Bringing Hope for Heart Failure with CCM Therapy with Simos Kedikoglou, CEO of Impulse Dynamics: Audio automatically transcribed by Sonix

Bringing Hope for Heart Failure with CCM Therapy with Simos Kedikoglou, CEO of Impulse Dynamics: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.

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Saul Marquez:
Welcome back to the Outcomes Rocket everyone, Saul Marquez here. Today, I have the privilege of hosting the outstanding Simos Kedikoglou. He is the Chief Executive Officer at Impulse Dynamics. He became the CEO in 2013 and working with the board and management team. He’s responsible for defining and executing their corporate strategy. During his tenure, the company has obtained approvals and launched the optimizer device globally with sales and clinical work in the US, Europe, China, Japan, Australia, Brazil and India. Simos was previously a Corporate Vice President of Business Development for Boston Scientific, with responsibility for acquisitions, licensing, and distribution deals in the US and really globally. Simos was an Associate Partner with McKinsey and Company as well prior to that in the US, advising clients in health care, mergers, and acquisitions. He holds his medical degree from the University of Athens, Greece, and his MBA with distinction from Harvard Business School and a Master of Public Health from Harvard as well. And on top of that, also a CFA Carterholder. So just an impressive leader in health care. And today he’s going to be talking to us about the work that he and his team are doing at Impulse Dynamics. Simos, such a pleasure to have you here today.

Simos Kedikoglou:
Thank you very much, Saul. It’s great to be here.

Saul Marquez:
Thank you. And so, you know, you are calling in from the UK, and I love that the work you guys are doing from there is translatable. And, you know, the NIH and there’s a lot of learning that we could do in the US health system and overall, just in general across the globe. But before we dive into the work that you’re doing at Impulse Dynamics, tell us a little bit about you and what inspires your work in health care.

Saul Marquez:
Health care is a great field to work in because you can do well for our employees, for our shareholders, for the people of the Impulse team, by doing good for the patients, getting the best thing for the patients helping them is what inspires us every day. We have quite a lot of cases on our website where patients themselves are talking or we interview them or they spontaneously talk to us about how we have been able to change their lives. And this is very motivating. That is, everybody wants to have professional fulfillment. But seeing these patients, being able to play with their grandchildren, go shopping with their partner when they could, then it’s something we find very motivating.

Saul Marquez:
Yeah, for sure. And it’s just an amazing time to be able to do what we do in health care. And so talk to us about your company and how exactly you guys are adding value to the health care ecosystem.

Saul Marquez:
Yes, Impulse Dynamics has developed CCM technology, which is for patients with heart failure. We had interventional heart failure who have an implantable device. It’s for those patients that have exhausted pharmaceutical treatment but are not yet sick enough to qualify for a heart transplant or a full replacement of the pump through if and take this device. This is a lot of patients. It’s six to seven million patients globally, roughly one, one, and a half in the United States. And this and the heart failure epidemic is growing fast. The American Heart estimates that is growing by three to four percent per year. The number of patients grows to four percent. But here, these are very vulnerable patients. They can work at most one flight of stairs. They can walk a thousand feet and then they stop. They have shortness of breath. They retreat from activities of daily life. They cannot go to the church or the synagogue. They cannot go shopping. They cannot spend time with their family. What we do is to try to help them to live their lives better. We have developed through extensive clinical trials and antibiotic development, a device that makes them be able to enjoy life again. And we have a motto that the hope is here. And I think this is how we think we are adding value to them. Now, we have also shown on many occasions that we also reduce the frequency of their visits to the hospital. These patients get hospitalized very much, and so we save on resources. We have a touch of technology that allows them to go for long without replacement. So we do take into account the economics that we actually create value to the system, but we also create value to the patients themselves by being able to enjoy their lives.

Saul Marquez:
Now, that’s fantastic. And so so the work you guys are doing, obviously, you guys have brought the technology to the US really globally. You’re based in Europe, but it sounds like you’re making a big difference here. What would you say makes CCM therapy just different or unique and what it’s able to provide to patients?

