LSI Alumni Innovator Spotlight: CardiaCare CEO Amir Soltanianzadeh

Soltanianzadeh’s medtech journey has taken him from start-up entrepreneur, to investor, to CEO of CardiaCare: an innovative AI-based neuromodulation therapy company working to revolutionize atrial fibrillation treatment. In the midst of a Series A raise, he will be presenting at the March LSI USA ‘25 event in Dana Point, CA.

For Amir Soltanianzadeh, once you’ve been bitten by the medtech entrepreneurial bug, building a business around transforming the lives of as many patients as possible becomes part of your identity. And when the rare opportunity presents itself to disrupt one of the biggest markets in medtech, you must take it. 

Soltanianzadeh began his journey in 2016 while earning his MSE degree at the Johns Hopkins Center for Bioengineering Innovation and Design (CBID) program. Through this unique Biodesign-esque program, he started his first company, Spine Align. Spine Align developed a platform for measuring the intraoperative 3D biomechanics of the spine during complex spine surgeries via advanced sensors and computer-vision algorithms that complement navigation and robotic systems. Amir led the company from its founding to an M&A exit in late 2021 to one of the leading musculoskeletal companies, Globus Medical. 

After becoming active in the investing world post-exit, Soltanianzadeh launched his boutique VC firm, Solardis Health Ventures, to invest exclusively in medical device innovations. One of Solardis’ core investments in 2023 was CardiaCare, a breakthrough neuromodulation therapy for atrial fibrillation (AF). The technology is a wearable, non-invasive device that combines proprietary neurostimulation of the median nerve with AI-enabled cardiac monitoring. Soltanianzadeh was searching for a disruptive innovation in AF, one of the fastest growing medtech markets in need of innovation— and CardiaCare was just that. 

This January, Soltanianzadeh stepped back into the operator role and joined the CardiaCare leadership team as its new CEO. 

Originating from Israel, CardiaCare was founded by Amos Ziv (CSO) in 2015 to provide an alternative therapy modality for AF patients that are limited by the current standard of care (i.e., antiarrhythmic drugs, cardioversion, and/or an ablation procedure). The solution was cleverly designed to modulate the body’s own autonomic nervous system to reduce AF burden, mitigate arrhythmia triggers, and improve patient quality of life and symptoms. Ziv was then joined by co-founder Tsahi Holand (CTO) who helped develop the first-of-its-kind wearable neurostimulation device. 

CardiaCare has recently completed a RCT pilot feasibility trial and is now raising a Series A financing to fund pivotal trials for both indications (paroxysmal AF and post-ablation), with targets to achieve FDA clearances in 2027. 

Recently, LSI met with Soltanianzadeh to discuss his roles as both investor and medtech CEO, what it takes to translate a novel technology into a disruptive product, his team’s achievements and upcoming milestones, advice to other entrepreneurs, and his perspective as a long-time LSI event alum. 

Q. How did you first get involved with CardiaCare? 

“I first heard of CardiaCare through the Chairman of the Board, Ken Nelson, who is a prolific executive with an impressive track record of commercializing cardiac monitoring technologies. Ken has commercialized three of the four largest cardiac monitoring companies in iRhythm, Biotelemetry, and Bardy, and thus his involvement caught my attention. He shared that he joined CardiaCare’s board because he had already helped AF become more widely diagnosed and monitored with his past commercial successes, and that he was very excited to finally help a breakthrough therapy get to market to help those diagnosed AF patients. 

After meeting the leadership team and learning more about the technology, I was blown away by what the team had developed, which is completely out of left field. Instead of another invasive procedure or implant, CardiaCare created a wearable, non-invasive, patient-centric device. It’s a wearable form factor, but is very much not another monitoring or wellness tracker device. 

I said to myself, there’s no way this wrist-worn, non-invasive therapy could actually work. But then I dove into the clinical data and literature and saw how much impressive work this small team had done on the technology and clinical science. I talked to some of the leading cardiologists in the world, and with their support, I quickly fell in love with the possibilities of this technology. It can potentially help avoid costly and unwanted drugs and additional interventions, and make existing therapies more effective and durable. It’s great for patients, it’s great for providers, it’s great for payors, and can really be a scalable breakthrough. 

Solardis led the Seed round in July 2023, and then I became heavily involved as a board observer and advisor to the company. At that time, I realized how much I was enjoying the investor journey—gaining a broad view of the market and witnessing groundbreaking innovations firsthand. However, as an operator at heart with a deep entrepreneurial drive, it was impossible to ignore the rare and transformative opportunity that the CardiaCare team had built.

And so, I discussed with the team about how I could be more involved and add more value, and we mutually decided that I could help advance the team’s mission as CEO. This is one of those rare opportunities in one’s career to disrupt one of the biggest markets in medtech with a transformative technology, and so it was a no-brainer for me to take the role. I’m all in.” 

