Taking the guesswork out of tracking high blood pressure

Startup CoraVie Medical aims to give patients and their physicians better control over hypertension with a tiny implantable device.

Aimee Garza wants to do for high blood pressure what continuous glucose monitors are doing for diabetes.

The veteran medtech engineer and marketing maven brings 25 years of experience at two of medtech’s biggest companies— Medtronic and Integer — to a problem she’s wanted to solve for years: the suffering caused by cardiovascular disease.

High blood pressure, or hypertension, increases the risk of heart attack and stroke, the leading causes of death in the United States, according to the Centers for Disease Control and Prevention. But relying on a once-a-year blood pressure measurement in a doctor’s office is not enough to track what is known as the silent killer. Even periodic measurements taken at home are just that — periodic.

Garza’s idea is to create an implantable, continuous blood pressure monitor equipped with sensors and wireless communication capability to notify physicians of abnormal readings. The doctor could then summon the patient for a visit or adjust medication and then monitor the patient’s progress on the new med.

“Our device is prescribed by a physician for a clinical need, and then it is inserted under the skin in the upper arm,” Garza said. “This should not be any more difficult than getting a flu shot at your doctor’s office.”

Garza’s journey

Garza started at Medtronic as an electrical engineer and spent many years in cardiac rhythm technical sales. She went back to school, got an MBA and started working in marketing business strategy, working closely with scientists and researchers. Before leaving Medtronic after 20 years, Garza had become senior manager of strategy and planning for the connected care and diagnostics monitoring group.

At Integer, she led marketing for cardiac rhythm and neuromodulation devices, rebuilding relationships with customers after Greatbatch’s 2015 acquisition of Lake Region Medical.  The companies rebranded as Integer the following year.

Garza left Integer in early 2020 and launched CoraVie Medical in Edina, Minn., in April, pursuing an entrepreneurial goal and a desire to be closer to patients. The decision to leave Integer was not an easy one, Garza told Medical Design & Outsourcing in an interview. She deeply values the leadership of Integer CEO Joe Dziedzic.

“I saw an unmet need and an opportunity to address it,” she explained. “And at the same time, tackle the spiraling costs of healthcare.”

Garza described going from billion-dollar companies to being a first-time founder as simultaneously empowering and scary.

“I’ve grown 200+% since founding CoraVie Medical and have more conviction, confidence and determination to lead CoraVie Medical to achieve its goals,” she said. “Each month brings new successes that move us forward to our ultimate goal — improving the health outcomes of people with high blood pressure.”

The technology

The CoraVie device under development is smaller than a dime and designed to be implanted alongside the brachial artery, Garza said. The sensor technology was developed through a collaboration with the University of California at Berkeley and is undergoing bench tests that are looking very promising, according to Garza. Preclinical testing will kick off in the first quarter of 2021 at the University of Minnesota, she added.

Garza has recruited business partners from the clinical and business sides of medtech.

“I’ve been very fortunate to recruit an amazing group of teammates and advisors around me that bring years of expertise and leadership,” she said. “They’ve really helped push me, push CoraVie Medical, forward. They fill in my gaps, they advocate for me and CoraVie Medical and ultimately ensure that we’re successful.”

That team includes retired Integer COO/CFO Jeremy Friedman, now CoraVie CFO, with whom Garza worked for about five years. When she contacted him about her new business idea, Friedman thought it was great — a unique device that would fill a significant market need.

“I have a lot of confidence in Aimee,” Friedman said. “She’s an incredibly hard worker. She is very capable. She has a good mix of engineering background and skill and knowledge along with a real understanding of the medical device world per her experience at Integer and Medtronic. We’re just perfectly aligned with starting up this kind of business.”

Garza is also developing her product at a perfect time, Friedman added. “There’s been a lot of advances over the years in miniaturization and the ability to do something like this,” he said. “There’s always been a desire for some kind of continuous blood pressure monitor, but I don’t think it was so easy to do before. We’re leveraging a concept that has been around for decades but hasn’t been applicable in this way until recently.”

The clinical team

An advisor with ties to Medtronic is Dr. Michael A. Weber, a professor of medicine at State University of New York Downstate College of Medicine in Brooklyn and former editor-in-chief of the Journal of Clinical Hypertension. Weber’s career has focused largely on hypertension and preventive cardiology, including the development of ambulatory blood pressure monitoring.

“Aimee is very structured and well-organized, and seemingly a very good engineer and a very good designer,” Weber said. “I was impressed right from the beginning that this wasn’t some wild idea that needed some genius to make it work. In Aimee, we already had a top-notch researcher to make it work.”

Physicians have come to understand that the most important blood pressure measurements take place outside their offices, including overnight when patients are asleep, Weber said. And while several companies make ambulatory blood pressure monitors, their ability to deliver reliable data depends on a few important factors, such as patients’ daytime activity levels. Also, Weber added, there are several home blood pressure monitors available on the market, but many patients grow bored with the task of measuring their blood pressure carefully, so their technique slacks off and the measurements suffer.

“The device that CoraVie has gets around all of these problems because it’s working 24 hours a day to provide accurate readings during time periods of interest to the patients’ medical advisors,” Weber said.

Like other connected medical implants, CoraVie’s device would generate reams of data, which could overwhelm healthcare providers if not managed and analyzed properly. Company officials have plans to include experienced medical advisors to determine the best way to inform and present not reams of data, but actionable insights.

“The sheer volume of readings and the ability to analyze them through a computer system would probably give the most robust possible interpretations,” Weber said.

In addition to measuring blood pressure, the device might also be able to signal arterial stiffness and endothelial function, or the workings of the lining of the artery’s inner wall, another measure of cardiovascular health, Weber added.

Filling a need

A third advisor has recently retired from Medtronic. Dr. Marshall Stanton, a former Mayo Clinic cardiologist, spent 21 years at the medtech giant, working in cardiac rhythm management, remote disease management, clinical research and implantable defibrillators. When he left, Stanton was SVP and president of the pain therapies business.

Stanton said he believes CoraVie’s technology is “very much needed,” given that one-third of Americans have high blood pressure, but most don’t appreciate the health implications. The device may have a built-in target market, though.

“Somebody who has had a stroke is highly motivated to not have another stroke, particularly people who have not had a devastating stroke. They’ve been scared — appropriately so — by what has happened,” Stanton said. “You do everything you can to prevent having a recurrence.”

Garza and her partners have set a goal of 2023 for first-in-human use. They have raised about $800,000 in seed money from angel investors and are on target to meet initial investment goals. CoraVie Medical is also pursuing non-dilutive funding from the National Institutes of Health and will seek further funding from angel investors and from venture capital firms interested in early-stage companies, according to Friedman. CoraVie will also consider strategic alliances with other manufacturers and hospitals that have R&D capabilities.

“I think that we’ve gotten good traction quickly,” Friedman said. “There’s a lot of medical device companies that start and disappear… but this certainly has the ability to be very successful.”

Added Stanton: “If anyone can pull this off, she can.”

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