Steven Mickelsen, M.D.
Chief Executive Officer
Field Medical, Inc.
Interview conducted by:
Lynn Fosse, Senior Editor
Published – May 15, 2023
CEOCFO: Dr. Mickelsen, the first thing I see on the Field Medical site is “Pioneering the Next Generation of Pulsed Electric Field Ablation Technology.” What is the state today of this type of technology and what will Field Medical be adding or changing to the mix?
Dr. Mickelsen: Currently, the standard of care for treating heart rhythm disorders like tachycardia—a condition where the heart beats abnormally fast—is either medication, which does not work very well, or catheter ablation. In many cases catheter ablation is curative, and even when it’s not curative it is often much more effective and safer than drugs. This is why over 1 million catheter ablations are performed worldwide and the number of procedures is growing rapidly with a continual annual growth rate that is somewhere between 10 & 20% depending on which specific arrhythmia is treated. Field Medical is pioneering a new way to perform these procedures using an energy technique.
Today radiofrequency energy is used to cauterize the heart tissue causing the arrhythmia. This made up 80% of all procedures performed last year with about 20% using freezing technology. However, both thermal methods have inherent limitations leading to unwanted complications and technical challenges that ultimately impact effectiveness and safety. Field Medical is working on a new type of energy delivery tool that can ablate cardiac tissue with significant improvements in safety and speed, and efficacy; called pulsed-
You may be aware that I founded a company called Iowa Approach now called FARAPULSE, that was the first company to commercialized PFA to treat atrial fibrillation. The early clinical data was so impressive that the entire industry product development quickly pivoted away from thermal ablation recognizing because of the clear advantages of PFA. With pulsed electric field ablation, we were able to destroy the heart tissue causing the arrhythmia while preserving all the surrounding tissues, leaving blood vessels, nerves, and other nearby structures virtually untouched. Its tissue selectivity has major advantages that were quickly recognized by all the companies, and that resulted in a paradigm shift in treating atrial fibrillation, one of the most common arrhythmias. My first company caught the attention of Boston Scientific in 2014, which eventually acquired the company for $425 million. Now it seems the entire catheter ablation industry—companies like Biosense Webster, Abbott, and Medtronic among them—are developing the first generation of PFA technologies designed to treat atrial fibrillation. However, I saw that many of these fast followers and pivots are sacrificing needed optimization for speed to market. This was an opportunity. This is also why I consider Field medical to be a truly second-
As for Field Medical, we aimed at pioneering the second generation of pulsed electric field technology. Our team of experts is already pushing some of the boundaries of what I thought was impossible a few years ago. The foundational innovation is called FieldBending™. This proprietary approach focuses energy in a predictable zone near the electrode but dramatically reduces the unwanted far field effects of strong electric fields, thus enhancing its effectiveness, safety, and procedural workflow. In fact, we are so excited about this discovery that we believe FieldBending may lead to a second PFA revolution within the field of cardiac electrophysiology.
CEOCFO: Why do we have Field Medical today?
Dr. Mickelsen: Field Medical is the result of years of experience, serendipity, and recognition that serious gaps remain in technology used to treat cardiac arrhythmias. In order to make significant strides in the treatment of cardiac arrhythmias, we cannot limit ourselves to just one problem such as atrial fibrillation. I saw that many of the companies engaged in the PFA development appeared hyper focused on a single component of AF treatment: pulmonary vein isolation (PVI). This is exactly what Farapulse offers. However, PVI may be necessary to treat atrial fibrillation, but it is often insufficient. Thus, in treating all atrial fibrillation many physicians will need to perform additional ablation using a traditional RF ablation catheter to address all the other treatment targets. Furthermore, Atrial fibrillation represents only half of the catheter ablation procedures performed in recent years, so there is also a very large segment of the current market that could benefit from a catheter that could be more versatile with all the benefits of PFA. Thus, Field Medical was born out of necessity.
