I'm. Very. Pleased, to speak with all of you today, you're. Part of the future of America, to. Study engineering and, to. Use it for the benefit, of all mankind, that, has been my goal and. I hope you learned something from my lecture, today to. Make it your goal because, there's. A great deal of satisfaction in. That so. Today I'm going to talk to you about. Three. Of my few, hundred. Patents. And inventions. About. Three medical, devices that, have, been used by many many persons. In the, US and around the world and. I. Call. Our field, engineering. For, Humanity and I, think is one of the best fields, of engineering. That any of us could do so. In today's lecture and, if you don't mind I'm, going to sit down of course I am, in fact four, months from 90 years old, so. So. Today's lecture will. Be a presentation, about, three medical devices the. First is a new me means, that's. Actively, being used for the treatment of epileptic, seizures, the. Second, is a. Way that we have recently, received FDA clearance, for which. Is the device if you have it you, will not die of a heart attack. The. Third device, that I'm working on very actively, now is a, device, that's. Of able, to eliminate all human, pain without, medications. Or side effects, and. So. Let us begin, the. First company, we're going to talk about is called neuro pace Inc and it's. A device that prevents. Epileptic, seizures, by, detecting, a precursor, of that seizure in the brain and providing. Electrical, pulses, onto that region, of the brain to. Prevent the, seizure from. Happening. Is there. Anybody here, in the room who has epilepsy or. Knows somebody who. Has epilepsy raise, your hand. See. That's quite a few hands, so. The prevalence of, epilepsy. 1%, of the world population. 2.3. Million Americans with, epilepsy. 700,000. With, uncontrolled. Seizures. 1.4. Million with. Medication. Side effects, one, of the wonderful things about, the medical devices that, I have, developed is that, they have no side. Effects. The. Cost in the USA, in last, year, the. Cost to the USA twenty, two billion. Dollars, we, need a better way to treat epilepsy, so. What is our concept. For it I'll. Show it to you in this diagram. Here. Is a, computer. System that's. About one, inch wide a quarter. Inch thick and two inches long and it. Is a computer, system that's connected, to a wire one, wire the blue one deep in the brain if the. Epileptic, seizure begins, there we, detect it there if the. Epileptic, seizure begins, on the surface, of the brain we. Have five, electrodes, there to, detect, the start of the, epileptic, seizure. So. We. Then have a response, to it by. If, we sense, the seizure we. Then run, an electrical, current through that portion, of the brain and it, prevents, the seizure from occurring, so. It, detects, and terminates, seizures, before, clinical. Symptoms, appear, it provides. Stimulation. Only, when, it's needed if you don't have a seizure it doesn't, do anything. Can. Be turned off if the seizures, disappear, which, has happened in a few of our patients, it has. Minimal, side effects. Is just, implanted, once implanted there, no side-effects. And it's, invisible, cranial. Implant, that, if you have it no, one knows you have it because, it's been just replaced a piece of the cranial, bone with, the device. So. How. Have we done certainly. Early on with this so. Here are some. Cases in which we've done and. We've. Treated first, of all the red line was. For the placebo, patients. Patients. Who had to put in but not turned on to. See the difference, the, blue line is the reduction, in, the number of seizures, per day for, patients in whom we turned it on. Amazingly. And but not always surprisingly. In the, first month, with. The weather's placebo, are treated, they both had improvements. But, then the, truth started, to prevail, and the. Blue line shows a. Dramatic, reduction in their. Having seizures. Less. The fewer than 50%, as, many, seizures as the, patients, had before. The implant. So. How do we do relative. To drugs. Well. Here we see that. With responsive. Neural stimulation. 15. Percent, of our patients never. Had a seizure again. This. Is the leading drugs. Look. How they've had how long it's what, percentage. Of them never. Had it again, and by. None. Of them in the long run really, succeeded. With it. So. What. Is the retention rate of, our product, versus, the use of drugs to, treat epilepsy that's.
