Today, we have Lyn Yaffe joining us. Lyn is the Co-founder, Chairman, and CEO of EPR-Technologies. EPR Technologies is a biomedical spinoff of the Safar Center for Resuscitation Research, University of Pittsburgh. EPR Technologies is committed to the preservation of human life through rapid profound hypothermia, by pursuing techniques and patented products for emergency preservation and resuscitation (EPR) to save a life when standard cardiopulmonary resuscitation (CPR) fails.
In the past decade, Lyn has been actively involved in research and development programs related to patient/casualty monitoring strategies, emergency hypothermia and rapid cooling techniques for point-of-injury care to induce ultra-profound cooling and temporary suspended animation (EPR), and semi-automated to automated, rapid vessel access techniques for therapeutic hypothermia, and a range of automated needle/catheter guidance and placement technologies.
About Lyn Yaffe
Lyn Yaffe, M.D., was instrumental to the development of the concept of EPR during the research and development work at the Safar Center of Resuscitation Research, University of Pittsburgh, School of Medicine. Lyn has been dedicated to the concept and knowledgeable with regard to its emergency life-saving utility and potential applications in the field of resuscitation. Given the complexities of the EPR procedure and the demanding setting in which it will be used, these points take on special importance in this regard. Lyn and his team are therefore the best group to bring EPR forward successful development and product commercialization. Lyn completed undergraduate education at the Johns Hopkins University, School of Arts and Sciences, majoring in biophysics, in 1968. He received his M.D. degree at the University of Maryland, School of Medicine, in 1972, and completed pathology and research post-graduate training at Columbia University, New York, NY, with additional molecular biology research experience at the Roche Institute of Molecular Biology, in 1978. In the past decade, Lyn has been actively involved in research and development programs related to (1) patient/casualty monitoring strategies, (2) emergency hypothermia and rapid cooling techniques for point-of-injury care to induce ultra-profound cooling and suspended animation (EPR), and (3) semi-automated to automated, rapid vessel access techniques for therapeutic hypothermia, and a range of automated needle/catheter guidance and placement technologies.
Our Vision is that EPR is the next emergency life-saving “Standard of Care” procedure following failure of CPR on any victim of cardiac arrest. And that every victim is able to come home from the hospital and live a normal life.
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Hey everyone. Thanks for joining the show today. I'm Kelly from Qualio and I'm your host here at, From Lab to Launch. If you haven't already please subscribe and give us a review on Apple or Spotify. We'd love that. If you want to be on the show, please see the application link to the show notes. We've had a lot of people reach out and it's been a pleasure to connect with you Today we have Lynn Yaffee joining us. Lynn is the co-founder chairman and CEO of EPR technologies. EPR technologies is a biomedical spinoff of the CFR center for resuscitation research, university of Pittsburgh. EPR technologies is committed to the preservation of human life through rapid profound hypothermia by pursuing techniques and patented products for emergency preservation and resuscitation to save a life when standard cardiopulmonary resuscitation. In the past decade, Lynn has been actively involved in research and development programs related to patient causality, monitoring strategies, emergency hypothermia, and rapid cooling techniques for point of injury care, to induce ultra profound, cooling and temporary suspended, animation, or EPR, and semi automated to automated rapid vessel access techniques and placement technologies. Let's bring him in. Hi Lynn. Thanks for joining usLyn Yaffe:
today. It's my pleasure.Kelly Stanton:
We love hearing about people's backgrounds and you have a really impressive one. Attending John Hopkins university, university of Maryland school of medicine, Columbia university, and additional molecular biology research experience at the Roche Institute of molecular biology. Tell us a little bit about your journey.Lyn Yaffe:
