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CVR Medical Corp. (CVM.V)

TSXV - TSXV Real Time Price. Currency in CAD
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0.0500-0.0050 (-9.09%)
At close: 9:30AM EDT
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  • d
    dan
    We finally made it to 0.00
  • h
    herbb
    Need some news.
  • h
    herbb
    I hope they are advancing their technology and will be updating up soon. They are supposed to updates up about the restructuring and nothing.
  • h
    herbb
    Let's hope this week we see a nice run. The COVID vaccination should help them get back to testing. I hope by summer we are above the teens. I hope we hear news of new product line, but want to at least complete the first product.
  • B
    Big
    Any news on this thing?
  • l
    lillian
    Wonder why they don’t get sponsors investors with deep pockets?... they should go on Shark Tank....wonder if product is all it’s cracked up to be...
  • h
    herbb
    All the news they provided are updates about new staffing and commitment on working on the machine, but no updates on the progress of testing or intent to resubmit. It's been two year so they should have done some testing or updates.
  • d
    dan
    CVR Medical Corp. Message from the Chief Executive Officer
    Vancouver, British Columbia--(Newsfile Corp. - February 9, 2021) - CVR Medical Corp. (TSXV: CVM) (OTC: CRRVF) ("CVR Medical" or the "Company" or "we") a Canadian listed and US based healthcare company in the medical device market is pleased to share an update from new Chief Executive Officer (CEO) Michael Rhodes:

    The Board of Directors is continuing to make progress on the terms of a restructuring agreement with input and guidance from me and Harvey McKenzie. We expect to be able to publish a circular with the proposed terms and conditions within the next few weeks to provide sufficient time for our shareholders to review ahead of the Annual General Meeting / Special Meeting to be scheduled thereafter.

    A key element of the restructuring agreement is to ensure CVR Medical has total and unincumbered ownership of all intellectual property. Giving us the freedom to apply the non-emitting, non-invasive science and solutions behind the Carotid Stenotic Scan (CSS) to applications beyond the carotid artery. Opening the way for new stand-alone or integrated products in the future.

    I am pleased to report that all of the Duplex Ultrasound centers of excellence that we are working with remain enthusiastic about the CSS technology and are looking forward to being a part of proving its efficacy in identifying patients at risk for stroke. They have indicated that they will be ready to resume their research projects and support clinical trials once their local communities have established some measure of control over the COVID-19 virus. It is not possible to predict precisely when this will be, but it affords us time to work with the FDA to ensure that our response and plans to action their feedback on the original De Novo submission fulfills all requirements prior to commencing the final phase of multi-center clinical trials.

    On another positive note, our strategic partners and suppliers remain committed to producing the CSS and associated peripheral devices and we have begun to identify how to best leverage their significant expertise beyond the current scope. We are in the first phase of these discussions and there are clearly opportunities in areas such as supply chain, manufacturing, aftermarket services and technical support. I look forward to sharing more information in the coming weeks.
  • h
    herbb
    No action. What's going on?
  • d
    dan
    Now .11. Anybody know why?
  • l
    lillian
    This stock is hopeless.
  • h
    herbb
    Good movement yesterday, but need good news to support this level and climb higher. Management seems to be keeping us updated, However I wish there were news on the status of testing and manufacturing. Updates on timeline they expect to resubmit.
  • A
    AL
    Let's not forget this article 7 months ago, Usually these trials take a year, So August we should be hearing something from the FDA.
    With more than 70 combined years of medical device and pharmaceutical experience across the firm's partners, JD Lymon focuses on accelerating market access through multi-disciplinary strategies that address the complex interrelationship between policy, evidence, and practice in order to optimize the market position of emerging therapies. Specifically, JD Lymon will be guiding CVR through the complex and ever 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.
    CVR Medical Chief Operating Officer, Tony Robinson, stated, "As we prepare our FDA submission and eventual market release for the CSS device, the JD Lymon team will apply its insights and experience to help map out and articulate a reimbursement pathway to government and commercial payors.
    Chris Lyle, Partner at JD Lymon, states, "We are honored to be selected by CVR to support their market access and study design needs. We understand the reimbursement challenges faced by small companies and emerging technologies. We look forward to a great collaboration and advancing the CSS System."
  • M
    Michel
    debts is more then the assets
  • J
    JrSr
    This email is to provide a news update from CVR Medical Corp. CVR Provides Letter to Shareholders

