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MEDTECH OPINION LEADER VOL. 2 | ISSUE 2 | CARDIOVASCULAR MEDTECH

ROB KRUMMEN: REVOLUTIONIZING ARRHYTHMIA CARE

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“INTERNATIONAL MEDICAL DEVICES EXECUTIVE MAGAZINE” Opinions and Strategies for Thriving in an Uncertain Economy

MEDTECH OPINION LEADER VOL. 2 | ISSUE 2 | CARDIOVASCULAR MEDTECH

ROB KRUMMEN SCOTT NELSON JOE MULLINGS JOHN YIANNI JORDI MARTORELL STEFFEN WUTTKE FILIP PETERS JIM FIDACARO DAN ROSE DAVID FISCHEL DR. DYLAN ATTARD RAMIN MOUSAVI MICHAEL HEUER

THIS ISSUE 05

Rob Krummen talks about how Vektor Medical’s vMap technology uses non-invasive, patient-specific ECG data to help physicians better understand atrial fibrillation, personalize ablation planning, and improve clinical decision-making and outcomes.

Scott Nelson talks about leading FastWave Medical by focusing on real physician needs, improving treatment for calcified artery disease, advancing faster nextgeneration IVL technologies, and building reliable cardiovascular tools that improve patient outcomes and fit naturally into clinical workflows.

Joe Mullings talks about how AI, imaging, reimbursement, and workflow innovation are reshaping cardiovascular medtech, with the biggest opportunities coming from improving access to care and controlling the clinical decision-making layer rather than simply building better devices.

23 John Yianni talks about the future of cardiovascular

MedTech, focusing on AI, minimally invasive therapies, clinical evidence, reimbursement, and the key factors that drive successful investment, adoption, and scaling of medical device companies.

29 Jordi Martorell talks about transforming aortic disease

treatment through bioresorbable, minimally invasive cardiovascular technologies. He focuses on leadership, innovation in aortic repair, biomimetic patches, precise imaging, and improving patient outcomes with safer, more natural healing approaches.

33 Steffen Wuttke talks about improving cardiovascular

care through hypertension prevention, renal denervation technology, business-driven healthcare leadership, minimally invasive treatments, AI and digital health tools, and future innovations in heart disease management.

THIS ISSUE

Filip Peters talks about using AI and non-invasive technology to improve cardiovascular care, especially heart failure, by enabling earlier detection, better monitoring, and more personalized treatment while supporting clinicians with evidence-based insights.

Jim Fidacaro talks about transforming hypertension care through continuous, cuffless blood pressure monitoring powered by advanced biometric sensing and AI.

Ramin Mousavi talks about how CathWorks uses AI and computational science to improve the diagnosis and treatment of coronary artery disease, with a focus on non-invasive technology, patient safety, clinical evidence, and global impact.

Dan Rose talks about how Endovascular Engineering’s Hēlo technology aims to improve pulmonary embolism (PE) and VTE treatment through safer, more efficient mechanical clot removal, while discussing clinical evidence, commercialization, innovation, and the company’s vision for improving patient outcomes.

David Fischel talks about how Stereotaxis’ magnetic robotic technology improves precision and safety in minimally invasive procedures, and how combining robotics with AI and connectivity will transform interventional medicine into a more precise, datadriven, and widely accessible form of care.

Stan Kalinin explores how flexibility, data-driven hiring, and global talent strategies are redefining the MedTech workforce, enabling companies to stay agile and innovative in a shifting market.

THIS ISSUE

Dr. Dylan Attard highlights Malta’s rise as a dynamic MedTech hub and how MedTech World serves as a global platform for collaboration, innovation, and patient-focused healthcare progress.

Michael Heuer talks Innovation in Afib management, AI in EP, European market adoption and cross-industry collaboration.

FROM THE EDITOR

I would like to welcome you to our issue MedTech Opinion Leader. At MedTech Opinion Leader, we are dedicated to bringing you the latest insights from industry trailblazers, comprehensive analyses, and forward-thinking perspectives. Our mission is to empower you with the knowledge and insights needed to shape your own vision in the ever-evolving medical technology landscape. Through expert commentary and in-depth coverage, we strive to be your go-to source for staying ahead of the curve in this dynamic field. Editor in Chief Stan Kalinin

THE LATEST ISSUE OF MEDTECH OPINION LEADER EXPLORES HOW CARDIOLOGY MEDTECH IS TRANSFORMING HEALTHCARE— THROUGH INNOVATION, DATA, AND GLOBAL COLLABORATION, WHILE HIGHLIGHTING THAT SUCCESS DEPENDS NOT JUST ON TECHNOLOGY, BUT ON LEADERSHIP, TRAINING, SOFTWARE, ECOSYSTEMS, AND CLINICAL EVIDENCE.

ROB KRUMMEN MEDTECH OPINION LEADER: ROB KRUMMEN TALKS ABOUT HOW VEKTOR MEDICAL’S VMAP TECHNOLOGY USES NON-INVASIVE, PATIENTSPECIFIC ECG DATA TO HELP PHYSICIANS BETTER UNDERSTAND ATRIAL FIBRILLATION, PERSONALIZE ABLATION PLANNING, AND IMPROVE CLINICAL DECISION-MAKING AND OUTCOMES. 05

Stan: AF is complex and varies from patient to patient-where do current approaches still fall short?

standard 12-lead ECG. The real opportunity is making better use of that data to support more personalized therapy.

Rob: Atrial fibrillation (AF) is one of the most challenging arrhythmias electrophysiologists treat today because the underlying electrical drivers of AF vary significantly from patient to patient.

By reviewing non-invasive electrical mapping data before or during a procedure, physicians may be better positioned to understand patientspecific arrhythmia characteristics and develop a procedural strategy. This can support more focused case planning and help physicians make better-informed decisions as part of their overall clinical workflow.

Pulmonary vein isolation (PVI) has become the foundation of catheter ablation for AF, targeting the pulmonary veins to eliminate triggers that can initiate the arrhythmia. For many patients with intermittent or paroxysmal AF, PVI can be reasonably effective. But in patients with longstanding persistent AF, the disease is often far more complex than isolated pulmonary vein triggers. In those patients, single-procedure success rates frequently remain in the 50-60% range, and repeat procedures have become commonplace rather than the exception. One of the key challenges in improving AF outcomes is identifying and targeting the underlying electrical drivers sustaining AF. Historically, attempts to do so have required invasive mapping inside the heart, which can add significant procedure time and become particularly difficult in patients with unstable or intermittent arrhythmias. That gap between patient-specific AF mechanisms and the tools available to identify them remains one of the biggest limitations in current AF care. Stan: How do you see decision-making in AF ablation changing in the next few years? Rob: I see two major opportunities to reshape decision-making in AF ablation. Decision-making is moving upstream, from an intra-procedural “map first, then decide where to ablate” approach to more proactive, preprocedural planning driven by patient-specific data. Every AF patient already generates a tremendous amount of information through the

Second, procedural volumes are accelerating rapidly with the adoption of pulsed field ablation (PFA), creating pressure to improve efficiency while maintaining efficacy. As procedures become faster, the value of intelligent guidance becomes even greater. Technologies like vMap support pre-procedural planning and can complement existing mapping technologies. Compared with conventional mapping approaches, this has the potential to aid physicians in reducing procedural complexity, saving valuable time, and improving procedural effectiveness. Stan: Where are the biggest gaps today between diagnosis, mapping, and treatment of AF? Rob: The challenge in AF today is not in recognizing the condition. It’s figuring out what is actually causing the arrhythmia in a given patient and how best to treat it. Over the past decade, several innovative intracardiac mapping technologies have emerged with the goal of identifying patient-specific AF drivers and enabling more personalized ablation approaches. Those technologies have demonstrated the potential value of moving beyond a one-size-fits-all strategy. But even with invasive mapping, AF remains extraordinarily complex and dynamic. Physicians are still often faced with difficult questions during procedures about what to ablate, where to ablate, and when

THE CHALLENGE IN AF TODAY IS NOT IN RECOGNIZING THE CONDITION. IT’S FIGURING OUT WHAT IS ACTUALLY CAUSING THE ARRHYTHMIA IN A GIVEN PATIENT AND HOW BEST TO TREAT IT.

Vektor Medical vMap supports electrophysiologists by providing an accurate, non-invasive perspective on cardiac electrical activity that can be used for physician analysis before or during an electrophysiology procedure. By transforming standard 12-lead ECG data into patient-specific maps, vMap helps physicians validate clinical hypotheses, refine procedural strategy, and identify potential arrhythmia sources that may otherwise be difficult to localize.

enough (or too much) ablation has been applied. That is where the next major opportunity exists. Rather than relying exclusively on information gathered during the procedure, technologies like vMap can provide physicians with an additional, non-invasive perspective on cardiac electrical activity using data already collected through the standard 12-lead ECG. The advantage is not only personalization but delivering this information in a way that fits naturally into existing clinical workflows. Stan: How important are partnerships with mapping systems, ablation companies, and hospitals for real adoption of your technology?

Rob: Partnerships across the EP ecosystem are absolutely essential. No single technology solves AF on its own, and physicians do not want or need more disconnected systems competing for attention in the lab. The future of EP will depend on technologies that work together seamlessly to help physicians move faster, make more informed decisions, and deliver more personalized care. That’s why interoperability and integration are such a major focus for us. We are actively collaborating with leading 3D mapping and EP recording providers to integrate directly into existing clinical workflows and enable real-time data exchange during procedures. The goal is to make advanced insight available without adding friction or complexity for the physician.

PARTNERSHIPS ACROSS THE EP ECOSYSTEM ARE ABSOLUTELY ESSENTIAL. NO SINGLE TECHNOLOGY SOLVES AF ON ITS OWN, AND PHYSICIANS DO NOT WANT OR NEED MORE DISCONNECTED SYSTEMS COMPETING FOR ATTENTION IN THE LAB.

vMap supports electrophysiologists by providing an accurate, non-invasive perspective on cardiac electrical activity that can be used for physician analysis before or during an electrophysiology procedure. By transforming standard 12-lead ECG data into patient-specific maps, vMap can help physicians validate clinical hypotheses, refine procedural strategy, and identify potential arrhythmia sources that may otherwise be difficult to localize. This is particularly important as AF ablation becomes more complex and procedural volumes increase with the adoption of PFA. As procedures become faster, the value of intelligent, patient-specific guidance becomes even greater. vMap can support pre-procedural planning, complement existing mapping technologies, and contribute additional insight throughout the clinical workflow. Integration is central to our strategy. vMap is designed to fit into existing EP workflows and work alongside the technologies physicians already use, including ECG platforms, 3D mapping systems, and EP recording systems. The goal is to make advanced insight available without adding unnecessary friction or complexity for the physician or care team. Stan: As a leadership team, how do you balance bold innovation with clinical and regulatory rigor in a fast-evolving MedTech landscape? Rob: At Vektor, bold innovation is inseparable from clinical and regulatory discipline. vMap is an FDA-cleared, non-invasive platform developed with AI to analyze arrhythmia sources using data from a standard 12-lead ECG. That innovation is grounded in years of rigorous development, clinical research, and regulatory oversight. Every advancement we pursue is anchored in scientific rigor, with compliance built into the process from the outset to support clinical relevance, reproducibility, and patient safety. We are committed to generating high-quality

evidence that helps physicians understand how vMap can support real-world decision-making and procedural strategy. Our clinical programs reflect that commitment. The IMPRoVED-AF clinical trial is a prospective, multi-center, randomized controlled study designed to evaluate whether vMap-guided ablation improves outcomes in patients with persistent and recurrent atrial fibrillation by targeting non-pulmonary vein electrical drivers. Together with our VITAL-EP real-world data registry, this reflects our long-term focus on building adoption through evidence, physician collaboration, and outcomes-driven innovation. Stan: What strategies has Vektor Medical employed to gain trust and traction with leading cardiac centers and KOLs in electrophysiology? Rob: From the beginning, Vektor’s strategy has centered on clinical collaboration, workflow integration, and data-driven validation. We have worked closely with electrophysiologists to understand real-world challenges in AF and complex arrhythmia care, and to ensure vMap fits naturally into existing clinical workflows. Trust in electrophysiology is built through evidence and experience. vMap has been evaluated in peer-reviewed studies, clinical abstracts, randomized trials, and real-world registry programs that explore its accuracy, procedural impact, and role in emerging ablation strategies. Equally important is our ongoing collaboration with leading cardiac centers and physician innovators. Some of the most meaningful advances in EP come directly from the physicians treating these complex patients every day. Their feedback helps us continuously refine the technology, strengthen workflow integration, and build solutions that reflect the realities of modern EP practice.

TRUST IN ELECTROPHYSIOLOGY IS BUILT THROUGH EVIDENCE AND EXPERIENCE. VMAP HAS BEEN EVALUATED IN PEER-REVIEWED STUDIES, CLINICAL ABSTRACTS, RANDOMIZED TRIALS, AND REALWORLD REGISTRY PROGRAMS THAT EXPLORE ITS ACCURACY, PROCEDURAL IMPACT, AND ROLE IN EMERGING ABLATION STRATEGIES.

When technologies are connected effectively, the benefits compound. Physicians work more efficiently, and procedures become more coordinated. Teams spend less time managing systems and more time focused on patient care. Partnerships with hospitals and physicians are equally important. Some of the most meaningful innovation in electrophysiology comes directly from the physicians treating these complex patients every day. We work very closely with leading centers to continuously refine our technology based on real-world clinical experience and workflow feedback. That collaborative approach is critical not only for adoption, but for building solutions that truly fit the realities of modern EP practice. Stan: Do you see AF care becoming more data-driven and -connected, and what role will your company play in that? Rob: Unquestionably. Arrhythmia care is moving toward a far more connected and data-driven future. For decades, many treatment decisions in AF were made using relatively limited information gathered at isolated points in time. Today, that is changing rapidly. Wearables, implantable monitors, imaging systems, and procedural technologies are generating enormous amounts of patient-specific data across the continuum of care. The opportunity now is not simply collecting more data but transforming that data into actionable intelligence that improves decisionmaking and personalizes therapy. That is where we see Vektor playing an important role. At its core, vMap is a softwarebased technology designed to transform electrical data into patient-specific maps for physician analysis. This creates a foundation that can evolve over time, scale efficiently, and fit across different stages of the clinical workflow.

