Movano Health Commences Clinical Study with New Cuffless Blood Pressure Device
Movano Health (MOVE) has initiated a blood pressure clinical trial featuring its new cuffless blood pressure wrist wearable. The study, scheduled for completion in the second week of February 2025, will involve at least 70 participants and compare pulse pressure waveforms against a hospital-grade device.
The enhanced wearable will monitor multiple vital signs, including pulse rate, blood oxygen saturation (SpO2), respiration rate, and ECG waveforms. This trial follows three previous studies conducted between October 2023 and November 2024, which collected data from over 60 participants of diverse demographics.
The company plans to conduct an additional 100-150 person continuous-blood pressure study using an arterial line in mid-2025, aimed at finalizing the algorithm for a future FDA pivotal trial.
Movano Health (MOVE) ha avviato uno studio clinico sulla pressione sanguigna che utilizza il suo nuovo dispositivo indossabile per il polso, senza bracciale. Lo studio, previsto per essere completato nella seconda settimana di febbraio 2025, coinvolgerà almeno 70 partecipanti e confronterà le onde di pressione del polso con un dispositivo di livello ospedaliero.
Il dispositivo migliorato monitorerà diversi segni vitali, inclusi il battito cardiaco, la saturazione di ossigeno nel sangue (SpO2), la frequenza respiratoria e le onde ECG. Questo studio segue tre ricerche precedenti condotte tra ottobre 2023 e novembre 2024, che hanno raccolto dati da oltre 60 partecipanti di diverse fasce demografiche.
L'azienda prevede di condurre uno studio continuo sulla pressione sanguigna con 100-150 persone usando una linea arteriosa a metà del 2025, con l'obiettivo di finalizzare l'algoritmo per un futuro studio cruciale della FDA.
Movano Health (MOVE) ha iniciado un ensayo clínico sobre la presión arterial con su nuevo dispositivo portátil de muñeca sin manguito. El estudio, programado para finalizar en la segunda semana de febrero de 2025, involucrará al menos a 70 participantes y comparará las formas de onda de presión del pulso con un dispositivo de calidad hospitalaria.
El dispositivo mejorado monitoreará múltiples signos vitales, incluidos la frecuencia del pulso, la saturación de oxígeno en sangre (SpO2), la frecuencia respiratoria y las formas de onda del ECG. Este ensayo sigue a tres estudios previos realizados entre octubre de 2023 y noviembre de 2024, que recolectaron datos de más de 60 participantes de diversas demografías.
La empresa planea realizar un estudio continuo de presión arterial con 100-150 personas utilizando una línea arterial a mediados de 2025, con el objetivo de finalizar el algoritmo para un futuro ensayo pivotal de la FDA.
Movano Health (MOVE)가 새로운 커프리스 손목 혈압 착용 장치를 사용한 혈압 임상 시험을 시작했습니다. 2025년 2월 둘째 주에 완료될 예정인 이 연구에는 최소 70명이 참여하며, 맥파 형태를 병원급 장치와 비교할 것입니다.
향상된 착용 장치는 맥박수, 혈중 산소 포화도(SpO2), 호흡수 및 ECG 파형을 포함한 여러 가지 생명의 징후를 모니터링합니다. 이 시험은 2023년 10월부터 2024년 11월까지 진행된 세 가지 이전 연구를 따르며, 다양한 인구 통계의 60명 이상의 참가자로부터 데이터를 수집했습니다.
회사는 2025년 중반에 100-150명의 지속 혈압 연구를 진행할 계획이며, 이는 향후 FDA 주요 연구를 위한 알고리즘을 완성하는 것을 목표로 하고 있습니다.
Movano Health (MOVE) a lancé un essai clinique sur la pression artérielle avec son nouveau dispositif portable sans brassard pour le poignet. L'étude, dont l'achèvement est prévu pour la deuxième semaine de février 2025, impliquera au moins 70 participants et comparera les formes d'onde de pression du pouls avec un dispositif de qualité hospitalière.
Le dispositif amélioré surveillera plusieurs signes vitaux, y compris la fréquence du pouls, la saturation en oxygène dans le sang (SpO2), le taux de respiration et les formes d'onde ECG. Cet essai suit trois études précédentes menées entre octobre 2023 et novembre 2024, qui ont collecté des données auprès de plus de 60 participants de diverses démographies.
L'entreprise prévoit de réaliser une étude continue de la pression artérielle avec 100 à 150 personnes utilisant une ligne artérielle à la mi-2025, avec pour objectif de finaliser l'algorithme pour un futur essai décisif de la FDA.
