Business as Usual: ALung

Transcription: 

Okay, good afternoon, everyone. This is Audrey Russo, President and CEO of the Pittsburgh Technology Council, I am very thrilled about today we're going to have Pete como. And I'll weave in some reasons why I'm particularly thrilled. But before we bring him on, I just want to, you know, thank everyone for being here today. I know this is going to be a great session. And I want to thank Huntington bank for their belief in us right from the beginning, if you don't know them, get to know them. They're great business partners. And I also want to thank Jonathan kersting, for all things media, he is been part of the tech Council for 23 years. And he is, you know, our our actual storyteller. He is talking to people writing about people and making sure that everyone in Pittsburgh and beyond knows about what's happening here. So he will be monitoring the chat and throwing in some questions for Pete, because Pete has been a longtime friend of the tech Council. So we've muted your mic so that you can hear and we won't be hearing some background noise. I myself don't even have my dogs today. So hopefully, there'll be quiet on this end. And I also want to say that we have a chat. So hopefully, we'll have time to take some questions. And just, you know, enjoy, sit down to have your lunch, enjoy this conversation, because I'm going to bring out Pete to como and Pete DeComo has been, I just want to set the table just a little bit, because Peter camo has been an incredible friend to the Pittsburgh technology community, for probably most of the time that the tech Council has been around. And that since that's almost four decades, but Pete is not quite that old. But he has been around being an active supporter, he has been on the board of the tech Council for many, many years, he was on the executive committee, he actually personally helped me through my transition of taking the organization over. And he was one of those guys that while I did not know a lot of people across the tech ecosystem, Pete really made sure that I stayed connected, and understand different ways of how the ecosystem was working, and actually helped with the vision of making sure that Southwestern Pennsylvania is an amazing place for people to build businesses. Pete himself has done that a couple of times. And he's now in the middle of a company called a long, and we're gonna talk about that in a moment. And all that's happened since COVID. But Pete has an amazing background and an amazing perspective. And he is, he is funny, he is warm. He has an amazing sense of humor. He is just been just a stellar steward for this region. He doesn't have to live here, he lives here. And he's building a company here. And he's built another company before this here. So I'm gonna pass the baton and just say, Pete, it is so great to see you. It is so great to have this opportunity to talk to you, you know that I'm one of your biggest fans. And it's just thrilling to have you here.

Well, I'm sorry. Go ahead. now gone. Welcome. Thank

you say thank you. Thank you very much. I'm not sure I deserved all that. But I greatly appreciate it. Thank you very much.

Well, I think you do deserve it. Because now what we're going to do is we're going to say Who is the man to give us a little bit about Pete yourself, because your actual professional background was not necessarily that of an entrepreneur, but you pivoted so can you just tell everyone about that?

Yeah,

I never thought I would be an entrepreneur. But as I look back, both my parents were entrepreneurs, and I didn't realize it at the time, didn't even know the definition of entrepreneurship. At that time, but they were, you know, small time on small town entrepreneurs, running businesses up a little bit up north, up the Allegheny River and Ford city, and they have a number of restaurants out there at that point in time. And, you know, they were truly entrepreneurs. And I doubt I delved into the restaurant business one time, I'll never do that again. But I shouldn't learn my lessons from my mother and father, but you know, I've grown up in this area. I've stepped away from this area a couple of times. I was out in San Diego for a while in a startup out there, and I was also in Indianapolis for a while with a startup out there. And you know, I became an entrepreneur about 25 years ago. But prior to that I started my career in here in Pittsburgh, got my education at initially at community college, became a respiratory therapist. Then went on for my bachelor's And master's degrees at the University of Pittsburgh and, of course, graduated from there.

And,

you know, it never occurred to me that I would come full circle back into the pulmonary medicine space with a long.

