Revolutionizing Cardiovascular Health: A Conversation with Aimee Garza of CoraVie Medical
- Michael Browers
- Apr 1, 2024
- 9 min read
In this Q&A session, Aimee Garza, the Founder and CEO of CoraVie Medical, shares insights into her visionary journey in the medtech industry. Garza's leadership has been pivotal in developing CoraVie Medical's innovative circadian blood pressure monitor, a device representing not just an advancement in medical technology, but a potential paradigm shift in cardiovascular health management.
Based in Minneapolis, MN, CoraVie Medical is at the forefront of the battle against cardiovascular disease, the leading cause of death globally. The company's cutting-edge technology is designed to inform treatment decisions and monitor therapy effectiveness, epitomizing a dynamic approach to cardiovascular health management and enhancing patient-clinician communication.
CoraVie Medical has made significant strides in a relatively short period, securing both equity investments and non-dilutive funding, including a grant from the National Science Foundation. These achievements highlight the promising potential of their blood pressure monitoring solution.
The company has also collaborated with major university research centers to expand and validate the applications of its technology, underscoring its commitment to healthcare innovation and excellence.
In this conversation, Aimee Garza explores the origins of CoraVie Medical, the motivation behind their groundbreaking blood pressure monitor, and the challenges and triumphs encountered along the way. This discussion offers an opportunity to discover the story of CoraVie Medical under Garza's inspired leadership and learn how their novel approach is reshaping healthcare standards and improving patient care.
Would you describe CoraVie's subcutaneous blood pressure monitor and how your technology aids in the management of uncontrolled hypertension?
Our fundamental mission is to empower people worldwide with actionable insights that when acted upon, will slow, and possibly prevent, the progression of cardiovascular disease. Our insertable circadian blood pressure management solution transforms the paradigm for how dangerous blood pressures are monitored and detected. Through CoraVie’s unmatched accuracy and predictive analytics we will prevent dangerous hypertension-related emergencies like strokes.
Hypertension Crises (or blood pressures above 180/120mmHg that require urgent care) occur in 1-2% of the population and require emergency care to prevent organ damage. CoraVie offers physicians early and accurate detection of these events.
We are genuinely enthusiastic about these advancements.
I understand. On a personal note, I believe that's fantastic. You might have come across my LinkedIn post about my mother-in-law, Roza, and her battle with uncontrolled hypertension, leading to her untimely passing. Had she still been with us, she would have been an ideal candidate for the technology that CoraVie is developing.
I’m sorry to hear about your mother-in-law. It is indeed tragic. Reflecting on my early days at CoraVie, I shared Wanda's story, who at just 46, suffered a hemorrhagic stroke due to uncontrolled blood pressure. This left her with severe physical, emotional, and financial hardships, affecting her for many years. Such a situation could have been avoided. Hypertension crises can become emergencies that cause damage to critical organs, such as strokes impacting the brain, acute renal failure affecting the kidneys, and acute myocardial infarctions and heart failure concerning the heart.
These serious situations highlight the importance of not underestimating blood pressure issues. When people think 'blood pressure monitoring', they often envision buying a basic cuff from a pharmacy. However, relying on consumer health and wellness devices like a Fitbit or a wrist-worn device to capture the infrequent and sudden onset of critical health issues is risky due to the sporadic and likely infrequent measurements and potential data inaccuracies. Many of these devices have not been validated, are not calibrated, and are often not trusted by physicians to be accurate.
At CoraVie, we have developed remarkable technology with the precision of intra-arterial blood pressure, the gold standard in healthcare. Our patented technique ensures unparalleled accuracy and the ability to automatically monitor consistently over day and night, crucial in managing serious health conditions.
How does the device provide actionable insights for patients and healthcare providers?
I have a few thoughts regarding the importance of actionable insights and what we do at CoraVie. Currently, doctors are dissatisfied with the tools available to them to capture actionable out-of-office insights. Can a physician trust the data provided by a patient? Often, the answer is no. Factors like patient anxiety, exemplified by white coat syndrome, can lead to falsely elevated blood pressure readings, not reflecting the true values.
Errors in patient measurement techniques add to the problem. Even well-educated and capable individuals may not execute all steps correctly for accurate blood pressure measurement. Additionally, as I mentioned previously, the market is flooded with non-standard, non-validated, and non-calibrated home blood pressure monitoring systems. A study in Australia estimated that over 90% of blood pressure monitors sold online are inaccurate.