     

    DENVER, NC / August 30, 2019, / CVR Medical Corp. (CVM.V) (TSXV: CVM) (OTCQB: CRRVF) ("CVR Medical” or the “Company”) a Canadian listed and US based healthcare company in the medical device sector provides the following letter, which was sent to shareholders of the Company:
     

    Dear CVR Medical Shareholder,
     
    After a silence which spanned far longer than both you, and I, deem to be reasonable I am taking this opportunity to shed some light on the current status and trajectory of CVR Medical Corp. Over the past quarter we have all been very frustrated with many aspects of this venture, many of which were not plainly apparent to those of you following the project. The primary cause of this frustration has been the delayed submission of our 2018 independent audit, both halting the ability to trade on the TSX-V and greatly impairing the progress of the Carotid Stenotic Scan (CSS) on its path to market. Many variables come into play with the audit; the previous accounting practices of prior members of the CVR team, a lack of true understanding of the relationship between CVR Medical Corp. and CVR Global Inc. after the restructuring enacted in 2018, as well as frustration on the part of the internal audit committee with the current structure of the organization. I personally take responsibility for the failure of establishing clear communication and collaboration between all parties involved. This lack of foresight allowed for what should have been an insignificant speed bump to become a major roadblock. As it became apparent that critical components, both internally and externally, were going to delay the release of the audit, the timeline was always communicated as being near completion to both myself and management. This lack of communication allowed for the issue to escalate and span a timeframe which is wholly unacceptable.
     
    Even though the delay of the audit was a standalone situation, it had wide ranging impact on many aspects of the overall project, specifically our timeline to market and the ability to raise the funds necessary to meet the milestones previously communicated. Following the De Novo submission of the CSS to the US Food and Drug Administration (FDA) in January 2019, feedback was received from the FDA within the allotted time regarding perceived deficiencies and recommendations for submission enhancement. Immediately upon receipt of this communication an in-person meeting was requested with the FDA for clarification and was conducted on May 31, 2019. The meeting was attended by the expert review team assigned to the submission by the FDA, as well as representatives from CVR’s leadership, clinical advisory board members, and regulatory consultants from both Hyman, Phelps, & McNamara, P.C. & J.D. Lymon. The primary purpose of the meeting was to receive feedback and clarification on several topics; specifically, CVR’s proposed Indications for Use, amended clinical substantiation plan (including statistical justification), and outline overall submission trajectory. We came out of this meeting feeling very confident in the understanding of FDA recommendations with a clearly defined pathway to approval, and our ability to work with them in amending the required documentation, conducting additional testing, and updating the overall clinical implementation plan (CIP). Though these tasks seemed onerous, internally we felt confident it could be conducted quickly, with the major hurdle being the additional (~244) patients required under the updated CIP to acquire the statistical justification requested by the FDA. Based on our current clinical footprint and the projected recruitment rate it was estimated that the data could be obtained in time to potentially hit our targeted 2H 2019 market clearance based on prior submission metrics. Our timeline has always been based on the premise that we are functioning at 100% capacity, both organizationally and financially. This then is where the audit delay and the timeline directly oppose each other to the detriment of the project. Without the ability to raise funding to support our clinical substantiation, a major cost within our budget, we lack the necessary capital to acquire the clinical data necessary. Though we continue to collect data, the rate of collection had to be slowed due to capital limitations, therefore making it near impossible to complete the requisite updates to the current FDA submission within the mandatory window. Given the capital limitations, the current FDA submission time limit will expire September 25th, 2019 necessitating a new De Novo submission planned for the first quarter 2020. Once we are funded following this audit delay both myself, and our internal Clinical Advisory Board, believe that we will be able to collect the additional data in the required timeframe, allowing us to re-submit. This delay will push the targeted market
  • J
    JrSr
    Vancouver, British Columbia--(Newsfile Corp. - January 19, 2021) - CVR Medical Corp. (TSXV: CVM) (OTC: CRRVF) ("CVR Medical" or the "Company" or "we") a Canadian listed and US-based healthcare company in the medical device market is pleased to announce Michael Rhodes as Chief Executive Officer (CEO). Michael is a proven senior executive and has held several leadership positions at Fortune 100 and Fortune 500 Companies including Chief Quality Officer at Motorola Solutions Inc. based in Chicago and Global Head of Quality for Technology at HSBC in London. His experience spans a broad spectrum of industry sectors including Health Care, Communication Services, Financials and Information Technology with a strong record of focusing on customer experience, technology and process excellence to successfully drive product differentiation. Michael has an Electrical and Electronic Engineering background and significant program management experience delivering products and solutions on time and within budget for major clients including Shell, Motorola, Microsoft, Transport for London with key partners such as Bechtel, KPMG and Oracle.
    Michael Rhodes advanced the medical device development lifecycle model that drives best practices and helps to ensure that all laws and regulatory requirements are met prior to FDA submission. The lifecycle model integrates FDA guidance and FDA recognized quality standards at every phase of the product development process, ensuring timely design reviews and essential risk management actions are identified and managed throughout the life of the project.