Today, vMap helps physicians visualize and analyze patient-specific information before or during electrophysiology procedures. Longer term, we believe this same foundation may support broader opportunities in procedural planning, workflow optimization, longitudinal disease management, and future recurrence-risk assessment. Ultimately, our vision is to create a more connected AF ecosystem where patient-specific data leads to more informed treatment decisions, more personalized care, and better outcomes for patients. Stan: How does Vektor Medical’s technology directly improve outcomes or experiences for patients with cardiac arrhythmias? Rob: Vektor Medical was founded to help improve outcomes for patients suffering from cardiac arrhythmias by giving physicians better, earlier insight into each patient’s unique arrhythmia. Our vMap technology provides a novel, completely non-invasive way for physicians to visualize and analyze cardiac electrical activity using data from the standard 12-lead ECG. Developed with AI and advanced computational analysis, vMap rapidly identifies potential arrhythmia sources across all four chambers of the heart, including areas that may be difficult to visualize or identify using conventional approaches. For patients, the value is a more personalized treatment pathway. By helping physicians better understand patient-specific arrhythmia characteristics before or during an ablation procedure, vMap can support more informed decision-making, more focused procedural planning, and the potential for improved ablation outcomes.

AT ITS CORE, VMAP IS A SOFTWARE-BASED TECHNOLOGY DESIGNED TO TRANSFORM ELECTRICAL DATA INTO PATIENTSPECIFIC MAPS FOR PHYSICIAN ANALYSIS. THIS CREATES A FOUNDATION THAT CAN EVOLVE OVER TIME, SCALE EFFICIENTLY, AND FIT ACROSS DIFFERENT STAGES OF THE CLINICAL WORKFLOW.

SCOTT NELSON MEDTECH OPINION LEADER: SCOTT NELSON TALKS ABOUT LEADING FASTWAVE MEDICAL BY FOCUSING ON REAL PHYSICIAN NEEDS, IMPROVING TREATMENT FOR CALCIFIED ARTERY DISEASE, ADVANCING FASTER NEXT-GENERATION IVL TECHNOLOGIES, AND BUILDING RELIABLE CARDIOVASCULAR TOOLS THAT IMPROVE PATIENT OUTCOMES AND FIT NATURALLY INTO CLINICAL WORKFLOWS. 11

Stan: How would you describe your leadership style in guiding FastWave Medical within the cardiovascular field?

Right now, our focus is on advancing these platforms into rigorous IDE trials throughout 2026 and 2027.

Scott: I try to stay close to the clinical problem. That sounds obvious, but it’s easy to drift when you’re fundraising, building a team, hiring engineers, and managing a board. The pull toward abstraction is constant. My role is to keep our team anchored to what actually happens in the cath lab and angio suite: the friction physicians deal with every day and the workarounds they’ve come to accept. I spent 10+ years at Medtronic and Boston Scientific before entering the world of startups, and one of the biggest lessons I took from those experiences is that technology adoption is ultimately a people problem. You can build something technically superior, but if it doesn’t fit how physicians actually work, it won’t get used. So I lead with that filter: does this make the physician’s job easier and the patient’s outcome better? If yes, we move fast. If the answer is unclear, we go back and refine. Stan: As CEO, what is your top priority when it comes to improving outcomes for cardiovascular patients? Scott: Getting better tools into physicians’ hands faster. That’s the priority. Calcium is one of the most common reasons interventional procedures fail or underperform, and physicians have been dealing with limited options for too long. We recently completed a 30-patient first-in-human (FIH) study with our coronary laser-based intravascular lithotripsy (IVL) system, which demonstrated impressive performance. We achieved similar results with our peripheral IVL platform as well. Although these were relatively small studies, the data tells us we’re on the right track.

MY ROLE IS TO KEEP OUR TEAM ANCHORED TO WHAT ACTUALLY HAPPENS IN THE CATH LAB AND ANGIO SUITE: THE FRICTION PHYSICIANS DEAL WITH EVERY DAY AND THE WORKAROUNDS THEY’VE COME TO ACCEPT.

SCOTT NELSON GETTING BETTER TOOLS INTO PHYSICIANS’ HANDS FASTER. THAT’S THE PRIORITY. CALCIUM IS ONE OF THE MOST COMMON REASONS INTERVENTIONAL PROCEDURES FAIL OR UNDERPERFORM, AND PHYSICIANS HAVE BEEN DEALING WITH LIMITED OPTIONS FOR TOO LONG.

Stan: What do you see as the biggest challenges in treating conditions like calcified coronary or peripheral artery disease today?

consistent energy across the full treatment zone. It’s designed with a lower crossing profile, a rupture-resistant balloon, and one-click, handsfree therapy delivery.

Scott: Calcium is everywhere, and it’s unforgiving. As the population ages, we’re seeing more and more heavily calcified lesions that resist traditional treatment modalities. The challenge is that first-generation IVL systems, while a real step forward, still have limitations. Energy availability can be limited, especially when trying to treat diffuse or multi-vessel disease. Balloon ruptures happen more often than they should. Acoustic pressure delivery can be inconsistent. As a result, physicians are forced to improvise, which adds time and cost to the procedure, and risk to the patient. The gap between what physicians need and what current tools deliver is still quite wide. That’s what we’re focused on closing.

SolaTM is our coronary platform, which uses laser energy to generate 360-degree sonic pressure waves with every pulse of energy. Therapy is delivered via a novel, translating emitter, which gives physicians maximum control. In addition, the catheter pulses energy at 5 Hz, which is five times faster than existing IVL technology. Both peripheral and coronary platforms were designed around specific pain points physicians have emphasized since our early days of development: they need more energy to work with, faster and more consistent therapy, and a catheter that can navigate challenging anatomy without compromise. Every feature traces back to a specific procedural problem physicians have raised with us over and over again. Stan: How does your company’s approach stand out in the cardiovascular medtech landscape?

Stan: In what ways is FastWave Medical supporting physicians in managing complex cardiovascular cases? Scott: We’re developing two purpose-built IVL platforms in parallel, each designed for its specific anatomy. ArteroTM is our peripheral system. It delivers sonic pressure at 4 Hz (2-4x the speed of current IVL), with independently powered emitters for

Scott: We’re advancing two differentiated IVL platforms simultaneously, which is unusual for a company at our stage. Most startups pick one bet. We picked two because the unmet needs are different across coronary and peripheral applications, and the underlying physics are unique enough that a single platform can’t fully address both. ArteroTM uses electric IVL. SolaTM uses our laser-based IVL. Each one is purposebuilt for its anatomy. The other thing that separates us is speed. In less than five years, we’ve generated first-inhuman data with both IVL platforms, have been issued nine patents, and earned recognition as MD+DI’s 2025 Medtech Company of the Year and Fierce Medtech’s Fierce 15.

WE’RE ADVANCING TWO DIFFERENTIATED IVL PLATFORMS SIMULTANEOUSLY, WHICH IS UNUSUAL FOR A COMPANY AT OUR STAGE. MOST STARTUPS PICK ONE BET. WE PICKED TWO BECAUSE THE UNMET NEEDS ARE DIFFERENT ACROSS CORONARY AND PERIPHERAL APPLICATIONS, AND THE UNDERLYING PHYSICS ARE UNIQUE ENOUGH THAT A SINGLE PLATFORM CAN’T FULLY ADDRESS BOTH.

FASTWAVE MEDICAL WE’RE DEVELOPING TWO PURPOSE-BUILT IVL PLATFORMS IN PARALLEL, EACH DESIGNED FOR ITS SPECIFIC ANATOMY.

FastWave’s pace is unusual in medtech, and it reflects a team that operates with urgency. Stan: What criteria do you use to choose which cardiovascular innovations to pursue? Scott: It comes down to three questions. First: is the clinical need real and large? Calcium in coronary and peripheral arteries affects millions of patients globally, and the burden is growing as the population ages. That’s a clear yes. Second: can we build something meaningfully better than what exists? If the improvement won’t move the needle, we pass. We’re looking for a clear technical edge. Third: will physicians actually adopt it? That means the device has to work within existing workflows, not force physicians to retrain or restructure their approach.

If something checks all three, we pursue it aggressively. If it only checks two, it’s usually deprioritized. Stan: How important are data, imaging, and digital tools in shaping the future of cardiovascular treatments? Scott: Very important, but with a caveat. Data and imaging are only useful if they change what a physician does in the moment. Intravascular imaging has already altered how interventionalists approach calcium. You can see the depth and arc of calcification before you treat it, and you can confirm fracture patterns after. That’s a significant clinical shift. But the medtech industry has a tendency to bolt on digital tools and call it innovation without asking whether the physician’s decision actually changes. The goal is better decisions at the point of care — regardless of whether the procedure is in the cath lab or another setting. Everything else is just noise.

DATA AND IMAGING ARE ONLY USEFUL IF THEY CHANGE WHAT A PHYSICIAN DOES IN THE MOMENT. INTRAVASCULAR IMAGING HAS ALREADY ALTERED HOW INTERVENTIONALISTS APPROACH CALCIUM.

Click here to watch Stan: Which upcoming innovations in cardiovascular care do you believe will have the greatest impact?

calcified disease will be in a strong position to lead.

Scott: I’m biased, but I think next-generation IVL is going to expand who can be treated. First-generation IVL proved the concept. The next wave (including what we’re building at FastWave) is about making it faster, more reliable, and effective across a wider range of anatomies and calcium burden. Beyond IVL, I’m watching drug-coated technologies evolve, and I think AI-assisted procedural planning will eventually compress the learning curve for complex interventions. That said, the innovation I care most about is less flashy: devices that work the way they’re supposed to — consistently — in the hands of any trained interventionalist. Reliability at scale is the hardest problem in medtech, and the company that solves it for

FIRST-GENERATION IVL PROVED THE CONCEPT. THE NEXT WAVE (INCLUDING WHAT WE’RE BUILDING AT FASTWAVE) IS ABOUT MAKING IT FASTER, MORE RELIABLE, AND EFFECTIVE ACROSS A WIDER RANGE OF ANATOMIES AND CALCIUM BURDEN.

JOE MULLINGS

MEDTECH OPINION LEADER: JOE MULLINGS TALKS ABOUT HOW AI, IMAGING, REIMBURSEMENT, AND WORKFLOW INNOVATION ARE RESHAPING CARDIOVASCULAR MEDTECH, WITH THE BIGGEST OPPORTUNITIES COMING FROM IMPROVING ACCESS TO CARE AND CONTROLLING THE CLINICAL DECISION-MAKING LAYER RATHER THAN SIMPLY BUILDING BETTER DEVICES. 18

Stan: What are the most significant unmet needs in the cardiovascular medical device market today?

Stan: Which cardiovascular device segments do you believe will experience the highest growth over the next five years?

Joe: The most significant unmet need is not a device; it is access. The bottleneck in structural heart and complex intervention is not patient demand or implant performance. It is imaging expertise, anesthesia availability, and the cardiac imager's schedule. An LAA or TAVR case today requires a dedicated imager, often general anesthesia, and a tertiary center. That gates throughput far more than any catheter limitation. The real unmet need is decoupling expert-level execution from the scarcity of expert operators and expert imagers. Solve that and cases move from academic centers to community cath labs and eventually ASCs, expanding the addressable population rather than fighting over the existing one. The second unmet need sits above the procedure. Every case generates rich telemetry that dies in the room. No one yet owns the coordinating intelligence that turns imaging, implant selection, and outcomes into a compounding decision system. That is the deeper white space, and it is worth more than any single device improvement because it is the layer the incumbents cannot easily buy or rebuild.

Joe: Structural heart leads, but the steeper growth is in the enabling layer, not the implants. TAVR, LAA through Watchman FLX, and the tricuspid set, including EVOQUE, keep climbing, but the faster curve is cath lab imaging and procedural guidance, ICE catheters, and AIguided ultrasound, because that is what unlocks the site-of-care migration that actually expands volume. Pulsed field ablation in EP, currently being led by Farapulse, is a genuine high-growth franchise on its own. Interventional and endovascular robotics grow too, but as a node in the stack, not as the value owner, so I would not confuse unit growth with margin capture there. The segment I would watch hardest is AI cardiac imaging democratization, the UltraSight class of platforms that let a novice acquire expert-quality images, because that is the leverage point that pulls the average performer up and moves procedural volume downstream into lower-acuity settings. Growth concentrates wherever the average operator reaches expert outcomes, because that is where new addressable population is created rather than redistributed.

THE MOST SIGNIFICANT UNMET NEED IS NOT A DEVICE; IT IS ACCESS. THE BOTTLENECK IN STRUCTURAL HEART AND COMPLEX INTERVENTION IS NOT PATIENT DEMAND OR IMPLANT PERFORMANCE. IT IS IMAGING EXPERTISE, ANESTHESIA AVAILABILITY, AND THE CARDIAC IMAGER'S SCHEDULE.

JOE MULLINGS AI's real impact in cardiovascular is not making the best operators better. It is collapsing the gap between the average performer and the expert, and that is the more consequential economic change.

Stan: How are AI and digital health technologies reshaping innovation in cardiovascular medical devices? Joe: AI's real impact in cardiovascular is not making the best operators better. It is collapsing the gap between the average performer and the expert, and that is the more consequential economic change. As an example, UltraSight published data at ACC 2026 with Mayo Clinic showing novices reaching 99.8% accuracy on ejection fraction below 40. iCardio.ai is interpreting ICE images with Abbott. When AI allows a community interventionalist to run an imaging-dependent case without a dedicated cardiac imager, you have not improved the procedure; you have expanded where it can be performed. That is going beyond efficiency and creating a new category. The deeper shift is structural. Diagnostic and therapeutic are merging into a single coordinated data system, and the digital cloud layer that owns the patient and therapy decision becomes the primary battleground. Everything below it- the valve, the catheter, the robot- becomes a subordinate instrument inside that system. The company that owns the coordinating intelligence owns the economics. We will see less of a feature race in devices and a race to see who sits at the top of the stack.

Stan: What are the biggest regulatory and market access challenges facing cardiovascular device companies globally? Joe: The binding constraint is not FDA clearance; it is reimbursement and site-of-care

policy. The procedure is reimbursed, not the device and not the robot. A technology that improves outcomes but cannot be recovered within a reasonable depreciation window against the reimbursed procedure will have a challenge getting adopted, no matter how good it is. The real friction is the lag between clinical capability and CMS recognizing a new site of care. When CMS shifts a procedure category to favor ASC delivery, every operator in the country needs a capital strategy overnight, and that policy timing drives volume more than any clearance does. Globally, the problem is fragmentation. CE Mark under MDR has become slower and more expensive, and reimbursement pathways differ market by market with no shortcut. For OUS innovators, US market access is the hardest problem they face, harder than the technology itself. The companies that win build the reimbursement and economic argument in parallel with the clinical one, not after it, because access is now the path to success, not approval. Stan: How do successful cardiovascular device companies differentiate themselves in an increasingly competitive market? Joe: The defining competitive dynamic over the next five years is the collision between the capital imaging companies and the implant companies, and how you differentiate depends on which side of that line you sit. Historically, the lanes were clean. Philips, GE, and Siemens owned the room, the angio suite, and the imaging capital relationship. Abbott, Boston Scientific, Medtronic, and J&J owned the blade, the recurring valve and catheter, and consumables. As AI imaging and interventional robotics grow, those lanes are merging. Philips bought DiA and launched VeriSight Pro 3D ICE. Siemens has AcuNav. GE owns Caption Health and the Vivid franchise. Every one of those moves pushes the imaging OEM downstream toward the procedure the implant company thought it owned. Meanwhile, Abbott, through ViewFlex and its iCardio.ai partnership, is the only implant major with a native ICE franchise, which is its differentiation and head start. The companies that win will not differentiate on device performance, which gets repriced.