In This diagram here, we are responsive. Neural stimulation. Nine, more than ninety percent of our patients retain. It but. These are the different, drugs used, and they. Don't get retained, cause after a while they don't do the job. So. The. Good news. The. Neuro pace responsive. Neural stimulation, device, was. Presented. To a review panel by. The FDA, on February, 22nd. 2013. The. Final, vote on the panel was. 13. Yeses, to zero knows that the device is safe. 12. Yeses, and 1 abstention device. Was effective, for the treatment of epilepsy and, 11. Yeses in two abstentions. That, the device should be approved. For use in the USA, and so. In this. Usual, way the FDA said, how. Can we slow it down now. And. What. They did was saying. But. You don't know that maybe it'll the. The device will damage the skull or something, so, we had to put it in rabbits for six months, and, finally. Eight months after the unanimous, approval the. FDA finally was forced to approve us so, that American, patients now. By the hundreds, each. Month, can get the device. So. The usage in the USA is now climbing, upward, at a high rate I'm very glad to say that and, so, of the fortunate. Patients, who've been able to use. The device. In. Medical, news there is new hope tonight, for the millions, who suffer from migraines, the. Headaches hit women especially hard, almost, three times as many as men and, often. The medication, just doesn't, work now. There may be an effective pill free alternative. As, Sharon Alfonzo reports, it's medicine on the cutting edge, when. Carol Murphy gets a migraine she can barely lift her head I've been, to the hospital. Six. Or seven times to finally say I am, too tired to fight this just, give me anything I really don't care, now. A new device allows migraine, sufferers, to take treatment into, their own hands, it's. Called a transcranial, magnetic, stimulator. Or TMS, you, push a button and the TMS sends two very brief magnetic, pulses, into, the brain. Scientists. Believe those pulses, short-circuit. The building, electrical, storm in the brain that occurs just before migraine. It's called an aura it, turns on a very powerful magnet, and that generates. A tiny, amount of current in the brain that, has the effect of turning. Off the migraine aura seven. Million Americans, have migraines, with aura changes, in vision like spots or grain this. Study looked at 201, patients, with or migraines, 39. Percent who tried the device say they were pain-free two hours later Caryle, Murphy was, among them there, was no pain I waited that 10 minutes and nothing happened, and. Nothing. Happened ever again after that and it, was like this is some. Sort of miracle for, about half the people who suffer from migraines, medication. Doesn't, work so, this offers, some hope but, it hasn't been approved by the FDA yet, so Carol Murphy had, to give hers back please. I want my machine back i want. My life back for migraine sufferers, the only thing more excruciating, than, the headache maybe, not, being able to get your hands on the one thing that, could stop it Sharon, elf on see ABC, News New, York so. Let us go on to the next thing and. Which. Is a. Company. I started called. Angel. Medical. Systems, Inc it's. An implanted device, implanted. In. The chest like a pacemaker. That. Detects, the occurrence, of a heart attack, before. The patient realizes. That it's, happening. Acute. Myocardial, infarction. Or a mi is a big word so the doctors, can charge you more money for having a heart attack and. We'll. Talk about what the situation, with a mi, in the United States. The. Annual incidence in, 215. Was. 1.2. Million. Americans, had. A heart attack. The. Annual mortality, rate, about 40%. 500,000. Died. Approximately. 50%, have. Significantly. Damaged, heart muscle which, can lead, to congestive, heart failure. Thus. About. 90, percent or 1 million of these heart attack patients. Either, die or have, significant. Damage to heart, muscle, in the, USA, every, year. Symptoms. Are often denied, by. The patient. Especially. Us men because. We are very grave. You. Got that. Now. He recognized, bravery, when you hear it. 20. To 25, percent of all patients never. Have any symptoms, and, they. Really need something to tell them they're having a heart attack so their life can be saved, this. Is most likely in. Diabetic. Patients and elderly, women. So. We start a company called angel, medical systems. The. Average, time from a heart attack to get to the hospital. Emergency, room, is 3 hours. The. Average time, from emergency. Room to get treated for a heart attack is about, 3 hours.
