CVR Medical Corp
CVR Medical Corp is a Canadian-listed, US-based medical device company developing the Carotid Stenotic Scan (CSS), a non-invasive diagnostic tool using subsonic, infrasonic, and low frequency sound wave analysis to detect carotid arterial stenosis in at-risk patients. The company is pre-commercial, awaiting FDA clearance.
- Company typePublic
- Founded2016
- HeadquartersVancouver, Canada
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What CVR Medical Corp does
CVR Medical Corp. is a Canadian-listed, US-based medical device company developing the Carotid Stenotic Scan (CSS), a diagnostic tool that uses proprietary subsonic, infrasonic, and low frequency sound wave analysis to detect and measure carotid arterial stenosis for identifying patients at risk for ischemic stroke. The company is in pre-commercialization: the original FDA De Novo submission was filed in January 2019 and withdrawn in September 2019 due to capital constraints, and no re-submission has been disclosed. The device is intended for primary care physicians, hospitals, and clinics to screen asymptomatic at-risk patients — a population that current ultrasound products do not address. The CSS is designed to be non-emitting and non-invasive, positioning it as a complementary front-line screening tool to Duplex Doppler Ultrasound.
The business model is contingent on FDA clearance and is structured around hardware sales of the CSS device plus recurring revenue from associated disposable medical items. Under the November 2022 amended restructuring agreement with CVR Global Inc., CVR Medical holds an exclusive global license to all relevant IP for a 5% royalty on sales of the CSS, its future renditions, and disposables. Operational control is split between a Vancouver, BC headquarters and a Denver, US presence, with clinical trials conducted at Mayo Clinic, Cleveland Clinic, Thomas Jefferson University, and Henry Ford Hospital. Commercialization, reimbursement, and regulatory readiness are supported by Canon Financial Services (leasing), ICR Healthcare (IR/PR), JD Lymon Group (reimbursement strategy), and Hyman, Phelps & McNamara (FDA regulatory counsel).
The company is publicly traded on the TSX Venture Exchange (CVM.H, NEX) and OTCQB (CRRVF), with approximately 126.4 million shares outstanding and 6.1 million stock options. Historical indicators raise execution risk: two cease trade orders (2020 and 2022), three CEO transitions in roughly 22 months, board and CFO departures, and minimal disclosed funding (the only recent raise was a CDN$150,000 non-brokered private placement in January 2022). Revenues are not disclosed and the company is effectively pre-revenue until FDA clearance is achieved and the CSS is re-submitted.
CVR Medical Corp firmographics
Firmographics- Name
- CVR Medical Corp
- Legal name
- CVR Medical Corp.
- Website
- https://cvrmed.com
- Company type
- Public
- Founded year
- 2016
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- CVR Medical Corp is a Canadian-listed, US-based medical device company developing the Carotid Stenotic Scan (CSS), a non-invasive diagnostic tool using subsonic, infrasonic, and low frequency sound wave analysis to detect carotid arterial stenosis in at-risk patients. The company is pre-commercial, awaiting FDA clearance.
- Ownership category
- akta.pro rank
CVR Medical Corp industry classification
Industry- Product category
- Cardiovascular Diagnostic Medical Devices
- NAICS
- Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)
- SIC
- Surgical & Medical Instruments & Apparatus (3841)
- akta.pro primary industry
- Hemodynamic Monitoring & Cardiac Diagnostics (Cath Lab, FFR/IVUS/OCT) (HLAHAFAI)
- akta.pro secondary industries
- Thrombectomy, Embolic Protection & Stroke Intervention Devices (HLAHAFAJ), Personal Medical Devices & Home Diagnostics (Thermometers, Blood Pressure Monitors, Glucose Meters, Rapid Tests) (CRADAMAK)
Keywords
Where CVR Medical Corp is headquartered
LocationHeadquarters
- HQ city
- Vancouver
- HQ country
- Canada
- HQ region
- North America
Offices2 records
Markets served
CVR Medical Corp business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Marketing or Sales, Operations, Supply Chain
Revenue model
- CSS Medical Device Sales: Revenue anticipated from commercialization of the Carotid Stenotic Scan (CSS) diagnostic device. The device is designed for use by healthcare providers to assess carotid arterial health. Under the amended restructuring agreement, CVR Global Inc. receives a 5% royalty on all sales of the CSS, future updates/renditions of the CSS, and associated disposable medical items.
- Disposable Medical Items: Revenue from associated disposable medical items used with the CSS device. A 5% royalty is paid to CVR Global Inc. on sales of disposables.