And

I'm one of those individuals and entrepreneurs that mostly takes advantage of opportunities that are presented without having a, you know, a clear path mapped out for myself. What's interesting about my entrepreneurial career is that the last three companies that I've been with, without any pre planning whatsoever, or all extracorporeal components, what that means is that they've been in the medical device space, and they've been with technologies that take blood from the body, treat it in some fashion, and then put that blood back into the body. The first one was out in San Diego when I was chief operating officer of a company called chemotherapies. And it was the first FDA cleared medical device for liver dialysis. So people that had liver disease, and toxins were building up in the body because the liver couldn't remove them, we had a device that removed those toxins, and then return the blood back to the body. That was a short stint. And then I met my co founder there for my next company, which was renal solutions, which was based here in Pittsburgh. And that company was a technology that was founded in an r&d house in, near Purdue in in the state of Indiana. And they asked me to find the company and I said, I would only do that if I could go back to Pittsburgh and take the company to Pittsburgh. So we founded renal solutions with my co founder in actually in early 2000s, July of 2000 brought it back to Pittsburgh. And that is also when the Pittsburgh Life Sciences greenhouse was being formed. And we were sort of in the right place at the right time. And, you know, to jump to the end of the story, that company was very successful. We raised $40 million in venture capital, and then five years later sold that company to largest kidney dialysis company in the world, for syneos for $200 million. And that was a that was a great journey. But the world was very different back then, in terms of the ability to raise venture capital, the strategic strategics out there that would acquire companies had a very different outlook, they bought or acquired much earlier than they are today. But a very successful company. And then a number of my investors in renal solutions became involved with a long, and they asked me to come over day long in 2009, after we were acquired at renal solutions. And we were acquired by a $12 billion dollar foreign giant, if you will, at renal solutions, and I had to spend a year in that environment. And you know, being an entrepreneur is much much different than spending your time in a $12 billion a year revenue company with lots of bureaucracy. So I couldn't wait to get out of there and was very, very thankful that I can I could come over to to a long and help assure a long along to where it's at today. You know, a funny story regarding a long is that some of my investors who recruited me to come over basically said, Hey, Pete, this is going to be a quick turnaround. Probably two years, at most, three years at most, you will be out of here you'll have another exit and you'll have a lot of fun and you can finally retire. And it's been 11 years now. And it's it's clearly a sign of how times have changed in entrepreneurship and how they very much change for medical device companies because you know, the old cliche that it takes longer and cost more is clearly the way it is today. We've raised a ton of money and a long. Fortunately, our investors are believers, they've been very supportive of the company and on the technology. And one of the reason they've been supportive and and believe in the technology is some of the accomplishments that we've achieved. Most of Recently, especially as it relates to COVID-19. So it has been a long journey, I think you can tell that from looking at me. It's often joke when I talk to entrepreneurs that get in CMU that I'm only 39 years old.

But, but it's been a, it's been a great ride, I wouldn't change it for the world. I grew up in large companies after my after my education and learned very quickly that I was a person that enjoyed entrepreneurship, small companies much better than I enjoyed large companies and all the bureaucracy that comes along with that.

Well, so talk about a long Tell, tell us what a long is and what's happened since COVID.

Well, yeah, you know, for those of you that don't know, a long actually the devices in the picture right behind me here. And we refer to our therapy as respiratory dialysis. Because if you're familiar with kidney dialysis, and you saw a patient on our device, you would oftentimes think that they're on kidney dialysis, because there's a catheter here in the neck, or in the femoral down in the groin area, and we're removing blood from the body, and we're passing it through an artificial organ, in this case, an artificial lung, and then we're returning it to the body. And this technology was conceived at the University of Pittsburgh McGowan Institute for Regenerative Medicine, in what was called the artificial one program. Believe it or not, it was conceived all the way back in 1997 1998. So the technology has been around for a while, and yet it is still disruptive and very different, and very much differentiated from any competitive technology that's in the space. And it's really the only technology. It's not only been conceived, but designed and manufactured from the ground up for a therapy that we call extracorporeal carbon dioxide removal. So our focus as an artificial long is to remove carbon dioxide directly from the blood. And the reason for that is when your lungs are failing, for whatever the reason may be, and you cannot move enough air into and out of your minds, you're then not removing enough carbon dioxide from your body, which is a byproduct of normal metabolism. And so we're an artificial long that functions very much like the native line that sits outside the body and removes up to 50% of the metabolic carbon dioxide that the body produces. Now, we never want to remove 100% of the carbon dioxide that the body removes because that could be detrimental number one, and number two, we want the patient to continue to breathe on their own and use their own respiratory muscles. We don't want those muscles to become debilitated for from lack of use. And so we want that patient, for example, that has emphysema or chronic bronchitis to continue to breathe on their own. But there are times that patients need an artificial ventilator and machine that sits beside the bed and inflates their lungs because they can't breathe on their own. And in that particular case, we use our device simultaneously with the ventilator. But the objective there is different, we're still removing carbon dioxide directly from the blood. But what we want to do in that case, is allow the physician to turn the breath volume down from the ventilator. Because in order to inflate the lungs with the ventilator, oftentimes, very high pressures from the ventilator are used to drive that volume into the lung. And those high pressures can cause what's called a ventilator induced lung injury. Basically, you're beating up the very gentle tissue of the lung with high pressures from the ventilator in order to force that air into the lungs. So our technology enables the physician to lower breath volume and lower the associated pressure, because you don't need as much breath volume when we're removing the carbon dioxide directly from the blood. So it's a remarkable technology. And I can tell you as a respiratory therapist

