Movano Health Commences Clinical Study with New Cuffless Blood Pressure Device
Rhea-AI Summary
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.
Positive
- 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
Negative
- 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
This press release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially from those anticipated. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding plans with respect to the commercial launches of the Evie Ring and EvieMED Ring; our expectations regarding potential commercial opportunities; planned cost-cutting initiatives; anticipated FDA clearance decisions with respect to our products; expected future operating results; product development and features, product releases, clinical trials and regulatory initiatives; our strategies, positioning and expectations for future events or performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission, including under the caption "Risk Factors." Any forward-looking statement in this release speaks only as of the date of this release. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
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SOURCE Movano
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