Breakout with Chet MoritzPosted: October 18, 2014
A dozen people in the room . . .
What’s your road map to get to clinics . . .need FDA approval. To get there you need your devices to be safe. Probably they won’t approve the implants together at this point; the brain one is now being tested through a company called Cyberkinetics, but the investors rolled back. Now it’s being done out of Brown University, Ohio State. They’re using the blackrock system . . . c4 ASIA A spinal cord injury is the injury model. Have done 5 patients now.
Would do brain stem stroke patients as well, because symptoms are the same and there are about as many of those as there are sci patients. The whole package is extremely expensive.
What will the collaboration between stem cells and stimulating wires look like? They’ve been working on this but haven’t seen good results yet . . . also haven’t seen negative ones. They put 100,000 iPS cells in, sacrifice the animals after a month, then count how many cells survive. This is how they know that the cells survive.
Differences in inflammation with or without wires? . . . haven’t done that. All their animals get wires, but only some get stimulation through those wires.
Results of epidural stim stuff . . .is that informing your work? It has us very excited in thinking about an early human trial. We have a new neurosurgeon who is doing about 2 surgeries a month on people who have been losing sensory or motor loss to relieve bone compression on the cord that happens in people with longterm issues. They’re talking about adding the epistim device to the patients who are getting this surgery.
Seems very low risk and a case of “why not” since they’ll already be in there. We’re seeing this as the most exciting thing we’ve seen in the last five years.
The epistim model mechanism hasn’t been explained . . . lots of people are prepared to jump in.
Was there improvement from your stimulation in any area? We didn’t see improved pain sensation. We don’t have good animal measures for sensation improvement or proprioception. Anecdotally, we saw evidence that there may have been some improvement in both. There was also a marked reduction in flexor tone, like you see in FES cycling.
What’s the end game for the core research tracts?
I’m a basic scientist. We’re looking for partners, though, in the commercial medical device world.
How realistic is the wireless thing? I think that will happen very soon. We don’t have to develop our own technology because consumer electronics are doing it for us. The challenge is whether or not we can make it stable biologically.
But your electrodes look very small . . .
We have a grid that will cover a larger area of cortex . . . most likely a thin wire that works like the epilpsy stimulator. The issue is breaking the skin, which is how infections happen, but once you’re inside you can run wires safely all over the place.
What about the creepy factor? When you’re looking at somebody who’s chronic and complete you’re more likely to say yes, no matter how creepy it seems. It will be worth it to some people. This isn’t going to be something anybody wants to do during the first six months because they might be getting return during that time.
Question about proprioception. The answer is technical and has to do with setting up electrical fields instead of doing stimulation. He says that stimulation works better.
Another techy question that is going by me, sorry. It looks like a lot of the people in this room are AB folks who work in the field rather than people in chairs/caregivers.
With the pace of technology, it seems like the time lengths are getting really compressed . . . but how much time are we talking between today and when this gets to patients in the field.
What we know is that getting all the way through a clinical trial takes 5 years. From starting today. But we aren’t starting today. So, much longer. That’s where the 5-10 years comes from. BUT there are a lot of smart people working on the device/body interface, and there could be a breakthrough that changes that whole calculus.
What would you tell a patient to be doing to be a candidate? Our intervention is stimulation to restore movement. So patients will need muscles. That means FES. Maintain good health generally. Keep doing rehab. Don’t believe people who tell you that 6 months is a physical plateau . . . it may be a psychological plateau, a place where adjustments have been made, but there are people in this room for whom 6 months was not even close to being a physical plateau. Someone adds that range of motion is also important.
What about a brain/exoskeleton interface? it may not be technically that hard, but I don’t know anybody who has moved down that path.
Anything you didn’t get to? Okay, bladder and bowel. There are some opportunities from Big Pharma . . . they think they’ve tapped out pharmaceuticals, and they want to get involved in devices. In large populations, which isn’t us. For example, if we could develop something for mass consumers who have bladder issues — an implant in the peripheral system that could tell when the bladder is filling . . . you would wave a magnet over it and it would assist with voiding. It would be a small surgery, not terribly invasive. Would you be interested in that? Someone says that it’s more complicated than that . . . the muscles that control the bladder are not simple. So, if GSK wanted to spend millions on this, would people be interested?
Man says, my daughter would jump. She’s 21. She’s going to live another 50-60-70 years, and she would choose b and b over learning to walk in a second. Her network of young women with sci — all of them would say that. She was most interested in the return of b and b and sex from the epistim study.
Man says, he had a friend who lived sitting in pee for 10 years until she got a pacemaker thing. A spasming bladder has a mind of its own.
Well, GSK has set a very high bar. They want to put a cuff around the bladder that can sense the fullness, can stimulate the system JUST to void, and then can block activity if you need to. There’s currently a $1 million prize for figuring this out, along with a few others. Like blood pressure control, hypoxia, and bronchial constriction. You need to solve two of these. They’re giving out $200k to people who can demonstrate that they have a good idea. The $1 million would be for whoever solves it in the end.