During their recent visit to Victoria BC for lab testing services, Second Heart Assist Chairman and CEO, Howard Leonhardt (HL), and VP of Engineering & Product Development, Alex Richardson (AR), spoke with ViVitro Lab and Interim General Manager, Rob Fraser (RF), about their work at Second Heart Assist, and Leonhardt Ventures.

RF: You both have a long history with medical devices.  Please tell us what types of devices you’ve worked on and what your focus is today.

AR: I’ve spent the last 30 plus years in manufacturing, mostly involving Class II and III medical devices. I spent a great deal of that time in contract manufacturing supporting a myriad of complex medical devices for new and emerging technologies and commercialized world class devices for large renown OEM companies. I am very fortunate to have a history of deep exposure into design and manufacturing of complex devices such as cardiac pacemakers/ defibrillators, spinal cord stimulators and neurostimulation devices, cochlear implants, and other cutting-edge technologies.  Putting my product knowledge and engineering experience into applications for cardiac assist and advanced regenerative technologies is very rewarding.  The platform technology I am involved with at Leonhardt Ventures is extremely exciting. Considering the technologies I’ve worked on historically, that is a huge statement.

HL: I’ve been working in the field since the 1980s when we patented and developed a predictably compliant balloon that could be used with cardiovascular balloon catheters. We built a modest business around that.  In the early 1990s we developed the first stent graft that could be delivered with the percutaneous entry for repairing aortic aneurysms. In 1995 in Australia we completed the first non-surgical repair of an aortic aneurysm. That product has become the leading product in the world for repairing aortic aneurysms. It’s now part of Medtronic. We sold it to Medtronic via a merger first with Arterial Vascular Engineering, Inc. in 1998. During that time period we took that same stent, put a heart valve in the middle, and patented the very first percutaneous heart valve system that was also sold to Medtronic.

During those years we developed intervascular lung catheter, a radiation delivery catheter, and we patented the first stem cell delivery catheter, PROCELL, that we designed to deliver stem cells to damage heart tissue. We moved that into work that resulted in our team completing the very first stem cell repair of a human heart without surgery in May of 2001 in the Netherlands. We built that company up and spent a lot of money learning how to regenerate hearts, making mistakes along the way and making some progress along the way. In 2008 that company went public on NASDAQ.

I wanted to get back to innovation and the team at Bioheart wanted to focus on injecting stem cells alone one time into the heart. I had already begun developing bioelectric stimulation, a micro infusion pump, and complementing the stem cells with an egg yolk like mixture. We set up an Innovation Accelerator in California in 2008 and set about trying to see if everything we learned in regenerating hearts could be applied to other organs.  That would be a base of bioelectric stimulation, a micro infusion pump that was refilled with stem cells, and an egg yolk. And we’ve been working on that ever since.

RF: When you’re putting muscle stem cells in the heart it is presumed to help in regeneration if you offload the heart a little bit. That took you on a bit of a detour which became Second Heart. Please tell us more.

Second Heart takes a similar aortic stent originally developed for repairing aortic aneurysms and put a pump inside and put it in the aorta with the idea to reduce the workload of the heart, reduce fluid overload and to revive kidneys,  while we were trying to use our bioelectric stimulator and pump to regenerate the heart. We had meetings with some of the top opinion leaders in heart failure from places like the Mayo Clinic, Cleveland Clinic and Ohio State University. They told us we’d like to have that pump within the aortic stent separate from the heart regeneration, as a stand alone product.  We have patients that could use that solution even without it being a bridge to heart regeneration. While we were working, we determined it would be a shorter regulatory path to have a catheter temporary aortic stent pump which could relieve the patient of excess fluids, help them get through a high risk Percutaneous Coronary intervention (PCI) procedure, maybe help them recover from cardiogenic  shock and, most needed to help patients recover from cardio-renal dysfunction, where both their hearts and their kidneys are both failing.  Just short term use for a few hours for High Risk PCI or maybe up to a day 24 hours for cardio-renal dysfunction recovery. That is certainly a market worth going after and a great unmet patient need. We are diligently working  to have a more long term aortic stent with a pump powered wirelessly and last April announced our first successful demonstration at Queensland University of Technology (QUT) in Brisbane, Australia.  We believe we hold the earliest pioneering patents in the field of wireless power of percutaneously delivered circulatory assist pumps.