Well, I've always was interested in, in research, particularly medical research and in my last year of high school in Baltimore, where I grew up I was at the Rosewood hospital, working in a laboratory, doing different things with you know, mice and rats, various things. And then when I went to Johns Hopkins, I majored in biophysics. And during those years, I continued to work at Rosewood hospital. And when I graduated or before I graduated, I had early admission to the university of Maryland school of medicine. And I went to. And I also continued when a time permitted to work in a laboratory there at the university of Maryland. And then my interest for a post graduate training was in pathology. And so I went to Columbia university and uh, work there in pathology. And at the same time as time permitted, I would cross the river through the Holland tunnel and go to Hoffman Laroche. At the time they had a sort of an independent institution called the rose Institute of molecular biology. And I worked there on B-cell the lymphocyte responses using mice. B-cell tumors. And eventually because I had obligated service at the end of Vietnam, it was called the Berry plan under, I think it's Senator Barry, that you were permitted to finish all your medical and residency training without being drafted. And if you signed up for that, of course, you obligated yourself to four years of service. So I signed up for that and it was sort of shortly after I signed the Vietnam war came to an end, but I had four years of obligated service. And I stayed at Columbia university and the Roche Institute, you know, beyond four years of residency training. And eventually the Navy said you have to pay us your four years. So I asked where I could do research. And at the time the the strongest possibility was that the Us Naval research Institute, which was in Bethesda across from NIH, where, which is now the Walter Reed national Naval medical center. And the laboratories have you know, being rebuilt at other locations. But at the time it was on that campus. And I worked there in. Combat casualty care related research, blood research. I had to you know, spend some time at the Pentagon in the in the medical office there under the director of defense research and engineering. I spent time at the bureau of medicine in the department of. Of the Navy and and went back to the lab Navy lab. And at one time I controlled tens of millions of dollars in Navy research, money, medical research, money that went to different Navy medical research labs and also to universities and companies. I wish. Called a beltway sailor, which means I spent my entire Navy time within the Washington beltway and was never really a C though. I visited many Navy ships when they were in port just to see what the medical setup was. And so, in my career, in the Navy and combat casualty care, there was always a major interest in how to shape the line. Combat casualties who were killed in action. And because of that interest, I came in touch with Dr. Safir. Now, Dr. Chapar who died in 2003 in the he's considered the father of CPR, the father of cardiopulmonary resuscitation. It wasn't really. A viable technique until he invented together with an associate of his James ELAM mouth to mouth resuscitation. And Dr. Chapar really. Introduce that. And and, and joined it together with chest compressions. And he wrote the first book called the ABCs of, of emergency medicine, a being airway, being open breathing, meaning mouth to mouth and C meaning, chest compressions, or establish a good circulation. And and then. You know, went around the world and isn't directly responsible for saving hundreds of thousands of lives because he popularized CPR. A lot of people don't realize that, but that occurred in the 19 56, 19 57, 19 58. So it's really only since the early 1960s that CPR has been has been done. Dr Schaeffer. It's also interesting history and he was a very great individual. He was nominated several times for the Nobel prize. Never won, but obviously being nominated is quite an accomplishment. He started the first paramedic service in the world because prior to CPR being a technique. Paramedics didn't really exist. They were essentially ambulance drivers, you know, they couldn't do any cardiopulmonary resuscitation wasn't available. So he took a group of unemployed, African Americans in Pittsburgh, where he was at the time and he trained them to be paramedics. He trained them to administer CPR and it was called freedom house. And it was really the first paramedic service in the world. And he took African Americans to do that because white ambulance drivers, you know, in the early sixties, they wouldn't go into African-American neighborhoods in Pittsburgh and probably in most major cities in the U S. And so now then with a freedom house, they had their own. Paramedic service, which he ran together with his protege at the time whose name was Nancy, Caroline, and she, after her training and freedom house, she went to Israel and started the equivalence of the American red cross emergency service and paramedic service in Israel. She unfortunately is deceased as well. But Peter Saffer had an interesting career, you know, eventually freedom house was taken over by the city and the African-Americans were slowly eliminated from the service and it became an all white paramedic service back in the early sixties. That was the you know, the way things happened, unfortunately in those days. But Hollywood documentary was made about freedom house and a to not available to stream. At least I haven't seen it on Netflix or Amazon prime than I've seen it at pitch. And so his career was very interesting. He, he also started the first independent department of anesthesiology before that anesthesiologists really were in the departments