Q. Please tell us about the company’s technology. 

“While researching alternative therapies for cardiac arrhythmias, founder Amos Ziv, a clinical research scientist and entrepreneur, uncovered compelling preclinical data highlighting the median nerve as a promising therapeutic target. Recognizing the opportunity to leverage the body’s own nervous system to influence cardiovascular function, he saw a novel path forward: using neuromodulation to indirectly stimulate the vagus nerve, a key regulator of heart rate and blood pressure, via transcutaneous stimulation of the median nerve. 

The app that accompanies our technology transforms AF management by providing therapy management, real-time ECG tracking and arrhythmia alerts, continuous vital sign monitoring, and personalized insights into symptoms and triggers. Given AF’s multifactorial nature—often influenced by medical conditions, medications, alcohol, caffeine, sleep apnea, stress, and genetic predisposition—this comprehensive platform for understanding and managing each AF patient with a personalized approach is critical. In addition, a cloud-based dashboard enables clinicians to remotely monitor patient disease progression, treatment effectiveness, device compliance, trigger patterns, and overall cardiovascular health.

What sets this technology apart is its seamless integration of closed-loop monitoring and machine learning-driven algorithms with proprietary stimulation parameters, refined through years of development and clinical know-how. And in terms of user experience, it’s as simple as wearing an Apple Watch. Our sophisticated digital health platform empowers patients to manage their condition at home, non-invasively, instead of enduring treatments at the hospital. We hope to shift the paradigm away from reactive hospital-based treatment to proactive, patient-centric care. With this technology, CardiaCare is not just improving AF management, it’s redefining how we think about digital therapeutics and neuromodulation in cardiology. 

While pulsed field ablation in cardiac electrophysiology has seen recent dramatic growth, this is still a small fraction of the AF market and is not a silver bullet solution. Not only does our technology offer a non-invasive alternative that physicians can offer patients outside of invasive ablation procedures, but interestingly, it is being studied for its use as a post-ablation adjuvant therapy to improve patient outcomes and the long-term durability of these interventions. 

This technology really opens the aperture for how many AF patients we can treat and better manage in our healthcare system, from the earlier stages to the later stages, and whether they are pre- or post-ablation.”

Q. What stage has CardiaCare reached in its clinical development, and what key milestones have been achieved so far? 

“CardiaCare’s technology is designed to address two primary indications of AF: paroxysmal AF, an early stage of the disease, and post-ablation therapy, to enhance the procedural durability of cardiac ablation and reduce the need for repeat interventions. Currently, the redo rate for ablation is significant— approximately 20-30% within one year—which presents a major clinical and economic challenge in need of more solutions. 

For the paroxysmal AF indication, we successfully completed our first-in-human study in 2022. This single-arm trial evaluated ten patients who underwent eight weeks of home-based neuromodulation therapy using the CardiaCare device. The results demonstrated a strong safety profile, a significant acute reduction in AF precursor arrhythmia events—such as premature atrial complexes (PACs)—and a long-term decrease in AF recurrence. Notably, patient compliance with both the monitoring and therapeutic aspects of our device was exceptionally high. 

Building on this, we recently completed a double-blinded, sham-controlled, randomized feasibility study in 31 patients. The results were compelling, showing a significant reduction in AF burden that is comparable to leading drugs on the market, and with no significant side effects. In addition, we observed a tremendous improvement in severe AF symptoms and quality of life questionnaires, as assessed by blinded physicians and patients, respectively. This is very promising, as regulatory bodies, payors, and providers are increasingly focused not just on AF burden reduction but also on tangible improvements in patient-reported quality of life.

With strong clinical results, we are now advancing directly into the pivotal trial stage. Planning is well underway for our pivotal study in paroxysmal AF, with patient enrollment set to begin by the end of this year. 

For our second indication—post-ablation therapy—we recently launched a pilot study under the leadership of Dr. Vivek Reddy, a globally recognized cardiac electrophysiologist and a long-time advocate of our technology. This study is evaluating the effects of immediate post-procedure neuromodulation, where patients receive the CardiaCare device in the recovery room and begin therapy right away. The pivotal study for this indication is expected to commence in 2026 after the paroxysmal AF pivotal study is enrolled.”

Q. Can you describe challenges you have faced along the way, and how did you overcome them?

“One of our biggest challenges has been overcoming skepticism around non-invasive therapies. Historically, many medical wearables have underdelivered, leading to hesitancy from clinicians and investors alike. There’s a prevailing belief that meaningful therapeutic impact requires an interventional approach. But we believe healthcare is at an inflection point— one where external, patient-friendly solutions can and should play a much larger role. 