We now have an incredible team of engineers, clinicians, regulatory experts, scientists, lawyers, business people working tirelessly to optimize, invent, and deliver a much needed technology that can enhance the safety and procedural efficiency of using the benefits of optimized Pulsed Electric Field ablation.
CEOCFO: What were your ideas when you started and what have you learned to put you in the right direction?
Dr. Mickelsen: When I started on this journey, I had an unconscious recognition that there was a major unmet need in cardiac arrhythmia treatment that could be solved if I could take a leap away from my comfort zone. I knew that PFA had major benefits, but I also know there were substantial technical challenges that stood in the way. I imagined the qualities that electric field must have in order to be perfect as a cardiac ablation tool. I took a step back and started working backwards from the electric field itself.
Inspired by modern engineering techniques, such as computational and finite element modeling, parametric modeling, I leveraged many of the latest technological advancements to evaluate a wide range of concepts all focused on shaping the electric field. It was an open-
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CEOCCFO: Where are you today in the development process?
Dr. Mickelsen: Since the inception of the company in August of 2022, our team has made remarkable progress. We have already developed functional prototypes and completed early preclinical animal testing. I must say that these early results are not just promising but exceed all my expectations in ways that leave me astounded and giddy. Our next major milestone is early human trials, projected to take place in less than 12 months. Considering the complexity of the technology, our development timeline thus far has been rapid, especially for a class-
Dr. Mickelsen: It comes down to rigorous regulatory requirements set by institutions like the FDA in the USA and Notified Body in Europe. This regulatory environment impacts the timeline. Medical devices, especially class-
As you might expect, the process of obtaining regulatory approvals for our technology is both time-
CEOCFO: What have you learned from past experience that is going to help you make it sooner rather than later, given all the constraints?
Dr. Mickelsen: Having been involved in multiple medical device development projects, I have gained invaluable insights from both successes and failures. Learning from challenges and mistakes has been a significant driving force in refining our approach for this project. Additionally, networking and collaborating with experts in the field of medicine has been instrumental in shaping our strategies. The field of medicine and medical devices is relatively small, and I have been fortunate to connect with intelligent and experienced professionals. Even competitors can offer insights and influence decision-
CEOCFO: What has been the response from people in the medical community who are aware of what you have developed so far?
Dr. Mickelsen: Field Medical has already received incredibly positive feedback from the medical community. We were honored that prominent electrophysiologist presented Field Medical technology at this year’s AFIB Symposium in Boston this year, and FieldBending is being included in talks about emerging technologies. Given my background as one of the pioneers in the PFA move towards new energy in cardiac arrhythmia treatment, I believe this recognition has been helpful. Despite being a relatively new company, in just seven months, we have gained significant attention and have garnered the support of key thought-
CEOCFO: Do we know why your approach works?
Dr. Mickelsen: The value proposition of Field Medical's technology is based on the fact that it is faster and has less chance of causing complications compared to traditional thermal ablation methods. The use of pulsed electric field, which was developed in my first company, has significantly reduced the procedure time for atrial fibrillation ablation from over four hours to just thirty minutes. This shift towards pulsed electric field has been driven by the understanding that it is more efficient and effective in treating certain arrhythmias. Field Medical takes this approach one step further by optimizing it to not just treat nuisance problems like atrial fibrillation, but also to target more serious and deadly arrhythmias, particularly ventricular arrhythmias. Currently, drug-
The expansion of the capability of Pulsed Field to be used in the critical part of the heart where these deadly arrhythmias occur is seen as a crucial development for the future. Investors and colleagues in the field, including cardiac electrophysiologists and cardiologists, understand the value of this approach and the potential it holds for improving treatment outcomes for patients with arrhythmias.
CEOCFO: Why are there so many ventricular arrhythmias?
