing, you've got something that works a little but not a lot, then you're better off on the consumer path.
• 14:03
  But you've probably got masses of data to, to back up, you know, what's worked and what hasn't worked.
• 14:10
  And you now have these external forces, hello- Health Canada, a very big validation here, that's saying what you have works. What you've been working on for decades actually works.
• 14:24
  You've known it works for, for years, which is why you're- Yeah... bringing this to the world. Can you talk about just very briefly how this works, what it's doing to someone? Is this a matter of 10, 15 minutes?
• 14:40
  Is it a daily? How... Where would someone... How would they use it? And then just give frame for kind of the listeners and audience really what's going on here and why you think this is such a breakthrough.
• 14:55
  So originally I went off a bridge in Yemen, so I had SCI, TBI, and PTSD. And I had a five-year life expectancy because of the degree of nerve damage pain. And realistically, I wouldn't have waited five years.
• 15:10
  I was like, "No, I'm not gonna do that. I'm just gonna check out if that's the case."
• 15:14
  But then in hospital they tried to teach me meditation, and meditation gives you present moment awareness, which when you're in pain increase... It does the exact opposite of opioids.
• 15:24
  It gives you more pain, 'cause it makes you more aware of how much pain you're in. You're focused on the pain. You're focusing on the pain. Yeah. You, you become aware of how much pain you're in. And that gave...
• 15:34
  But then I watched a movie, and the movie flipped me in and out of what we would now call a flow state. And then I was like, "Oh, when I was in a flow state I had less pain. Interesting.
• 15:45
  Maybe I can figure out a way to recreate that with an external stimulus instead of having to try and find a good film every now and again, every time I wanna get out of pain."
• 15:54
  So I reverse engineered the frequency patterns that had already been proven to come in long-term meditators, and do that with pulse light and sound. And so this is the current version. Uh, this is the next version.
• 16:09
  Biggest difference being the next version will use a laser-based PPG. So it'll use a sensor that won't care about skin tone.
• 16:18
  Current wearables, the sensors have to optimize the battery consumption over signal quality, and the biggest weakness of most wearables, including the latest version Apple Watch, is the paucity of data and how good that data is when someone has skin, one of the darker skin tones.
• 16:38
  And in the DOD and the VA, more than 60% of their PTSD is in people with the two or three darkest skin tones. Oh, yeah. And that, this next generation solves it. This version,
• 16:52
  put it on, turn it on, pulses of light, pulses of sound, and usually it's then going to sleep.
• 16:59
  And that is then this thing is waking up, this is then on the floor or in someone's bed or sometimes people stay awake just enough to put it on their bedside table and, and then in the morning.
• 17:12
  St- most of the long-term use is someone using at night to go to sleep, and that's the same whether it's PTSD, anxiety, depression, or pain. And those all come in a cluster.
• 17:23
  Every study where we've improved sleep or decreased depression or decreased anxiety, any one of those areas, and people improve in all of them every time, because chronic pain is essentially a mental health problem.
• 17:36
  It's a are you in fight, flight, or rest recovery? So you have a peripheral signal that is then amplified by the brain's response to it based on all the other mental health factors.
• 17:48
  And the overall aim is that a primary physician will be able to go... So 30% of Americans take a psychoactive drug every day. Right. So this reduces the need potentially for medication, opioids.
• 18:02
  These, this is a big deal f- if you're in kind of chronic pain or having PTSD. This is a really transformative opportunity here.Yeah. Yeah.
• 18:14
  Typically what happens when someone starts using a device, and I'm sure it'll be the same in other people in the space, is that people will drop the drugs they hate the side effects of the most.
• 18:26
  So opioids people drop a little bit over time, 'cause they don't like the long-term risks, they don't like the constipation that comes with opioids, but they don't really hate them.
• 18:35
  Lyrica gabapentin in our pivotal trial we had an 80% drop in the amount of those drugs that people were taking, and that was even though we told them, "Please don't change your medications during the pivotal trial."