So. The total time you see how well good I am at adding, total, time about 6 hours. No. Other device, other than the one we have can, warn a patient, that, a heart, attack is, occurring. The. Angel, medical, device provides, a solution, for. Detection, within, 90, seconds, of the. Onset. Of the. Heart attack and you can arrive at the hospital within. 30 minutes, and we, will save your life. Now. How do we do this job, ok. I'm about to make you an eat, an expert, on heart attacks, here. This, looks like an electrocardiogram. Right when. You measure, it in the heart it's called an electro. Gray but. Has the same general picture, and shape but, is much higher voltage, when, you do it in the heart. These. I don't know why they call this qrst, instead. Of ABC, maybe, so they can charge more money for treating heart attacks, but. What. Happens, when you the. Yellow is normal, this. Piece here, is. Equal. To that piece there so. PQ. Is this, segment, is. Equal to st, in. A, heart attack if. The, ST jumps, up to a higher voltage, so. If we have a computer, that can, detect, the difference between this, voltage, and that, voltage, we. Can detect a heart attack every time and, we're doing it so that. Is all there is to Angel. Medical, so. Let's. See what happened, when we tried to do this. First. We thought by, the way pigs, have a heart that's, almost, identical to, humans why, I don't, know so. Here, on top is the, electrocardiogram. Of a pig with. A normal, heartbeat. Now. We see, what happened, we, by the way we put in a copper stent, in the pig and, that's. A really bad thing it causes, a heart attack but. We want to see the. Pig signal, on his, electrocardiogram. So. Next we see it. Sometime, later from. Thursday, morning to Friday morning. And, now. You see, it changing, it and look, look. What we see. St. Much. Higher than. PQ, you, see that after the r wave how the voltage went, up, the. R wave is that very sharp. Spike. That's. What we detect, for a heart attack in human, so. Here it is again and. Here. Is the pig, going to ventricular, fibrillation. Which. Happens, before you die and. Then the, pig was. Flatline, which means the. Heart was no longer functioning, so we. Showed exactly, what happens, with. An animal. Which. Has the same type of heart as a human, so. Then I have got my son Tim, who's. A cardiologist. To. Say that, let's try it on a human, let's, give them an. Artificial. Heart attack, for. Two minutes and let's, watch them and see how we detect, so, this is what we did and here, we see. Like. Here we see st. And. His, the. Other thing look at the height here, so, as this, blockage. What he did is he put a stent, in the patients, are, inflated. The balloon and. Therefore. There's no blood flow which, is a heart attack and, then, he measured the electrical, signal. Deflated. The heart rate heart went back to normal then, he did, it again later, and look look how severe, it becomes so, what we do with. Angel, medical, is we detect, the voltage, difference between here, and here and when, we detect, it we, said we tell the patient, you're, having a heart attack and I'll show you how, we, do that. So. Here is the system that we have we. Have in the patient. In. The patient, we have this device it has a, wire in the heart that measures, that, sees the electrical, signal in the heart and, if. You detect, a heart attack it vibrates, like your cell phone it goes be, beebeep, beebeep beebeep. Beebeep. And, then. Your. External, device that you have in the pocket, goes off with an audio, with the same thing so. You can press a button the Middle's turn it off and immediately. Get to the hospital, and here's. Just a programmer, that can program, it for everybody's. A unique. Characteristics. So. How. Have we done we. Can accurate. Detect our merry occlusion, which is a heart attack. Get, patients with occluded, coronary, orders to the hospital, faster. Alert. Patients who have no symptoms. Who. Would otherwise not. Present, to a medical facility. Notify. Patients of other heart related, conditions, that require treatment, reduce. The worry of knowing, when. Your next heart attack might occur, because, that event could cause your death each, of our patients when the battery wears out they.
