Here is some past news collectively, 2018:
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* CVR & U.S. FDA: A Meeting of the Minds
Concludes De Novo Pathway Best Suited
VANCOUVER, BC / May 9, 2018 / CVR Medical Corp. (TSX.V:CVM) (FRANKFURT: B3BN) (OTCQB: CRRVF) (“CVR Medical”) announces the receipt of official meeting minutes for their Pre-Submission meeting on March 23, 2018 with the U.S. Food and Drug Administration (FDA) regarding the Carotid Stenotic Scan (CSS) device and it’s upcoming FDA submission for market release. Attendees of the meeting included CVR management, regulatory consultant’s Duval & Associates, and key reviewers from the FDA. The purpose of the meeting was to receive feedback and define the necessary regulatory pathway, clinical trial substantiation requirements, and device testing.
cvrmedicalprefdasubmay2018Based on prior communication with the FDA and input provided by key regulatory advisors, CVR had considered the potential for either a 510k, De Novo, or PMA submission; with the De Novo being the preferred pathway. During the meeting these topics were discussed and in follow-up communication the FDA team stated the CSS was sufficiently different from other devices on the market today to decide the De Novo pathway was best suited, which is designed for low to moderate risk novel devices.
CVR COO Tony Robinson states, “The pre-submission meeting went as expected. The CVR leadership team had quality dialog with the FDA reviewers, resulting in meaningful clarity and understanding of the project for both sides. We truly value the FDA’s input, alleviating much of the concern stemming from questions about the direction and pathway of the project. Upon further discussion, we understand the clinical trial requirements will
fall within the previously expected range. Altogether, I believe we align with the FDA on this undertaking, and CVR is poised for our upcoming submission and subsequent approval.”
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* Canon Showcasing Carotid Stenotic Scan (CSS) At NPE The World’s Leading Plastic Tradeshow
VANCOUVER, BC / May 7, 2018 / CVR Medical Corp. (TSX.V:CVM) (FRANKFURT: B3BN) (OTCQB: CRRVF) (“CVR Medical”) is pleased to announce that Canon Virginia, Inc. (CVI) will be showcasing our Carotid Stenotic Scan (CSS) at NPE 2018: The Plastics Show, the world’s leading plastic tradeshow. Canon Virginia, Inc. (CVI), a wholly owned subsidiary of Canon U.S.A., Inc., provides custom manufacturing solutions, including mold making, injection molding, medical contract manufacturing and automated assembly capabilities. NPE Participants includes buying teams from over 100 countries and more than 20,000 companies comprising the entire global plastics supply chain. NPE draws over 2,000 exhibiting companies, 65,000 manufacturing representatives from every segment of the plastic industry and its vertical markets including, medical devices and supplies, automotive, building and construction, packaging and consumer products.
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* Tom J. Harris Former CFO At Time Warner Cable And Associated Press Appointed Chief Financial Officer Of CVR Medical
VANCOUVER, BC / May 1, 2018 / CVR Medical Corp. (TSX.V:CVM) (FRANKFURT: B3BN) (OTCQB: CRRVF) (“CVR Medical”) has appointed Mr. Tom J. Harris to the position of Chief Financial Officer effective May 1, 2018. As CVR transitions to a sales and marketing focused company, Mr. Erwin Wong retires from his position as CFO. Tom J. Harris will spearhead fiscal preparations while contributing to overall organizational expansions as CVR continues its shift from research and development to a sales and marketing focus for the upcoming launch of their flagship medical device, the Carotid Stenotic Scan (CSS).
Over a career spanning nearly 50 years, Mr. Harris has held various senior executive roles within both public and non-public companies, including Time Warner, Inc., the Associated Press, and several development stage and start-up entities within the biotech and medical device industries. Mr. Harris played a key role in the successful Initial Public Offering of American Television and Communications Corporation, predecessor to Time Warner Cable (TWC), as well as leading the effort to decentralize the TWC’s operations into several dozen autonomous operating units. While serving as CFO of TWC, Mr. Harris lead the efforts to structure, finance and complete several multi-billions dollar (and smaller) acquisitions, and successfully integrate the acquired businesses into TWC, and manage a financing and capital allocation process that resulted in $5 billion in capital investments to improve and increase TWC’s operating footprint.