• 18:48
  Still 80% drop in how much they were taking of those drugs because they don't like the side effects.
• 18:54
  Xanax is another one that people hate the side effects from, and any time they can to reduce the side effect burden, they, people will stop taking them. And it's the same with most of the mental health drugs.
• 19:04
  There's the long-term evidence says something like Adderall is good, it helps kids enough that their brain actually at age 18 is better off than had they not taken the drugs, because the drugs allow them to actually get stuff done.
• 19:19
  But that's one of only two examples in the mental health space where the drugs actually have a long-term positive benefit. Nearly everything else is amelioration of symptoms.
• 19:30
  Which is why devices and neuromodulation in particular are such a big part of the future equation.
• 19:37
  If you're looking five years down the line, the health system will not be able to bear the burden of the costs unless all pain and mental health care moves to multimodal care.
• 19:50
  And that multimodal basket is gonna be neuromodulation, some software related stuff like cognitive behavioral therapy delivered by app or delivered by VR, and some drugs.
• 20:03
  That's, and your, and the neuromodulation is gonna include us, it's gonna include magnetic, electric. You've got a very large amount of in the startup health portfolio. Right.
• 20:15
  And the bu- and working together in a basket of care is the only way that we're gonna reach scalability for improving pain and mental health long term in this country or anywhere in the world. I couldn't agree more.
• 20:30
  One of the things that I think you've also done is you've gotten here and gotten so far
• 20:38
  on a fraction of the budget what I know some very large companies and institutions have done to get to a similar kind of stage.
• 20:49
  I also know you're probably al- always fundraising, looking for new partners, looking for collaborators. I believe the mission you're on is, is critical.
• 21:01
  It's critical to the world, it's critical to people in pain, it's critical to soldiers everywhere, it's critical to families and to people's mental health and wellbeing. Who needs to know about this?
• 21:13
  Who do you want to work with? Who are you looking to collaborate with?
• 21:18
  I wanna open the aperture here so more people inbound know to go to Sana.io and connect with you, because I see this as something that needs to make its way into the world more quickly, not just in Canada, but here in the US and Israel and everywhere else in the world as well.
• 21:39
  Who are you trying to meet? Who should be reaching out to you, whether that's on strategic side, investor side, customer, partnership, et cetera? I, I massively appreciate that. The first is the investor side.
• 21:51
  My, my existing investors have done as, al- almost as much as they can. Al- they're always finding little bits more even when we carry on pushing the need for it.
• 22:01
  We need a little bit more to get us to early commercial data, because as I'm sure you've seen in other places, there's a bifurcation of there's a lot of money available at commercial rounds, and the earlier stage stuff is, is a lot harder to get ahold of now than it used to be.
• 22:19
  But once you've got one to five million in sales, then there's a massive pool of liquidity available. So the question is, like, how do we get to that, those larger commercial rounds now that we're very close?
• 22:30
  And you're, you're very close. You're almost there. It- Exactly. So now we are a really good risk, r- r- risk reward equation for newer, smaller investors in this last stretch now that the majority of the work is done.
• 22:43
  And then outside of that it is when it comes to the people like Blue Cross Blue Shield and so on, the feedback we've very frequently had is, "We don't want point solutions, and we, we want you to come to us with a at home pain service end to end, then we'll be happy."
• 23:05
  And so anybody who's trying to build those platforms that we can plug into. Originally I tried to talk to people like the Calms and the Headspaces because they were saying they wanted to do that.
• 23:18
  But it turned out that their business model didn't really work very well with kind of building out that multimodal platform. But the people...
• 23:27
  But I know there are people out there who are actually doing it, and also people who have existing contracts to deliver to the DA who we could plug into. 'Cause we don't want to build the platform.
• 23:39
  That's not our expertise. We wanna find the people who are building those platforms that we can plug into. And you'll plug into that platform- Yeah... as a key pillar to the multimodal kind of solution here. Yeah.