Only Last seven years. Says. Give. Me a new one because I don't want to worry about having, a heart attack. So. How, is it performed. It. Was dramatic and statistically. Significant. Reduction in the median, time to, the emergency, room for patients. With, positive tests. 51. Minutes from detected, to hospital, versus. 1808, minutes, which is 30, hours and eight minutes for. People, who did not have it and when. It comes to a heart attack time. Is myocardium. Meaning. If. You get there sooner your life can be saved if you get there later it will not be and this, product does the job of getting you there on time, across. An average of two year follow-up we, detected, an alert of 30, patients. Including, 23 with. Core lab confirmed, heart attacks we, accurately detected. Each and every heart attack as was. Indicated by, our device. In the FDA trial, and therefore. After only, 16, years and a, hundred sixty million dollars, this. FDA, approved, finally. On April, 8th of this year, after. Only 16, years a very hard work and a. Hundred sixty million dollars, invested so, it's, not the easiest, field, to get into but. Let's see what my son Tim so. As an interventional, cardiologist. Thinking, about this device and what it could do what we've seen it do already we could have a very stark contrast I, think in. The future between patients, who, are, at risk of having heart attack. We at them without a guardian device so if we take for example especially, say elderly women who are. At risk of having heart attacks and who often, had atypical, symptoms and she might ignore. Her symptoms for. Hours. Days maybe even weeks and then, she ultimately, has a big heart attack doesn't, recognize that and comes into the emergency room very late three or four hours into the heart attack lucky, enough that she didn't die but, is already going into what we call cardiogenic shock or, blood pressure is low and by, the time we get her in the cath lab two, hours later she's, even sicker and we, ultimately, go. In and put a stent in and open her artery at this point she may be so sick that she actually has to have a breathing tube put in and be sent to the coronary care unit, and be in the hospital, perhaps four or five days if she's lucky and end. Up with a large heart attack in a huge hospital bill or. We. Can contrast that let's, say the same woman who had an angel med device she, had known coronary disease they put this thing in because she had a stent put in five years ago and now. Three. Days before this big event was gonna happen she's having very modest, symptoms, the alert goes off and she calls. 911 comes, into the hospital and they download, the signal seeing these significant. Changes in the electro, gram in the heart bring. Her to the cath lab take a picture in see a ruptured. Plaque with, some clot and haziness. But. She's fine she's stable, I just put a wire down through there put a stent in inflate, the stent take it out send, her home that evening or the next morning at, a very low cost and she's.
Lost No, heart muscle cells she's. Alive healthy. Able, to go out whatever, compared, to the other patient. Who's still sitting in the coronary, care unit just having her breathing tube removed and hoping, to survive and then, again. Having perhaps a million dollars worth of healthcare expenditures, over the next ten years dealing, with this horrible large, index, heart attack. I'm. Going to talk about one of my favorite. Companies, the one I'm working on now intensively. The. Name of the company, is zai. Good, like. Desire, good. But. Able to get a trademark a device. That uses intense, magnetic. Pulses, onto. The human body to relieve, pain from. Various, medical conditions such, as lower, back pain and the, foot pain from cancer, chemotherapy or, diabetic. Neuropathy. What. Is. Transcutaneous. Magnetic. Stimulation, or. TCMS. It's. A means of method for eliminating. Or significantly. Reducing. The, pain experienced. By human subjects. As a, result, of a variety of human, conditions. By. The application. Of Faraday's, law a. High-intensity, magnetic, pulse will. Generate, an electrical. Pulse, within. Those neurons, that. Sense, pain, that. Prevents, those particular, neurons. From. Sending, the signal, to the brain that. The brain recognizes. As. Pain. When. You have pain how. Do you know you have pain there. Are special, neurons, within the human body, whose, only job is, to tell you when you have pain. How. Do they tell you you have pain. They. Send, a series, of electrical, pulses, from. That neuron, along, an axon, to your vertebra to. Your brain and that. Series, of electrical, pulses, says. I'm. Having, pain in this finger, if we. Have a lot of pulses, per second high pain, fewer. Pulses, per second, less pain so. That's how the human, body, senses. Pain so. How can we do something about. That. Electrical. Stimulation, to relieve lower back pain has, already been proven by the surgical, implantation, of electrodes, along. The spinal column using. Implants, from Medtronic a, giant. Company advanced. Neural modulation. Systems, and Advanced Bionics each. One of those devices, requires. Surgical, implantation, and maintenance. For the production. Of electrical. Pulses along. Your, back, and they. Cost. $40,000. Each, so. This is what they look like you. Know, talk. To you about them some so. Here, is a vertebra, and, here. Are a series, of electrodes, along the vertebrae, and the, view of back pain these. Electrodes. Connected. For, example, to, a device, like this this. Device would be in your body this. Device, would connect. With it and when. You obtain you can turn it on and put, electrical, current, and voltage, along, your spine and reduce, your pain. So. That's. Doesn't, seem to be anything, to do with magnetics. Does it. But.