that worked at the

University of Pittsburgh Medical Center for 15 years in critical care, and took patients took care of patients on mechanical ventilation. It's a remarkable device in terms of avoiding the ventilator totally or minimizing the need for the ventilator. Once the patient is on the mechanics. ventilator and then protecting the lungs while the patient is on a mechanical ventilator. So we're a small company, we produce small volumes of our technology. But since we started to treat humans back in 19, I'm sorry, 2014. We've treated 1100 patients worldwide. We've been all over Europe, Latin America, the Asia Pacific, as well as in the United States. And for a new technology out of the box, we've not had one and unanticipated serious adverse events associated with our technology. And so what we're doing now is working with the FDA to have our technology approved here in the United States.

So what has changed, anything changed since COVID-19? Like just a long, the demand,

a lot has changed, a lot has changed a lot of doors for many companies, not only in the medical device space, but also in life sciences in general, a lot has changed due to COVID-19. Many companies have been affected adversely, especially revenue generating companies have been affected adversely with COVID-19, especially if their product lines have nothing to do with treating COVID-19. So for us, in particular, we're not a revenue producing company, were still pre revenue. So it did not have that negative impact on us. But it had a tremendous negative impact on us and closed the door, if you will, on a very important clinical trial that we were conducting here, United States that would have led to approval of our technology here in the United States. And it's not just our clinical trial, the great majority of clinical trials being conducted here in the United States, were basically halted as a result of COVID-19. Because the hospitals were consumed with taking care of COVID-19 patients, and clinical research personnel were considered on essential and sent home. And so as a result of that our clinical trial back in March of this year of 2014, basically came to a screeching halt. We've been we've enrolled a few patients since March, maybe five or six, but not many in the in the clinical trial had a target of enrolling 180 patients, we basically stalled at 93 patients. So we're about halfway through the trial. And we couldn't conduct a trial. So we needed to pivot to be honest with you. And you know, I often use a quote by Alexander Graham Bell, you know that sometimes one door closes. But another door opens, but we spend so much time focused on the door that closes we don't recognize the door that opens. And so what that what that really means is, when you're confronted with things like COVID-19, that affect your company, you do need to pivot. And so I went to the FDA and I said, Well, two things have happened here. First of all, we can't conduct a trial. And if we can't conduct a trial, we can't raise money, because no investor is going to invest in a company that has an uncertain future in terms of when it's going to be approved for the US market. But perhaps more importantly than that, we can help with COVID-19 COVID-19 manifests itself in respiratory failure. It's a syndrome called acute respiratory distress syndrome, or RS a RDS. And we just concluded a 412 patient trial in the United Kingdom on a RDS we had a lot of good experience there. So we petitioned the FDA for what's referred to as emergency use authorization. And the FDA turned that around pretty quickly within 30 days and granted us emergency use authorization to treat COVID-19 patients. And so a small company we can't we can't treat the world with our technology. We don't have enough of it. But we've treated 42 COVID-19 patients worldwide 36 here in the United States, and six in the United Kingdom and Ireland. And the reason for the United States and the UK and Ireland is that's where we had our major presence. We were already installed in clinical trial sites in those countries. We had hospitals and hospital personnel already trained in those hostels in those countries and in those hospitals, and they could turn around pretty quickly and start to treat COVID-19. So we're in, we're in very prestigious hospitals here in the United States, University of Texas Heart Institute, Memorial, Hermann, Minneapolis heart, Tufts University up in Boston LSU in Louisiana, and I can go on and on. And