• 23:53
  S- stupid question maybe, but it seems, I know this is a medical device, but it seems like there's a, an even larger opportunity for, let's call it everyday people who want to get into those flow states, who want...
• 24:10
  Maybe they don't have PTSD or chronic anxiety, but this could also be helpful to them. Is there a-An opportunity to, at a certain point, open this up to a wider audience.
• 24:24
  I think of what a Oura Ring now, everybody's monitoring their sleep, and that's benefiting a whole generation of people, not just people with severe sleep disorders. Yeah. Is that... Am I going down the wrong path here?
• 24:39
  Is that a potential future opportunity or- Yeah, it's worth it in the future... shift out of focus or? I'm, I'm, I'm a Whoop user.
• 24:46
  Again, because 30% of Americans are taking a psychoactive drug every day, the idea that the non-medical is a larger market, I think is false. That's a good point. Having said that, yes, if we could...
• 25:00
  Like, I am a health and wellness user now. Every time I get on a long-haul plane, I can get a... My last trip to the UK, the device put me to sleep seven times, and my kid woke me up six times. So device wins.
• 25:13
  But it was literally again and again. I could just put myself to sleep, and it was... And my kid, he's nine, I never argue with him about him saying he can't go to sleep.
• 25:23
  Because once it's bedtime, if he's not tired, he just puts on the device and goes to sleep. I would love every parent to, to have that a- as a thing. The challenge in the short term is that
• 25:37
  because healthcare is such a problematic issue in America, like in the UK, the last person to go medically bankrupt was in 1956. Mm. In this country, it's 50% of personal bankruptcies every single day- Mm...
• 25:52
  are completely or majority caused by medical expenses. And therefore, when someone has a big enough problem, their ability to pay out of pocket is usually deteriorated.
• 26:05
  So the things that do really well out of pocket are the things that don't damage your ability to earn, like LASIK surgery, like hearing aids, anything to do with fertility or... Those are the things that...
• 26:16
  And I- I'm sure you've seen the data in the portfolios. Anything that doesn't damage your ability to earn, you, there's a big, there's a big market there for pay out of pocket- Yeah...
• 26:27
  uh, because of the difficulties of insurance. No, I mean, it's huge, huge market and we're running short on time here, but I think what I'd like to do is do several updates.
• 26:35
  'Cause you're in this phase where you're just making so much progress so quickly, and we need the world, we need this to get into the hands of more people so they can not be in pain. So what else does...
• 26:48
  Parting last words, what else does the world need to know? And I assume send people to Sana.io, S-A-N-A dot I-O? Yeah. Yeah. Okay. Yeah, so number one is very definitely the money in this round.
• 27:01
  It's now a really good time for people to capitalize on all the money that's already been invested, like, just get a very quick uplift.
• 27:08
  When we go through FDA, our valuation is gonna almost double, um, on the 16th of January with about a 70% likelihood, and there's about a 20% chance that there is a delay for a few months, but we're still in that kind of doubling of anybody who comes in now, it's a quick win, uh, to- There, there's some opportunity here.
• 27:28
  Yeah. So if you are a strategic, if you're a customer, if you're an accredited investor, you should reach out to Richard Hanbury at Sana.io, and we'll do several check-ins coming up.
• 27:40
  But Richard, I just, I'm so grateful that you're persevering through this mission. You're going up the ladder one or two or five rings at a ti- rungs at a time.
• 27:52
  So thank you for the moonshots you're supporting with your innovation and everything that you do as a health transformer. Very much help. Appreciate all the help that you and Startup Health have given
• 28:05
  me and everyone else in, in our community. It's, it's a real pleasure, and thank you for all of your work. Thank you. Talk soon.
• 28:14
  [upbeat music] And finally, an invitation to all of the extraordinary health transformers, whether you are a startup, someone building the future of health, or whether you are an investor, funder, or buyer of the solutions out there in the marketplace, this is an invitation to you to join the Startup Health member community.
• 28:37
  Learn more at startuphealth.com. Look forward to hopefully seeing you soon. [upbeat music]