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CVR Medical Corp. (CVM.V)

TSXV - TSXV Real Time Price. Currency in CAD
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0.01500.0000 (0.00%)
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  • E
    Evan
    Down 96%. Have they finally closed up shop?
  • J
    JrSr
    CVR halted trading 7:45am today
  • 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."
  • 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
  • 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!
  • 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.
  • J
    Jeky
    Can some one explain if there is any explanation to what is happening now? We are waiting for trials to finish the one that was not started as they run out of money and all trials were stopped and needs to be restarted. So XCEO or whatever their position was already not with the company and took money and left all the mess to others. The stock is not traded and who knows when it comes back. In at the give up point but have no choice and have to hold the stocks as I can't sale them even with loss. Any other ideas?
  • L
    Larry
    I sent them an urgent request for info on their website contact form, to a guy named Ludlow as i recall. so far no answer or acknowledgement at all. This is pretty discouraging, for a company with a patented device that could save so many lives. What can we do to find out what's going on? Anybody know if there are any Canadian gov. sources of info?
  • J
    JrSr
    Dr. Dallas Hack interim CEO/CFO and Director stated, "We are grateful for the contributions of Peter Bakema. On behalf of the Company and our stakeholders, we extend our sincerest appreciation for his dedication to advancing the commercialization of the CSS device, we wish him all the best. We are currently speaking with numerous individuals to serve in both Executive and Director level roles and will keep all of our stakeholders abreast of our progress." Dr. Hack went on to say, "Our focus in the very near term is to complete and file our Q3 financials, continue dialogue with the Canadian Regulatory bodies pertaining to the Trading Halt and prepare the necessary documents pertaining to the Annual Shareholders meeting which is set for January 15, 2020."
  • J
    JrSr
    Resignation and Termination of Term Sheet Due to Review of the Two Alternate Proposals Received from its Former CEO and CVR Global

    Vancouver, British Columbia--(Newsfile Corp. - March 9, 2020) - CVR Medical Corp. (TSXV: CVM) (OTCQB: CRRVF) ("CVR Medical" or the "Company" or "we" or "us" or "our") a Canadian listed and US based healthcare company in the medical device sector announces, effective immediately, Dr. Dallas Hack has resigned from the Company as a result of "Material Differences with the Board of Directors, the ongoing related party, common control and conflicts of interest with its former CEO and CVR Global Inc. ("CVR Global" or "Global") all of which continue to hamper the Company's ability to raise capital." Dr. Hack has served as the interim CEO, CFO and also as a Member of the Board of Directors. Additionally, the company has ceased dialogue with certain former members of the management team and board who resigned in 2019, who have been negotiating on behalf of an investment group looking to fund and revive the company. Dr. Dallas Hack, has worked tirelessly and heroically since assuming these roles, at a great financial sacrifice, and has loaned the company almost USD$100k in order to pay for its limited ongoing operations. Wayne Hellman and Joel Kanter notified Dr. Hack of the Termination of the Non-Binding Term Sheet which was executed on November 25, 2019 by them on behalf of the investor group, CVR Medical, CVR Global and its former CEO. A brief summary of those terms and conditions of the Non-Binding Term Sheet are as follows:

    Former CEO to receive USD $10,000 per month for 24 Months as Severance
    25M Shares of CVR Medical to be released from escrow (subject to 3-year Lock-up on all 36.6M Shares held by Global)
    Upon achieving FDA approval and achieving Sales, a Royalty of 7% on all Device Sales (less discounts) and a Royalty of 3% on all consumable sales (less discounts) was to be paid to Global
    CVR Medical would only be responsible for any AP accrued on its own books and would
  • N
    Nathaniel
    With Canon Relationship even stronger with their financial arm providing the financing, and all the top tier medical trials, this thing is legit and big names getting behind it. Back that bank truck up baby!
  • N
    Nathaniel
    Lubow just announced he resigned. Key Directors and others leaving. Distancing themselves from the FRAUD perpetrated by the CEO.
  • F
    Finooche
    There are 3 things i see that may give the css from cvr an edge...
    1- the ultrasound screening requires a trained technician and the css from cvr does not. Not sure exactly how big an advantage that is, but it is indeed an advantage.

    2- even with a ultrasound cost at 150$, the css from cvr is projected to cost 100$

    3- the big one- the new css device will cost 49k to purchase compared to 250k for an ultrasound device. resulting in more devices being bought, in theory of course
  • J
    Jeky
    someone please tell me what are we doing now with the stocks, hold until when? what's the next step the company is doing to bring the trading back? is there any light in the end of this tunnel?
  • 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.
  • J
    JrSr
    Listened into the conference call earlier today and info on FDA submission (they meet Friday) was of interest as well as timelines for production and discussion on latest warrant amendment, along with discussion on the China LOI. Call will be up on the webiste if you are interested. Stock up over 7% at this time.
  • j
    joe
    What has management done to this company? There was potentially successful product yet the company is almost into bankruptcy with serious legal issues yet management takes good care of themselves and keeps draining the company of funds.
    Doesn’t seem like responsible management and and the board sits by and let’s this happen. All seem derelict of their duties to the stock holders.