THE DEFINING COMPETITIVE DYNAMIC OVER THE NEXT FIVE YEARS IS THE COLLISION BETWEEN THE CAPITAL IMAGING COMPANIES AND THE IMPLANT COMPANIES, AND HOW YOU DIFFERENTIATE DEPENDS ON WHICH SIDE OF THAT LINE YOU SIT.

They differentiate by reaching across the old line, the imaging company moving onto the implant decision, or the implant company owning the imaging and guidance layer, before the other side gets there first. Stan: What common mistakes do cardiovascular medtech startups make when scaling from development to commercialization? Joe: The most common fatal mistake is building a better device without securing a control point, which leaves you as ammunition in someone else's war rather than an independent company. Endovascular robotics shows it cleanly. A pureplay robot owns no economic engine of its own. The imaging vendor owns the room, the device maker owns the consumable, the hospital owns the data. Absent new territory or a non-replicable data asset, the structural default is subordination and a distressed sale that sets your price downward. The second mistake is mistaking acquisition by a giant for survival. J&J spent billions on Auris, yet internal politics strangled the velocity. The third is designing for the academic center instead of the site of care where volume is actually moving. A platform priced and configured for the tertiary OR cannot follow procedures into the ASC. The fourth is treating reimbursement as a later problem when the economic model has to clear before the clinical story matters. Build the control point and the economics first and let the device be the instrument, not the other way around. Stan: How are reimbursement and healthcare economics influencing product development and adoption decisions? Joe: Reimbursement should be the primary design input, not a downstream gate. The single most important number is that the procedure is reimbursed, not the technology, so every development decision has to be reverseengineered from the reimbursed procedure economics and the site of care where that procedure will live. Payers have strong incentives to move cases from inpatient to ASCs and office-based labs, wherever clinical safety permits, and the clinical safety threshold is partly

a function of the technology available at each setting. A platform that makes a moderately complex case consistently executable by a community operator effectively moves that threshold and unlocks the site shift, which is a volume catalyst independent of any single facility's capital decision. The implication for product development is concrete. Design for total cost of ownership per procedure, fast setup, operational simplicity, and site-of-care flexibility, not maximum capability. Over-engineering for the academic center is a value-cost mismatch in exactly the settings where volume is growing fastest. The economics now decide the feature set, and the teams that internalize that early build for where the market is going rather than where it has been. Stan: If you were advising a company entering the cardiovascular medical device space today, where would you focus investment and innovation efforts? Joe: I would not put the capital into the device. I would put it into the coordinating intelligence layer that sits above the device and makes the therapy decision. The valve, the catheter, and the robot are all heading toward subordinateinstrument status inside a data system that controls implant selection and procedural guidance, and that data layer is the one position the incumbents cannot easily buy or rebuild. Concretely, three priorities. First, AI imaging that pulls the average performer up to expert outcomes, ICE and TEE guidance that removes the imaging-expertise bottleneck, because that is what unlocks site-of-care expansion. Second, a design built for the ASC and office-based lab from day one, with total cost of ownership per procedure as the governing metric, not academic-center capability. Third, a data asset that compounds across procedures and becomes genuinely non-replicable, not procedural telemetry that merely sets your acquisition price. Win the access problem and the decision layer, let the device be the instrument, and build the reimbursement argument in parallel rather than after. That is where durable value will concentrate over the next decade.

I WOULD NOT PUT THE CAPITAL INTO THE DEVICE. I WOULD PUT IT INTO THE COORDINATING INTELLIGENCE LAYER THAT SITS ABOVE THE DEVICE AND MAKES THE THERAPY DECISION.

JOHN YIANNI MEDTECH OPINION LEADER: JOHN YIANNI TALKS ABOUT THE FUTURE OF CARDIOVASCULAR MEDTECH, FOCUSING ON AI, MINIMALLY INVASIVE THERAPIES, CLINICAL EVIDENCE, REIMBURSEMENT, AND THE KEY FACTORS THAT DRIVE SUCCESSFUL INVESTMENT, ADOPTION, AND SCALING OF MEDICAL DEVICE COMPANIES. 23

Stan: Through your Board roles at ArgaMedtech and Perfuze as an Investor at Earlybird Venture Capital, alongside your CEO role at CryoTherapeutics, what cardiovascular trends are you most excited about over the next 5–10 years? John: What excites me most about cardiovascular innovation over the next 5-10 years is the shift towards more proactive, personalized cardiovascular care, from early detection through to treatment. At ArgaMedtech, we're seeing a transformation in treatment through pulsed field ablation (PFA) for cardiac arrhythmias. In just a few years, PFA has evolved into one of the fastest-growing segments in cardiovascular medtech, with the potential to significantly improve the safety and effectiveness of ablation procedures. At Perfuze, innovation in acute ischemic stroke treatment continues to raise the bar for patient outcomes. The company has demonstrated industry-leading first-pass effect results, including 75% first-pass success in M1 occlusions, highlighting the potential of nextgeneration thrombectomy technologies to deliver faster, more effective treatment. At Hilo, we're seeing how AI-enabled wearables can bring clinically meaningful monitoring into everyday life. Continuous blood pressure monitoring has the potential to transform how we identify and manage cardiovascular risk, moving care upstream and enabling earlier intervention. And, as CEO of CryoTherapeutics, I'm particularly excited by advances in AI-powered CT imaging and disease characterization. These technologies are enabling physicians to better understand coronary artery disease and make more informed treatment decisions, creating new opportunities for targeted interventional therapies. Structural heart disease is another area that I find particularly exciting. We are seeing significant innovation in transcatheter therapies

for various valve diseases, expanding the range of conditions that can be treated without openheart surgery. Companies such as Polares Medical are helping advance this shift towards less invasive interventions for large and growing patient populations. Taken together, these developments point towards a future where cardiovascular disease is detected earlier, diagnosed more precisely, and treated more effectively. For a company like Earlybird that operates at the intersection of healthcare delivery and prevention, the most relevant implication is that cardiovascular care is moving from episodic procedures towards a continuous model that combines screening -> imaging -> intervention > remote monitoring -> long-term disease management. That continuum is where many of the new digital health and population health opportunities are emerging. Stan: Across your experience with Earlybird, ArgaMedtech, Perfuze, and CryoTherapeutics, what do you see as the biggest unmet needs in cardiology today?

WHAT EXCITES ME MOST ABOUT CARDIOVASCULAR INNOVATION OVER THE NEXT 5-10 YEARS IS THE SHIFT TOWARDS MORE PROACTIVE, PERSONALIZED CARDIOVASCULAR CARE, FROM EARLY DETECTION THROUGH TO TREATMENT.

John: Despite significant progress, major unmet needs remain in cardiology. A key challenge is identifying which coronary plaques are most likely to lead to future events. While AI and CTbased imaging are improving disease characterization, translating this into better clinical decision-making is still evolving. A second major gap is in treatment. While we have effective therapies for many forms of coronary artery disease, options remain limited for directly treating certain plaque types and preventing disease progression. There is also a growing recognition of the importance of microvascular disease, which remains underdiagnosed and undertreated despite its significant impact on patients. Structural heart disease is another area with significant unmet need, specifically in the mitral and tricuspid valve spaces. Companies such as Polares Medical are developing less invasive transcatheter therapies to treat mitral valve regurgitation. The field continues to advance technologies that can repair or replace different heart valves without the need for open-heart surgery.

Over the next decade, I believe the greatest opportunities in cardiology will come from combining more precise disease characterization with therapies that can target disease earlier and more effectively, before patients experience major cardiovascular events, while also expanding minimally invasive treatment options for patients with structural heart disease. Stan: How do you see AI changing cardiovascular diagnostics, monitoring, and treatment over the coming years? John: AI is already reshaping cardiovascular care, and over the coming years, its biggest impact will be in diagnostics, procedural decision-making, and treatment planning. In imaging, AI is enabling far more sophisticated interpretation of CT scans and angiograms, moving beyond simple detection towards detailed characterization of coronary disease, plaque assessment, and more accurate risk prediction. This shift is helping physicians better understand which patients need intervention and which can be managed medically. We are also seeing AI enter the cath lab, where it can support automated measurements, procedural planning, and real-time decision support during interventions. Looking ahead, patient-specific modeling and digital twins could allow clinicians to simulate treatment strategies before entering the procedure. In parallel, robotics is beginning to play a growing role in interventional cardiology and surgery. The opportunity lies in highly precise procedures where human limits become a constraint, such as microvascular interventions or other ultra-delicate procedures where only a small percentage of operators currently achieve consistent outcomes. Across stroke care, AI is also accelerating diagnosis and treatment selection, improving time-to-treatment and outcomes.

OVER THE NEXT DECADE, I BELIEVE THE GREATEST OPPORTUNITIES IN CARDIOLOGY WILL COME FROM COMBINING MORE PRECISE DISEASE CHARACTERIZATION WITH THERAPIES THAT CAN TARGET DISEASE EARLIER AND MORE EFFECTIVELY, BEFORE PATIENTS EXPERIENCE MAJOR CARDIOVASCULAR EVENTS.

Overall, I see AI and robotics as tools that augment clinicians, enabling greater precision, consistency, and ultimately better patient outcomes. Stan: If you were building a new cardiovascular medical device company today, which therapeutic or clinical area would you focus on and why?

Equally important is reimbursement. Without a clear path to reimbursement, even highly innovative technologies struggle to scale, regardless of clinical promise. In some cases, the absence of strong clinical evidence and the right reimbursement strategy have significantly delayed the adoption of technologies that ultimately proved valuable but took many years to reach widespread use.

John: If I were building a cardiovascular medical device company today, I would focus on heart failure. It remains one of the largest unmet needs in cardiovascular medicine, with a growing patient population and a significant burden on healthcare systems. While pharmacological therapies have improved outcomes, there is still a substantial gap when it comes to effective interventional approaches that can complement them and meaningfully change disease progression and improve long-term outcomes.

The most successful cardiovascular innovations are those that align clinical validation with a clear economic and reimbursement framework from an early stage. That combination is what ultimately enables true clinical adoption and market scale.

This is also an area where innovation has proven challenging. Despite significant interest and multiple attempts over the years, there are still very few solutions that have delivered consistent, scalable clinical impact. That said, I believe this is exactly where the opportunity lies. Companies such as Axon Therapies are exploring new therapeutic approaches in this space, reflecting a broader shift towards addressing heart failure through device-based and interventional technologies.

John: When evaluating cardiovascular medtech companies, we look for a combination of clinical need, strength of evidence generation, a credible path to adoption, and a strong management team.

Stan: What separates a cardiovascular technology that achieves real clinical adoption from one that remains technically impressive but struggles to gain traction? John: The biggest factor separating technologies that achieve real clinical adoption from those that remain technically impressive is whether they are built on robust clinical evidence and a clear reimbursement pathway. In cardiovascular medtech, it is not enough for a technology to work in principle or even to demonstrate technical superiority. It needs to be validated through properly designed clinical trials that demonstrate meaningful patient benefit and support adoption by physicians and payers.

Stan: As an investor at Earlybird and an operator at CryoTherapeutics, what signals do you look for first when evaluating a cardiovascular medtech company?

The starting point is the clinical problem: whether the technology addresses a clearly defined and meaningful unmet need for which existing solutions are insufficient. From there, the quality of the clinical development plan is critical. Companies need to be designed to generate robust, well-structured clinical evidence that demonstrates real patient benefit, not just technical performance. Then, we look closely at the pathway to adoption, particularly reimbursement. Even strong technologies can struggle if they are not aligned early with how they will be adopted into real-world clinical and hospital systems. Finally, an experienced management team with a track record of execution, including taking innovative products to market and navigating regulatory pathways, is key to making all of the above possible.

IF I WERE BUILDING A CARDIOVASCULAR MEDICAL DEVICE COMPANY TODAY, I WOULD FOCUS ON HEART FAILURE. IT REMAINS ONE OF THE LARGEST UNMET NEEDS IN CARDIOVASCULAR MEDICINE, WITH A GROWING PATIENT POPULATION AND A SIGNIFICANT BURDEN ON HEALTHCARE SYSTEMS.

Taken together, these factors, clear unmet need, strong clinical validation strategy, a realistic route to reimbursement, and a strong management team, are the most important early signals. Stan: How important is clinical evidence and validation when deciding whether a medical device company has long-term potential? John: Clinical evidence and validation are fundamental because they are the primary mechanisms for reducing risk in healthcare innovation. Stakeholders, including investors, clinicians, regulators, payers, and strategic acquirers, ultimately make decisions based on evidence. Strong clinical data does more than demonstrate that a technology works. It validates the clinical hypothesis, increases confidence in the development pathway, and creates the foundation for financing, partnerships, and longterm value creation. Just as importantly, clinical validation is tightly linked to reimbursement. Payers and healthcare systems increasingly require clear evidence of value before supporting widespread adoption. Without this, even promising technologies can struggle to scale. In my view, clinical evidence is not a milestone to be achieved late in the development process; it needs to be embedded from the very beginning as part of the company’s core strategy. Stan: What are the biggest mistakes you see first-time cardiovascular medtech founders make when building and scaling companies? John: First-time founders often make a few recurring mistakes. The first is surrounding themselves with the wrong team. Many founders feel they need to be the smartest person in the room, when in reality, the opposite is true. Success depends on hiring people who are stronger than you in their respective domains and building a team that complements your weaknesses.