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* CVR Medical Bolsters Board Appoints Wayne Hellman Vice-Chairman
VANCOUVER, BC / May 1, 2018 / CVR Medical Corp. (TSX.V:CVM) (FRANKFURT: B3BN) (OTCQB: CRRVF) (“CVR Medical”) is pleased to announce the addition of Mr. Wayne Hellman to its Board of Directors and appointment as Vice-Chairman. Mr. Hellman will assume an active role focused on the continued development and upcoming launch of CVR Medical’s novel medical device, the “Carotid Stenotic Scan (CSS).” Mr. Hellman’s career spans forty years having spent 16 years in various senior management roles with General Electric, culminating with the final four years reporting directly to Jack Welch (Chairman/CEO) where he led GE’s Venture Lighting Portfolio. In 1983, Mr. Hellman founded Advanced Lighting Technologies and served as its Chief Executive Officer until his retirement in 2014. Advanced Lighting Technologies, a Global Leader in Specialty Chemicals, Advanced Materials, Thin Film Coatings, Metal Halide Lighting and other Specialty Lighting Products launched with first year sales of $900,000. During his tenure, Mr. Hellman maintained consistent revenue growth and expanded global influence achieving Global revenue in excess of $250M. With manufacturing facilities and sales offices in 9 countries, employee headcount in excess of 1,000, completing 7 acquisitions and four international joint ventures in the Asian Pacific market, in 1995, Mr. Hellman led Advanced Lighting’s Initial Public Offering. In addition, he completed three secondary offerings totaling $200M, as well as completing a $100M high yield debt offering. Mr. Hellman took the Company private in 2003 and prior to his retirement, in 2012 he led and completed an additional $170M High Yield Debt Offering where a significant amount was a distribution to the company’s shareholders.
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* Second Trial Data Report: Clinical Substantiation for CVR Medical
VANCOUVER, BC / March 7, 2018 / CVR Medical Corp. (TSX.V: CVM) (FRANKFURT: B3BN) (OTCQB: CRRVF) (“CVR Medical”) advisory staff member Dr. Phillip J. Bendick, PhD, has completed his second clinical report summarizing additional data collected from tertiary clinical trials for the Carotid Stenotic Scan (CSS) device. His report confirms the evaluation stated in the prior report, issued in September 2017, which predicted improved accuracy in the ability to identify the narrowing of arteries.
In commenting on the report, evaluating 295 Carotid Arteries within tertiary clinical trials, Dr. Bendick states, “Internal re-evaluation of the tertiary clinical data for the Carotid Stenotic Scan (CSS) using the latest software has shown significant improvement in the ability to accurately differentiate carotid arteries without stenosis versus those with clinically important atherosclerotic disease.
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* CVR Medical Expands Clinical Footprint
February 27, 2018 / CVR Medical Corp. (TSX.V: CVM.V) (FRANKFURT: B3BN) (OTCQB: CRRVF) (“CVR Medical”) announces Internal Review Board (IRB) approval by The Cleveland Clinic, sanctioning CVR to conduct clinical trials using the Carotid Stenotic Scan (CSS) device. The trial will be overseen by Primary Investigator Dr. Heather Gornik, Medical Director of the Non-Invasive Vascular Laboratory in the Cleveland Clinic Department of Cardiovascular Medicine.
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* Critical Milestone: CVR Medical to Launch Pivotal Trials
February 20, 2018 / CVR Medical Corp. (TSX.V: CVM.V) (FRANKFURT: B3BN) (OTCQB: CRRVF) (“CVR Medical”) announces the launch of pivotal clinical trials beginning Monday March 5, 2018 for the Carotid Stenotic Scan (CSS) device. This anticipated milestone represents the final phase of clinical substantiation which CVR will use to support the upcoming FDA submission. Initially, Thomas Jefferson University Hospital (Philadelphia, PA) and Henry Ford Hospital (Detroit, MI) will act as the key pivotal trials locations, but CVR plans to expand the footprint as other locations come online, increasing the speed of data procurement and shortening the timeframe to submission.
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* CVR Medical Adds Two Wireless CSS Devices to Methodist Hospital – Expanding Clinical Substantiation Data for FDA Submission
February 13, 2018 / CVR Medical Corp. (TSX.V: CVM.V) (FRANKFURT: B3BN) (OTCQB: CRRVF) (“CVR Medical”) announces placement of two additional wireless Carotid Stenotic Scan (CSS) devices into clinical trials at historic Methodist Hospital, part of the Thomas Jefferson University Hospital System. This deployment will be combined with the three wireless CSS devices already in use across the Thomas Jefferson University Hospital footprint. This critical milestone will assist in increasing the volume of clinical substantiation data to be used in the upcoming FDA submission to acquire market clearance.
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* CVR Medical, Canon Showcasing Carotid Stenotic Scan (CSS) at PLASTEC West 2018
February 8, 2018 / CVR Medical Corp. (TSX.V: CVM.V) (FRANKFURT: B3BN) (OTCQB: CRRVF) (“CVR Medical” or “CVR”) has joined Canon Virginia, Inc. (CVI) at PLASTEC West (February 6 – 8, 2018), the largest domestic conference and expo for advanced design and manufacturing of plastics technologies. CVI, subsidiary of Canon U.S.A., Inc, is the sole manufacturer of the cart for CVR Medical’s “Carotid Stenotic Scan (CSS)” device.
