Ultrasound surgery -- healing without cuts - Yoav Medan

[Music] [Music] [Applause] For the last 13 years, 1 three 13 years, I've been part of an exceptional team at Insite Tech in Israel and partners around the world for taking this idea, this concept, non-invasive surgery from the research lab to routine clinical use. And this is what I'll tell you about.

13 years, for some of you, they can empathize with that number. For me, today on this stage, it's like a second Bar Mitzvah experience. Yeah, so this dream is really enabled by the convergence of two known technologies. One is the force of ultrasound, and the other one is the vision enabled by magnetic resonance imaging.

So let’s first talk about focused ultrasound. I hold in my hand the tissue-mimicking phantom. It is made out of silicon. It is transparent—made just for you. So you see it’s all intact, completely transparent. Okay, I’ll take you now to the acoustic lab. You see the phantom within the aquarium. This is a setup I put in the physics lab. On the right-hand side, you see an ultrasonic transducer.

So the ultrasonic transducer emits basically an ultrasonic beam that focuses inside the phantom. Okay, when you hear the click, this is when the energy starts to emit, and you see a lesion formed inside the phantom. Okay, so everything around it is whole and intact; it's just the lesion formed inside.

So think about this as in your brain. We need to reach a target inside the brain; we can do it without harming any tissue. So this is, I think, the first kosher Hippocratic surgical system. Okay, so let’s talk a little bit about ultrasound, the force of ultrasound. You know all about imaging, right? Ultrasound imaging. And you know also about loty, right? Breaking kidney stones.

But ultrasound can be shaved to be anything in between because it's a mechanical force, basically—it’s a force acting on a tissue that it transverses. So you can change the intensity, the frequency, the duration, the pulse shape of the ultrasound to create anything from an airbrush, you know, to a hammer.

Okay, and I'm going to show you multiple applications in the medical field that can be enabled just by focusing, physically focusing. Okay, so this idea of harnessing focused ultrasound to treat lesions in the brain is not new at all. It’s when I was born; this idea was already conceived by pioneers such as the Fry brothers and Lars Leksell, who is known actually as the inventor of the gamma knife.

But you may not know that he tried to perform lobotomies in the brain non-invasively with focused ultrasound in the '50s. He failed, so he then invented the gamma knife. And it makes you ponder, you know, why? Why those pioneers fail?

And there was something fundamental that they were missing. They were missing the vision. It wasn't until the invention of the MRI, and really the integration of MRI with focused ultrasound, that we could get the feedback, both the anatomical and the physiological, in order to have a completely non-invasive closed-loop surgical procedure.

Okay, so this is how it looks, you know, the operating room of the future today. Okay, this is an MR suite with a focused ultrasound system, and I’ll give several examples. So the first one is in the brain. One of the neurological conditions that can be treated with focused ultrasound are movement disorders like Parkinson's or essential tremor.

What is typical to those conditions, for essential tremor for example, is the inability to drink or eat cereal or soup without spilling everything all over you, or write legibly so people can understand it and be really independent in your life, without the help of others. So I’d like you to meet John. John is a retired professor of history from Virginia.

So he suffered from essential tremor for many years, and medication didn’t help him anymore. And many of those patients refused to undergo surgery to have people cut into their brain. About four or five months ago, he underwent an experimental procedure.

It is approved under an FDA IDE at the University of Virginia in Charlottesville, using focused ultrasound to ablate a point in his thalamus. Okay, and this is his handwriting on June 20th, if you can read it—2011. Okay, this is handwriting in the morning of the treatment before going into the MRI.

So now I’ll take you through how a typical procedure like that looks, how non-invasive surgery looks. So we put the patient on the MRI table; we attach a transducer, in this case to the brain. But if it were a different organ, it would be a different transducer attached to the patient.

And the physician will then take a regular MRI scan. Okay, and the objective of that—I don’t have a pointer here—but you see the green sort of rectangle or trapeze? This is a sort of a general area of the treatment. It’s a safety boundary around the target; it’s a target in the thalamus.

Okay, so once those pictures are acquired and the physician has drawn, you know, all the necessary safety limits and so on, he selects basically a point. You see the round point in the middle where the carotid is, and he presses this blue button called “sonicate.” We call this instance of injecting the energy “sonication.”

The only hand work the physician does here is moving a mouse. This is the only device in this treatment. So he presses “sonicate,” and this is what happens. You see the transducer, the light blue—there‘s water in between the skull and the transducer—and it does this burst of energy. It elevates the temperature.

We first need to verify that we are on target, right? So the first sonication is at low energy; it doesn’t do any damage, but it elevates the temperature by a few degrees. And one of the unique capabilities that we leverage with MRI is the ability to measure temperature non-invasively.