A second mistake is underestimating the board's role. Founders often fail to use the board as a true strategic resource, something that can support, challenge, and guide the company. In some cases, they also do not think carefully enough about board composition or how to actively leverage that experience. Third, there is often a lack of adaptability. Firsttime founders can become overly attached to a predefined plan, even when market conditions, data, or external events change. In reality, successful companies require constant adjustment and the ability to pivot based on what is happening around them. Finally, in medtech specifically, there is a tendency to over-engineer early products. Teams often spend too long trying to perfect a first-generation device instead of focusing on a safe, functional MVP that can generate realworld clinical data. In cardiovascular devices, getting into first-in-human studies early is often more valuable than prolonged development cycles in isolation. Stan: Having operated and advised companies across different stages through Earlybird, ArgaMedtech, Perfuze, and CryoTherapeutics, how has your perspective on identifying successful healthcare innovations evolved? John: Over time, my perspective on identifying successful healthcare innovations has become more focused on the maturity of evidence required to reach a successful outcome. Historically, early-stage cardiovascular technologies could be acquired primarily on the basis of technical innovation, often before extensive clinical validation and commercial traction. Today, that dynamic has shifted significantly. Strategic acquirers tend to engage later in the development cycle, which means companies need to be funded for longer and demonstrate greater clinical de-risking before they become attractive acquisition targets.

CLINICAL EVIDENCE AND VALIDATION ARE FUNDAMENTAL BECAUSE THEY ARE THE PRIMARY MECHANISMS FOR REDUCING RISK IN HEALTHCARE INNOVATION. STAKEHOLDERS, INCLUDING INVESTORS, CLINICIANS, REGULATORS, PAYERS, AND STRATEGIC ACQUIRERS, ULTIMATELY MAKE DECISIONS BASED ON EVIDENCE.

As a result, our approach has evolved, and we are now looking for stronger early clinical signals, often including first-in-human data, at the point of investment, rather than purely preclinical validation. This reflects the reality that capital needs to bridge a longer and more complex path to adoption. At the same time, the funding ecosystem itself is adapting. Early-stage capital, such as grant funding, has become increasingly important in helping companies reach the level of clinical validation required today. While strategics continue to play a role in supporting innovation, their acquisition behavior has become more selective, reinforcing the need for stronger early evidence. Overall, the key evolution has been a shift from funding ideas and technologies to funding clearly de-risked clinical opportunities with a defined path to adoption.

OVERALL, THE KEY EVOLUTION HAS BEEN A SHIFT FROM FUNDING IDEAS AND TECHNOLOGIES TO FUNDING CLEARLY DE-RISKED CLINICAL OPPORTUNITIES WITH A DEFINED PATH TO ADOPTION.

JORDI MARTORELL MEDTECH OPINION LEADER: JORDI MARTORELL TALKS ABOUT TRANSFORMING AORTIC DISEASE TREATMENT THROUGH BIORESORBABLE, MINIMALLY INVASIVE CARDIOVASCULAR TECHNOLOGIES. HE FOCUSES ON LEADERSHIP, INNOVATION IN AORTIC REPAIR, BIOMIMETIC PATCHES, PRECISE IMAGING, AND IMPROVING PATIENT OUTCOMES WITH SAFER, MORE NATURAL HEALING APPROACHES. 29

Stan: How would you describe your leadership approach in building Aortyx in the cardiovascular space?

It expands and contracts with every heartbeat, and any intervention must respect that movement.

Jordi: My leadership approach at Aortyx is rooted in three principles: honesty, combativeness, and teamwork. Aortyx consists of a highly multidisciplinary team of extremely intelligent people. I built a company to be surrounded by people smarter than me, and that's what I enjoy the most. My leadership is fundamentally mentorship and guidance.

In aortic dissection, current treatment options have important limitations. Open repair remains invasive and carries significant morbidity and mortality; endovascular stent grafting can be less invasive but eligibility is limited and long-term complications or reinterventions remain a concern; and medical therapy does not repair the tear itself.

Everyone is responsible for their areas, everyone owns their results, choices and vouches for them. They have to be empowered to make the right choices. They also need to convince both their peers and the leadership of their decisions. This way, everyone is on board with every critical choice made, and everyone pushes in the same direction.

Stan: How is Aortyx helping clinicians better manage complex aortic diseases? Jordi: Aortyx is helping by developing a new therapeutic category: a bioresorbable, biomimetic endovascular patch designed to seal the entry tear in aortic dissection.

Stan: What is your top priority as CEO when it comes to improving outcomes for patients with aortic disease?

The patch is delivered via a proprietary dualsteerable catheter, enabling controlled and accurate deployment inside the aorta.

Jordi: Aortic disease patients have been historically mistreated by large MedTech companies. Indeed, only five large companies are dedicated to aortic diseases, while other cardiovascular diseases have dozens of companies fighting for the space.

The clinical idea is simple but powerful: instead of replacing or covering long segments of the aorta, we aim to treat the focal lesion — the tear — and allow the vessel to heal.

I co-founded Aortyx to support patients directly, with a solution tailored for them, and not inherited from exploiting companies' old pipelines. My top priority is to help transform aortic disease care from a model that often manages risk to one that can repair the disease in a more physiological, less invasive, and durable way. Stan: What are the biggest challenges today in treating aortic conditions such as aneurysms or dissections? Jordi: The biggest challenge is that the aorta is not just a tube; it is a living, dynamic, biomechanical organ.

Our patch is designed to adhere to the aortic wall, mimic the mechanical properties of the native aorta, promote tissue integration, and progressively resorb after fulfilling its function. For clinicians, this could mean a minimally invasive tool that is more anatomically respectful and potentially applicable to patients who currently have limited options. Stan: What makes your technology or approach unique in the cardiovascular and aortic repair field? Jordi: What makes Aortyx unique is our philosophy of respecting the aorta.

I CO-FOUNDED AORTYX TO SUPPORT PATIENTS DIRECTLY, WITH A SOLUTION TAILORED FOR THEM, AND NOT INHERITED FROM EXPLOITING COMPANIES' OLD PIPELINES.

JORDI MARTORELL Aortyx is helping by developing a new therapeutic category: a bioresorbable, biomimetic endovascular patch designed to seal the entry tear in aortic dissection.

We are not trying to replace the aorta or impose a rigid structure on it. We are developing an adhesive, biomimetic patch that is designed to move with the vessel, support tissue regeneration, and then gradually disappear. Our patch is bioresorbable and designed to mimic the natural mechanical properties of the aorta, while our catheter system is designed for precise deployment. That combination — biomaterials, biomechanics, tissue integration, and minimally invasive delivery — is what differentiates our approach. Stan: How do you decide which cardiovascular innovations to focus on developing? Jordi: We focus on innovations that meet three criteria. First, there must be a major unmet clinical need. Aortic dissection is one of the most catastrophic events in cardiovascular medicine, and current standards of care still have significant limitations. Second, the innovation must be scientifically and technically feasible. At Aortyx, our foundation is in biomaterials, vascular biology, fluid dynamics, and minimally invasive engineering.

the tear is. With an adhesive patch, this is different. We only cover a fraction of the circumference (20-30%), so we need to be precise at implantation. Surgeons do not need to be William Tell, but they need a certain awareness of where, in the aorta circumference, the tear is, and imaging plays a key role here. Stan: What future innovations in aortic or cardiovascular care are you most excited about? Jordi: Anything bioresorbable. We need to move on from metallic permanent onto polymeric bioresorbable. All vessels remodel, and they need structural support as long as the vessel is remodeling. After that, any permanent implant is not only useless, it's a permanent risk. But bioresorbable devices cannot be designed following the rules of metallic implants. They are a whole different animal, and they should be designed as a novel category, not relying only on acquired knowledge. This design misconception has been at the origin of the recalls seen in polymeric bioresorbable scaffolds, that we should not be seeing in the future.

Third, it must have a realistic path to patient impact. That means we think early about usability for clinicians, regulatory strategy, manufacturing, clinical evidence, and scalability. Stan: What role do data, imaging, or digital tools play in improving aortic treatment? Jordi: High quality imaging is a must to properly plan cases. Because we change the treatment paradigm, we need the best imaging available to give surgeons the certainty of success. When surgeons implant a stent, they do not really scrutinize the shape, size or position of the entry tear. They put a cylindrical tube slightly cranial to the tear, in whichever angle versus the centerline

OUR PATCH IS BIORESORBABLE AND DESIGNED TO MIMIC THE NATURAL MECHANICAL PROPERTIES OF THE AORTA, WHILE OUR CATHETER SYSTEM IS DESIGNED FOR PRECISE DEPLOYMENT. THAT COMBINATION — BIOMATERIALS, BIOMECHANICS, TISSUE INTEGRATION, AND MINIMALLY INVASIVE DELIVERY — IS WHAT DIFFERENTIATES OUR APPROACH.

STEFFEN WUTTKE MEDTECH OPINION LEADER: STEFFEN WUTTKE TALKS ABOUT IMPROVING CARDIOVASCULAR CARE THROUGH HYPERTENSION PREVENTION, RENAL DENERVATION TECHNOLOGY, BUSINESS-DRIVEN HEALTHCARE LEADERSHIP, MINIMALLY INVASIVE TREATMENTS, AI AND DIGITAL HEALTH TOOLS, AND FUTURE INNOVATIONS IN HEART DISEASE MANAGEMENT. 33

Stan: How has your cardiology background shaped the way you lead in Recor Medical? Steffen: I began my career as a sales rep in cardiac rhythm management. Being in the OR, supporting implants and follow-ups for patients was just incredible and I was never bored. From there I was fascinated by medical devices in many dynamic cardiovascular fields: electrical shocks saving patients lives, stents reopening coronary arteries or catheters denervating renal arteries of hypertension patients. Stan: What is your main leadership focus when improving cardiovascular patient outcomes? Steffen: Clinical evidence and guidelines have cleared the pathway towards commercialization and the focus has turned towards generating business results. An organization requires revenue in combination with profit in order to make the therapy available to as many patients as possible - and to innovate progress.

Experts often refer to hypertension as the silent killer. The challenge is to increase patient knowledge of the disease and/or be aware all treatment options. There remains a strong argument for physicians to be made aware that compelling clinical evidence now exists. Another challenge is to circumvent the concept that hypertension patients are not by default ending up in a cath lab of a hospital. As a consequence there is a high importance on developing patient pathways and referrer networks. Stan: How is Recor Medical helping improve care for patients with high blood pressure? Steffen: Recor Medical has developed a catheter-based denervation system to ablate the renal arteries. It is a minimally invasive and very safe procedure. Randomized controlled trials have shown that this procedure can significantly reduce blood pressure for patients with resistant and uncontrolled hypertension. Compared to meds the effects of a procedure are "always on", 24/7. It is not just another pill.

A focused strategy and highly competent committed team are key to make this happen. In summary: Focusing on reaching your business results and people to make it happen. Stan: What are the biggest challenges today in treating cardiovascular diseases, especially hypertension? Steffen: Each year there are exciting innovations in the pharmaceutical and medical device industry. But from a payer's perspective it must be affordable. Clinical and economic value have to fit together. That's why I believe prevention will become increasingly important in the future. Helping patients avoid developing serious cardiovascular diseases may mitigate requiring further complex healthcare interventions. Renal denervation is a perfect example: offering an additional treatment option for patients with resistant and uncontrolled hypertension.

RECOR MEDICAL HAS DEVELOPED A CATHETER-BASED DENERVATION SYSTEM TO ABLATE THE RENAL ARTERIES. IT IS A MINIMALLY INVASIVE AND VERY SAFE PROCEDURE.

RECOR Medical

From a technology perspective, Recor Medical uses ultrasound as an energy source to ablate the renal nerves. This has several advantages, for example, a circumferential treatment for effectiveness and a short ablation time.

Stan: What makes your approach to cardiovascular disease different from others in the field? Steffen: First, as mentioned before, it is about prevention. Avoiding hypertension reduces the risk for cardiovascular disease as a progression.

Overall, I'm intrigued by the rapid pace of new innovations in structural heart and heart failure prevention, along with the growing applications for intravascular lithotripsy, robotics, and electrophysiology.

Secondly, from a technology perspective, Recor Medical uses ultrasound as an energy source to ablate the renal nerves. This has several advantages, for example, a circumferential treatment for effectiveness and a short ablation time. We also significantly invest into awareness and education, partnering with centers to develop the therapy. Stan: What role do digital tools or data play in managing heart disease today? Steffen: Patients become increasingly informed and take ownership of their healthcare decisions, searching for credible information on the internet and on social media platforms. Artificial intelligence can also assist in finding the right information faster and determine the best suitable physician or hospital. Another evolving field for AI is diagnostics. Apps in combination with wearables have also been evolving quickly, helping patients and physicians monitor vitals constantly and consistently, circumventing the need for a doctor's office or a hospital visit. Stan: What future innovation in cardiovascular care are you most excited about? Steffen: While there are still many physicians and patients who are unaware of the new clinical evidence and guidelines for renal denervation, new data is emerging that could lead to other areas where renal denervation could play an interesting role in improving cardiovascular outcomes. Examples under investigation are heart failure and atrial fibrillation.

WHILE THERE ARE STILL MANY PHYSICIANS AND PATIENTS WHO ARE UNAWARE OF THE NEW CLINICAL EVIDENCE AND GUIDELINES FOR RENAL DENERVATION, NEW DATA IS EMERGING THAT COULD LEAD TO OTHER AREAS WHERE RENAL DENERVATION COULD PLAY AN INTERESTING ROLE IN IMPROVING CARDIOVASCULAR OUTCOMES.

FILIP PETERS MEDTECH OPINION LEADER: FILIP PETERS TALKS ABOUT USING AI AND NON-INVASIVE TECHNOLOGY TO IMPROVE CARDIOVASCULAR CARE, ESPECIALLY HEART FAILURE, BY ENABLING EARLIER DETECTION, BETTER MONITORING, AND MORE PERSONALIZED TREATMENT WHILE SUPPORTING CLINICIANS WITH EVIDENCE-BASED INSIGHTS. 37

Stan: How would you describe your leadership approach in building Acorai in the cardiovascular space? Filip: Our leadership approach at Acorai is mission-driven, clinically grounded, and evidence-led. Cardiovascular care, and heart failure in particular, is an area where the stakes are high, so we believe ambition has to be matched with scientific discipline. We are building Acorai by bringing together clinicians, engineers, data scientists, regulatory experts, and commercial leaders around a shared goal: creating technology that can make meaningful cardiovascular insights more accessible and actionable. We also believe that leadership in medtech requires patience, resilience, and trust. We are not just building a product; we are building confidence with clinicians, regulators, partners, investors, and ultimately patients. That means being transparent, rigorous, and committed to

generating the clinical evidence needed to support responsible adoption. Stan: What is your top priority as CEO when it comes to improving outcomes for patients with heart failure? Filip: Our top priority is to help clinicians detect worsening heart failure earlier and manage patients more proactively. Too often, deterioration is recognized only once symptoms become severe or once the patient is already moving toward hospitalization. We believe there is a major opportunity to support earlier intervention by giving clinicians better access to objective, pressure-related information. At Acorai, our mission is to make cardiac and pulmonary pressure insights more accessible, non-invasive, and clinically useful. If we can help clinicians better understand a patient’s hemodynamic status earlier and more frequently, we believe care can become more personalized, timely, and preventive.

