World's first automated 24/7 blood pressure monitor comes to the USA

Aktiia announces landmark hypertension trial in collaboration with top US hypertension center

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Jan 03, 2022, 19:15 ET

NEW YORK, Jan. 3, 2022 /PRNewswire/ -- Aktiia, the global leader in continuous blood pressure monitoring, today announced that it is bringing its 24/7 Blood Pressure Monitor to the United States¹, delivering the next generation of clinical wearables specifically designed to meet the needs of both patients and physicians. Consumer wearables have struggled to gain acceptance and trust in the healthcare community. Eighty-one percent of physicians would not make a decision about a patient's treatment or care based on data from a consumer wearable². By comparison, physicians across Europe are already utilizing Aktiia to personalize their patients' care.

AKTIIA IS AVAILABLE FOR INTRODUCTION AND DEMONSTRATION AT CES 2022 JAN. 5 TO 7 IN LAS VEGAS OR VIA ZOOM FOR THOSE REPORTERS COVERING CES VIRTUALLY.

Aktiia's 24/7 blood pressure monitor automatically gathers over 100x the data and has over 10x the engagement of other blood pressure monitors.³ Aktiia's optical sensor at the wrist measures around the clock, providing data that can be instantly viewed in a mobile app and easily shared with a physician or family member. Aktiia's 24/7 Blood Pressure Monitor has already received the CE Mark as a Class Iia medical device and is currently available for sale in seven countries across Europe. To date, tens of thousands of units are in use and over 20 million readings have been captured. Aktiia's new clinically integrated physician dashboard, launching in Europe in spring 2021, will allow the medical team to be dramatically more effective in patients' hypertension diagnosis, monitoring and management.

In the United States, nearly 50% of adults, about 116 million people, have high blood pressure. Of these, up to 75% do not have their blood pressure under control. The rate of control is worsening, due in part to low patient engagement and lack of comprehensive data for physicians to properly diagnose and manage their patients. This ongoing hypertension epidemic is the number one cause of major cardiovascular events like heart attack and stroke, and leads to more than half a million unnecessary deaths every year in the US alone. Aktiia's automated approach removes the patient's daily burden of cuff measurements and enables patients and their physicians to shift their focus to improving cardiovascular health by implementing and monitoring changes, rather than struggling to get the measurements necessary to understand the patient's true condition.

Aktiia's solution improves patient engagement, with current users checking their blood pressure on average 15 to 20 times per week, versus 1 to 2 times with traditional blood pressure cuffs. Cuffs require the patient to interrupt their day, while Aktiia's solution automatically triggers 150 readings per week in multiple body positions, while awake and sleeping. It is the only solution able to measure a patient's "time in range" – the percentage of time their blood pressure is within a healthy range. Recent large-scale studies have demonstrated that the more consistently a patient stays in their target blood pressure range, the lower their risk of heart attack and strokes.

Aktiia's co-founders spent 17 years developing its game-changing technology, which has since been validated in multiple clinical studies. The results of Aktiia's pivotal clinical trial have been peer-reviewed and published in highly regarded journals, including "Nature" and "Blood Pressure Monitoring." In addition to endorsement by leading experts in hypertension management, Aktiia is now also an official partner of the International Society of Hypertension and the World Heart Foundation. With accuracy already proven, Aktiia has a further nine clinical trials underway, focused on demonstrating the clinical impact of its solution.

Now, Aktiia is coming to the United States via a landmark study with Brigham and Women's Hospital (BWH), a top 10 hospital for cardiology with one of the world's most innovative hypertension clinics. BWH's Remote Hypertension Program has over 3,000 patients enrolled to date, and has demonstrated how more consistent at-home monitoring and digital interventions can lead to extraordinary improvements in rates of control across a broad demographic of hypertensive patients. Aktiia is sponsoring the COOL-BP (Continual vs. Occasional Long-Term BP) study within the Remote Hypertension Program, to be conducted by Dr. Naomi Fisher, Associate Professor of Medicine at Harvard Medical School and Director of BWH's Hypertension Service, and a consultant and advisor to Aktiia. Dr. Fisher states: "Hypertension affects nearly half of Americans, every hour of every day. Yet current measurement devices only capture a brief snapshot of overall blood pressure, and they are burdensome to use. The COOL-BP study will test an optical cuffless technology in BWH's remote hypertension management program. An innovation that automatically provides blood pressure readings continually through days and nights holds tremendous promise in our efforts to control hypertension, both for individuals and for global health."

Eighty-nine percent of wearable owners would like their physician to be able to utilize the data², but existing consumer wearables have proven frustrating to patients and physicians alike. "Consumer wearables generally lack sufficient published validation, do not provide actionable clinical insights, and don't integrate into our clinical workflow. Aktiia has been extensively validated and is trusted by both patients and physicians to be used as the basis for medical decisions," said Aktiia Chief Medical Officer Jay B. Shah, Medical Director of Thoracic Aortic Diseases at the Mayo Clinic and faculty of Mayo Alix School of Medicine.

Speaking at CES, Aktiia CEO Michael Kisch says consumer wearable companies mislead consumers by marketing 'health' features that have limited clinical utility and don't contribute to improved care. Mr. Kisch said: "We see an opportunity to develop solutions that meet the needs of both the patient and the physician in the pursuit of improving blood pressure control and cardiovascular health outcomes."

Editor's Note:

CES Availability

In addition to the study at BWH, Aktiia also will be available for introduction and demonstration at CES 2022 at ShowStoppers January 5 from 6 – 10 pm in Las Vegas. Open hours for media and scheduled interviews are also available on site or by Zoom.

How It Works

Aktiia's Optical Blood Pressure Monitoring (OBPM®) algorithms leverage optical sensors worn on the wrist and provide blood pressure values using photoplethysmography (PPG) to analyze the changing diameter of the arteries occurring at each heartbeat. This optical measurement is done automatically, so users are not aware and stressed, and do not have to interrupt their day or their sleep to take a measurement.

About Aktiia

Founded in Switzerland in May 2018, Aktiia's team has some of the world's leading scientific and technical experts in optical blood pressure monitoring. The core technology was first developed over decades of research at the prestigious Swiss Center for Electronics and Microtechnology (CSEM), under a team lead by Aktiia co-founders, Dr. Mattia Bertschi and Dr. Josep Sola. In late 2021, Aktiia raised a $17.5M Series A round of funding, led by UK-based venture capital firm Molten Ventures (formerly Draper Esprit).

Pricing & Availability

Aktiia is available for purchase now in the UK (£199.99), Switzerland (CHF219.99), Germany, Austria, France, Ireland, and Italy (€199.99).

To learn more, visit Aktiia.com.

¹ Aktiia is available in the USA for inclusion in clinical investigations, under an Investigational Device Exception. Pending FDA authorization for commercial availability.

² Data via survey conducted by Aktiia of physicians and consumer wearable owners in December 2021.

³ Calculations based on an average oscillometric cuff usage of 1-2 times per week, compared to: a) Aktiia's 168+ weekly measurement attempts and b) the average Aktiia user's 15-20 weekly app sessions.

SOURCE Aktiia