Stanford Spinoff PhysioWave Announces Clinical Study with Omron Healthcare
PhysioWave, a spinoff from Stanford University, successfully completed a 200-subject clinical study with OMRON Healthcare Co., Ltd., a global leader in medical devices for health monitoring and treatment. PhysioWave has been developing rapid, non-invasive technology to measure a person’s risk of cardiovascular disease, using a weight scale, when they arrive for a clinic visit. PhysioWave’s technology is mature and FDA-cleared, and PhysioWave is seeking opportunities to bring this important new technology to the consumer space through partnerships.
The PhysioWave Pro™ scale measures the stiffness of the major blood vessel into which the heart pumps, the aorta. Stiffness increases with age, but excess stiffness among people of similar ages can be a warning sign of risk. It is established that increased vascular stiffness can predict the later development of high blood pressure, or hypertension, and a higher risk of cardiovascular disease.
“The chance to work with OMRON Healthcare is a true honor. We have used their blood pressure instruments as reference standards on many clinical studies and greatly value their brand power,” said PhysioWave founder, Greg Kovacs, MD, PhD.
The study was carried out in Kyoto, Japan, and was intended to explore the use of PhysioWave’s technology to assess cardiovascular disease risk at home. This new technology could be used to monitor the beneficial effects of lifestyle changes or prescription medicines for preventing and managing cardiovascular disease. It is widely recognized that cardiovascular diseases are the leading cause of death globally, and the PhysioWave vascular stiffness technology is low-cost and requires no disposables to deliver meaningful information in under one minute. The study validated the accuracy and reproducibility of PhysioWave’s vascular stiffness technology in a wide distribution of subject attributes such as age and BMI. “As we move more aggressively into disease prevention, rather than treating cardiovascular disease after it has manifested, the ability to carry out personalized cardiovascular risk assessment assumes even greater importance to our healthcare systems” said Judith Swain, MD, PhysioWave CMO, and previous Chair of Medicine at Stanford and previous Chief of Cardiovascular Medicine at the University of Pennsylvania.
“OMRON Healthcare is exploring innovative technologies to help prevention and management of cardiovascular diseases for its “Going for ZERO” vision, including collaboration with partners. The accuracy of PhysioWave’s vascular stiffness technology was excellent. We look forward to further exploration of cardiovascular measurement technology at home with this collaboration,” said Minoru Yoshimura, Executive Officer, OMRON Healthcare Co., Ltd.
PhysioWave and OMRON intend to continue to explore opportunities for vascular stiffness in consumer settings, including its use to help identify persons with a higher risk of cardiovascular disease and to provide feedback as they manage their conditions.
Dr. Timothy Broderick Joins PhysioWave Medical Advisory Board
Menlo Park, CA MAY 9, 2022
PhysioWave, Inc is pleased to announce Timothy J. Broderick, MD has joined the company as a medical advisor. Dr. Broderick is the Chief Science Officer and Senior Research Scientist at IHMC (Florida Institute for Human & Machine Cognition). He is a General Surgeon, with broad experience in human health and performance. He has extensive biomedical experience in academia, government, and industry. He formerly served as a DARPA program manager from 2010-2014.
Dr. Marsh Cuttino to become PhysioWave CEO
Menlo Park, CA FEB 2, 2022
PhysioWave, Inc announced today the promotion of C. Marsh Cuttino, MD FAAEM FACEP to CEO. Dr. Cuttino has been a long term member of the PhysioWave Medical Advisory Board. He is replacing the current interim CEO and Founder Dr. Gregory Kovacs. Dr. Kovacs will continue as Chairman of the Board at PhysioWave. Dr. Cuttino has a distinguished background in clinical emergency medicine, healthcare administration and entrepreneurship.
Dr. Marsh Cuttino is a Board-Certified Emergency Physician and physician leader with experience in aerospace, disaster, and mass casualty medicine. He received his undergraduate education at James Madison University, and his medical degree from Virginia Commonwealth University. He completed his Emergency Medicine residency at the University of Florida (Jacksonville). He was on the faculty at Virginia Commonwealth University where he was a founding faculty member of the Emergency Medicine residency. He expanded and grew the medical simulation program there.Dr. Cuttino served as the Chairman of Emergency Medicine for the Henrico Doctors’ Hospitals system, and Medical Director of the HCA Henrico Doctors’ Hospital Forest Emergency Department for 10 years. As Regional President for Virginia with ApolloMD (Atlanta, GA) he was responsible for contract management for 15 hospitals in central Virginia with over 500 physicians and advanced practice providers. Dr. Cuttino then served as a System Medical Director TEAMHealth (Knoxville, TN) prior to joining PhysioWave. An FAA Senior Aviation Medical Examiner, he has provided past medical support for NASA Space Shuttle operations from 1994-1998. He has an operational research background in microgravity, including extensive parabolic flight campaigns, and has flown 2 projects to space as a NASA Principal Investigator. He assists with microgravity flights for ZeroG corporation and is a medical advisor to the Commercial Spaceflight Federation.
PhysioWave Receives FDA Clearance for Breakthrough Pulse Wave Velocity Cardiovascular Analyzer
“The new device measures PWV, shown to be an independent biomarker for assessing cardiovascular risk, with no appreciable change to patient workflow.”
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.
PhysioWave Introduces PhysioWave Pro™ for Pulse Wave Velocity Measurement at the Annual American Heart Association Meeting
PhysioWave, Inc, a developer of cardiovascular risk assessment instruments, is introducing the company’s new PhysioWave Pro™ device at the annual American Heart Association meeting being held in Anaheim, CA, November 11 through 15, 2017. The new device is designed to provide a straightforward method for healthcare providers to measure Pulse Wave Velocity (PWV) quickly and easily during patient intake (during weighing) for routine physical examinations. PWV is a clinically validated biomarker for the detection of potential cardiovascular (CV) risk.
“Multiple studies over the past several years, including the Framingham study published in 2010, have identified the measurement of PWV as one of the key biomarkers in assessing CV risk,” said Judith Swain, MD, Chief Medical Officer of PhysioWave. “Until recently, measurement of this biomarker would require a dedicated room and technician at substantial expense. With the PhysioWave Pro™, it will soon be as simple as stepping on a weighing scale to capture this critical measurement and help guide the physician’s next course of action.”
PWV measures arterial stiffness, which can be a precursor to possible future cardiac events. Arterial stiffness relates to the material properties of the arterial wall which, according to a scientific statement from the American Heart Association published in Hypertension in 2015, has functional consequences for the artery because it affects how pressure, blood flow and arterial diameter change with each heartbeat. The statement also indicates arterial stiffness is a major determinant of vascular impedance, and can modulate the pressure/flow relationship.
“Such studies have led researchers to conclude that higher aortic stiffness assessed by PWV is associated with increased risk for a first cardiovascular event,” said Laurent Giovangrandi, PhD, Chief Technical Officer and co-founder of PhysioWave. “The PhysioWave Pro™ is meant to provide a first-line assessment which can be used in the office. Depending on the assessment results, the clinician will be able to make more informed decisions on additional testing or additional therapy, which can be as direct as simple lifestyle changes.”
The PhysioWave Pro™ is an arterial pulse sensing technology, that is designed to provide PWV measurements in less than a minute, without disrupting clinical workflow. The technology is covered by multiple patents, and PhysioWave executives are anticipating a decision on their 510(k) application by the FDA early next year.