    Michael Rhodes comes to CVR Medical Corp. with the clear vision of bringing the Carotid Stenotic Scan (CSS) through FDA clearance and to the marketplace. The Board believes that Michael has the knowledge and expertise to navigate CVR Medical Corp. forward to successful introduction of the CSS including future upgrades and new innovations in sound technologies. Based on Michael's experience and track record, he is well positioned to lead CVR Medical Corp. forward to an anticipated successful future in the medical device industry.
  • E
    Evan
    Bill, which member of the company claimed that the CFO walked during the lapse of financial filing? The Executive Informational Overview dated 7-23-18 and the Full Investor Overview updated June ‘19 both have Tom Harris listed as CFO. I followed up with EVP Lubow and he replied that Mr. Harris joined the company in 2018 and is still currently their CFO. I am asking who your communication was with in hopes that we can see why there are conflicting stories. Thanks
  • J
    JrSr
    Vancouver, British Columbia--(Newsfile Corp. - January 25, 2021) - CVR Medical Corp. (TSXV: CVM) (OTC: CRRVF) ("CVR Medical" or the "Company" or "we") a Canadian listed and US based healthcare company in the medical device market is pleased to share a message from new Chief Executive Officer (CEO) Michael Rhodes:
    I am delighted to be offered the opportunity to lead CVR Medical Corp. as we focus on getting our Carotid Stenotic Scan (CSS) into the hands of primary care doctors so that patients at risk of ischemic stroke can be diagnosed earlier, helping to save lives and improve quality of life. The Board of Directors have worked diligently to restructure the business and my primary focus from day one is to create the team and drive the actions needed for a new De Novo submission at the earliest opportunity.

    I've had the advantage of working closely with the CSS engineering team and the regulatory consultants as a consultant to CVR Global during the original FDA application process and this has provided me with first-hand knowledge of the CSS device and its regulatory status. The FDA provided excellent feedback after the original De Novo submission and, to ensure ongoing alignment with the FDA and eliminate any potential ambiguity, I intend to use the FDA Q-Submission program to ensure that our response and plans to action their feedback is designed to meet FDA expectations from the outset. The project scope and timeline will quickly follow.
    It has been a little over 2-years since the original CSS De Novo submission and there is still no medical device on the market readily available to help primary care doctors evaluate at risk patients for carotid arterial stenosis. With stroke accounting for approximately 1 of every 19 deaths in the United States and total direct medical stroke-related costs projected to more than double to $94.3 billion by 2035, I believe that the CSS is uniquely positioned to solve the technical challenge and fulfill the urgent need to diagnose patients earlier.
    During the same period, we have seen new technologies gain a foothold and influence user expectations in the ultrasound arena. Unlike the CSS, these ultrasound products are not available for asymptomatic, at risk patients, but they have created greater interest in sonography which is to our advantage. They have also changed the form factor with increasing use of highly portable smartphone-based products, and we will thoroughly explore the market opportunity for smartphone or similar derivatives of the CSS for next generation products along with additional revenue streams such as software subscription. Achieving FDA clearance for the existing fully integrated cart-based CSS will pave the way for 510(k) submissions for future derivatives.
  • R
    Robert Barr
    By crunching numbers from other medical devices the projection leads us to a price of $.40-&.70 price as of August 2018. August of 2019 price of $2.50+. August 2020 $12.50. Depending on the sales force used, the acceptance of the medical community and merger possibilities the prices could just be the tip of the iceberg!