Our, First goals for, the TMT. CMS. Transcutaneous. Through the skin, magnetic. Stimulation. We. Want to eliminate foot, pain caused. By cancer chemotherapy. We. Want to eliminate foot, pain caused, by. Diabetic. Neuropathy. Eliminate. Lower back pain and eliminate. The rotator, cuff shoulder. Pain that, so many people get and. How. Do we do that well, this is how we do it. We. Have a, pulse, generator plugged. Into the wall and, these. Knobs adjust. How many pulses and how strong, and we. Have wires. Connected. To these. Are wires from, the patent, that. Are wrapped around, the foot and with. This we. Can put a. Great. Deal of electric, current, at our. Peak we're. Using. Nearly. 8 million. Watts, of electric. Power for. Five microseconds. Think. About it five. Microseconds, now, convert, to a magnetic, field the. Peak field twenty. Thousand, times the Earth's field, for. A few microseconds. And is. The time rate, of change of. Magnetic. Field. In an. Electrical, conductor like, a human, body that, converts to an electrical, current so. We can, get electrical, currents, into the body. Better. Than if we could for example tens. Transcutaneous. Electrical, nerve, stimulators. Has anybody, in the audience ever heard of tent and used it, well. There are a few these, are electrodes, you can put on your back and, when. This first turned on is painful. Our. System, is never painful, and we, can get very, much more electrical. Pulse on to the pain or on with. No discomfort, because, the. Body attenuates. Electrical. Signals, when it goes in goes, the body conducts, electricity, but. It does not attenuate, magnetic. Pulses, because, the human body is not magnetic. And in. The body by Faraday's, law, the. Magnetic, pulse converts, to electrical, that, acts on the electrons, the. Pain, neurons excuse, me act on the pain neurons and. Causes. Them to be unable to send, to the brain the, message, that's pain, so. Here is a picture of the, coil that we put on the back some. People have back, lower back pain. So. What's our market, opportunity. For this product. The. Following, are estimates, from the Institute, of Medicine as, to. The patients, with pain in the United, States, the. Number of USA patients, who, are treated for paint each year about a hundred. Million now that's not a bad market. The. Annual medical, cost of the treatment, of pain in the, United, States is about six. Hundred billion. Dollars, a year now I am NOT greedy I'm willing, to only take 10% of that is that if that mean is that being greedy only. 10%. The. Annual sales revenue, for implanted. Spine electrical. Stimulators. And they, cost 40,000. Ancien as major surgery, two. Billion, dollars a year now, it's, a two billion dollar market, and it's growing at the rate of 15% per, year we. Can replace that with. No implant. So. What, have, been our recent, results. There's. A Kaiser Permanente, hospital. In Lago, Maryland, it's not very far away. We. Have treated 13, patients with severe, foot pain from. Cancer, chemotherapy and. Diabetic. Neuropathy. Have. All been treated there while. I watched. That. Was in the, last two. Months of these. 13, patients, who. Had no, means in years, to, reduce their foot pain eight. Of the 13 were completely, cured of pain and five. Had reduced pain and each. Patient, had, a restored. Normal. Walking, gait, when. These patients, walked in before. Our treatment, with, the foot pain they had. They. They would walk like this and, when. They walked out they, were like this and my, biggest pride, one. Of them have a brace, on his right, foot and he, walked in with it like this tell. The doctor you know I've been working on me for two years I still have the pain he. Walked out skipping. Holding, the brace. That. Will make more than your day that'll make you a week or month. So. At. The University, of Maryland Hospital. This. Past Monday. One. Patient, with severe put thing foot pain from diabetes, for, eight years was. Again completely. Cured, of pain when. Nothing, else that that medical, staff had, that, made it possible for a cure.