The reimbursement landscape is evolving to support non-invasive, at-home therapies, and we see an opportunity to reshape the narrative around external neuromodulation. CardiaCare is at the forefront of that shift, proving that an external device can drive real clinical outcomes. Our approach isn’t just about treating AF—it’s about redefining how medtech integrates with the digital health ecosystem to deliver more accessible, scalable, and cost-effective care. 

If we ask ourselves, where is healthcare headed in the next 10, 20, or 50 years, it’s clear that it won’t be dominated solely by interventional procedures. The future lies at the intersection of the digital and physical worlds, where technologies like ours enable proactive, continuous disease management. That’s the vision we’re committed to realizing.”

Q. What advice do you have for the medtech entrepreneurs out there, and lessons learned along the way?

“One of the most important lessons I’ve learned is that you will never have all the answers. As an entrepreneur, you have to strike a balance between unwavering belief in your vision and a deep understanding of what stakeholders—investors, strategics, providers, and patients—truly need. 

A common mistake, and one I’ve made myself, is assuming that because something makes sense to you, it will naturally make sense to others. But investors think in terms of market impact, risk-reward balance, and short- and long-term value creation. Physicians have a clear threshold for adopting new technologies. Patients need usability and demonstrated benefits. Payors must know why the cost of a device is a worthwhile investment to the healthcare ecosystem, and not another fancy technology. Understanding these perspectives early on is critical. 

Another key takeaway is that medtech must learn from the consumer mindset. While our industry is highly regulated, we should embrace the same principles that drive consumer markets—innovation, cost-efficiency, and seamless user experience. Healthcare is moving in that direction, whether we acknowledge it or not, and the companies that recognize this shift will be the ones that thrive.”

Q. How does your experience as an entrepreneur, investor, and as a strategic come into play in your new role as CEO of CardiaCare?

“Going into this role, I assumed that being a second-time CEO would give me greater confidence and insight. What I didn’t fully appreciate was how my experience as a full-time investor in between these leadership roles would double my perspective. 

Now, I approach challenges with a much broader view— anticipating what investors will prioritize, understanding what strategics seek in partnerships and acquisitions, and critically evaluating how our solution fits into the clinical workflow. Balancing all of these factors while staying agile as a startup is a complex challenge, but one that’s essential. 

Had I transitioned directly from my first CEO role to this one, I wouldn’t have had the same depth of understanding. My time as an investor has been invaluable in shaping how I now lead and position CardiaCare for long-term success.”

Left to right: Amir Soltanianzadeh, Solardis Ventures; Tal Wenderow, Genesis Medtech; Scott Pantel, LSI, at the “Financing and Innovation Strategies with Operators-Turned-Investors” panel discussion, LSI Europe ‘24

Q. Can you talk a bit about the LSI events, and your experience both as an alum and a speaker at the upcoming LSI USA ‘25 conference. Have the events and the connections you’ve made impacted your company’s trajectory? 

“LSI has been an incredible platform for the medtech ecosystem. I’ve attended several events, both in the U.S. and Europe, and what the LSI team has built is invaluable. It’s a true nexus—bringing together early-stage startups, growth-stage companies, strategic investors, and family offices, all in one setting. 

The relationships I’ve built through LSI have been transformative. I now work daily with people I met through these events—connections that otherwise might have taken years to establish. What sets LSI apart is that it’s not just a networking forum; it’s where real business happens. I know firsthand of deals that originated at LSI, and as the event expands globally, its impact will only grow. 

I’m incredibly proud to have been involved since the early years. Attending as an investor was a great experience, but now, returning as an entrepreneur, it’s even more meaningful. This is where medtech will continue to evolve, and for anyone serious about this industry, LSI is a must-attend event.”

Q. What’s next for CardiaCare?

“We are preparing to launch our pivotal studies by the end of this year. This is a major step forward in bringing our technology to market. 

In parallel, we’ve kicked off our Series A fundraising, which will fully fund our go-to-market strategy for both indications, covering pivotal trials, FDA clearance, and the establishment of an initial reimbursement pathway. 

The response so far has been strong, with significant interest from venture capital firms and strategic investors. We are on track to bring CardiaCare to market for our first two clinical indications by mid-to-late 2027, delivering a much-needed breakthrough therapy for AF patients. Our goal is not just to launch a product but to redefine how AF is treated for millions of patients globally. 

The next chapter is about scaling, executing, and delivering on this vision. I joined this team specifically to make this vision a reality, and we will pursue that mission relentlessly.

Note: Images in this article used with permission from Amir Soltanianzadeh. Watch his LSI Europe ‘24 in-studio interview, and Amos Ziv’s presentation at LSI USA ‘24, among other presentations, on the LSI website at Resources > Video Library.

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