Combining all these factors, if a doctor receives patient self-measured data, the chances of trusting this data are quite low. Therefore, clinical decisions are often delayed and therapy suboptimal, leaving patients at risk.
CoraVie is directly addressing the need for clinical accuracy. It’s important to emphasize the need for clinical accuracy, especially when we’re talking about hypertension emergencies because it is fundamental for accurate risk prediction. CoraVie is a direct measure of the blood vessel, and highly accurate. Because we are a direct, accurate data source, we can further magnify the insights by incorporating predictive analytics and artificial intelligence. This ensures that when it signals the need for care, it is indeed a legitimate alert.
Not to get too far into the future, but there is an emerging trend for circadian, day and night monitoring to identify patient risk, inform medication half-life, and personalized medicine based on a true blood pressure profile. CoraVie is the only solution that can automatically monitor over day and night to create a blood pressure profile, assess blood pressure variability and nocturnal hypertension. A single point-in-time measurement will no longer be sufficient. To draw an analogy- one would not expect a carbon monoxide detector or a fire alarm to only check for an issue once each day. Another relevant analogy is the introduction of continuous glucose monitoring in diabetes management. Continuous glucose monitors significantly enhanced the outcomes for diabetic patients. It's unrealistic to rely on single-point measurements taken hours or days apart and expect a linear understanding of a patient’s health between these points.
What have been the key milestones for CoraVie Medical since its founding?
I’m so excited for the team of experts advising CoraVie to get us to our next milestones! We recently had a technology advisory meeting that gave confidence in our ability to deliver a miniaturized fully insertable solution.
In terms of our progress, the feasibility work on our unique sensor technology has been pivotal. We have proven that our approach is not only reliable but also feasible, marking a major milestone. Reflecting on the past few years, our journey has transitioned from being heavily research-focused on technology innovation to now being a largely engineering undertaking. We now understand how to transform our invention into a commercially viable product.
Being immersed in the day-to-day details can sometimes obscure the appreciation of our progress. Our timing has been impeccably aligned to technology advancements to deliver an insertable device that can accurately derive intra-arterial blood pressure, representing a significant leap forward.
How does CoraVie address the issue of patient monitoring fatigue? What role does patient compliance play in the effectiveness of your device?
It's worth emphasizing: patient compliance is a crucial issue, and CoraVie has gained deep insights into this. Having interviewed over 300 physicians, patients, and economic stakeholders, we've clearly identified unmet needs, one of which is patient compliance, especially regarding long-term therapy or monitoring adherence.
The reality is stark: patient compliance, especially for ongoing tasks like blood pressure monitoring, is abysmally low. Asking a patient to measure their blood pressure twice a day, with multiple readings each time, and to continue this indefinitely, is a daunting request. The regimen's complexity – avoiding coffee, maintaining posture, etc. – further complicates compliance.
It ultimately boils down to human behavior. Despite knowing the benefits and the risks, such as the likelihood of a stroke, many of us neglect to take our medication or monitor our blood pressure routinely per doctor’s orders. This is especially challenging when there is no ”trigger” (or symptom) that tells us, “hey, you’re feeling a little off today, maybe you should take your blood pressure”. This isn’t about blaming the patients; it’s an acknowledgment of human behavior. Consequently, doctors often do not receive the necessary data to inform clinical decisions.
The longer the monitoring duration, the greater the likelihood that 'monitoring fatigue' sets in, diminishing the likelihood of obtaining reliable data for physician decision-making. CoraVie addresses this critical issue head-on. Our solution tackles patient monitoring fatigue, compliance challenges, and the self-awareness of measurements, eliminating concerns about inaccuracies due to patient behavior. Our tiny, subcutaneously inserted, fully automatic device revolutionizes patient monitoring. CoraVie is the only solution that fully addresses patient self-monitoring challenges to automatically deliver accurate insights to the doctor.
What has been the most surprising finding in your journey with CoraVie?
Reflecting on your question, I realize there isn't just one thing that has surprised me the most: it's a multitude of factors.