Tomorrow. Three. More patients, suffering foot pain of, diabetic. Neuropathy will. Be treated, for severe foot pain at that Hospital. In Baltimore so, I'll have something to do tomorrow, I. Still. Have a few slides. The. Purpose, of these slides is, to. Tell, each of you young people, sort. Of give you some philosophy. About life that, I have used and it's been moderately. Successful. So. What have I learned in, my. 89.7. Years. Give. Yourself, the opportunity to, get lucky. For. Example, the. Device I described, for. Treatment. Of pain, with the magnetic pulse, was. The first named inventor. Is my, wife Susan who. Has no training in engineering. We. Went out with some friends this, friend had severe, foot pain from two years of, cancer, chemotherapy. My. Wife suggested, we use the migraine, device to, a race of foot pain and I'm listening, I think. Oh this. I said, that's one the you know ridiculous, things I don't think it has a chance to work but. When we get home I'll give you ten magnetic. Pulses, on your head and ten, on your left foot and if, by some miracle it. Works. From. Your head both your feet will be better a different, miracle, it works locally your, left foot will be, the neighbor calls an hour later from home and says I have, no pain in my, left foot and that, is how angel, medical systems began, we. Treated a right foot every. Day for a week and at, the end of the week she said for the first time in the year she could feel the carpeting, under her bare feet so always. Give. Yourself the, opportunity, to, be lucky, if, your spouse has some cockamamie. Idea, try, at any. Problems. Can create, excellent. Opportunities. For innovation in. Your life as engineers, or, scientists, whatever if, you. See a problem. Don't. Say just as a problem, say and how. What can I do with my great education. To solve. That problem that's, how I live my life. When. The world gives you lemons, make lemonade. I've. Had like, when the wife suggests, you tried something, that you know won't work try, it anyhow. The. Harder, I work the luckier. I get, you. Think about that the. Harder, I work the luckier. I get and attaint, o'erlook. Do. Not follow where. The path may lead. Go. Instead, where. There is no path and blazed. A trail for others to follow, that's. Something, I've lived my life with of these many years and it's, working. Some. More philosophy. The. Difference, between what is impossible, and, what is possible is often. Determined, by persevering. And the, unrelenting. Desire. To overcome obstacles and. Your, drive to continue, even. Though some people have told you that it, can't be done or it'll never work, of. My, about, twelve. Medical, device companies, that I have started and they. Were I think at least eleven successful. More. Than one person told, me it would, never work but. We wore we, took our strengths, worked on it and we made it work so think, about that just because, someone says it won't work you think, about how to make it work. Some. More philosophy. The. Most consistent. Attribute. Of the greatest inventions, that, have ever been made is that, they were preceded. By a constant. Series of disheartening. Failures. Taken. From an expert, when, it comes to disheartening, failures, I've had a great number but. In, the, end we've. Gotten essentially. All of them to work and, the. Next slide was a good day that I had at the White House about Al over, a year ago. With. A former. President, and, he. Said when, he gave me the National Medal for technology. And innovation, that. It was for the innovation. Of novel, medical, devices, used. For the treatment of many illnesses. Thereby. Improving. The health and, saving. The lives of billions of patients, around, the world so, if you work hard like I do you. Can have it with some future, president, and. The. Last philosophy. From. The poem by Robert Frost. Only. When love and Nita one and I. Love to work and I need to work and. Workers. Play for mortal, stakes is, the. Job ever really, well done for, heaven, and the futures sake and that's, it for today.
2018-10-17