of surgery and he was at Johns Hopkins in the late fifties. When he was working on mouth to mouth resuscitation and he asked if he could start an independent department of anesthesiology, having independent farming is important for research purposes. You know, you sort of control your own destiny. And Hopkins said no at the time, but he had friends at Pittsburgh. So he went to Pittsburgh and started the. Anesthesiology department there, he was subsequently you know, did everything he did in resuscitation and disaster management. And he started at Pittsburgh, the international Institute of resuscitation, and now they it's named after him. It's the Safir center for resuscitation research and he obviously had a very interesting career after the Vietnam war. He Dr. Safir and a Colonel Bellamy got together to see what could be done about, about combat casualties, who were killed in action in Vietnam, because they recognize that that if you look at those children action without head injury, those who die. Killed in action without hit head injury. 80% of them died from rapid bleeding exsanguination so there wasn't any time to. To save their lives. So then Peter, Saffer a principal. He came up with the idea at the time he called it sort of temporary suspended animation. It's not true suspended animation, but in the, in the medical public literature, in those early days, he referred to it as suspended anime. And so as time, once, once forward, a lot of research was done in a large animals, particularly pigs, and they demonstrated that you could hemorrhage. Obviously under anesthesia, you could do surgical trauma, let them bleed out rapidly or slowly to the point where the animals went into cardiac arrest. You could rapidly cool them down. And I'll explain more about that. And then when they're in a cold state, meaning five to 15 degrees centigrade, or 41 to 59 degrees Fahrenheit. Their body is in such a low metabolic state that oxygen is not needed. So it buys time for surgical intervention.
essentially it's a temporary suspended animation. I mean, three hours is about the time for transport and surgical repairs, which what they would do on the, on the animals. And eventually a company was formed based on the techniques. And eventually the FDA approved a limited clinical trial, which is ongoing. Now it, it has been on pause because of the COVID pandemic, because so much was required to deal with. With patients in the ICU COVID patients who are having tremendous respiratory difficulties who were put on extra corporeal membrane, oxygenation, and an external sort of a lung that required blood to prime that and our EPR procedures. When you rewarm the patient to resuscitate them after surgical repairs, of course, you have to give them. I think it's during the cooling phase, the blood is flushed out with ice cold sailing. So we, our procedures are intensive as well. So it was put on pause, but they're getting ready now to hopefully restart the the clinical trial, hopefully. They're not going to have a paint of pink, a peak of COVID patients again, though. There seem to be. Increase in infections or at least for immunized people, it's not particularly serious. So, the company was formed, as I said, Dr. Schaeffer died in 2003 and all of the people who worked with him, myself included, We, we formed a a company and, and got to the point where clinical trial was granted. We changed the name of the procedure from suspended animation or temporary suspended animation. Cause it sounded too much like science fiction. So we it was suggested to call it emergency preservation and resuscitation EPR. So it was like when CPR fails, then you induce EPR. So we wanted to sort of, Letter M a phrase, but emergency preservation, that's the cool-down phase. And then after surgical repairs, rewarming and resuscitation is really delayed resuscitation. The primary resuscitation is delayed. And so, you know, that's the the, the basis of, of, of things, you know, life-threatening trauma where victims die. Let's say 500 cases a day in the United States, at least before the pandemic occurred. I mean, since the pandemic, I guess there may be a little less trauma because there's less driving perhaps. Though it's probably picking up again. People were staying at home and there were about 1500 cases of sudden cardiac arrest, severe heart attack where people can't be resuscitated now. Exsanguination cardiac arrest, meaning bleeding to the point of cardiac arrest. If that happens to you from an accident or a gunshot wound, you know, a mass shooting incident, your chances of surviving are less than 5%. Even if you go to the best university center in the U S it's a very poor. Survival rate because you can't get to the patient fast enough to stop the bleeding or give blood. So in those situations, EPR could be invaluable for sudden cardiac arrest. If you have sudden cardiac arrest or severe heart attack and requires resuscitation outside of a hospital setting, meaning at home or at work. Your chances of surviving or maybe 15 to 20% that CPR will get you resuscitated in a hospital. It's