AT ACORAI, OUR MISSION IS TO MAKE CARDIAC AND PULMONARY PRESSURE INSIGHTS MORE ACCESSIBLE, NON-INVASIVE, AND CLINICALLY USEFUL. 38

Acorai is developing a non-invasive platform designed to help clinicians identify hemodynamic congestion and support more personalized heart failure management.

Stan: What are the biggest challenges today in diagnosing and managing heart failure? Filip: One of the biggest challenges is that heart failure is complex and often difficult to assess using symptoms alone. Patients may appear relatively stable while pressures are already rising, and by the time congestion becomes clinically obvious, the opportunity for early intervention may have narrowed. Another challenge is that the most direct ways to measure cardiac and pulmonary pressures are invasive, resource-intensive, and typically limited to specialist settings. At the same time, heart failure is a large and growing burden for healthcare systems globally. We need solutions that can support clinicians with better information, but that are also scalable, practical, and suitable for real-world care pathways.

Stan: How is Acorai helping clinicians better detect and monitor cardiovascular conditions? Filip: Acorai is developing a non-invasive platform designed to help clinicians identify hemodynamic congestion and support more personalized heart failure management. Our approach combines multiple sensing modalities with advanced signal processing and machine learning to estimate cardiac and pulmonary pressure-related information without requiring an invasive procedure for each assessment. The aim is to give clinicians clinically meaningful insights that can be used across the patient journey: from assessment and diagnosis to therapy optimization and follow-up. We want to make advanced hemodynamic information easier to access, easier to repeat, and easier to integrate into clinical decision-making. Stan: What makes your technology and approach unique in the cardiovascular and heart failure space? Filip: What makes Acorai unique is the combination of non-invasive sensing, multimodal data capture, and AI-enabled interpretation of cardiovascular signals. Rather than relying on a single signal, we combine multiple physiological inputs to capture a broader picture of cardiovascular function. Equally important is our clinical approach. We are focused on building technology that can fit into real-world workflows and support the decisions clinicians already need to make. Our goal is not to add complexity; it is to make important hemodynamic insights more accessible, repeatable, and actionable. Stan: How do you decide which innovations or technologies to focus on developing? Filip: We start with the clinical problem, not the technology. The first question is always whether a potential innovation addresses a meaningful unmet need for patients, clinicians, and

WHAT MAKES ACORAI UNIQUE IS THE COMBINATION OF NON-INVASIVE SENSING, MULTIMODAL DATA CAPTURE, AND AI-ENABLED INTERPRETATION OF CARDIOVASCULAR SIGNALS.

healthcare systems. In heart failure, one of the clearest needs is better access to actionable hemodynamic information that can support earlier and more personalized care. From there, we evaluate clinical value, technical feasibility, regulatory pathway, scalability, and how well the solution can be integrated into care. In healthcare, innovation only matters if it can be trusted, validated, adopted, and used to improve decision-making. That is why our priorities are guided by clinical evidence, clinician feedback, and the potential to improve outcomes at scale. Stan: What role do data, AI, or digital health tools play in improving cardiovascular care? Filip: Data, AI, and digital health tools have an important role to play in moving cardiovascular care from episodic and reactive toward more continuous, personalized, and predictive. In heart failure, this matters because deterioration often develops over time, and earlier signals may be available before a patient becomes acutely unwell.

For us, AI is not a buzzword; it is a way to interpret complex multimodal physiological signals and translate them into information that clinicians can use. The goal is not to replace clinical judgment, but to strengthen it by providing earlier, more objective, and more consistent insight into a patient’s condition. Stan: What future developments in heart failure or cardiovascular care are you most excited about? Filip: We are most excited about the shift toward earlier detection, more personalized therapy, and better outpatient management of heart failure. The future of cardiovascular care will be less reactive and more proactive, with clinicians increasingly supported by tools that help them identify risk earlier and intervene before a patient deteriorates. We are also excited by the convergence of sensors, AI, and clinical-grade validation. When these are combined responsibly, they can expand access to advanced cardiovascular insights beyond highly specialized settings. For patients with heart failure, that could mean fewer avoidable hospitalizations, better quality of life, and care that is more closely matched to their individual physiology.

FOR US, AI IS NOT A BUZZWORD; IT IS A WAY TO INTERPRET COMPLEX MULTIMODAL PHYSIOLOGICAL SIGNALS AND TRANSLATE THEM INTO INFORMATION THAT CLINICIANS CAN USE. THE GOAL IS NOT TO REPLACE CLINICAL JUDGMENT, BUT TO STRENGTHEN IT BY PROVIDING EARLIER, MORE OBJECTIVE, AND MORE CONSISTENT INSIGHT INTO A PATIENT’S CONDITION.

JIM FIDACARO MEDTECH OPINION LEADER: JIM FIDACARO TALKS ABOUT TRANSFORMING HYPERTENSION CARE THROUGH CONTINUOUS, CUFFLESS BLOOD PRESSURE MONITORING POWERED BY ADVANCED BIOMETRIC SENSING AND AI.

Stan: What challenges with current blood pressure monitoring led you to start Sonion Health? Jim: Hypertension, often called the “silent killer,” affects 120 million Americans and 1.3 billion people worldwide, with nearly half remaining undiagnosed. It is the single most important risk factor for cardiovascular disease and related health issues, including stroke, kidney disease, diabetes, and heart failure. Despite this, the way we measure blood pressure has not meaningfully changed for decades. Traditional cuff-based readings are often uncomfortable, intermittent, and highly dependent on the setting in which they are taken. A single office reading may not reflect a patient’s true blood pressure profile throughout the day and night. Sonion Health was founded to address a fundamental challenge in hypertension care: blood pressure is highly dynamic, yet today’s monitoring tools provide only limited visibility into how it changes over time. Patients and clinicians need a better way to continuously, comfortably, and in real-world conditions capture longitudinal blood pressure to diagnose and manage hypertension. I am passionate about Sonion Health’s development of a first-of-a-kind solution to one of the most overlooked gaps in cardiovascular care: accurate, longitudinal blood pressure monitoring in real-world settings. We have worked closely with the European Society of Hypertension and US physicians to ensure our approach is clinically relevant and grounded in the realities of hypertension diagnosis and management. In parallel, our early discussions with the FDA and other regulators have helped shape a clear regulatory pathway and claims strategy. The result is a solution that not only improves blood pressure detection by shifting from intermittent to continuous monitoring but also equips clinicians with actionable longitudinal data in real-world conditions, driving better diagnosis and treatment management.

Stan: How does Sonion Health's technology improve the way hypertension is diagnosed and managed? Jim: Sonion Health is developing a cuffless, longitudinal blood pressure monitoring platform designed to capture higher-fidelity blood pressure measurements over extended periods. Rather than relying solely on episodic measurements, our platform aims to provide a more complete phenotyping of a patient’s blood pressure patterns across daily activity, rest, and sleep.

HYPERTENSION, OFTEN CALLED THE “SILENT KILLER,” AFFECTS 120 MILLION AMERICANS AND 1.3 BILLION PEOPLE WORLDWIDE, WITH NEARLY HALF REMAINING UNDIAGNOSED.

Sonion Health Sonion Health is developing a cuffless, longitudinal blood pressure monitoring platform designed to capture higher-fidelity blood pressure measurements over extended periods. Rather than relying solely on episodic measurements, our platform aims to provide a more complete phenotyping of a patient’s blood pressure patterns across daily activity, rest, and sleep. 44

The clinical value is not simply in capturing more blood pressure readings, but in helping clinicians make better treatment decisions. Longitudinal data can show whether a patient is responding to medication, whether control is sustained across daily life and overnight periods, and whether hypertension remains uncontrolled despite appropriate therapy. These insights can support medication titration, earlier escalation of care, referral to hypertension specialists, and identification of patients who may be candidates for advanced therapies such as renal denervation. The same monitoring approach can also be used after intervention to assess treatment response and guide ongoing management. Stan: What makes your approach to blood pressure monitoring different from traditional methods? Jim: Traditional blood pressure monitoring generally relies on an inflatable cuff, whether in the clinic, at home, or through ambulatory blood pressure monitoring. While these tools are valuable, they can be uncomfortable, disruptive, and limited in the number of readings they capture. Our approach is different because we are focused on a cuffless, wearable, and data-rich solution. Sonion Health combines advanced biometric sensing and AI-driven analytics to create a more practical way to monitor blood pressure outside the clinic. The goal is not just to replace an in-office single-cuff reading but to provide a broader cardiovascular profile that reflects how blood pressure behaves over time under real-world conditions for diagnosis, management, referral to therapies, and posttherapy monitoring. Stan: How does AI help improve the accuracy and value of the data you collect? Jim: AI is central to our platform because blood pressure is influenced by many factors, including movement, stress, sleep, vascular

characteristics, and individual physiology. Raw biometric signals alone are insufficient. The value lies in interpreting those signals accurately and consistently. Our AI models are designed to identify meaningful patterns, reduce noise, and improve the reliability of blood pressure estimation. Beyond accuracy, AI can also help turn continuous data into actionable insights for clinicians, such as trends, variability, nighttime patterns, early detection of hypertension crises, and potential risk indicators. The long-term opportunity lies in moving from episodic measurement to intelligent cardiovascular monitoring for more personalized hypertension treatment protocols and, eventually, to new digital biomarkers for cardiovascular risk. Stan: How do you see healthcare providers using your technology in everyday patient care? Jim: We see Sonion Health being used as a practical tool for both diagnosis and ongoing management, especially for patients with Stage 2 hypertension who are on medication. A provider could use our platform to better understand a patient’s real-world blood pressure profile before making a diagnosis or changing medication. It could also help monitor whether a treatment plan is working over time and help patients meet their blood pressure goals, since only 50% of patients meet their targets. In everyday care, this could be especially useful for primary care physicians, cardiologists, nephrologists, and remote patient monitoring programs. Instead of asking patients to manually take readings and record them, providers could receive more consistent, automatic and clinically meaningful data. That can make visits more productive and allow care teams to intervene earlier when a patient’s blood pressure is trending in the wrong direction or to refer the patient for therapy, such as renal denervation.

WE SEE SONION HEALTH BEING USED AS A PRACTICAL TOOL FOR BOTH DIAGNOSIS AND ONGOING MANAGEMENT, ESPECIALLY FOR PATIENTS WITH STAGE 2 HYPERTENSION WHO ARE ON MEDICATION.

Stan: What has been the biggest challenge in developing and validating your solution? Jim: The biggest challenge has been building a solution that is both technologically advanced and clinically reliable to earn clinical trust. Blood pressure is a complex physiological measurement, and developing a cuffless system requires strong sensing, robust algorithms, and careful clinical validation. It is not enough for the technology to work in a controlled environment. It needs to perform across diverse patients, body types, activity levels, and real-world conditions. That is why validation is such an important part of our development process. We are focused on building a product that clinicians can trust and patients can use comfortably by working with key opinion leaders in clinical practice, regulatory bodies, ISO committee members, the American Heart Association (AHA), and the European Society of Hypertension (ESH). Stan: How do you think advanced biometric sensing will change cardiovascular care in the future? Jim: Advanced biometric sensing has the potential to shift cardiovascular care from episodic, reactive care to earlier risk recognition and proactive management. Today, many cardiovascular risks are identified only after symptoms appear or after serious complications have developed. Rather than relying only on office readings or short monitoring periods, clinicians could use longitudinal physiologic data to understand how a patient’s cardiovascular status is changing over time.

Longer term, as biometric sensing platforms generate larger real-world datasets linked to outcomes, they may help clinicians recognize patterns associated with stroke risk, heart failure worsening, or other cardiovascular events before they become clinically obvious. The goal is not simply to collect more data, but to turn continuous physiologic signals into earlier, more actionable insight. Stan: What is your long-term vision for Sonion Health and its impact on patients with hypertension? Jim: Our long-term vision is to make blood pressure monitoring easier, more accurate, and more clinically useful for patients and providers. Hypertension affects hundreds of millions of people worldwide, yet many patients remain undiagnosed, undertreated, or poorly controlled. We want to help change that. Sonion Health’s goal is to become a leading platform for cuffless cardiovascular monitoring, starting with hypertension and expanding over time into broader cardiovascular risk management, including stroke, heart failure, and women’s health. If we can provide clinicians with better data and patients with a more ,simple way to monitor their health, we believe we can improve outcomes, reduce complications, and make cardiovascular care more preventive and personalized. We also see this as eventually becoming a digital biomarker that consumers can use to monitor their health and support a healthier lifestyle and longevity.

In hypertension, that means identifying patients whose blood pressure remains uncontrolled despite therapy, whose response to medication is incomplete or deteriorating, or whose realworld patterns suggest increasing cardiovascular strain. These insights could help clinicians intervene earlier, optimize medications more precisely, and escalate care before patients progress to more serious events.

SONION HEALTH’S GOAL IS TO BECOME A LEADING PLATFORM FOR CUFFLESS CARDIOVASCULAR MONITORING, STARTING WITH HYPERTENSION AND EXPANDING OVER TIME INTO BROADER CARDIOVASCULAR RISK MANAGEMENT, INCLUDING STROKE, HEART FAILURE, AND WOMEN’S HEALTH.

RAMIN MOUSAVI MEDTECH OPINION LEADER: RAMIN MOUSAVI TALKS ABOUT HOW CATHWORKS USES AI AND COMPUTATIONAL SCIENCE TO IMPROVE THE DIAGNOSIS AND TREATMENT OF CORONARY ARTERY DISEASE, WITH A FOCUS ON NON-INVASIVE TECHNOLOGY, PATIENT SAFETY, CLINICAL EVIDENCE, AND GLOBAL IMPACT.

Stan: Why did you decide to launch CathWorks, and what problem were you trying to solve? Ramin: Cardiovascular related deaths are the number one cause of deaths globally and in the United States. Close to 1 Million people in the US die from cardiovascular related disease, more than the other two leading causes of deaths combines, which includes cancer. Over 43% of these deaths are as a result of what is known as coronary artery disease (CAD), the blockage of the arteries that bring blood to and from the heart. Despite significant clinical and economical evidence, the current invasive standard of care diagnostic tool to detect CAD, a solution that requires an insertion of a wire inside the patients artery, is severely underutilized. CathWorks was founded to tackle the fundamental challenges with the current standard of care, doing it non invasively.

