PhysioWave Receives FDA Clearance for Breakthrough Pulse Wave Velocity Cardiovascular Analyzer

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The New Device Measures PWV, Shown To Be An Independent Biomarker For Assessing Cardiovascular Risk, With No Appreciable Change To Patient Workflow

This measurement provides real, actionable information on cardiovascular health to everyone, and can work in concert with all manner of wearables and health apps

PhysioWave, Inc, a developer of cardiovascular risk assessment biomarkers and Stanford University spin-out, announced the company has received FDA clearance for its PhysioWave Pro™ cardiovascular analyzer. This breakthrough device, many years in development, allows easy and quick measurement of an important new vital sign, pulse wave velocity (PWV). With Nokia’s recent withdrawal of the non-FDA-cleared PWV feature of its Body Cardio consumer scale, PhysioWave now has the only scale-based PWV device on the market, backed by an extensive patent portfolio.

“We are thrilled to be bringing this new technology to clinical practices worldwide and look forward to partnering to develop a lower-cost version for consumers,” said Greg Kovacs, PhysioWave’s founder and acting CEO, who has led the company for more than a year leading up to clearance. “This measurement provides real, actionable information on cardiovascular health to everyone, and can work in concert with all manner of wearables and health apps. We believe we are at the beginning of a highly significant development in medicine.”

PWV is a measurement of the stiffness of the blood vessels transporting blood from the heart to the body. Increased stiffness, associated with increased cardiovascular risks (e.g., coronary heart disease, stroke, hypertension), causes the blood pulses to travel faster, resulting in a higher measured PWV. Previously difficult to measure, PWV can now be measured simply by standing on the PhysioWave Pro™ device for less than a minute. The device, similar to a body weight scale, also measures pulse rate, weight and BMI. Early deliveries to clinical customers are planned for later in 2018.

About PhysioWave

PhysioWave was founded by a group of Stanford researchers who realized that one of the most meaningful measures of cardiovascular health, Pulse Wave Velocity (PWV), was not in widespread use because it was difficult to obtain. They invented a way to measure PWV in under a minute while a patient is being weighed, with no change to clinical workflow. Realizing the potential of this technology to identify individuals at high risk of cardiovascular disease, the company developed a clinical product, with a clinically valid home version to follow. For further information, visit http://www.physiowave.com

Media Contact:    Laurent Giovangrandi
[email protected]
+ 1 (408) 638-0008

Cautionary Disclaimer Statement
This news release contains forward-looking statements relating statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of PhysioWave. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release. and PhysioWave will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

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Laurie Hallwyler
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