We are now in the last stages of testing to begin clinical trials for the catheter based version of the aortic stent pump.

RF: What kind of reactions you get into that pump? 

HL: The heart failure community really embraces the opportunity to treat patients that have both heart failure and kidney dysfunction. We just reviewed the statistics: 30 to 60 percent of the 23 million patients in the world that have heart failure (six or seven million in the U.S. alone). It’s predicted that 30 to 60 percent of those have both their kidney failing while their heart is failing. The two things are connected. As your heart fails, you stop feeding the kidney with the right proteins and blood flow that keep the kidney in health. And so this device is designed to be placed right above the renal arteries in the aorta to remove the heart failure patient of excess fluids and to revive the kidneys. The economic benefit is that if you don’t use this, the patients often are back in the hospital after treatment to relieve excess fluids within 30 days. Which is hard in particular in the US and the health care system.  Medicare and insurance companies won’t pay the hospital or the doctors for the second treatment for patients that come back within 30 days.  After 30 days they will pay them. There’s a strong movement in the US to keep the patients out of the hospital at least 30 days. Other companies, doing this work and who are more advanced in clinical trials, have shown that by using a circulatory assist device even temporarily for six hours or 18 hours or 24 hours can extend the time out of the hospital for at least three months instead of one month. We’re on that path right now and reception has been very good and particularly if we bring forward the wireless power.

The sickest patients in this category are kept in the hospital for up to 11 days until they get back to being stabilized. That’s hard on the hospital, it’s hard on the nursing staff, it’s hard on the doctors, and it’s hard on the patients. Patients are much better served if they get up and start walking around. They’re not better served by laying in a bed for 11 days. With the devices that have the drive shaft going to the motor, patients are pretty much immobile. They can barely go to the bathroom. If they do, they have to drag the device along with them. And they have risk of infection because they have a line going out of the body into the body. If you go to wireless power, theoretically you should reduce the risk of infection, improve the quality of life, and the people can get up and walk around. For patients that are in that state, just getting up and taking a walk can make a big difference in the improvement of their health.

We’re striving to bring that forward with heart failure opinion leaders. We’ve had three expert panel meetings that have been attended by 20 of the top heart failure leaders in the United States. They’ve told us that if we could bring this solution, we would really bring a great contribution to the field of caring for these patients. Right now the options are heart transplant and an LVAD. Up until recently LVAD has been a big, clunky device that has issues with blood clotting and infection itself. A lot of LVADs are not wirelessly powered. They require an external line and have a temporary catheter from another company that has a limited use.  Clinicians are missing the in-between part. They don’t want to go to a heart transplant or a big LVAD with everybody and they don’t want to keep people in the hospital with the drive line catheter for 11 days. They need something in between. And this is one step in that direction.

RF: How has ViVitro helped you with that work to date? 

AR: Through testing utilizing ViVitro’s world class pulsatile pump and compliant aortic models, our device worked in tandem with their pump and provided simulation models to characterize our device’s performance.  The resident expertise and comprehensive facility has proven to be an extremely useful asset in gathering performance data and simulate how our device will perform in the body. It’s been hugely beneficial for us to be able to simulate our pump and system performance in a compliant human-like condition.

RF: You have alluded to some future plans. Is there anything else you want to talk about? 

HL: This device is placed in the aorta. We think that people under-appreciate the aorta. It’s kind of a joke that maybe only Americans would understand, but the Aorta is the Rodney Dangerfield of organs. It doesn’t really get any respect and a lot of people believe the aorta is just a conduit for carrying blood and no big deal. Any conduit will work. We’re discovering as we spend time and understand an aorta and the function better, that it’s much more than just a conduit for blood.

A healthy, compliant aorta that’s able to beat and pulse, like your device does, releases healthy protein expressions that allow for kidney health, reduce the risk of multiple organ failure, and dampen high blood pressure. For those of us who are lucky enough to be healthy, when our blood pressure rises from something that would normally cause a high blood pressure to rise, the aorta dampens that pressure, modulates it, and gets you back to normal. But people have stiffened aortas do not have that dampening. That causes the blood pressure to just keep increasing because there is no give.