Stan: What is your long-term vision for CathWorks? Ramin: CathWorks bold mission was to partner with physicians around the globe to transform how cardiovascular disease is diagnosed and treated. I believe the acquistion of CathWorks by Medtronic makes this vision a real possibility. Stan: What makes your technology different from others in the market? Ramin: CathWorks platform is the only technology that combines artificial intelligence and computational science, to transform three routine angiograms to a comprehensive 3D model of the coronary artery along with a suite of precision clinical decision making tools. Stan: How does your solution improve patient care? Ramin: By proactively detecting CAD, you tackle the number of cause of death globally.

CATHWORKS PLATFORM IS THE ONLY TECHNOLOGY THAT COMBINES ARTIFICIAL INTELLIGENCE AND COMPUTATIONAL SCIENCE, TO TRANSFORM THREE ROUTINE ANGIOGRAMS TO A COMPREHENSIVE 3D MODEL OF THE CORONARY ARTERY ALONG WITH A SUITE OF PRECISION CLINICAL DECISION MAKING TOOLS.

Stan: How does your solution improve patient care? Ramin: By proactively detecting CAD, you tackle the number of cause of death globally. Stan: What challenges do you face when expanding globally?

published in the New England Journal of Medicine, with exceptional results. I believe that if the pace of innovation and clinical evidence generation continues, with the global reach of Medtronic coronary and CathWorks team, millions of patients around the world can benefit from this amazing technology.

Ramin: The number of challenge we faced was that novelty of the technology at times surpassed the comfort and imagination of its audience. The skepticism of “this is too good to be true” required us to invest years of resources into generating world class clinical data to prove the accuracy and outcomes of CathWorks platform. Stan: How does leadership balance innovation with responsibility? Ramin: The only thing that forces change in healthcare is innovation. But we have to remember that this is an innovation that touches and impacts patients’ lives, so not only it’s not easy, it should not be easy. As the leader of the space, it is our responsibility to make sure every step is taken to make sure the transformational innovation brings the highest safety and efficacy to patients globally. Stan: What role do you see AI playing in healthcare in the future? Ramin: AI is here and it is changing how we do things. It’s making us faster, smarter and finally enabling us to take advantage of all the data we have been collecting. Those who acknowledge the change and invest in understanding their workflow and data will win. Where do you see CathWorks in the next 5– 10 years? Ramin: With Medtronic acquistion of CathWorks, there is a potential for a bright future, a world where CathWorks becomes the new Standard of Care. We completed the ALLRISE randomized control trial, which was

WITH MEDTRONIC ACQUISTION OF CATHWORKS, THERE IS A POTENTIAL FOR A BRIGHT FUTURE, A WORLD WHERE CATHWORKS BECOMES THE NEW STANDARD OF CARE.

DAN ROSE MEDTECH OPINION LEADER: DAN ROSE TALKS ABOUT HOW ENDOVASCULAR ENGINEERING’S HĒLO TECHNOLOGY AIMS TO IMPROVE PULMONARY EMBOLISM (PE) AND VTE TREATMENT THROUGH SAFER, MORE EFFICIENT MECHANICAL CLOT REMOVAL, WHILE DISCUSSING CLINICAL EVIDENCE, COMMERCIALIZATION, INNOVATION, AND THE COMPANY’S VISION FOR IMPROVING PATIENT OUTCOMES. 50

Stan: What inspired you to join Endovascular Engineering and how did you shape the vision?

Stan: What makes your clot removal technology different from other solutions on the market?

Dan: After our successful experience with LimFlow, I was in a position to put a lot of careful work in deciding which challenge to take on next. I wanted to work in a space with strong market dynamics in terms of size, growth outlook and unmet needs but it was really all about the actual technology and team. Once I had the chance to get my hands on E2's Hēlo technology in a flow model and met the incredible team that clearly had a great culture to build on, I was sold. This was a chance to make a significant impact with a truly new and different device unlike anything on the market today. Once onboard, I encouraged the team to expand even further on the innovation platform and began to scale talent as we completed the pivotal trial and moved towards commercialization. First and foremost, we always stay focused on the outcome — a positive impact on patients. But we also know that medical device development has its ups and downs, so we drive the team to enjoy the process, show grit, and persevere. Everyone who works at E2 is talented and could find work elsewhere. Making work meaningful and trying to have a good time doing it is a key part of building and maintaining a successful culture that delivers.

Dan: We set out to address all three of those core needs without requiring physicians to compromise on any one of them — and to do it through a lower-profile platform. Hēlo combines several different innovations that work interactively in a single platform to deliver a new standard of performance. One of the most unique aspects of the platform is its dual-action clot removal: the device utilizes a uniquely designed internal agitator inside a 24F funnel that can better extract large clots and avoids catheter clogging or “lollipopping”. This is not by any means everything that sets our product apart, but it is one important example. The features of the catheter handle enable physicians to control the position of the catheter and move across various clot locations, reducing the need for multiple passes and complicated wire exchanges. And completing the system is a first-of-its-kind integrated blood return mechanism, making Hēlo a truly complete solution.

Stan: What challenges do physicians face today when treating PE, and how is E2 helping to solve them? Dan: The use of mechanical thrombectomy in the treatment of Pulmonary Embolism (PE) presents real challenges. There are three core problems in clot removal: navigating consistently and efficiently to the clot, removing it safely and effectively, and minimizing procedural blood loss for both patient safety and efficacy. E2’s platform is designed to deliver on all three core challenges through a lower profile system platform, which reduces the inherent risks that typically come with larger bore catheters. Interventional markets always trend towards devices that are smaller, faster, safer and enable great procedural efficiency, and it is our goal to deliver just that.

E2’S PLATFORM IS DESIGNED TO DELIVER ON ALL THREE CORE CHALLENGES THROUGH A LOWER PROFILE SYSTEM PLATFORM, WHICH REDUCES THE INHERENT RISKS THAT TYPICALLY COME WITH LARGER BORE CATHETERS.

E2 Hēlo technology One of the most unique aspects of the platform is its dual-action clot removal: the device utilizes a uniquely designed internal agitator inside a 24F funnel that can better extract large clots and avoids catheter clogging or “lollipopping”. 52

Stan: How does your technology improve outcomes for patients and clinicians? Dan: For patients, they can now be treated with a smaller device that has demonstrated singlepass procedure capability, meaning the catheter crosses the heart once, limiting navigational risk and reducing the occurrence of clot becoming lodged at the catheter tip during a case. This has been validated in our ENGULF clinical study, which showed on CT angiography significant clot burden reduction when blood return was included, with low estimated blood loss. For clinicians, Hēlo delivers a more predictable procedure. Operators consistently tell us the system is intuitive and easy to learn, which matters enormously for both adoption and patient safety as programs scale. Stan: What key milestones has E2 achieved so far? Dan: Several milestones stand out. We completed the full ENGULF clinical study across both feasibility and pivotal phases — rigorous work that generated four late-breaking presentations at SCAI, VIVA, and SIR, some of the most respected physician societies in the space. We recently closed an $80 million Series C led by Gilde Healthcare and Norwest Venture Partners, a strong signal of investor confidence in where this technology is headed. Just as important of a validation, the FDA granted us 510(k) clearance on the catheter, and we are awaiting our clearance for the Hēlo blood return system. And throughout all of it, we've continued advancing our next-generation platforms, reinforcing E2's commitment to making a lasting impact on the treatment of PE and VTE more broadly. Stan: What have been the biggest challenges in developing and bringing your technology to market? Dan: Honestly, some of the greatest challenges were self-imposed — and intentionally so. We made deliberate decisions to solve harder engineering problems because we wanted to design a product that would significantly improve

outcomes for patients and clinicians. The catheter itself is a great example. E2 could have gone down the path of making a larger 24F device. However, the need was clear that having a smaller device that can remove the same amount of clot would provide tangible benefits to both physicians and patients. Additionally, creating a blood return system compatible with a continuous vacuum pump is no small feat. Navigating the regulatory pathway while simultaneously building commercial infrastructure and scaling the team is also genuinely hard. You're doing multiple complex things in parallel with real resource constraints. The Series C gives us the runway to execute, but the work is significant and the team has had to show a lot of grit to get here. Stan: How do you see the field of VTE treatment evolving in the coming years? Dan: The field is moving in a clear direction — toward earlier intervention, less reliance on systemic thrombolytics, and greater physician confidence in mechanical removal as a first-line option. The 2026 AHA/ACC PE guidelines reflect that shift. As the evidence base grows and more centers build structured PERT programs, the standard of care will continue to evolve. I also expect to see greater sophistication in how patients are risk-stratified, creating clearer decision trees for when and how to intervene. Devices that can handle a broader range of patient presentations — from intermediate to higher-risk — will define the next chapter of this space. Stan: What are your goals for E2, and what impact do you hope the company will have on patient care? Dan: The goal is straightforward even if the path is complex: we want Hēlo to become a leading option for mechanical thrombectomy in PE and VTE. That means building a commercial infrastructure that scales responsibly, continuing to generate the clinical evidence that gives physicians and institutions confidence, and advancing the platform so it meets patients

WE RECENTLY CLOSED AN $80 MILLION SERIES C LED BY GILDE HEALTHCARE AND NORWEST VENTURE PARTNERS, A STRONG SIGNAL OF INVESTOR CONFIDENCE IN WHERE THIS TECHNOLOGY IS HEADED.

where they are — not just the subset who fit a narrow device profile. If we do this right, we're talking about meaningfully changing outcomes for hundreds of thousands of patients a year who today are either undertreated or managed with approaches that carry unnecessary risk. That's the mission, and it's what keeps the team motivated.

WE WANT HĒLO TO BECOME A LEADING OPTION FOR MECHANICAL THROMBECTOMY IN PE AND VTE.

DAVID FISCHEL MEDTECH OPINION LEADER: DAVID FISCHEL TALKS ABOUT HOW STEREOTAXIS’ MAGNETIC ROBOTIC TECHNOLOGY IMPROVES PRECISION AND SAFETY IN MINIMALLY INVASIVE PROCEDURES, AND HOW COMBINING ROBOTICS WITH AI AND CONNECTIVITY WILL TRANSFORM INTERVENTIONAL MEDICINE INTO A MORE PRECISE, DATADRIVEN, AND WIDELY ACCESSIBLE FORM OF CARE. 55

Stan: How would you describe the core technological advantage of Stereotaxis’ robotic platform, and what differentiates it from other approaches in interventional robotics? David: Stereotaxis’ technology allows for an unprecedented level of robotic precision and safety during minimally invasive interventional procedures. Our robotic systems use precise computercontrolled magnetic fields to provide physicians with direct control of the tip of flexible catheters, addresses a core mechanistic challenge of tradition interventional catheters. In a typical endovascular procedure, small catheters are inserted into a patient’s blood vessels and then navigated through the challenging delicate tortuous anatomy. A physician only has control of the handle of the flexible catheter, but the procedure takes place a meter away at the other end, with all sorts of translational errors along that distance that limit catheter navigability, precision and stability.

Stereotaxis’ Robotic Magnetic Navigation technology bypasses these limitations with direct robotic control of the catheter tip. You can imagine the magnetic fields as a type of invisible finger allowing a physician to direct the tip specifically with millimeter precision. The magnetic catheter can also be designed with particularly atraumatic soft materials to help reduce adverse events. The ability to navigate interventional catheters beyond their typical limitations can not only improve care, but can enable treatment possibilities for patients with complex arrhythmia who might not otherwise be candidates for minimally invasive therapy. Robotics is designed to make difficult, high-risk procedures safer and more effective, while expanding access to minimally invasive therapy for patients who previously had limited options.

STEREOTAXIS’ TECHNOLOGY ALLOWS FOR AN UNPRECEDENTED LEVEL OF ROBOTIC PRECISION AND SAFETY DURING MINIMALLY INVASIVE INTERVENTIONAL PROCEDURES.

David Fischel: Stereotaxis At Stereotaxis, our AI efforts are geared toward augmenting, rather than replacing, the surgeon’s capabilities. We’re combining mechanical precision with cognitive support, so our platform can identify risks, guide navigation, and help deliver better patient outcomes. 57

Stan: Stereotaxis has built a strong reputation in cardiac ablation and catheterbased procedures. How do you see robotic systems transforming the future of electrophysiology and broader interventional cardiology? David: Over the last decade, robotic surgery systems have dramatically transformed fields like laparoscopic and orthopedic surgery. We have just started scratching the surface of what robotics can do in the cardiac ablation and broader interventional cardiology and neurointerventional fields. Our existing experience in cardiac ablation has been limited to over a hundred hospitals treating over 150,000 patients. As we look forward, we see several of our recent innovations – a much more accessible robot and a broader portfolio of robotically-steered devices for electrophysiology and interventional cardiology – allowing us to scale adoption of robotics in the field. We believe robotics will play a significant role in addressing the remaining unmet medical needs

in this field, and in overall streamlining and modernizing the interventional operating rooms. Looking ahead, AI integration will take robotic systems from being precise tools for a physician to intelligent partners of a physician, enhancing surgical awareness and supporting decisionmaking in real time. At Stereotaxis, our AI efforts are geared toward augmenting, rather than replacing, the surgeon’s capabilities. We’re combining mechanical precision with cognitive support, so our platform can identify risks, guide navigation, and help deliver better patient outcomes. In doing so, we’re not just improving procedures, we’re redefining what’s possible in the catheterization lab. Stan: Looking ahead, what emerging capabilities or applications of robotic navigation excite you most, and where do you see the greatest untapped potential for your technology? David: Looking ahead, what excites me most is our efforts to make the technology more powerful clinically, more accessible to hospitals and patients, and more applicable for a broader range of diseases. We are expanding our portfolio of devices across a broader range of procedures and integrating AI and advanced connectivity to fundamentally reshape how care is delivered. As these capabilities evolve, physicians can increasingly move from hands-on operators to strategic overseers, focusing more on decisionmaking, problem-solving, and personalized treatment design. In terms of untapped potential, one of the greatest opportunities lies in endovascular interventions, where navigating highly tortuous vasculatures is a significant challenge. Our technology is uniquely suited to address this, with its ability to control the tip of a device rather than relying on force transmission along its length. Combined with the system’s potential for remote connectivity, this opens the door to a more scalable, connected model of care. Ultimately, the greatest potential lies at the intersection of precision robotics, intelligent software, and global connectivity to transform both how procedures are performed and who can benefit from them.

OVER THE LAST DECADE, ROBOTIC SURGERY SYSTEMS HAVE DRAMATICALLY TRANSFORMED FIELDS LIKE LAPAROSCOPIC AND ORTHOPEDIC SURGERY. WE HAVE JUST STARTED SCRATCHING THE SURFACE OF WHAT ROBOTICS CAN DO IN THE CARDIAC ABLATION AND BROADER INTERVENTIONAL CARDIOLOGY AND NEUROINTERVENTIONAL FIELDS.