better. It's 30 to 40% that they'll get you resuscitated, obviously, because they're there with all of the equipment right away, but still the statistics for surviving a CPR. Very, very good. And so I think EPR, you know, when you talk about 2000 people a day in the U S alone, this could be attempted if the situation is right. I'm not saying it will be attempted in everyone, but certainly in a significant number of cases there's a good chance. You know, there's strong, anecdotal evidence that this will work aside from the animal research, which has extended. And it it obviously works in animals. We've all heard of cases where skiers have been caught in an avalanche. Now those are healthy individuals. They cooled down so rapidly that when they're dug out, they appear to be dead. There's no breathing, there's no heart function. Just like in EPR and then they rapidly rewarm those patients. You know, and they get them, fly them out by helicopter or something. And then there are some cases where those people are resuscitated and survived, not all of them, but it's anecdotal evidence. That's being cooled down to, you know, 10 degrees Celsius 41 degrees or so Fahrenheit in and of its shell. It's not going to kill you. It's the prolonged period. I mean, you can't go for days in that state. You need oxygen, but for a few hours you don't need oxygen because your metabolic requirements are almost a zero. And then there are cases where children or adults have fallen on, you know, through ice on a frozen lake. They also pull down very quickly and if they can be rescued, they can be rewarmed. So there's strong anecdotal evidence and also in in serious neurovascular Scherzer. They frequently will cool the patient down, not too profound, temperatures that we use any PR, but into a deep hypothermia which is above you know, it's mild, deep, profound ulcer. I can explain some of this, but they are in a controlled situation. They'll cool. The patient down while they were put on cardiopulmonary bypass to perform difficult neurovascular surgery. So, you know, overall in medicine, it's called Therapeutic hypothermia and temperature management, mild is used in severe heart attacks where the patient is resuscitated, but cooling them down. Just a couple of degrees, takes the burden off of recovery and is sort of neuroprotective. You can't go much lower than a few degrees because your heart will stop beating obviously. We go to that low temperature of ultra profound our profound hypothermia to ultra profound using ice cold Shaylene. So, so that's, that's essentially the story. All started by Peter. Saffer continued by the people who work with him, clinical trial, ongoing, and that's what we're all dedicated to, to getting. To the point where it works. I mean, I guess the company wants to make money in order to do second and third generation products. And ultimately when this is done at trauma centers and then a hospital emergency rooms and possibly on on the floors, the way their crash carts, we want to as quickly as possible, get it out to a paramedics which were acquired. I'll just say semi-automated equipment to, to make it easier and faster to do so you don't have a team of. Eight surgeons. They're trying to get it done. You might have two paramedics. And so, you know, we've got plans for all of that. How to do that. Yeah, I was goingKelly Stanton:
to say the portability. I was thinking about this as you were speaking, you know, the, the portability of the technology would be the challenge to solve. I thinkLyn Yaffe:
a portability is a challenge because to cool down an adult, you need to have available. Well, let's say 30 liters of ice cold Shaline in the future. We'll probably have some attitudes, but you know, for the initial clinical trial, it's sort of proof principle. But there are some additives that would add some neuroprotection during the cool-down that sort of thing, but it's possible for an ambulance or a medevac helicopter. To have 30 liters of solution sort of at their parking spot, you know, where they back into an emergency that is plugged in and and kept cold. And then all they have to do is grab a container. That'll stay cold for their, you know, 10 minute drive to wherever they have to go. So, so there is portability there and of course ambulance has have electricity. So theoretically you could have a small refrigerator to hold the fluid on board. And you know, they could just take 20 liters of it, you know, it could be in 10 liter bags and then you need. The vascular access, you know, how do you pumping that solution? That's where semi-automation comes. I won't go into all the details, but you know, you don't want the paramedics in a patient who's been shot or traumatized in some ways, bleeding out. You don't want them spending 10 or 15 minutes trying to access an artery. You want to be able to do it like that, or to have them access. Before the patient goes into cardiac arrest, or while they're doing CPR access, the the the, the artery clearly, you know, if someone needs CPR, for whatever reason, you must have good CPR until EPR has started, you