Cre8MDI is creating medical device innovations that will improve the quality of health care and reduce cost through prediction, early detection, and monitoring. The first product is a simple, low-cost, noninvasive, accurate method to measure aortic Pulse Wave Velocity (PWV).
Over 450 million people suffer from cardiovascular disease (CVD) – nearly 17 million will die from it this year. Unfortunately, clinicians do not have reliable and easy-to-use tools to assess risk or direct therapy. Researchers at the Framingham Heart Study, Johns Hopkins Hospital, and others have identified PVW as an early indicator of cardiovascular events. Cre8MDI’s technology provides a quick, reliable, and easy-to-use measurement of PWV in a simple, non-invasive, low-cost system that contains reusable sensors, single-use disposable components, and an instrument for user interface. The disposable portion gives patients peace of mind from infections while providing a continuous, high-margin revenue stream for the company.
Current technologies to measure PWV use expensive, complicated pressure measurements or even more expensive imaging (e.g., ultrasound and MRI) techniques. Cre8MDI has adapted bioimpedance measurements – similar to the methods for measuring ECG – to assess how fast pulses move through the major vessels. The innovation is in applying this method to measure PWV parameters, including the distance between two measurement points.
Pending patents cover capacitive impedance sensors, measurements in humans, sensors with embedded and modifiable data, determining arterial length in measuring PWV, and measuring arterial length using pressure wave propagation. Additional IP is in development and all IP is assigned to the company.
Cre8MDI was founded by David Cassidy. He has over 25 years’ experience in developing innovative medical devices, taking them from concept through production and launch, and authored numerous patents. His previous start-up, Enginivity, was sold 3 ½ years after its founding to GE Healthcare. Key people that contributed to Enginivity’s success have joined Cre8MDI: Marie Getchell as VP of Quality & Regulatory and Mark Lewis as VP of Operations and Manufacturing. Allison Reveley, VP of Marketing & Public Relations, and Roy Wallen, Chief Business Officer, complete the management team. Roy also brings over 25 years’ experience in successful, global commercialization of new medical technologies. Additional support is in software development, IP, and finance. Cre8MDI is supported by researchers at Johns Hopkins University as world leaders in PWV measurements and the University of Massachusetts for noninvasive cardiology and community health applications.
The WHO, CDC, European Society of Cardiology, and epidemiology studies in Japan show that over 300 million people live with CVD in the US, EU, Japan, and China with over 12 million additional cases diagnosed annually. Strong recommendations from global researchers and medical societies (European Society of Cardiology and European Society of Hypertension practice guidelines) have endorsed PWV as a gold standard for assessment for CVD. In the US where prevention lags Europe and Japan, the American Medical Association (AMA) has recommended reimbursement for noninvasive calculation and analysis of central waveforms to assess CVD. As a result of AMA endorsement, the US Centers for Medicare and Medicaid Services (CMS) have approved these arterial measurements for reimbursement. At annual meetings of medical societies, numerous papers are presented on PWV and point to expanded use of this measurement.
Initial commercialization is projected through distribution partners in order to validate the market and establish Cre8MDI as a revenue-generating company. The goal for widespread adoption of the technology is to establish a strategic partnership with a company that has global reach into a variety of clinical areas.
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