Stan: In what ways does robotic-assisted intervention improve patient outcomes and safety, and how is Stereotaxis ensuring that innovation remains aligned with patient needs? David: Robotic-assisted intervention brings a high level of precision, stability, and control to complex procedures. What we’ve seen from robust clinical experience is that this translates into reliable, reproducible results that show high success rates, low complication rates, and reduced radiation exposure for both patients and care teams. With more than 500 publications and multiple head-to-head studies comparing robotic and manual approaches, the evidence continues to reinforce that robotics can help standardize care and deliver safe, consistent outcomes. At the same time, when you’re building systems that patients quite literally trust with their lives, there’s no margin for error. At Stereotaxis, that means safety and security are embedded from day one. All our systems go through rigorous testing, resilient system architecture, and continuous monitoring for vulnerabilities. Ultimately, everything we do is grounded in patient needs, and using clinical evidence, physician feedback, and ongoing innovation we ensure we’re delivering technology that is not only advanced but truly makes care safe and effective.

Our general approach towards the topic of Digital Surgery is to identify opportunities that enhance, rather than replace, the physician during a procedure. We’re putting significant effort into combining the mechanical precision of our system with emerging AI-driven insights to give physicians better visibility into complex anatomy, help identify potential risks earlier, and support more confident navigation during procedures. A key component is creating a more connected and streamlined environment in the lab. Our recently began commercial launch of the Synchrony digital operating room technology, which consolidates and streamlines all information systems into a central cockpit for the operating room. This helps streamline the operating room environment and workflow, reducing cognitive load and simplifying decisionmaking. On top of that, we developed a connectivity app that enables remote monitoring, training, and collaboration, so physicians can leverage the Synchrony system to access remote support and expertise. Synchrony is also serving as the backbone for our AI efforts to introduce automate decision-support throughout the procedure to provide an early warning towards risks or guide physicians on potential best practices. Together, these capabilities are helping move the cath lab toward a more integrated, data-driven ecosystem that improves efficiency and expands what’s possible in procedural care.

Stan: Cath labs are evolving rapidly with increasing digitalisation and automation. How does your platform contribute to the modernisation of the cath lab environment and workflow efficiency? David: Robots have predominantly been adopted for their mechanistic benefits: precision, stability, and safety. As we look towards the coming years, robots will increasingly serve as a central platform within the operating room to provide cognitive benefits to a physician performing a procedure.

A KEY COMPONENT IS CREATING A MORE CONNECTED AND STREAMLINED ENVIRONMENT IN THE LAB. OUR RECENTLY BEGAN COMMERCIAL LAUNCH OF THE SYNCHRONY DIGITAL OPERATING ROOM TECHNOLOGY, WHICH CONSOLIDATES AND STREAMLINES ALL INFORMATION SYSTEMS INTO A CENTRAL COCKPIT FOR THE OPERATING ROOM.

Stan: What are the key barriers to broader adoption of robotic systems in interventional medicine, and how is Stereotaxis addressing them? David: Adoption of robotic systems in interventional medicine comes with a few real and understandable challenges. Healthcare tends to move more slowly than other industries for good reason—human biology is complex, and patient safety is critical. Physicians and hospitals naturally take a cautious, evidencebased approach when trying new technologies. While that cautious pace is important, it can also slow the broader benefits these innovations can bring. At Stereotaxis, we focus on building strong clinical evidence and working closely with physicians so they can see firsthand how our systems improve precision, safety, and outcomes, helping to bridge that gap. Another key consideration is making sure robotics technology is as accessible and affordable as possible for healthcare providers. The impact of even the most beneficial technologies are muted if they can only be accessed by a small percentage of hospitals. Much of our recent innovation efforts have been focused on developing our core robotic technology into a form factor that can easily be deployed at any hospital, without complex construction and leveraging infrastructure already available. This, combined with more flexible financial models that allow hospitals to access a robot without having to make long-term purchase commitments, should allow the benefits of our robotic technology to scale broadly throughout the field.

We are confident that over the coming decade endovascular surgery will be transformed be robotics in a similar fashion to how soft-tissue laparoscopic surgery has been transformed over the last decade. There are now over 10,000 laparoscopic robots treating patients around the world. We expect a similar trajectory for robotics becoming standard of care in endovascular surgery. Pioneering that effort is an exciting mission for us and we recognize the importance of our efforts for physicians, patients, and medical progress.

Stan: As CEO, what is your long-term vision for Stereotaxis and the role of robotics in shaping the future of minimally invasive medicine? David: With all of the exciting innovation taking place across medicine, there remains significant unmet medical need in the world. Stereotaxis’ mission is to improve outcomes of and enhance access to minimally-invasive endovascular surgery by pioneering advanced robotic technology.

STEREOTAXIS’ MISSION IS TO IMPROVE OUTCOMES OF AND ENHANCE ACCESS TO MINIMALLY-INVASIVE ENDOVASCULAR SURGERY BY PIONEERING ADVANCED ROBOTIC TECHNOLOGY.

STAN KALININ MEDTECH OPINION LEADER: STAN KALININ EXPLORES HOW FLEXIBILITY, DATA-DRIVEN HIRING, AND GLOBAL TALENT STRATEGIES ARE REDEFINING THE MEDTECH WORKFORCE, ENABLING COMPANIES TO STAY AGILE AND INNOVATIVE IN A SHIFTING MARKET. 61

Q: You’ve been recruiting in the MedTech sector for over seven years. What are the biggest challenges you see today when it comes to attracting and retaining talent in this highly specialized industry? A: Markets are getting more and more competitive. Larger corporations are pivoting at the moment, defining which devices and segments are performing well and bringing the required revenue to address their long-term growth objectives. Smaller and mid-sized players are fighting for market share while trying to bypass regulatory hurdles that directly affect their daily operations and cash flow. Startups, on the other hand, are challenged by limited funding, new market entry barriers, and an increasingly stringent regulatory environment. The main challenge for all remains the same — staying focused and aligned with their size, capabilities, and strategic objectives. We’re also witnessing growing appetite from private equity firms to step into the medical devices space, while venture capital investors are becoming far more selective with their investment choices. The European market, in particular, is still in what I would call a “winter mode” — the lingering effects of the MDR transition, supply chain disruptions, and strained healthcare budgets continue to weigh heavily on the sector. All these factors combine to make talent acquisition extremely challenging. The best professionals are not only in high demand but are also more cautious about career moves. MedTech companies must now sell more than just a job — they must communicate purpose, flexibility, and stability. In many cases, this means rethinking traditional hiring approaches and embracing flexible workforce strategies that allow them to remain agile and competitive despite ongoing uncertainty.

Q: How can contingent workforce solutions and flexible payrolling models help MedTech companies overcome their current hiring challenges? A: First of all, in such a fast-paced environment, companies are looking for faster decisionmaking processes. Contingent Workforce (CW) teams are expanding, and we can clearly see growing interest from larger corporations in identifying and engaging talent differently. Flexibility and the ability to adapt quickly to market conditions will only continue to increase the demand for these models. However, it’s not only large corporations that benefit. Smaller and mid-sized MedTech companies can also take advantage of flexible hiring and payrolling solutions — especially when hiring outside of their core markets in regions such as the EU, APAC, or the Middle East. These solutions simplify compliance, minimize risk, and accelerate time-to-hire, which is crucial for companies operating across multiple regulatory jurisdictions. Another important factor is cost efficiency and scalability. Through a flexible payrolling model, organizations can onboard specialists for critical projects — whether in regulatory affairs, clinical operations, or product development — without committing to permanent headcount until the market or funding environment stabilizes. This gives them the agility to innovate and expand without overextending resources. Finally, flexible workforce solutions empower MedTech companies to access a global pool of highly specialized professionals, including niche experts who might not be available locally. In an industry where innovation cycles are short and compliance requirements are complex, having the ability to engage the right expertise at the right time can make the difference between getting a product to market — or missing the window of opportunity.

THE BEST PROFESSIONALS ARE NOT ONLY IN HIGH DEMAND BUT ARE ALSO MORE CAUTIOUS ABOUT CAREER MOVES. MEDTECH COMPANIES MUST NOW SELL MORE THAN JUST A JOB — THEY MUST COMMUNICATE PURPOSE, FLEXIBILITY, AND STABILITY.

AWARD WINNING Global provider of complete workforce solutions

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Q: In your experience as Country Manager at InfoTree Global Solutions, how does adopting a global and data-driven hiring approach give MedTech companies a competitive edge?

Q: There’s often a perception that flexible work arrangements can dilute company culture or commitment. How do you see MedTech organizations balancing flexibility with long-term engagement and innovation?

A: First of all, by adopting a global and datadriven hiring approach, MedTech companies benefit from a much wider and more diverse pool of talent. This is particularly important in an industry where specialized expertise — whether in R&D, regulatory affairs, or product engineering — is often concentrated in specific regions. A global strategy allows organizations to identify, engage, and onboard the right experts regardless of geographical boundaries, ensuring access to the best talent available rather than the best talent locally available.

A: We already learned during COVID-19 that many companies successfully transitioned from traditional, office-based setups to more flexible, hybrid, or fully remote models. For many professionals, this has now become the new norm — not just an emergency measure, but an expectation of how modern work should function.

Secondly, companies become far more adaptive and precise in their hiring strategies. Leveraging data and global insights enables them to anticipate market needs, identify skill gaps early, and make informed workforce decisions. This level of intelligence supports not only short-term project execution but also long-term workforce planning, something that’s essential in MedTech, where product lifecycles and compliance requirements can shift rapidly. Thirdly, a data-driven global model gives companies greater control over their cashflow and headcount expenditure. By working with a trusted global partner like InfoTree Global Solutions, organizations can deploy contingent or contract talent quickly and compliantly, while maintaining full visibility into costs, performance, and workforce distribution. Our global infrastructure and local expertise help clients navigate complex employment regulations, tax laws, and payrolling requirements — allowing them to stay focused on innovation rather than administration. Ultimately, this approach turns hiring from a reactive process into a strategic advantage. MedTech companies that embrace flexibility, backed by data and global reach, can scale operations efficiently, enter new markets faster, and remain competitive in an increasingly demanding and regulated industry.

Secondly, advancements in telecommunications and video conferencing tools have fundamentally changed the way we collaborate. Today, teams can work seamlessly across borders and time zones while still maintaining high levels of communication and connectivity. Technology has eliminated much of the friction that once made remote work feel isolating or inefficient. Third, the vast majority of teams in MedTech — particularly in global organizations — are already distributed in some form. What has shifted most is culture. We’ve moved away from a purely corporate, centralized culture toward something much more personalized, inclusive, and trustbased. The focus now is on outcomes rather than presence, and on empowerment rather than control. The key is to keep the right balance. Organizations must ensure that their teams understand the foundation of the company’s mission, values, and objectives, regardless of where they sit physically. This can be done through intentional communication, regular engagement initiatives, and leadership that models transparency and accountability. In MedTech, where innovation thrives on collaboration and precision, culture becomes the glue that holds a dispersed workforce together. I’ve seen companies successfully maintain strong engagement by combining flexibility with purpose — giving employees autonomy, but also connecting them to a shared goal: improving patient outcomes and advancing medical technology.

I’VE SEEN COMPANIES SUCCESSFULLY MAINTAIN STRONG ENGAGEMENT BY COMBINING FLEXIBILITY WITH PURPOSE — GIVING EMPLOYEES AUTONOMY, BUT ALSO CONNECTING THEM TO A SHARED GOAL: IMPROVING PATIENT OUTCOMES AND ADVANCING MEDICAL TECHNOLOGY.

Ultimately, flexibility doesn’t dilute culture — it reshapes it. It allows organizations to attract and retain top talent from anywhere in the world, while fostering a sense of trust and mutual respect. The companies that will thrive are those that build a culture of connection, not location. Q: As both a recruiter and publisher of MedTech Opinion Leader, what trends or innovations do you foresee shaping the future of MedTech talent acquisition and workforce strategy?

strategy are blurring. Talent strategies must reflect that — by embracing multidisciplinary thinking, promoting lifelong learning, and encouraging collaboration across borders and functions. The future of MedTech talent acquisition will not be about filling roles; it will be about building ecosystems of expertise. Organizations that recognize this early — and align their workforce strategies with purpose, flexibility, and creativity — will be the ones driving the industry forward.

A: I believe we are at a pivotal moment in time when many of the frameworks that defined the MedTech industry over the past decade are being questioned. The traditional models of hiring, working, and even leading teams are evolving rapidly. This brings a certain level of market uncertainty, but at the same time, it opens exciting new opportunities — especially for talent. We’re entering an era where professionals have far more autonomy over their careers. Whether you’re part of a global corporation or a small start-up, the ability to shape your own professional journey has never been greater. The democratization of information, access to global networks, and the rise of digital collaboration tools mean that geography and hierarchy are no longer the defining factors of success. Everyone truly has the potential to create their own fortune. Modern tools — from AI-driven talent analytics to virtual collaboration ecosystems — are changing how organizations identify, engage, and retain talent. But beyond technology, the real differentiator will be creativity and adaptability. Those who think outside the box, who can connect science, technology, and human insight, will lead the next generation of MedTech innovation. As a publisher of MedTech Opinion Leader, I see this shift reflected in the conversations we host every day. The lines between clinical expertise, digital innovation, and commercial

THE FUTURE OF MEDTECH TALENT ACQUISITION WILL NOT BE ABOUT FILLING ROLES; IT WILL BE ABOUT BUILDING ECOSYSTEMS OF EXPERTISE. ORGANIZATIONS THAT RECOGNIZE THIS EARLY — AND ALIGN THEIR WORKFORCE STRATEGIES WITH PURPOSE, FLEXIBILITY, AND CREATIVITY — WILL BE THE ONES DRIVING THE INDUSTRY FORWARD.

