Movano Conducts IRB-Approved Clinical Study with Prototype Blood Pressure Device
Movano Inc. (NASDAQ:MOVE) has received IRB approval to conduct blood pressure studies using its wrist-worn prototype device. The Company will test up to 200 participants in segmented groups to gather data for enhancing algorithm development. Initial testing involved 45 participants, and the data collected will support future studies. Movano aims for Class II FDA clearance while developing affordable, non-invasive health monitoring devices for chronic disease management. The recent study marks a vital step in their journey to innovate health technology.
- IRB approval for blood pressure studies enhances research credibility.
- Initial testing with 45 participants shows progress in data collection.
- Prototype development aims for eventual Class II FDA clearance.
- Focus on affordable, non-invasive health monitoring could capture underserved market.
- Dependent on successful data analysis for future studies to proceed.
- Potential regulatory challenges in achieving FDA clearance.
After recently receiving IRB-approval to perform blood pressure studies in the Movano Clinical Lab, the Company used its investigational wrist-worn device to perform initial accuracy testing
PLEASANTON, CA / ACCESSWIRE / July 6, 2021 / Movano Inc. (NASDAQ:MOVE), a health technology company designing devices that empower individuals to optimize their health in order to help prevent and better manage chronic diseases, recently received approval from the Institutional Review Board (IRB) to conduct blood pressure studies on up to 200 participants in the Movano Clinical Lab. Under the approved protocol, Movano plans to conduct multiple studies in small, segmented groups, as the Company continues to build on lessons from each group. Recently, Movano used its non-invasive, iPhone-sized prototype device to collect pulse pressure waveform data from 45 external participants with varying gender, age, ethnicity and BMI. During each session, participants wore Movano's wrist-worn device along with a hospital-grade FDA-cleared vital signs monitor as the control. The Company expects to further evaluate key modeling factors and continue to improve upon algorithm development with this data.
"Since conducting our first blood pressure and glucose studies at an external clinical research site under a separate IRB approval in December 2020, we've made several enhancements to the way we collect, process and filter data using our existing prototype, enabling us to capture cleaner arterial waveforms," said Dr. John Mastrototaro, Movano's Chief Executive Officer. "The IRB-approved blood pressure-focused study conducted in the Movano Clinical Lab at the end of June will give us the volume of data needed to further accelerate our algorithm work. It will also help prepare us for larger, more complex studies in the future using our smaller and more power-efficient wearable prototype, which is in development."
The prototype used in the study is comprised of custom integrated circuits that allow the Company to generate glucose, blood pressure and heart rate estimates and is supported by a radio-frequency technology platform complete with an app and cloud infrastructure. Movano continues to work toward a single-chip solution, which will enhance the Company's clinical testing process by enabling studies on more people for extended periods of time.
"As we develop our single-chip solution, we're charting a course to our ultimate goal - Class II FDA clearance - while also creating opportunities to bring a Class II exempt or Class I product to the market," continued Mastrototaro. "We believe the products we develop will contain competitive features that will drive rapid, widespread adoption and provide meaningful insights that allow users to help mitigate, delay or avoid the effects of chronic disease. We expect our patented technology will be deployed on a non-invasive and cuffless basis, in a small and stylish device, so wearers feel like people, not patients. Compared to existing medical devices, we plan to be priced more affordably for users and payers, so that we can provide glucose, blood pressure and other vital health data to a massive and underserved population. Our recently completed IRB-approved study is another critical step for Movano as we move forward on our multi-year journey to develop simple, smart and personalized medical devices."
About Movano Inc.
Founded in 2018, Movano Inc. (NASDAQ:MOVE), is a health-focused technology company creating simple, smart and personalized devices designed to help individuals on their health journey optimize for good health today and prevent and manage chronic diseases in the future. Movano's technology is being developed to provide vital health information, including glucose and blood pressure data, in a variety of form factors to meet individual style needs and give users actionable feedback in order to improve their quality of life.
Forward Looking Statements
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Company Contact:
Lauren Jaeger
Movano Inc.
Chief of Staff
lauren@movano.com
SOURCE: Movano Inc.
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