To Aimee Garza, it’s no wonder hypertension remains one of the most prevalent yet most uncontrolled conditions in the U.S., costing the country about $131 to $198 billion each year. This is because the fundamental approach to blood pressure monitoring has not changed in “literally over a century,” she pointed out in an interview.
Garza serves as CEO of CoraVie Medical, a Minneapolis-based startup seeking to transform the way blood pressure is monitored through its implantable continuous blood pressure monitor. The device employs a similar approach as continuous glucose monitors, which have become a popular way for diabetes patients to monitor their blood sugar levels over the past decade. Instead of measuring a patient’s blood sugar, CoraVie’s implantable measures the patient’s blood pressure throughout the day.
Last month, a panel of investor judges crowned CoraVie the winner of the medical devices track of MedCity News’ INVEST Pitch Perfect contest, favoring it over five other startups in the space.
The company’s name combines the Spanish word for heart (corazón) with the French word for life (vie), Garza explained.
“The name represents who we are and what we do,” she declared. “CoraVie Medical is focused on improving the monitoring and management of blood pressure to prevent strokes, heart attacks and other life-threatening cardiovascular events. So we intend to be a global company — because high blood pressure is a global problem — hence the use of words from other languages.”
The startup was founded in 2020. When the company was being formed, Garza and her team spoke to “many, many physicians,” most of whom told her that they don’t trust patients’ at-home blood pressure monitoring data.
Physicians believe that these at-home data collection methods for hypertension are usually inaccurate, and this can be for a few reasons, Garza noted. For example, a patients’ awareness that their blood pressure is being measured often will affect the data. Other factors like whether the patient has their feet on the floor or is handling the equipment correctly also often impacts the reliability of the measurement.
“The other major piece of this is that today’s monitoring protocols are infrequent and inconsistent, which creates delays in detecting risks. That makes it really difficult to get ahead of the problem,” Garza stated. “And with blood pressure specifically, that is very challenging — blood pressure is largely asymptomatic. There is no internal physiologic trigger to tell you like you need to go step on the scale or go take your medications.”
To combat this issue, CoraVie developed a device that is implanted under a patient’s skin, allowing for their blood pressure to be monitored continuously throughout the day. The device, which is intended to be prescribed by a physician, can be implanted in a simple office procedure that takes just minutes, Garza said.
Once the device is implanted, it begins automatically monitoring the patient’s blood pressure and uploading that data to the EHR. Physicians can access this information in real time on the patient’s health record, and patients can access this data on their phone, Garza explained.
“This creates peace of mind. Alot of patients really value the fact that it’s 100% automatic and they don’t have to think about it. They don’t have to remember to take their blood pressure or worry when they’re traveling. Instead, they know that this is silently and painlessly monitoring them in the background over day and night to detect these dangerous blood pressures and to help get blood pressure under control,” she remarked.
With its first-generation device, CoraVie is targeting a yearlong longevity period. In the future, the company is hoping that patients will need to get their device replaced every three to five years, Garza said.
Looking ahead, she thinks CoraVie’s device could help create a closed-loop system of monitoring and treatment, similar to continuous glucose monitors. Some diabetes patients use continuous glucose monitors that feed into their insulin pumps and deliver the exact amount of therapy they need, Garza pointed out. She sees a similar future for blood pressure monitoring.
“Continuous blood pressure monitoring creates this amazing opportunity to create closed loop therapies. There are neurostimulators out there and new technologies that are being developed that have the therapy for high blood pressure and are waiting for the matching monitor that can support that type of a solution. That would create a complete continuous closed loop system — you won’t have to worry about your medications or your monitoring protocols at all,” Garza declared.
While that vision has a while before it might come to fruition, CoraVie is taking steps toward achieving FDA approval for its technology. Two years ago, the startup’s device received breakthrough device designation from the agency. The company plans to submit its device on the de novo Class II medical device 510(k) approval pathway by the end of 2027, Garza said.
CoraVie is currently raising capital to miniaturize its device and conduct its first in-human studies, she added.
Lewis Kilongo — a principal at Unorthodox Ventures and one of the judges who awarded CoraVie its prize as the contest winner — is hopeful that the startup’s technology can help hypertension become less of a “silent killer,” he said in an emailed statement.
“Accurate continuous monitoring of blood pressure trends is crucial since it would enable early detection of uncontrolled rising blood pressure levels and timely intervention before hypertension leads to serious complications, such as stroke, heart attack, kidney failure or death. I think CoraVie should allow physicians to optimize the treatment regimen by making necessary adjustments in a timely fashion, based on reliable information,” he stated.