- Future Technology/IP Applications: With full control of the IP acquired through restructuring, CVR Medical can pursue other avenues the IP allows, potentially developing additional technology and devices utilizing the subsonic, infrasonic, and low frequency sound wave analysis technology beyond the CSS.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels5 records
CVR Medical Corp product offering
Product offeringCore offering
CVR Medical Corp is developing the Carotid Stenotic Scan (CSS), a patented diagnostic medical device that uses proprietary subsonic, infrasonic, and low frequency sound wave analysis technology to detect and measure carotid arterial stenosis for identifying patients at risk for Ischemic Stroke. The device is designed for use by primary care physicians to evaluate asymptomatic, at-risk patients. The CSS is non-emitting and non-invasive, and is currently in the FDA De Novo approval process with clinical trials conducted at Mayo Clinic, Cleveland Clinic, Thomas Jefferson University, and Henry Ford Hospital.
Product overview
CVR Medical Corp offers a single unified medical device product: the Carotid Stenotic Scan (CSS). The CSS is a patented diagnostic tool that encompasses subsonic, infrasonic, and low frequency sound wave analysis technology, designed to detect and measure carotid arterial stenosis for identifying patients at risk for Ischemic Stroke.
Differentiator
Problem solved
Functional benefit
Products and services
- Carotid Stenotic Scan (CSS) A patented diagnostic medical device that uses subsonic, infrasonic, and low frequency sound wave analysis technology to detect and measure carotid arterial stenosis for identifying patients at risk for Ischemic Stroke. Designed as a non-emitting, non-invasive tool for use by primary care physicians to assess asymptomatic, at-risk patients.
Quantifiable outcome
- CSS Device Has To Date Exceeded Expectations for Specificity and Sensitivity Compared to Duplex Doppler Ultrasound
- +1 more outcomes
Companies that use CVR Medical Corp
Customer profileSegments3 records
Ideal customer profiles2 records
CVR Medical Corp technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability2 records
Feature3 records
CVR Medical Corp partnerships and signals
Strategic signalPartnerships
Nine partnerships are on record, tiered core and supporting.
- CVR Global, Inc.coreCVR Global Inc. has exclusively licensed to CVR Medical Corp. all the Intellectual Property (IP) for all potential uses in exchange for a 5% royalty on all sales of the Carotid Stenotic Scan (CSS), future updates/renditions of the CSS and associated disposable medical items. The November 2022 Amended Restructuring Agreement replaced the original 2018 agreement, reducing royalty from 8% to 5% and removing restrictions on IP use. CVR Global receives no additional equity position in CVR Medical Corp. under the new agreement.
- Canon Financial ServicessupportingCVR Medical announced prospective collaboration with Canon Financial Services for leasing of the Carotid Stenotic Scan (CSS) device. The company stated it is in negotiations with Canon for providing equipment leasing arrangements to healthcare customers.
- Mayo CliniccoreMayo Clinic's Gonda Vascular Center provided Internal Review Board (IRB) approval sanctioning CVR to conduct clinical trials using the Carotid Stenotic Scan (CSS) device. Thanila A. Macedo, M.D., Professor and Radiologist at Mayo Clinic Rochester leads the clinical trial as Primary Investigator. Mayo Clinic is recognized for high-quality patient care and was ranked the best hospital in the nation by U.S. News & World Report in 2018-2019 rankings.
- Cleveland CliniccoreCleveland Clinic is one of the leading research institutions conducting clinical trials for the CSS device. The company has been conducting clinical trials at several preeminent research institutions.
- Thomas Jefferson UniversitycoreThomas Jefferson University is one of the leading research institutions conducting clinical trials for the CSS device as part of the pivotal trial process.
- Henry Ford HospitalcoreHenry Ford Hospital is one of the leading research institutions conducting clinical trials for the CSS device as part of the pivotal trial process.
- Hyman, Phelps, & McNamara, P.C.supportingRegulatory consultants from Hyman, Phelps, & McNamara, P.C. attended the FDA meeting on May 31, 2019 and provided guidance on the De Novo submission process, proposed Indications for Use, and clinical implementation plan.
- JD Lymon GroupsupportingMinneapolis-based JD Lymon Group provides reimbursement and study design support for the CSS device. The firm specializes in healthcare reimbursement strategy and clinical study design consulting.
- ICR HealthcaresupportingNYC-based ICR (established 1998) provides investor relations and public relations services to support the company's communications and marketing activities as it explores a US National Market listing and advances toward regulatory submission for the CSS device. ICR Healthcare is a specialty practice within ICR serving clients in biopharmaceutical, MedTech, HCIT and healthcare services sectors.
Scale indicators4 records
Recent moves6 records
Expansion highlights5 records
CVR Medical Corp competitors and assessment
Company assessmentBroad incumbents
- GE HealthCare: GE HealthCare is a major incumbent in diagnostic imaging including ultrasound systems used for carotid Doppler studies. Comparable as the dominant incumbent in the imaging modalities (Doppler ultrasound) that CSS would compete against or complement.
