Hilo's Continuous BP System: A $119M Bet to End Snapshot Health Data

NEW YORK, NY – July 21, 2026 – For decades, understanding one of the most critical metrics of cardiovascular health—blood pressure—has been a frustratingly intermittent affair. A visit to the doctor or a squeeze from a home cuff provides a single snapshot, a momentary data point in a constantly fluctuating biological system. Today, a company named Hilo, backed by Swiss developer Aktiia, is making a significant move to change that paradigm with the U.S. launch of Hilo Core, a system designed to transform blood pressure monitoring from an event into a continuous narrative.

The launch targets a massive and underserved market. According to the American Heart Association, nearly half of all adults in the United States live with high blood pressure, a condition the CDC notes is widely misunderstood and under-monitored. Hilo's strategic entry into the U.S. isn't just about a new gadget; it's a calculated play to create a new category of health technology that sits between clinical-grade medical devices and consumer wellness wearables, powered by a stream of data previously unavailable to the average person.

The Technology: From Snapshots to a Continuous Stream

Hilo Core's innovation lies in its departure from the 19th-century inflatable cuff as the primary method of daily measurement. The system is a three-part ecosystem: a lightweight wearable band worn on the wrist, a sophisticated mobile app, and an FDA-cleared connected cuff used for periodic calibration. The magic happens in the wearable, which uses proprietary Optical Blood Pressure Monitoring (OBPM®) technology. By shining light onto the skin, its optical sensors capture photoplethysmographic (PPG) signals, which reflect changes in blood volume. Advanced algorithms then translate these signals into blood pressure estimations.

The result is a torrent of data—30 to 35 readings per day, including during sleep, a critical time when dangerous nocturnal hypertension can go undetected by traditional methods. The system contextualizes these readings with other vital metrics like sleep patterns, step counts, and heart rate, aiming to provide a holistic view of how lifestyle choices impact cardiovascular health.

"Hilo represents a fundamental shift in how we approach blood pressure, especially in the U.S., where nearly half of adults live with hypertension and many remain undiagnosed or undertreated," said Stefan Petzinger, CEO of Hilo by Aktiia. "For too long, blood pressure has been measured in isolated moments, leaving critical gaps in understanding. By moving to long-term, real-world insights, we're empowering people and their care teams to take earlier, more informed action."

This technology isn't new or untested. Developed over two decades in Switzerland, the underlying science has been validated in eight clinical studies. Peer-reviewed research, including studies published in the prestigious journal Nature Digital Medicine, has demonstrated the accuracy of Aktiia's optical monitoring technology against both standard cuffs and invasive arterial lines in intensive care settings. This scientific backing is a key pillar of Hilo's strategy, providing a foundation of credibility as it enters the discerning U.S. market.

A New Category: Navigating the Wellness vs. Medical Divide

Hilo's market entry is strategically nuanced. The company is explicit that Hilo Core is launching as a "wellness product" intended to support awareness and lifestyle optimization. It is not, at present, a medical device cleared by the U.S. Food and Drug Administration (FDA) for diagnosis or treatment. This distinction is crucial for consumers and clinicians to understand. The system cannot be used to diagnose hypertension or make clinical decisions about medication.

However, the inclusion of an "FDA-cleared connected cuff" for calibration is a clever move. It anchors the system's accuracy to a recognized medical standard while allowing the continuous monitoring component to operate under the more flexible 'wellness' classification. This strategy enables Hilo to enter the market quickly while it pursues a more rigorous regulatory pathway.

In Europe, the Aktiia device has already achieved CE Mark certification as a Class IIa medical device, signaling its compliance with European health and safety standards. Hilo's stated plan to "expand into a regulated medical platform in the future" suggests a similar ambition for the U.S. market. This dual-pronged approach—launching first as a wellness tool to build a user base and gather real-world data, while simultaneously working towards medical device clearance—is a sophisticated strategy for navigating the complex and time-consuming FDA approval process.

"Hilo stands out from a clinical perspective because it makes it easier for individuals with hypertension to understand and manage a condition that often goes unnoticed," noted Dr. Marat Fudim, a medical advisor to Hilo and Associate Professor of Cardiology at Duke University. "By providing consistent, longitudinal insights, Hilo Core helps both individuals with hypertension and clinicians better understand how lifestyle and treatment decisions are impacting blood pressure, enabling earlier, more informed intervention."

The Strategic Bet: A $119M Wager on the 'Hilo Effect'

The launch of Hilo Core is backed by serious capital and investor confidence. The company has amassed over $119 million in total funding, bolstered by a recent $19 million Series B extension that includes a new investment from the Dell Family Office, the investment firm of Dell Technologies founder Michael Dell. In the competitive health tech landscape, such substantial funding signals a strong belief in Hilo's disruptive potential.

The competitive landscape is crowded but fragmented. On one end are traditional, highly accurate cuff-based monitors from giants like Omron and Withings. On the other are smartwatches from Apple and Samsung, which are inching towards blood pressure monitoring but have yet to deliver a continuous, validated solution in the U.S. Hilo aims to carve out a unique position by offering the best of both worlds: the data richness of a wearable with the validation of a clinical-grade tool.

Hilo's business model combines an initial hardware cost ($89.99) with a recurring annual subscription ($149.99), creating a sustainable revenue stream that is attractive to investors. Making the system pre-approved for HSA and FSA eligibility is another smart move to lower the barrier to adoption for U.S. consumers.

The company is also leveraging compelling data from its European user base, which now exceeds 200,000 people. A large-scale study of over 30,000 users revealed what the company calls the "Hilo Effect": users who engaged more with the app saw up to a fivefold greater reduction in systolic blood pressure over six months compared to less engaged users. This powerful outcome-based narrative is central to Hilo's value proposition, suggesting that access to continuous data can drive meaningful behavioral change and improved health outcomes, transforming a passive monitoring tool into an active health management platform.