all of those institutions are treating COVID-19 patients with our technology. In addition to that, in addition to our clinical trial sites, we have a lot of 10 additional hospitals that were dark clinical trauma hospitals, to treat these patients on an emergency use basis as well. Now, one of the one of the features that I want to point out about our technology is that it's designed to be very simple to use. And that's, that's very unusual for a device that touches blood removes blood from a body and, and then treats it and puts it back. But it is very simple to use. There are similar devices, but they can only be used in academic medical centers where you have specialized personnel, like perfusionists that can use them and not every hospital has a perfusionist. So in the UK, there are only five of those hospitals in Germany, maybe 100. In the United States, maybe 300 of our technology is designed to be used in any intensive care unit. So it's really targeted for the thousands of hospitals that exist worldwide, especially in Europe, and in the United States, places like Japan, for example. And the biggest compliment we get is it's a set and forget it type of technology where the nurse can take care of the patient and not necessarily have to pay attention to the technology. And so one of the hospitals treating covid 19 is a hospital in Florida called Palm Beach Gardens. It's a small community hospital that could have flooded of COVID-19 patients because it's just north of Miami, which was a hotbed for COVID-19. They're our largest user. And they have no extracorporeal therapy experience whatsoever. We train them virtually, because they would not permit us into the hospital due to COVID-19.

And I'll tell you

a little story. They called us they said we have all these COVID-19 patients, the specialty hospitals won't let us transfer them in. We need a technology where we can treat these hospitals. And they said we have this patient who's a physician who was treating COVID-19 patients that contracted COVID-19 was in critical condition. How soon could you get a machine there now we typically ship them by freight here in the United States. But two of our technicians very dedicated employees availa put two of these machines in a van left on Sunday morning and arrived in Florida. They

drove straight through taking turns took them 17

hours. They had the technology there 10am Monday morning, and that patient was on therapy at 1pm. Monday afternoon that patient was in a coma for 87 days. And the hospital released a great story a video story was on all of the local news stations in that geographic area, about the patient being discharged from the hospital and wheeled wheeled out of the hospital. And the brother of the patient said if it weren't for the hemo lung technology from Pittsburgh, my brother would have been dead we were making funeral arrangements for him. And so it was just a great story for us. And certainly we used it. We had another patient in

the United Kingdom as an example,

that

the hospital requested that the patient be transferred to a specialty hospital. The specialty hospital said we won't take him due to futility, meaning that the patient most likely was going to die in their eyes. They requested our technology. We rushed it to that hospital, they treated the patient for six days. That patient was eventually discharged as well and went home. And that was published in a peer reviewed journal as a case study. So we're very proud of that one as well. Now, I don't want to give you the impression that our technology is a panacea. For COVID-19, because it certainly isn't, these patients are critically ill, and about 50% of them die anyway, regardless of what you do. But what we do with our technology is we enable the physician to have more time to treat these patients medically, while we're supporting the lungs. And by giving that physician more time, we hope to increase the probability of success in terms of the patient's surviving COVID-19 or a RDS or COPD, whatever, whatever the underlying cause is for that respiratory failure.

So how do we get how do we help you get more of these out into the world into the United States into an art? Is anything being used in Pittsburgh?

Oh, yes.

Well, you know, it's no secret that UPMC is an investment in us. Okay, we have treated not COVID-19. But we treated to emergency use patients at UPMC. Kresge successfully. But UPMC cannot be one of our clinical trial sites, because they are an investor. And that's a conflict of interest. But Allegheny General, on the north side is one of our clinical trial sites. And one of our best clinical trial sites in terms of its utilization of our technology. I think they ranked number three of all of our clinical trial sites in terms of the number of patients that they are treated, and they've not used it yet on COVID-19. But they have the ability to use it on COVID-19 sure, that patient that requires our technology present. So yes, we're here. We're right here in the Pittsburgh area. The other hospitals that were close to or close to Pittsburgh, were at the Cleveland Clinic. Were at Ohio State University were two hospitals, Penn and temple in Philadelphia, as well. So we're kind of surrounded, but the only one in the local area is Allegheny General Hospital.

So what do you think, you know, we had Paul mango on a few weeks ago from operation work speed. And you know, they've really educated A lot of us about, you know, the process of using medical, you know, trials, etc. Safety, efficacy, do you think that the FDA has learned through COVID? That the the movement, you talked about the 30 day turnaround that you receive? Do you think that this will help accelerate the pace of innovation and technology, particularly in medical devices?