can't say, well, the person is not responding to CPR. And then. 10 minutes to do EPR and you don't do CPR because they, they need oxygen until they're cooled down. So you have to do good, you know, bystander good paramedics CPR, while you're ready to do EPR and then EPR as soon as you start the. You get the brain down within five minutes via rapid flow. And of course you have to take care of where does the blood flow out of. So we've got plans for that in a trauma victim. You know, the blood is already flowing out. So. If you're on the street, I guess, flow somewhere. Otherwise you have sort of a, a cocoon plan where, you know, you couldn't collect the blood. You don't want to have a flood of blood and ice, cold Shaylene and an ambulance shedding. So, you know, those things are essentially easily solved. Everything has to be FDA approved, of course. But you know, this is going to happen in the future. You know, You know, the company is one thing we want to be successful, but this is a medical advance saving lives. So it's going to happen. It's just like, you know, there's a current. Yearly flood of new cancer drugs. You know, now it's augmenting the immune response, educating one's T-cells to fight their tumor plus messenger RNA, which everyone knows about because of COVID. But messenger RNA was originally looked at as a way of augmenting your fight against cancer. So that's not stopping, even though cancer hasn't been cured, obviously in all cases, the same with failed CPR, EPR, it's just going to get better and better as time goes on. So, you know, we're dedicated for the long run.Kelly Stanton:
That's exciting.Lyn Yaffe:
That's exciting. It is very exciting. It's very exciting.Kelly Stanton:
Definitely. Well I guess you know, we kind of hit on a lot of the things I was thinking of asking you about as far as, you know, what did COVID obviously COVID interrupted a lot of clinical trialsLyn Yaffe:
for a lot of folks. Yeah. Aside from the loss of lives with COVID, I should say that did the January. What was it now? January, 2020, I can't keep practicing or COVID got started. It was just. To be identified in the us. I had two visitors from China. They came and they visited the Sapper center. They visited me. I took them to Maryland shock trauma, where the clinical trial is being done. They met shame tissue in the trauma surgeon. Who's leading clinical trial. They met the chief trauma surgeon and director of Maryland shock trauma. His name is Thomas They were very impressed that he had a plaque from the Chinese government on his bookshelf because he had led a trauma team to China when they had, I forget the year when they had a serious earthquake there and a lot of trauma victims. And so he's been to China many times. They were very impressed with that. And they were very impressed with the APR and, you know, we were negotiating a sizeable. Infusion of money, you know, here for the U S effort and to do some things jointly in China, obviously they're interested in, you need PR and then the, the two visitors, they had trouble getting back to China because of a flight problems with COVID. I think they were in California for a couple of weeks, so they got back and then of course COVID has made it difficult to to, to really to complete a an agreement they're very interested. They keep in touch with me and, you know, the investors there in Shanghai, they're all on lockdown now. But I think as COVID hope. Sooner than later it gets behind us. We'll get some investment from China, but we've, we've ramped up our efforts here because of the ongoing, ongoing clinical trial, you know, we've started a crowdfunding campaign via stark. Start engine.com. They're a premier crowdfunding organization. They do a number of injury industries in including healthcare related stuff. And so we thought that would be start to generate interest. Podcasts is generated interests. We have a number of a small investors, you know, the general. You know, they can put in just $200 and we've had about 80 people who have been vested, small amounts of money, which is gratifying, the larger investors. They sort of wait to watch what happens. And and we're also talking with some family foundations who are very interested and also some well healed investment types are watching what we're doing and talking to. So I think it's only a matter of a little bit of time and we'll have some us investment and, you know, people are very cautious. It's a big step. There are risks associated with EPR as, as there are with every medical advance. So, you know, one can never make guarantees to an investor. The only thing I can guarantee is that we're going to be dedicated to this and we're going to be persistent and eventually things will happen. I just can't put a date on, on it. Of course, thatKelly Stanton:
is the hard part. That is the hard part too well. So in a, in a career that started off, you know, in Navy and trauma all the way to now, Pursuing things in the, in the public sector. Although I assume they military is still incredibly interested in, well, theLyn Yaffe:
military funded all of the research and they're funding the clinical trial. So the us army. Primarily a little bit from the Navy, but the us army has been tremendous supporters as they have put in over the years about 17.7, 5 million. So they're dedicated to this. I mean, right now, it's the only. Possibility for saving those killed in action. Whether you look at the whether you look at Afghanistan, whether you look at Iraq, those us military killed in action without a head injury. Obviously, if your heads blown off, there's not much you can do. There's nothing you can do, but those who are killed in action. For based on their chronic traumatic injuries and bleeding, there's still nothing that can be done. And so they remain interested in any PR. Obviously the military has gotten much, much better in, in combat casually survival when it comes to limbs and injuries, but rapid exsanguination. There's very little they can do. And so the hope is held that EPR will provide a technique to help to save additional lives in the future is necessary. ThatKelly Stanton:
would be solutely saying absolutely. Well, where can people go to learn more follow along and connect with you?Lyn Yaffe:
Well, we have a website and of course our crowdfunding sites. Could I hold up a little sign because it's a sort of a mouth full of blood. Ah, there you go. W w start engine.com EPR dash technology. Yeah, I guess it can be read correct. And WWE pr-technologies.com. We are also an EPR email@example.com as well as EPR technologies.Kelly Stanton:
Perfect. Yeah. And we'll make sure that's all linked in our show notesLyn Yaffe:
as well. Absolutely. There's a lot of information on the on the crowdfunding. There are a lot of videos that are, are that they're, they can look at you know, it will take them to YouTube and there's a lot of source material because they're very careful about due diligence and compliance. So, you know, I can't say. You know, 500 people a year or rather 500 people a day are affected with severe trauma. They need a source for that. So give them all of the scientific literature for that. Absolutely is authenticated. And then our bio's are on there as well. And, and and as required by the securities and exchange commission that oversees this crowdfunding. So all of the potential risks are mentioned as well. And then I put in I try to frequently put in updates, you know, with historical information and more details about the clinical trial. So. It's a lot of reading, but hopefully people will find it interesting and not too too heavy, you know, keep like, keep the science at a bit of a mess. Sure. Sure.Kelly Stanton:
Well, it was just a fascinating history that you talked about. I use the, for CPR to EPR and how that all came about. You know, those of us who, you know, did the CPR certifications when we were kids. So we could babysit. I had no idea. Yes,Lyn Yaffe:
she PR is taught more and more in schools. And I think particularly high school and college students, they should all get certified in during CPR. You know, an interesting side note, the the mannequins that people practice on, you know, the little mouth to mouth and mannequins and, and the chest compression mannequins that the. CPR mannequin was really produced on the behest of of Dr. Scott. Back in the sixties, he met a layer doll in Norway and at the time layer doll was a doll manufacturer. As far as I can recall, they made a doll that when you put it to sleep, the eyes would close. So, they made a mannequin and it was called And if you look up for subs to any there's a museum about it, I think. And the, the face of necessa, Annie is a guest death mask that was made of a young woman who committed suicide by jumping into the same river in Paris. So they just chose that. And now so Peter Saffer was involved in that tomb now layer doll. They don't make dolls anymore. They make they make a deliberate Slaters and other medical equipment. They make a resuscitation. Mannequins as well as full computer controlled AI control mannequins that present symptoms to medical students for for training you know, very expensive mannequins, you know, they can cost a quarter of a million dollars and most medical schools have centers for simulation now. And I think that the layer doll even makes a, a small mannequin, you know, sort of upper chest and head to teach elementary school children. What resuscitation is about. Obviously they're not going to do it, but introduce them early on to the idea. Then they go home and talk to their parents about it and, you know, get their parents to think about getting certified in In CPR, it's something particularly that every, every new mother should do just in case your infant gets into a problem. That's very important.Kelly Stanton:
Well, thank you so much for your time today, LAN, and really appreciate that dive into your technology. And I'm super excited to see how that one turnsLyn Yaffe:
out. I appreciate you giving me the time to to go on for so long.Kelly Stanton:
Absolutely. All right, well, thanks again. And it's been a pleasure. Have a great one. Thank you. ThankLyn Yaffe:
you very much.