Simos Kedikoglou:
So the companies based out of the United States and the technology, the brain development has been done in the United States, in New Jersey. What is unique is that we are helping people through a completely different way. Before people are getting pharmaceutical treatment. Obviously, everybody will exhaust pharmaceutical treatment before they consider any device. But instead of moving to the very invasive heart transplant, surgical procedure divides things that cost hundreds of thousands of dollars and it’s extremely invasive for the patient. We have a stimulator. So it’s a very unique concept. We have to develop. It has taken more than 20 years of research and more than 100 applications that basically trained the myocardium. Think of it like when you go to the treadmill and you start getting exercised over time, over the three-month window, you start feeling better. It’s a very similar concept of device. It’s a very simple implant. It’s now the fifth generation of th implant, very simply flat 40, 45 minutes. Patients typically go back to the same day at home and they don’t even need anesthesia for the implantation, just like sedation. And they start feeling better. They see the effect building up. And this is what I consider unique is not only that, it’s a completely different concept. We’re not replacing the pump. We’re just training the pump. We’re supporting the pump and training it to make it able to deliver the blood that the body needs, but also that it’s a fairly simple process. Just a four to five-minute implant. The patient typically has to charge because we use a rechargeable battery to charge once a week for 40, 45 minutes. And we have shown that more than 99 and a half percent of our patients charge regularly because they see improvement. So I would consider the uniqueness here is the concept itself, which is a simulation, but from the patient’s standpoint, is a relatively big help for a not very invasive procedure and not requiring a lot from this patient rather than a weekly chat.

Saul Marquez:
That’s very good. Very good. And is it charged externally or how is it done? Yeah, it is.

Simos Kedikoglou:
It’s not completely externally, just like, you know, your toothbrush charging. And in new generations of the device, which I’m happy to talk, we are actually improving what we get out of the device. So not only the patient is charging, but also the device is being checked every week. So we get out of the typical go to the hospital every three months and check your device, which is just a burden to the patient. We have tried to think it through from the beginning in a way that is convenient to the patient and efficient for the health care system.

Saul Marquez:
Very good. Very good. And so as you think about some of the outcomes that have resulted from this, what can people expect as far as improved conditions? Tell us a little bit more about that.

Simos Kedikoglou:
Typically, our patients get hope back. What this really consists of is they get at least 20 to 50 percent improvement in their ability to exercise, in their ability to walk. Our patients, typically, when they start, can walk only around 10000 feet. They see an improvement that we’ve shown and in studies in six and 12 months. Studies show that life continues for longer 3-4 years. They are able to spend activities of their daily life to do a lot more of their daily life, and therefore they report much higher satisfaction. There is this emphasis on many treatments on what’s going to be reported outcomes, and they are very specialized ones in heart failure, like the short term to concentrate the question. And we’ve shown tremendous improvement and those improvements that really go way beyond what you get with a pharmaceutical. Again, all of our patients have a choice for much of the treatment. We’re not competing with the pharmaceuticals, but they are very surprised to see how much their daily life improves. We have patients that have been able to resume activities and assume if they were working and if they wanted to work and his professional life or just spending a lot better and their lives in retirement, for example, of activities like fishing or even mountain climbing that was completely off-limits before. That’s the biggest health and the biggest encouragement is exactly that the patients themselves see how much better they feel.

Saul Marquez:
That’s fantastic. And we consider the type of outcomes delivered. Is it improving the quality of your life? Are you able to have a better healthspan? And I think these are the things that you get a patient that wants to go to the grocery store and not be exhausted and or even it sounds like with the help of this device, do even more than that and be active and obviously with the consultation of their physician. But it sounds like it’s really opening up some great opportunities that don’t require drugs. And you said it’s not competitive with the drug. But I would say we look at drugs as very expensive, one of the most expensive things that we incur in the health system. You know, I think of a device, you pay for it and that’s it, right? I mean, so can you talk to us about the economics there?

Simos Kedikoglou:
Of course. First of all, our device is fully covered by Medicare. It is actually Medicare is actually providing down payments both in the outpatient setting where most implantations are taking place, as well as in the rare cases where someone is hospitalized, the device for symptoms and they give their device during these customizations. The device is fully paid for by Medicare. Most of our patients are on Medicare, we do have younger patients. However, more than 80 percent are actually covered by their Medicare age and the device is fully covered there. But from the health care system, there are two important points to make. We have shown in many of the European results that we reduce. We keep the patients out of the hospital. And it’s well known that hospitalization is not only expensive for the system, it’s also very detrimental for the patient. Typically, hospitalization for these patients is the trigger for a vicious circle where the patient feels weaker, retreats further from life, goes back to the hospital. 30 or 50 percent of the patients end up getting rehospitalized for keeping them out of the hospital is something that we have shown in our European data and we are hoping to bring this claim in the United States. In addition, we have done that as a rechargeable device which spares the patients the need, as in other devices, to change every five years or seven years because the party depletes our device would go for 15, 20 years. Practically, patients will not need to change or control, not only to spare the patients the angst of going under the not getting under the knife or just a simple generator change. But also we bear the cost to the health care system because each one of them is quite expensive for Medicare. So the economics are quite favorable. Again, we do not aim to replace pharmaceuticals. Most of these pharmaceuticals have kept the underlying treatment. But we do make the patients feel better and they think this is what the patients really value.

