On August 14, 2018, CVR Medical Corp. (CVM-TSX; CRRVF-OTCQB) announced that it has retained the services of Minneapolis-based medical device consulting firm, JD Lymon Group (www.jdlymon.com), to provide reimbursement guidance and help support CVR's FDA submission of its Carotid Stenotic Scan (CSS) device for U.S. market clearance by providing clinical trial design support.
JD Lymon has more than 70 combined years of medical device and pharmaceutical experience across the firm’s partners, with a focus on accelerating market access through multidisciplinary strategies that address the complex interrelationship between policy, evidence, and practice to optimize the market position of emerging therapies.
Specifically, JD Lymon will be guiding CVR through the complicated and evolving reimbursement landscape. This will be done by designing the clinical trials in support of FDA submission, payer advocacy, and overall medical reimbursement coding needs.
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Snapshot
CVR Medical Corp. is a medical technology company developing and commercializing a revolutionary device to assess carotid arterial health. The technology is intended to quickly and cost-effectively identify patients with arterial narrowing, which puts them at risk for ischemic stroke, in order to enable early intervention. Performed in a primary care physician’s office, the Company’s Carotid Stenotic Scan (CSS) uses low frequency sound wave analysis to non-invasively 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 (blockage)—which is the leading risk factor for stroke. The CSS, which can be performed within two minutes by a medical technician in the office, costs less than invasive diagnostics, such as duplex Doppler ultrasound (DUS), magnetic resonance angiography (MRA), computed tomography angiography (CTA), or cerebral angiogram, and provides results at the point of care. Stroke is a very serious medical condition that requires immediate emergency care as it can cause lasting brain damage, long-term disability, or death. Primary care physicians currently lack a cost-effective tool to initially assess their patients’ arterial health. The CSS device is undergoing final phase trials at several world-renowned medical institutions and is positioned for imminent U.S. FDA submission, expected to be followed by market clearance and launch—targeted for 1H 2019.
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