CVR Medical Corp. (“CVR Medical” or “the Company”) is a medical technology company dedicated to developing and commercializing a revolutionary device within the healthcare sector to assess carotid arterial health in a primary care physician’s office in order to quickly and cost-effectively identify patients at risk for stroke and enable early intervention.
Stroke is a serious medical condition that requires immediate emergency care as it can cause lasting brain damage, long-term disability, or death. As the fifth leading cause of death in the U.S., stroke results in one of 20 adult deaths, at cost of roughly $34 billion per year, with many of these deaths possibly preventable. While cardiac disease is the primary cause of death, stroke is the leading cause of long-term disability (50% of victims are permanently impaired).
The Company’s innovative Carotid Stenotic Scan (CSS) device uses low frequency sound wave analysis to detect and measure carotid arterial stenosis (narrowing of the blood vessels in the neck that carries blood from the heart to the brain) or occlusion (the blockage or closing of a blood vessel or hollow organ), which are the leading risk factors for stroke.
The stroke diagnostic market is currently devoid of cost-effective tools that primary care physicians and other healthcare providers can use to initially diagnose a patient’s risk of stroke prior to any symptoms or incidence. CVR Medical’s technology has been developed to address this void as its CSS device can be performed in a primary care physician’s office, is non-emissive (does not use harmful radiation to obtain a result), non-invasive, does not require a certified technician, and can be conducted within a few minutes.
CSS requires only a small footprint, and has a price per scan and cost requirement that is significantly lower than alternative stroke diagnostic technologies. With a proposed market price of $49,000, CSS is significantly less expensive than current diagnostic alternatives currently used to determine arterial health—including duplex Doppler ultrasound (DUS), magnetic resonance angiography (MRA), and computed tomography angiography (CTA)—which are priced as high as $2.5 million per device.
The CSS device is undergoing pivotal trials at several world-renowned medical institutions. These trials play a crucial role in accelerating substantiation for the CSS and shortening the FDA submission timeline for approval.
The Company’s CSS technology is being evaluated at Thomas Jefferson University Hospital in Philadelphia through the ENTICES (Evaluation of a Novel Technique to Investigate CAS piezo-Electric Sensors) Study, to evaluate CSS against current ultrasound technologies. Following promising results, Thomas Jefferson University Hospital is expected to begin pivotal trials imminently.
Another clinical trial at the Henry Ford Hospital in Detroit is underway. One device has been fully deployed, with two additional scheduled for the coming weeks.
In February 2018, the Company announced IRB approval by the Cleveland Clinic, sanctioning CVR to conduct clinical trials using the CSS device.
CVR Medical is transitioning from being a research company—undergoing clinical trials—into a full scale medical device sales and marketing company. The Company currently has a contract with Canon U.S.A., where Canon will manufacturer, assemble, service, and ‘white glove’ deliver the CSS to a doctor’s office. Canon brings significant value to the Company as it has a dedicated space with the ability to rapidly scale production.
CVR Medical has strong intellectual property (IP) position, including one issued patent, 13 patents pending, and over 20 patents under process, providing high barriers to entry, with significant IP surrounding its CSS.
The Company’s executive team consists of veterans from the medical device industry with business acumen from key areas in healthcare.