Okay, this is really a unique capability of MRI. It is not being used in regular diagnostic imaging, but here we can get both the anatomical imaging and the temperature maps in real time. And you can see the points there on the graph; the temperature was raised to 43° temporarily.

This doesn’t cause any damage, but the point is we are right on target. So once the physician verifies that the focal spot is on the target that he has chosen, then we can move to perform, you know, a full energy ablation like you see here. And you see the temperature rises to like 55 to 60°.

If you do it for more than a second, it's enough to basically destroy the proteins, the cells. This is the outcome from a patient perspective, same day after this treatment. Okay? This is an immediate relief, and John is one of like a dozen very heroic, courageous people who volunteered for the study.

And you have to understand, you know, what is in people’s minds when they are willing to take the risk. And this is a quote from John: after he wrote it, he said, “Miraculous.” And his wife said, “This is the happiest moment of my life.”

And you wonder why? I mean, one of the messages I’d like to carry over is about defending quality of life. I mean, those people lose their independence; they are dependent on others. And John today is fully independent; he returned to normal life routine, and he’s also playing golf like you do in Virginia, right when you are, you know, retired.

Okay, so you can see here the spot—it’s like 3 mm in the middle of the brain. There’s no damage outside; he suffers from no neural deficit. There’s no recovery needed, no nothing. He’s back to his normal life.

Let’s move now to a more painful subject. Pain is something that can make your life miserable, and people are suffering from all kinds of pain, like neuropathic pain, lower back pain, and cancer pain from bone metastasis. When the metastasis get to your bone, sometimes they are very painful. All those indications have already been shown to be successfully treated by focused ultrasound, relieving the pain again very fast.

And I would like to tell you about PJ. He’s a 78-year-old farmer who suffered from—how should I say it?—it’s called “pain in the butt.” He had a metastasis in his right butt, and he couldn’t see— even with medication, he had to forgo about all the farm activities.

He was treated with radiation therapy—state-of-the-art radiation therapy—but it didn’t help. Many patients like that failed radiation therapy, and again he volunteered for a pivotal study that we run worldwide, also in the U.S. And his wife actually took him; they drove like three hours from their farm to the hospital.

He had to sit on a cushion, stand still—I mean, not to move because it was very painful. He took the treatment, and on the way back, he drove the car, the truck, by himself. So again, this is an immediate relief, and you have to understand what those people feel and what their family experience when it happens.

He returned again to, you know, his daily routine on the farm and rides his tractor. He rides his horse to their mountain cabin regularly, and he has been very happy. But now you ask me, you know, what about war? You know, the war on cancer? Show us some primary cancer; what can be done there?

So I have good news and bad news. The good news is there’s a lot that can be done, and it has been shown actually outside of the U.S. and doing that in the U.S. is very painful. I mean, I don’t see, without, you know, this nation taking it as a collective active will or something that is a national goal to make that happen, it will not happen.

And it’s not just because of regulation; it’s because of the amount of money needed under the current evidence-based medicine and the size of trials and so on to make it happen. So the first two applications are breast cancer and prostate cancer. They were the first to be treated by focused ultrasound, and we have better surgery results in breast cancer.

But I have a message for the men here. We heard yesterday Kevin talking about the adverse event rate in prostate cancer. There is a unique opportunity now with focused ultrasound guided by MRI because we can actually think about prostate lumpectomy, treating just the focal lesion and not removing the whole gland and by that avoiding all the issues with potency and incontinence.

Well, there are other, you know, cancer tumors in the abdomen—quite little, very little actually—pancreas, liver, kidney. The challenge there, with a breathing and awake patient, and in all our treatments, the patient is awake and conscious, and he speaks with the physician, is you have to learn, teach MRI some tricks how to do it in real time.

And this will take time. This will take two years. But I have now a message to the ladies, and this is in 2004. The FDA has approved focused ultrasound for the treatment of symptomatic uterine fibroids. Women suffering from that disease or those tumors have heavy bleeding during periods, abdominal pressure, back pain, frequent urination, and sometimes they cannot even conceive and become pregnant because of the fibroid.

This is Frances; she was diagnosed with a grapefruit-sized fibroid. This is a big fibroid. She was offered hysterectomy, but this is an inconceivable proposition for someone who wants to keep her pregnancy option. So she elected to undergo a focused ultrasound procedure in 2008, and in 2010, she became the first-time mother to a healthy baby.

So new life was born. So in conclusion, I’d like to leave you with actually four messages. One is think about the amount of suffering that is saved from patients undergoing non-invasive surgery and also the economical and emotional burden removed from their families and communities and the society at large. And I think also from their physicians, by the way.

And the other thing I would like you to think about is the new type of relationship between physician and patients when you have a patient on the table who is awake and can monitor even, you know, the treatment. In all our treatments, the patient holds a stop sonication button. He can stop the surgery, you know, at any moment.

And with that note, I would like to thank you for [Applause] [Music] listening.