- Philips Healthcare: Philips Healthcare is a leading provider of ultrasound and cardiovascular imaging systems used in carotid stenosis screening. Comparable as the incumbent whose ultrasound platform CSS would need to displace or augment in primary care workflows.
- Edwards Lifesciences: Edwards Lifesciences is a major cardiovascular medical device incumbent with diagnostic and monitoring products. Comparable as a large, established player in cardiovascular diagnostics and structural heart devices, although broader portfolio than CSS.
- Medtronic: Medtronic is a global medical device incumbent with extensive cardiovascular, neurovascular, and diagnostic product lines. Comparable as a broad incumbent operating across stroke and cardiovascular diagnostics, although far larger and more diversified than CVR Medical.
Direct peers
- Penumbra: Penumbra develops interventional therapies for stroke and vascular disease, including thrombectomy systems. Comparable as a focused medtech company addressing ischemic stroke through novel device-based approaches.
- Silk Road Medical: Silk Road Medical develops devices specifically for carotid artery disease, including the TCAR (transcarotid artery revascularization) procedure. Directly comparable as a carotid-focused medical device company addressing stroke risk through novel intervention.
Emerging players
- HeartFlow: HeartFlow provides non-invasive cardiac diagnostic technology (FFR-CT) for coronary artery disease assessment. Comparable as a non-invasive diagnostic platform that brings advanced cardiovascular imaging to frontline care settings.
- Elucid Bioimaging: Elucid develops AI-based cardiovascular imaging software for non-invasive plaque and stenosis characterization. Comparable as a non-invasive cardiovascular diagnostic company targeting similar carotid/atherosclerosis clinical questions.
- Inspire Medical Systems: Inspire Medical Systems is an emerging medtech company that has built a novel implant-based therapy into a commercial franchise via specialist-to-primary-care expansion. Comparable as a smaller medtech that grew through a single novel device into broader clinical adoption.
Others
- AngioDynamics: AngioDynamics is a peripheral vascular and thrombus management medical device company with products overlapping stroke and vascular disease. Comparable thematically as a peripheral-vascular-focused medtech, although their products are interventional rather than diagnostic.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat3 records
Key risks6 records
Key highlights6 records
Customer concentration
CVR Medical Corp social profiles
Digital presenceCVR Medical Corp financial estimates
Financial estimateRevenue estimate
Valuation estimate
CVR Medical Corp leadership team
Management profileNumber of profiles
Profiles8 records
CVR Medical Corp funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
CVR Medical Corp M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about CVR Medical Corp
What does CVR Medical Corp do?
CVR Medical Corp is developing the Carotid Stenotic Scan (CSS), a patented diagnostic medical device that uses proprietary subsonic, infrasonic, and low frequency sound wave analysis technology to detect and measure carotid arterial stenosis for identifying patients at risk for Ischemic Stroke. The device is designed for use by primary care physicians to evaluate asymptomatic, at-risk patients. The CSS is non-emitting and non-invasive, and is currently in the FDA De Novo approval process with clinical trials conducted at Mayo Clinic, Cleveland Clinic, Thomas Jefferson University, and Henry Ford Hospital.
Is CVR Medical Corp a public or private company?
CVR Medical Corp is a public company. It is classified as public and is currently operating.
When was CVR Medical Corp founded?
CVR Medical Corp was founded in 2016. It employs 11 to 50 people.
Where is CVR Medical Corp based?
CVR Medical Corp is headquartered in Vancouver, Canada, in the North America region.
How does CVR Medical Corp make money?
Three revenue lines are on record. CSS Medical Device Sales are the primary driver. The others are disposable Medical Items and future Technology/IP Applications.
Who are CVR Medical Corp's main competitors?
Broad incumbents on record are GE HealthCare, Philips Healthcare, Edwards Lifesciences and Medtronic. Direct peers are Penumbra and Silk Road Medical. Emerging players are HeartFlow, Elucid Bioimaging and Inspire Medical Systems. AngioDynamics is listed as an others.
Does CVR Medical Corp have an API?
No public API is recorded for CVR Medical Corp.
What industry is CVR Medical Corp in?
CVR Medical Corp's product category is Cardiovascular Diagnostic Medical Devices. Its primary akta.pro industry code is HLAHAFAI, Hemodynamic Monitoring & Cardiac Diagnostics (Cath Lab, FFR/IVUS/OCT), with a secondary code of HLAHAFAJ, Thrombectomy, Embolic Protection & Stroke Intervention Devices. Its NAICS code is 334510 and its SIC code is 3841.