To talk about our future plans, we plan to take bioelectric stimulation technologies into this aortic implant to release healthy proteins to maintain the elasticity of the aorta. And one of our patented bioelectric signaling sequences is to release tropoelastin which increases elasticity. We also have controlled release of Klotho, sonic hedgehog SDF-1, PDGF and follistatin.  All of which, when appropriately used, can increase the health of any smooth muscle in the body. This would include the aorta. That’s a little peek at where we’re going.

RF: You mentioned you started an Innovation Accelerator in California. Can you tell us about that? 

HL: Second Heart is one of 30 startups we have in our innovation and startup accelerator. The charter of our accelerator is to try to take that core technology of a bioelectric simulator to stimulate and a micro infusion pump and a mix composition for organ regeneration, which we spent many years learning how to use for the heart, and see if it would work for other organs such as the kidney, pancreas, liver, and even surface things like skin and hair.

We’ve divided into groups.  We have the heart and cardiovascular group, which is where we originally started. We have the brain, cosmetic and personal care, which I think has nine startups in it now. Skin, hair, and erectile dysfunction are all in that cosmetic and personal group as well as breast augementation via a stem cell homing signal bra, Stem Cell Bra. We also have the major organ regeneration group which includes eye vision recovery where we have already published results on over 176 patients.  We didn’t intend to enter cancer, but while we were trying to regenerate organs we discovered some signals that seemed to stop cell proliferation, which could possibly be used to stop tumor growth. And while we were trying to grow blood vessels in the new organs, we discovered some signals that actually caused blood vessels to retreat which we now are applying to starve tumors of blood supply. We now are testing our 5 part CancerCell bioelectric therapy in animals at UCLA.  We custom read the tumors and deliver precise specific bioelectric signaling sequences designed to eradicate the tumor.  After the tumor is gone we regenerate the organ, at least this is our intention that needs to be proven out in well designed studies.

Those five groups all use the same core bioelectrics and biologics technology. Second Heart is an outlier. It originally was part of the heart regeneration project and spun out. And it’s the only technology in our whole 30 startups that doesn’t use, at this time, the bioelectric stimulation as its core.

Our business model is to take each organ-specific application, including Second Heart, through first-in-man studies, and then find a strategic partner to take the commercialization path the rest of the way. Our strength is getting things off the ground, to be innovators and to get things into the position of getting through first-in-man studies. And we think we can do that very well in a cost effective manner, especially partnering with groups like yours.

After that when it goes into big scale clinical trials, big scale finance, big scale manufacturing, almost big scale anything, we really believe the leaders of the field like Medtronic, Boston Scientific, J&J, Teleflex, Edwards, W.L. Gore & Associates and Abbott Labs can do those big scale things better than our small company.

We decided that for the rest of our careers, Alex and I are dedicated to focusing on the upfront part where we think we really offer something to them. Using our business model of exiting or finding a strategic partner after first-in-man studies, we expect to have five companies each year over the next six years that are in position to ask for a strategic partnership or strategic acquisition agreement. Some of those this year are our MyoStim ED www.erectistim.com product, which is for using non-invasive, bioelectric stimulation to cure erectile dysfunction and OrthodontiCell,  a bioelectric mouthpiece for straightening teeth in 2/3rds less time and keeping them straight with minimal use of retainers. We’re just about to bring these startups as well as a few others to a Dutch auction process where we plan to sell it to the highest bidder before the end of the year.

RF: Fascinating. Do you have any advice for other medtech entrepreneurs? 

HL: Alex and I are both technology guys and it fundamentally comes down to your product has to do something better than what is out there. We really believe if you do build a better mousetrap, people will come to your door. We like to dedicate most of our time, resources and energy into making the product better. That’s why we’re here learning the limitations of our device and how it performs in these human-like conditions. Part of the reason that we’re doing that is to key ourselves towards what improvements are necessary. In fact, on this trip we’ve learned a number of little things that can make the product slightly better. That’s why we commit to investment to continuously improve. So the advice is make sure your technology works. Everything else should work out okay. If you’re going to focus on one thing, focus on making sure your product works better than the other choices out there.

RF: Any additional wisdom, Alex? 

AR: Stay lean, stay focused, provide value, and be prepared for the ride.

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