Yeah, I think the FDA has learned it'll never be the perfect organization. It's a large and bureaucratic governmental agency. And I think with that, you know, it presents challenges in terms of getting through the FDA, I will tell you that the FDA has changed dramatically in the last three to four years prior to the way in which it was operating. Prior to that, and I tend to be a political on these things, but the FDA does go in terms of peaks and valleys in terms of difficult that is to work with. So for example, at Riedel solutions, like was a lot easier with the FDA. And then when I came to a long, it was very, very difficult for a period of time to work through the FDA, as evidenced by a very, very cumbersome and onerous clinical trial protocol that the FDA forced us into. But over the last two to three years, the FDA has been very collaborative, and been very compromising relative to getting innovative technologies to market sooner. So one of their programs is called the breakthrough device program. And when you're designated as a breakthrough device, you get an FDA team assigned to you and we are designated as a breakthrough device. And so that's been very helpful to us. And we've had the same team associated with us. For the last five to six years. They know us very well. We've established a great deal of credibility with them. And it's worked to our benefit. And most recently, you know, I mentioned that we because of COVID-19, we had to pivot. Well, one of the ways we pivoted was emergency use authorization. The other way we pivoted was to go back to the FDA and I had a very frank conversation and said, Look, we can't finish this trial. No one can finish a trial in this environment. Patient screenings are very low patient enrollments are very low. It was Take years and hundreds of millions of dollars to complete a trial in the world we live in today and we know investors going to invest in. And so we had a discussion with the FDA and said, well, as a result of our breakthrough device, there must be a program available to us that would accelerate your review and our approval to go to market. We are classified as the most risky device under FDA, there's class one, class two, class three, we are a class three device, which typically requires what's called a pre market approval trial, a PMA trial, that typically results in a very large number of patients that need to be run, which takes multiple years and millions and millions of dollars to complete. And as I said, I told the FDA, we can't do this any longer our you know, our investors are tired, we have no end in sight relative to finishing this trial. And that means the company and the technology is dead in the water. And as evidenced by treating COVID-19 patients. The FDA recognizes that this is a novel device and novel therapy and is justified in giving it breakthrough device Jen designation. The FDA, in very short order, reclassified us as a class two device burn down from a class three. And we are now working with the FDA on what's called a de novo 510 K, which is less burdensome and less onerous than a PMA pathway. What it really means in terms of timing, everyone is that, under the prior classification, and conducting a PMA trial, we likely would have not gone to market or been approved to go to market under the best of circumstances until mid 2023.

Under the de novo

510 k process, which

we're working with the FDA or FDA on right now, we project that will have approval to go to market mid 2021. So it's reduced our time to market by as much as 24 months. And that is a significant time savings and cost savings for all of our investors. And so that's sort of evidence that the FDA recognizes that it needs to get novel technologies to market sooner, and is working with putting programs in place that enable that to happen.

Well, Pete, as everyone can hear, you are just a bundle of information, and you are doing work that's really changing lives, you have spent a lot of your career also being an active member of the community, in entrepreneurship and innovation, along with the life sciences greenhouse in the tech Council, and venture capital. So, you know, hopefully these next two years will bring some acceleration, your work is so important. If people want to reach out to a long we put the link out there, I know there were a couple of questions that we didn't get to, but I want to be sensitive to time. P is an amazing human being who deeply cares. And you can tell that his priority is to get a long into a place where it really gets out into the world and scales. So I want to thank you, Pete, I'm glad that you never stayed working for large companies probably would have been fired time and time again. And you being an entrepreneur is is inspirational and aspirational for all of us. So I want to thank you for taking the time. I know time is precious to you. I really want to thank you for spending time with us and being such a good egg.

Well, Audrey, thank you for all the compliments. It's been a pleasure to

be with you here today. And hopefully we can get through this pandemic and start to see each other personally again, right. And for all of you that are dialed in to listen today. Thank you very much for your time and please stay safe out there. We don't want to see you on our machine.

No.

Thank you, everyone. Jonathan, who do we have tomorrow?

Tomorrow we have Ryan green from greenwise stopping by to talk about his platform and just trends in general when it comes to ride sharing and delivery technology platforms.

Awesome. All right. Thanks, everyone. Stay safe. Thank you again, Pete.

Transcribed by https://otter.ai