Saul Marquez:
Yeah. Now, that’s a good callout, appreciate your diving into that a little bit more Simos. And so, you know, I guess you think about it from a provider perspective and you also think about it from a patient perspective. How do people find out about this and how do physicians find out about it? Is it commonplace to do this type of thing? Maybe just some of the basics there would help our listeners understand how to access this technology.

Simos Kedikoglou:
Yes, absolutely. Thank you for the question. This is very important. We have launched a device in the United States last year, frankly, in the middle of COVID. It has not been that easy. We have generated quite a lot of interest, both via marketing efforts to the providers, but also through direct to the patient. We have some pilot direct to patients to make the patient themselves aware. Patients can also go on our website at Impulse-Dynamics.com and find our providers near them. We are signing up more and more providers. We have now nearly every state providers that can offer this device. It’s a very simple implant. It doesn’t require training. A lot of training for the provider. It’s implanted like a simple pacemaker. So that makes it very easy for us to add providers only. And of course, as I said, for anybody who is on Medicare, it’s a device Medicare covers. We are planning on expanding our outreach, especially as we hope the epidemic will subside somewhat in the summer timeline. We are planning a lot more outreach efforts to both providers and patients, and we hope that we will be able to have these outreach efforts more and more of the patients in her field. We are working with patient associations. We are working with heart failure doctors, and we expect to try to reach this message to more and more of the patients in need. And there are quite a few of them.

Saul Marquez:
That’s fantastic. Thank you, Simos. So, folks, different ways to engage and learn, but certainly Impulse-Dynamics.com. You’ve been leading the company. It’s been about eight years now. And so as you reflect on the previous eight years, what would you say is one of the bigger setbacks you’ve experienced and a key learning from that’s made you guys better?

Simos Kedikoglou:
Yes, this is a great question. And indeed, setbacks always exist in life. The company had the first round with the FDA and it was not successful. It was not successful because of being given the company was given a trial design that was unworkable, that has never been used since. But it was clearly a big disappointment when in our first trial we showed improvement, but we were not showing the one particular endpoint the FDA wanted. And they’ve since retracted, understood it was a wrong endpoint, but was very disappointing for the company. I joined the company right when it had to effectively restart. And you see that the. Many of the technologies developing a technology. Our technology has a breakthrough indication, it’s really something that is a big need, but that when you try to develop something for these large populations, there are always things you don’t know. Setbacks. In our case, it was that we had to do an additional study. And it’s easy to say perseverance. Yes, that’s what it is. But it’s not just your own. Personal perseverance is motivating employees, motivating physicians to participate in the trial, motivating investors to support the company.

Simos Kedikoglou:
So the biggest learning I have which we had to do back in the 2014 timeline, is that you need to be very clear in your communications on what went wrong and what you are doing to fix it. It’s easy to talk about perseverance. It’s something that’s required, but clear communication is required. And we have found that people, including patients, including physicians, including investors and employees, respond well when they’re given a message of clarity, not a message of just hope without specifics, but hope with specifics. We had quite a lot of patients that have been extremely well on the device. We know the device works. We know the device. It was just a question of designing a trial that would show exactly what the FDA and the patient wanted, which we understood. So my lesson out of this is you need to know, but you also need clear and specific communication. And that’s a big part of leadership, motivating the people, showing them a clear path forward. And then those pressures around will be patients, customers, employees, investors actually respond very well.

Saul Marquez:
Well said. Well said. Clarity and communication is huge. And just being able to navigate the difficulties, it’s more than just perseverance. It’s being clear and showing the way. And you certainly have you guys made it through the obstacles. You’ve got your FDA approval, you’re in the market. You launched during COVID, which obviously didn’t make things easy. But I think the muscle that you and the team have built through the challenge is going to be critical for the success that you guys will have. And so on that note, what are you most excited about today?