Movano Health (MOVE) hat eine klinische Studie zur Blutdruckmessung mit seinem neuen cufflosen Handgelenk-Überwachungsgerät gestartet. Die Studie, die bis zur zweiten Februarwoche 2025 abgeschlossen sein soll, wird mindestens 70 Teilnehmer einbeziehen und die Pulsdruckwellenformen mit einem Krankenhausgerät vergleichen.
Das verbesserte tragbare Gerät überwacht mehrere Vitalzeichen, darunter die Pulsfrequenz, die Sauerstoffsättigung im Blut (SpO2), die Atemfrequenz und die ECG-Wellenformen. Diese Studie folgt auf drei frühere Studien, die zwischen Oktober 2023 und November 2024 durchgeführt wurden und Daten von über 60 Teilnehmern aus unterschiedlichen demografischen Gruppen gesammelt haben.
Das Unternehmen plant, Mitte 2025 eine zusätzliche Studie mit kontinuierlicher Blutdruckmessung an 100-150 Personen durchzuführen, um den Algorithmus für eine zukünftige FDA-Hauptstudie zu finalisieren.
- Development of enhanced wearable device with improved signal fidelity
- Expansion of clinical trial scope from 60 to 70+ participants
- Device capable of monitoring multiple vital signs beyond blood pressure
- Planned larger-scale study of 100-150 participants in mid-2025
- Still in clinical trial phase, pending FDA approval
- Multiple iterations of trials required before pivotal FDA study
Insights
The latest clinical trial announcement from Movano Health marks a pivotal advancement in the $23 billion blood pressure monitoring market. The improved RF hardware architecture represents a significant technical milestone, as cuffless blood pressure monitoring has been a holy grail in wearable technology that giants like Apple and Samsung have yet to successfully implement.
The sequential clinical trial strategy reveals a methodical approach toward FDA validation. The current 70-participant study, combined with previous trials involving 60+ participants, demonstrates systematic data collection across diverse demographics. The planned mid-2025 study using arterial line measurements as the gold standard is particularly noteworthy, as it represents the highest accuracy benchmark for blood pressure validation.
The device's multi-parameter monitoring capabilities create a compelling value proposition in the medical wearables space. By incorporating SpO2, ECG, respiration rate and pulse pressure waveforms into a single wrist-worn device, Movano is positioning its technology as a comprehensive vital signs platform rather than just a blood pressure monitor. This approach could potentially accelerate market adoption in both clinical and consumer settings.
Critical success factors for the upcoming trials include:
- Achieving accuracy within ±5 mmHg mean difference and ±8 mmHg standard deviation compared to arterial line measurements
- Demonstrating consistent performance across various user demographics and conditions
- Maintaining signal fidelity during motion and daily activities
- Proving battery life sustainability with continuous monitoring
The progression from the November 2024 trials to this enhanced version suggests iterative improvements in the technology platform. The focus on signal fidelity improvements indicates potential breakthroughs in the RF sensing technology, which is important for accurate cuffless measurements.
New proprietary RF hardware delivers significantly enhanced signal fidelity
"We have learned a great deal since our last clinical trial in November 2024 and have refined the use of our proprietary cuffless blood pressure wearable in order to extract higher fidelity data," said Movano Health's CTO and Founder Michael Leabman. "I'm excited about the potential the enhanced design offers relative to our previous prototype as it represents a significant leap forward in cuffless blood pressure monitoring."
The February 2025 study follows three clinical trials that took place in November 2024, June 2024 and October 2023 where the Company used its non-invasive devices to collect pulse pressure waveform data from over 60 participants of varying gender, age, ethnicity and BMI. During each session, participants wore Movano Health's wrist-worn device along with a hospital-grade FDA-cleared vital signs monitor with cuffed blood pressure measurements or utilizing arterial blood pressure data as the control. In mid-2025, the Company plans on executing an additional 100-150 person continuous-blood pressure study using an arterial line, the results of which would help finalize the algorithm expected to be used in a future FDA pivotal trial.
About Movano Health
Founded in 2018, Movano Inc. (Nasdaq: MOVE) dba Movano Health, maker of the Evie Ring (www.eviering.com), is developing a suite of purpose-driven healthcare solutions to bring medical-grade data to the forefront of wearables. Featuring modern and flexible form factors, Movano Health's devices offer an innovative approach to delivering trusted data to both customers and enterprises, capturing a comprehensive picture of an individual's health data and uniquely translating it into personalized and intelligent insights.
Movano Health is developing its proprietary technologies and wearable medical device solutions to enable the future use of data as a tool to proactively monitor and manage health outcomes across a number of patient populations that exist in healthcare. For more information on Movano Health, visit https://movanohealth.com/.
Forward Looking Statements
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SOURCE Movano
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