I confirmed my own resilience and drive. If someone had detailed all the hurdles and 'bumps in the road' I would encounter from day one, I might have hesitated to start this company. The sheer effort and persistence required are immense, and I'm grateful I didn't let initial doubts or discouragement deter me. Overcoming these challenges has taught me that success is not a straight path; it's filled with ups and downs. I've embraced and mostly enjoyed these fluctuations. And perhaps there's a part of me that's motivated by a desire to prove doubters wrong.
Another revelation has been the power of networking and a great team. Early in this journey, I reached out to my connections, and the response was overwhelmingly positive. The support and willingness to help from my network of friends and acquaintances, who understand what it takes to start a company, has been astounding. I was expecting to run into a highly competitive and opaque environment; instead, I found a community eager to lend a hand, because they have “been there” and know it takes.
And I have found a team that shares CoraVie’s values and behaviors and sees the vision to prevent the progression of cardiovascular disease. I’m humbled every day to know these team players and build something great together.
Let me pose a question that naturally follows from our discussion. Considering the challenges and 'bumps in the road' you've encountered and overcome, if I had asked you three years ago about your aspirations for where you'd be in your journey today, would you say you're on track, or perhaps even ahead of where you hoped to be? I'm curious because, despite the obstacles, it doesn't seem like your progress has been significantly hindered compared to your expectations. However, I don't want to make assumptions. Could you share your perspective on this?
Reflecting on my initial expectations, I realize they were naive. Everyone says it will take longer than expected, and I didn’t appreciate the amount of research and invention that still needed to occur. For instance, when I applied for our first grant with the National Science Foundation, Pat Dillon, an invaluable resource in Minnesota for those considering grants, seemed amused by the optimism in my roadmap. I remember thinking that the entire process—from submitting the grant application to receiving funding—could take a year, a duration in which I assumed my project would already be completed. However, the process took its time, and the funding turned out to be immensely helpful when it arrived.
Now, I'm eager to accelerate our efforts to kick off the development of our product for early human feasibility, which is exciting. Our most recent challenge has been the 2023 venture capital markets. It has been a little bit of a slog raising capital to get to early human studies. This has slowed our progress as we work to extend our cash. But I am optimistic for 2024!
How does CoraVie contribute to the global conversation on hypertension management?
As for the global conversation on hypertension management, I hope I have partially demonstrated to you already how CoraVie contributes to enabling improved hypertension management. We're not just developing technology; we're actively participating in and shaping the discourse on effective hypertension management, bringing unique and innovative solutions to the table.
For decades, people have explored this area, but I believe we are now at the forefront, particularly in the way we're addressing hypertension through measurement and enabling sound decision-making for patients in need. Our approach is genuinely transformative and has the potential to revolutionize how blood pressure monitoring is perceived and implemented.
We are , and will continue to engage with the right advisors and societies, such as the American Heart Association and their Hypertension Council, to align with groups that understand and set guidelines. The American Medical Association is another key organization in this context. Building robust evidence is crucial, especially from the perspective of an implantable medical device. We must meet regulatory and clinical standards and demonstrate clinical and economic outcomes to secure reimbursement from governments or payers.
This high bar we're aiming for is essential in building the evidence necessary to drive adoption and change the standard of care to align with what we're doing. We are diligently following all these processes to achieve our goals. I'm really excited about this journey, despite knowing it will be a long one, and I'm enthusiastic about the potential we have to dramatically alter the way blood pressure is managed and understood.
What are the long-term goals of CoraVie Medical in the medical device industry?
Staying focused on our overarching vision is crucial, especially given the tendency to get mired in day-to-day operations and short-term milestones. Certainly, our long-term goals are ambitious, given the vast potential of our technology. CoraVie, with its name reflecting its French and Spanish roots—'Vie' meaning 'life' in French, and 'Cora' derived from 'Corazon', Spanish for 'heart'—is deeply committed to its vision of preventing the progression of cardiovascular diseases.
We're beginning with key markets and patient groups where we believe we can make a significant impact. However, our technology paves the way for a platform capable of enabling multiple opportunities.
Looking to the future, we envision integrating blood pressure and other hemodynamic data with implantable therapies to deliver closed-loop systems.
In the future we will utilize artificial intelligence and combine accurate, prospective clinical insights with broader population health data, enhancing personalization in medicine and improving overall population health.
The future is one where patient care is enhanced, where the information we provide not only informs but also motivates better health behaviors to prevent cardiovascular diseases.
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