Simos Kedikoglou:
I am very excited about the new things. I as you rightly said, this epidemic has clearly redefined how we approach health care. We have for quite a while we have looked and said what is next? And for us, what was next was twofold. One was to try to combine more devices into. Sure, a lot of our patients have a separate device and ICD and implantable cardioverter defibrillator, which is an insurance that sits there and delivers a shock. And what many of our patients have to carry two devices. And back in the day when maybe your youngest listeners will not know that, but we used to carry a cell phone and a camera. Now everybody carries just a cell phone that has a camera. Similarly, we have developed an integrated device that would allow them to actually spare three implants, not just our implementation, but also replacement, because this is something that is really exciting because it saves a lot of money in the system. It saves a lot of angst and anxiety from the patients because they don’t have to go for multiple times to get devices. They only get one. And then this device has taken a long time to develop, but it will be with the patients in a clinical setting. The of the separate things that we have been developing, both for our current device and the combined one, is a lot more patient engagement.

Simos Kedikoglou:
The concept is once you get the device, once you go and get implantation, you should get as much as possible out of it. So we are engaged. We have incorporated a lot of add-on diagnostics that actually including diagnostics from the device, including a patient that includes that previous patient engagement. We expect to launch all of this in the United States later this year, because, at the end of the day, the person who knows best about the health is the patient himself or herself. And we are trying to increase their engagement with them to provide a lot more data about their activity, about other metabolic parameters. But most importantly, we are trying to make it in a simple way that explains to the patient whether they are improving or not, and so that they can also see what changes they can do with their lives and be more engaged. So to summarize, what excites me is that now that we have got the main technology approved, all of the follow on innovation and some of it includes the better-integrated devices and some of it includes tools and diagnostics that, together with patient engagement, should lead to a much more to a much better life for the patient and a lot better communication with their physicians.

Saul Marquez:
That is exciting Simos and just the integration of both the ICD and your device. I mean, you get the kind of when needed shocks and then and then the in-between to stay with it on the day to day, that’s very promising and it sounds and feels like you guys are definitely moving forward with a strong appetite to innovate and to not just stop at this kind of breakthrough indication. You’re doing way more than that. And that certainly is exciting. So I appreciate you sharing that message. You know, before we conclude, Simos. I’d love to just have you here. Give us one final thought. What should we be thinking about as it relates to heart failure and health? And then the best place for the listeners could connect with you and your team to learn more about what you guys offer.

Simos Kedikoglou:
One closing thought is for the patient is that there is hope. It could be us, it could be other innovation. There is a lot of innovation and the patients themselves or their caregivers can be engaged, can look, they should not be disappointed or resigned into. This is a condition that we can no longer do anything about. There is a lot of innovation. We think we are at the forefront of it, but they should try it online. They should contact their physician or other patient associations or perhaps other physicians with a specialty in heart failure to try to find help for the innovators. Because this is another constituency. I want to say that it is such a great field to be able to do work. It pays off. We all remember the dark days when we had to respect and very doing, but it really pays of innovation in these fields. It could be heart failure or it could be diabetes. I’m not trying to compare needs, but it’s such an exciting field to innovate, do work, and eventually, it pays off. It is not the financial payment. It is the payment to see children of patients telling you I got my father, my mother back, I got my partner back. This is really a field where there is nothing that compares to the satisfaction you get as far as where a place where anybody can find us. Our website is Dynamic-Impulse.com, with or without hyphens, and you can contact us there. You can also see a lot of stories, true stories from patients, and how our device has helped them improve. I do want to finish with one message. The hope is here and it’s up to the patients and their caregivers to do some outreach in order to be able to find the help they need and deserve.

Saul Marquez:
Well, this is awesome Simos. And you mentioned it’s about the return, not about the financial return, although running a company it is, but the motivating factor, the North Star is, are we making patient outcomes better? Are we improving the quality of life? And there’s a big two big yeses to that in the work that you and your team are up to. I admire the work that you do Simos and really the work of MedTech innovators. You mentioned that. I mean, it’s just it’s a long road, but at the end of that road is a huge promise for humankind. And so grateful that you joined us today and shared the vision and the work that you guys are doing there. I’m certainly excited to see you guys succeed. Really, really thankful you made time for this podcast today.

Simos Kedikoglou:
Saul, thank you so much for having me.

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