Dr. Mickelsen: Heart disease is still the leading cause of death worldwide; there are currently about 45 million patients in the US and Europe. About 30% of these patients have clinical ventricular arrhythmias with varying degrees of severity. A good estimate is that about 7 million people have ventricular arrhythmia that require therapy in the regions where catheter ablation is routinely used. In fact, approximately 300,000 people die each year from sudden cardiac death related to ventricular tachycardia. It's important to note that while problems like atrial fibrillation are more common with around 40 million people worldwide affected, the clinical impact of ventricular arrhythmias is much more serious.
CEOCFO: What type of training would be involved in using your device?
Dr. Mickelsen: Minimal to no training. It's clear that electrophysiologists are already familiar with using focal catheter-
It's important to note that our goal is to provide electrophysiologists with a tool that enhances their capabilities, similar to upgrading from a regular bike to an electric bike. We aim to make the adoption of our technology as seamless as possible for electrophysiologists who are already proficient in using catheter-
CEOCFO: Are there any potential problems or challenges?
Dr. Mickelsen: With any new technology, there unknown challenges. This is where over a decade of experience in medical technology development plays an important role. My background and the network of advisors, partners, and professional friends within the MedTech space help me to identify potential challenges early on. The risks to the project at this point come mostly from external disruption impacting timelines/supply chain. There are some “unknown-
As a company, we will remain vigilant in identifying and addressing any challenges that may arise during the implementation of our technology. We are committed to the continued development and refinement of our device to ensure its safety and efficacy in clinical practice.
CEOCFO: Is this the type of product where it will be easy to find test patients?
Dr. Mickelsen: Yes, there are over a million patients with implantable defibrillators in the US and Europe. Somewhere between 30 and 50% of these patients will have clinical ventricular arrhythmias that require treatment. Currently catheter ablation makes up about 10% of the catheter ablation procedures. However, the growth in this segment of the market may be growing at between 10-
Ventricular tachycardia is one of the greatest unmet needs in medicine today. There are not many companies innovating in this space. The lack of therapy options makes it easier for a small company like Field Medical to enroll subjects in clinical trials.
CEOCFO: Why do you think that is the case?
Dr. Mickelsen: There are just not many other companies focusing on this specific patient population. We have had no lack of cardiac electrophysiologist interested in becoming investigators for the future trials. Possibly the biggest factor is that our FieldBending™ ablation system has the potential to cut procedure times 2-
CEOCFO: You have been through this before but how do you deal with the frustration of knowing you have something that can make a difference and yet it does take forever to get it in use?
Dr. Mickelsen: Field Medical is not my first start up. Innovation and company building is certainly an interesting challenge, full of frustration and rewarding excitement. As an entrepreneur, inventor, and physician, I come at this problem with deep knowledge into the problem I'm trying to solve. Also, like all entrepreneurs in this space I believe in the process to create technological solutions that make a remarkable difference in the future of health care. However, I must admit that there was some ignorance the first time I went through this process, and I didn't realize how long and challenging the journey for class-
It's akin to being a musician or a painter. Without that internal drive and passion, it's impossible to overcome the frustration of the risk of failure and the obstacles that come with trying to convince the rest of the world about the value of your innovation. And that's where the scientific process comes into play. One of the biggest challenges is the cost of running trials, even if there may be other ways to demonstrate safety. The trials have to be conducted in a specific manner, and the data has to be presented in a certain context. It's a process that cannot be easily circumvented.
So, to answer your question, I don't think there's a surefire way to avoid or overcome this frustration entirely. It requires resilience and grit, qualities that are inherent in entrepreneurs and inventors who are willing to see their vision through despite the obstacles. It's not an easy path, but the potential impact of making a difference in the world is what keeps me going, even when the journey is longer and more challenging than expected.
CEOCFO: What if anything might potential investors or the medical community, miss about Field Medical that should be recognized?
Dr. Mickelsen: Well, imagine this -
Field Medical, Inc. | Steven Mickelsen, M.D. | Cardiac Arrhythmias Treatment | Cardiac Ablation Treatment | Field Medical -