DR. DYLAN ATTARD MEDTECH OPINION LEADER: DR. DYLAN ATTARD HIGHLIGHTS MALTA’S RISE AS A DYNAMIC MEDTECH HUB AND HOW MEDTECH WORLD SERVES AS A GLOBAL PLATFORM FOR COLLABORATION, INNOVATION, AND PATIENT-FOCUSED HEALTHCARE PROGRESS. 66

Stan: What makes this year’s MedTech World Forum different from other global events? Dylan: Every year, when we sit down to plan MedTech World, I ask myself a simple question: what would I want to experience if I were a founder, an investor, a policymaker, or even a doctor exploring the future of medicine? The answer is never just about size or scale; it’s about intimacy, focus, and impact. This year, we’ve taken that philosophy even further. Unlike many global events that feel transactional, our forum is built to spark genuine connections. Panels are not just discussions but working sessions where regulators, innovators, and clinicians wrestle with real problems together. We’ve curated private roundtables, invite-only forums for MedTech CEOs, investors, and commercial leaders, and hands-on workshops so that attendees leave with actionable insights and not just a stack of business cards. We’ve also raised the bar by becoming a CPDaccredited event. This means that by attending, you’ll not only gain fresh insights from global healthcare leaders, investors, and innovators but also earn CPD credits to advance your professional development. And because we believe great ideas can flourish anywhere, not just inside the conference hall, we’ve woven Malta’s rich culture into the programme. From guided tours through our UNESCO heritage sites to evenings celebrating Mediterranean cuisine and music, we want people to experience the island as much as the event.

But I believed Malta had a unique story to tell. Growing up here, I saw how this small island always served as a bridge between worlds— Europe and Africa, the West and the East. That same spirit of being a crossroads is what innovation thrives on.

Malta also gave us something other hubs couldn’t: agility. Larger ecosystems often move slowly because of bureaucracy. Here, you can bring together government, academia, and private enterprise around a table and make decisions quickly. Add to that Malta’s growing life sciences infrastructure, its reputation as a trusted regulatory environment, and its cultural warmth, and it becomes the natural home for MedTech World.

The Mediterranean setting adds something special too. Malta provides an environment where people are more open, less rushed, and ready to engage in meaningful conversations. Stan: Why was Malta chosen as the base for MedTech World? Dylan: When we started MedTech World, many people assumed we’d base it in a major financial hub.

EVERY YEAR, WHEN WE SIT DOWN TO PLAN MEDTECH WORLD, I ASK MYSELF A SIMPLE QUESTION: WHAT WOULD I WANT TO EXPERIENCE IF I WERE A FOUNDER, AN INVESTOR, A POLICYMAKER, OR EVEN A DOCTOR EXPLORING THE FUTURE OF MEDICINE? THE ANSWER IS NEVER JUST ABOUT SIZE OR SCALE; IT’S ABOUT INTIMACY, FOCUS, AND IMPACT.

MedTech World I believed Malta had a unique story to tell. Growing up here, I saw how this small island always served as a bridge between worlds—Europe and Africa, the West and the East. That same spirit of being a crossroads is what innovation thrives on. 68

Stan: How is Malta building its reputation as a hub for MedTech innovation and research? Dylan: It’s been remarkable to watch Malta lean into MedTech. Ten years ago, we wouldn’t have imagined this momentum. Today, you see government support translating into incentives for startups, collaborations with universities driving early research, and global companies beginning to look at Malta as a strategic base. But reputation isn’t built on infrastructure alone; it’s built on people. What I find inspiring is the community that’s forming here: clinicians eager to pilot new technologies, entrepreneurs willing to test bold ideas, and regulators who are curious instead of resistant. Malta is building its brand by showing that even a small country can become a testbed for innovation that scales globally.

Stan: Which new technologies, like AI or robotics, do you think will impact medical devices the most in the near future? Dylan: If you ask me, we’re standing at the start of a wave that will redefine how devices are designed, regulated, and used. AI is not just a buzzword; it’s becoming the backbone of diagnostics, surgical planning, and even drugdevice combinations. What excites me is its ability to make devices adaptive, learning from every use, rather than static tools. Robotics is another area where the ceiling keeps rising. But the real magic will happen when AI and robotics converge. Imagine surgical robots that not only assist but also learn from outcomes and improve precision over time. I’d also add another dimension: digital twins and bio-printing. The ability to simulate or even replicate human biology could change clinical trials and personalized medicine forever.

MALTA IS BUILDING ITS BRAND BY SHOWING THAT EVEN A SMALL COUNTRY CAN BECOME A TESTBED FOR INNOVATION THAT SCALES GLOBALLY.

Dr. Dylan Attard I often tell startups that MedTech World is built for them. When I was starting out in this industry, I saw how easy it was for early-stage companies to get lost at big conferences. You’re competing with multinational booths and endless agendas. So, we designed our forum to flip that script. 70

Stan: How does MedTech World help startups grow and connect with investors or partners?

Stan: Looking to the future, what role will Malta and MedTech World play in shaping healthcare worldwide?

Dylan: I often tell startups that MedTech World is built for them. When I was starting out in this industry, I saw how easy it was for early-stage companies to get lost at big conferences. You’re competing with multinational booths and endless agendas. So, we designed our forum to flip that script.

Dylan: I see Malta as a lighthouse, a small place casting a beam that reaches far beyond its shores. MedTech World’s role is to amplify that light, creating a platform where global voices come together, but also where local ideas can rise onto the world stage. As healthcare becomes more interconnected, the need for neutral, collaborative spaces will only grow. That’s the role we’re embracing. Malta may not have the scale of Silicon Valley or Singapore, but what it offers is agility, creativity, and a willingness to take bold steps. Our ambition is not just to host a conference, but to build a community that influences how MedTech is regulated, funded, and most importantly, delivered to patients worldwide.

Our startup pitch competitions are only the beginning. What matters is what happens after the pitch. We facilitate direct introductions to investors who are actually writing cheques, and we host closed-door meetings where startups can sit with potential partners in a setting that feels less like a sales pitch and more like a problem-solving session. Beyond the event itself, our year-round roadshows and network ensure that startups don’t just meet people once but build lasting relationships that carry them through their growth journey.

Stan: In what ways does the forum highlight patient-focused innovations in medical technology? Dylan: At the end of the day, MedTech exists for one reason: to improve patients’ lives. But in the rush of investment rounds and regulatory approvals, that focus can sometimes blur. At MedTech World, we keep patient outcomes at the heart of the conversation.

AT MEDTECH WORLD, WE KEEP PATIENT OUTCOMES AT THE HEART OF THE CONVERSATION.

MICHAEL HEUER MEDTECH OPINION LEADER: MICHAEL HEUER TALKS INNOVATION IN AFIB MANAGEMENT, AI IN EP, EUROPEAN MARKET ADOPTION AND CROSS-INDUSTRY COLLABORATION. 72

Stan: What emerging technologies in AFib management do you find most promising? Michael: Pulsed Field Ablation (PFA) is rapidly becoming the gold standard in AFib treatment. With AFib cases rising globally, efficiency and safety are key factors, and PFA offers strong efficacy with a favorable safety profile. Several second-generation systems are in development, including Field Medical, Pulse Biosciences, and Arga MedTech. Additionally, hybrid approaches such as PulsedField-Cryo-Ablation (PFCA) are being explored in the field. However, these technologies still face challenges related to setup complexity and procedural efficiency, which currently limit its readiness for routine clinical use. Beyond PFA, alternative energy sources for ablation are emerging. Companies such as AQUA Heart, Inc. (California), Healium Medical (Israel), and MedLumics, S.L. (Spain) are developing novel ablation technologies, including both thermal and non-thermal approaches, which could introduce new safety and efficacy advantages.

These AI-driven analysis tools might significantly improve diagnostic accuracy, procedural efficiency, and data interpretation, leading to time savings and optimized ablation strategies. However, despite their clinical potential, commercial viability remains a major challenge, especially in Europe. Due to current reimbursement structures, many startups struggle to demonstrate financial sustainability. Successful adoption will require: Integration into large corporate platforms, ensuring broader accessibility and scalability. Alignment with existing healthcare infrastructure, allowing seamless implementation into clinical workflows. Without these steps, widespread adoption will remain slow, despite AI’s clear potential to enhance outcomes and efficiency in electrophysiology.

Stan: How do you see the role of AI, remote monitoring, or digital health tools in electrophysiology? Michael: The impact of AI, remote monitoring, and digital health tools in electrophysiology is growing, particularly in diagnostics and clinical decision support. Several startups are advancing AI-powered solutions in this space. Notable players include: Volta Medical, CathVision, and Cortex – already commercialized and actively used in clinical practice. Vector Medical Corporation and EnChannel Medical LTD – still in pre-commercial stages but developing promising AI-based diagnostic and mapping solutions.

PULSED FIELD ABLATION (PFA) IS RAPIDLY BECOMING THE GOLD STANDARD IN AFIB TREATMENT. WITH AFIB CASES RISING GLOBALLY, EFFICIENCY AND SAFETY ARE KEY FACTORS, AND PFA OFFERS STRONG EFFICACY WITH A FAVORABLE SAFETY PROFILE.

MICHAEL HEUER “Pulsed Field Ablation (PFA) is rapidly becoming the gold standard in AFib treatment. With AFib cases rising globally, efficiency and safety are key factors, and PFA offers strong efficacy with a favorable safety profile.” 74

Stan: What are the biggest challenges in adopting new technologies in this space? Michael: The regulatory landscape in Europe has changed dramatically, presenting significant hurdles for new technologies. 1. MDR & Regulatory Complexity: The introduction of Medical Device Regulation (MDR) in Europe has made the approval process longer, more complex, and resource intensive. Previously, Europe was the first market for innovative medical technologies, giving clinicians early access years before the U.S.. Now, many startups prioritize FDA approval in the U.S., seeking acquisition during clinical trials rather than navigating MDR hurdles in Europe. 2. Germany's Approval Delays & Clinical Trial Challenges: Germany, as the largest European MedTech market, has become less attractive for early-stage clinical trials. The introduction of BfArM (Federal Institute for Drugs and Medical Devices) has extended approval timelines from 3–4 months to 8–10 months, while other European countries still approve within 2–4 months. As a result, Germany is no longer the primary destination for First-in-Human or MDR trials, pushing innovation elsewhere. 3. Reimbursement & Economic Barriers: European hospitals, particularly privately managed institutions, operate under strict financial pressures. As a result, hospital administrations hesitate to adopt new, highercost technologies unless immediate economic benefits are clear. The current reimbursement model still favors repeated procedures rather than rewarding higher success rates in initial treatments. A more progressive reimbursement system could encourage better clinical outcomes while reducing overall healthcare costs. To remain competitive, Europe must streamline approvals, reform reimbursement policies, and incentivize innovation, or risk falling behind as a global MedTech leader.

Stan: How do you see cross-industry collaboration shaping the future of EP technologies? Michael: Cross-industry collaboration is becoming an essential driver of innovation in electrophysiology, enabling faster technology advancements, improved patient outcomes, and increased clinical efficiency. By integrating expertise from adjacent fields, the EP space can benefit in several key areas: 1. AI & Data Science: Enhancing EP Diagnostics & Decision-Making Collaborations with AI and big data companies are enabling real-time, AI-assisted ECG/EGM interpretation, improving diagnostic accuracy and procedural efficiency. Machine learning is helping to predict arrhythmia recurrence and personalize ablation strategies, ultimately leading to better long-term outcomes. 2. Imaging & Robotics: Advancing Precision & Workflow Optimization Partnerships with medical imaging companies (e.g., Siemens, Philips, GE Healthcare) are leading to better integration of real-time imaging with EP procedures, enhancing catheter navigation and lesion assessment. Even though robotics in EP is still struggling to gain full acceptance, collaboration with robotics firms remains necessary to drive the development of robot-assisted catheter navigation, improving precision while reducing radiation exposure and operator fatigue. 3. Consumer Health & Wearables: Remote Monitoring & Early Detection Partnerships with wearable technology companies (e.g., Apple, Fitbit) are improving early AFib detection through continuous ECG monitoring. Remote patient monitoring solutions enable earlier intervention and better post-ablation follow-up.

TO REMAIN COMPETITIVE, EUROPE MUST STREAMLINE APPROVALS, REFORM REIMBURSEMENT POLICIES, AND INCENTIVIZE INNOVATION, OR RISK FALLING BEHIND AS A GLOBAL MEDTECH LEADER.

4. Pharma & Bioelectronic Medicine: The Next Frontier Collaboration between EP device manufacturers and pharmaceutical companies is leading to drug-device combination therapies, such as bioelectric implants that modulate autonomic function to prevent arrhythmias. Bioelectronic medicine and neuromodulation technologies (e.g., SetPoint Medical, Galvani Bioelectronics) may offer non-invasive or adjunctive approaches to AFib treatment in the future. Cross-industry collaboration is reshaping EP technologies by integrating AI, imaging, robotics, consumer health, and bioelectronic medicine into smarter, more efficient, and patient-centric solutions. These partnerships will be key to improving accessibility, efficiency, and long-term outcomes in AFib management, while also addressing regulatory and reimbursement challenges. Stan: Having being one the most successful commercial executives in the MedTech space what are your top three strategies you follow to make positive impact on the performance of your teams? Michael: These are my top 3 strategies to ensure positive impact and performance of the team.

2. Close Collaboration, Co-Travelling & Regular Meetings Strong relationships foster better teamwork. Co-travelling and shared experiences strengthen team bonds. In remote settings, structured virtual interactions help maintain connection. Weekly check-ins ensure alignment, provide clarity, and address challenges early. Quarterly team meetings allow for strategic reviews, goal-setting, and long-term planning. 3. Clear Goals, Reviews & Development Plan Goals should be specific, measurable, and agreed upon by the team. Regular performance reviews help track progress, provide feedback, and support growth. If a team member struggles, a clear development plan should be implemented, including: Support from the team and leadership. A defined timeline with measurable progress indicators. Transparent expectations on outcomes.

Building a High-Performing, Trust-Based Team

If improvement does not occur, decisions about the role must be addressed openly.

A successful team thrives on trust, collaboration, and clear communication, ensuring that everyone is aligned and motivated. The key priorities for building such a team are:

A great team is built on trust, clarity, and shared accountability. With open communication, structured support, and a commitment to development, performance challenges can be addressed effectively—while ensuring the team remains strong and aligned.

1. Trust, Psychological Safety & Active Listening Trust is the foundation of effective teamwork. Psychological safety allows team members to express ideas, ask questions, and challenge decisions without fear. Leaders should actively listen to the team, seek feedback, and involve members in decision-making.

CROSS-INDUSTRY COLLABORATION IS RESHAPING EP TECHNOLOGIES BY INTEGRATING AI, IMAGING, ROBOTICS, CONSUMER HEALTH, AND BIOELECTRONIC MEDICINE INTO SMARTER, MORE EFFICIENT, AND PATIENT-CENTRIC SOLUTIONS.

MEDTECH OPINION LEADER COMING IN SEPTEMBER 2026

THAT WAS THEN. THIS IS NEXT. THE ZAP-X® GYROSCOPIC RADIOSURGERY® PLATFORM OPENS NEW FRONTIERS IN MODERN SURGICAL ROBOTICS.

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