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* CVR Medical Moving Forward With Touch Panels From Hitachi High Technologies America
February 6, 2018 / CVR Medical Corp. (TSX.V: CVM.V) (FRANKFURT: B3BN) (OTCQB: CRRVF) (“CVR Medical” or “CVR”) announces the placement of an initial order of touch panel PC’s for its “Carotid Stenotic Scan (CSS)” device. This order represents the preliminary inventory build necessary for an FDA submission and subsequent market launch.
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* CVR Medical Entering Into Pre-Pivotal Trial Phase – A Step Closer To FDA Clearance
February 1, 2018 / CVR Medical Corp. (TSX.V: CVM.V) (FRANKFURT: B3BN) (OTCQB: CRRVF) (“CVR Medical”) announces the launch of their Pre-Pivotal Trial clinical substantiation phase for the “Carotid Stenotic Scan (CSS)” device. This critical stage, prior to launch of final phase Pivotal Trials, will be conducted at Thomas Jefferson University Hospital (Philadelphia, PA), Henry Ford Hospital (Detroit, MI), and several other top-tier clinical research institutions within the United States. Transition from Pre-Pivotal trial phase to Pivotal Trials is expected to occur in the early part of February 2018, and only requires the placement of wireless CSS devices across CVR’s full clinical trial footprint. With the data produced through the Pivotal Trials, CVR will validate the safety and accuracy of their patented device as required for submission to FDA for market clearance.
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* Rapid Progress Toward FDA Submission – Clinical Trials Commence At Henry Ford Hospital
January 23, 2018 / CVR Medical Corp. (TSX.V: CVM) (FRANKFURT: B3BN) (OTCQB: CRRVF) (“CVR Medical”) announces the commencement of clinical data acquisition by the Carotid Stenotic Scan (CSS) device at the renowned Henry Ford Hospital. There is currently one wireless CSS device fully deployed within the Henry Ford system, with two additional devices slated for implementation in the subsequent weeks. This clinical trial plays a crucial role in accelerating clinical substantiation for the CSS device and shortening the timeline for CVR’s imminent FDA submission.
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* CVR Medical Enters China, Executes Preliminary LOI to Launch Its CSS Device in World’s Largest Market
VANCOUVER, BC / ACCESSWIRE / January 18, 2018 / Investment Inventory Regulatory Organization of Canada (“IIROC”), has requested CVR Medical Corp. (TSX.V: CVM) (“CVR Medical” or “CVR”) to re-state its press release entitled “CVR Medical Enters China, Executes Preliminary LOI To Launch Its CSS Device In World’s Largest Market” dated January 17, 2018, (the “January 17, 2018 Release”) with increased specificity with regard to the LOI between CVR Medical and Guangzhou LangRun Equity Investment Management Co., Ltd. (“GLR”).
CVR Medical stated in the January 17, 2018 Release that there would be “a significant investment of tens of millions of dollars dedicated to the funding of operational infrastructure, which includes manufacturing, marketing, and sales, CVR is effectively able to work with GLR and bring this project to profitability.” CVR wishes to clarify these terms wherein the LOI states the following:
GLR will fund and set up an operating JV company solely for the development, marketing and assembly of the CSS in China, GLR or the JV company will undertake all permitting requirements by the Chinese FDA and finance the JV until full market launch of the CSS
CVR Expects to own up to 35% interest of the JV without cash contribution which may need further negotiation, which will [be] subject to the actual cash or cash equivalent that GLR invested in the JV Company; and
In consideration, GLR will negotiate a technology transfer fee paid to CVR up to US$20,000,000.00 paid over two years, with certain cash considerations due on signing of a definitive agreement as deposit for future CSS machine deliver or initial payment. Remaining technology transfer fee will be deducted as a percentage of future sales, the total agreed technology transfer fee will be paid out no later than the second anniversary date.
The above terms are subject to the signing of a definitive agreement executed by both parties, and at that time a more comprehensive press release will be issued. CVR can provide no assurances that such definitive agreement will be entered into on the terms provided for in the LOI.
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* CVR Medical Eyes Expansion, Global Potential in South Korea
January 11, 2018 / CVR Medical Corp. (TSX.V:CVM.V) (FRANKFURT: B3BN) (OTCQB: CRRVF) (“CVR Medical“) is pleased to announce the signing of an official Memorandum of Understanding with the Seoul Metropolitan Government (SMG) of the Republic of South Korea. The Understanding states the mutual interest and intended collaboration on new business opportunities as part of CVR’s global market expansion and the South Korean government’s initiative to revitalize its bio-medical device industry.
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* CVR Medical & Henry Ford Hospital – A Giant Leap Forward
January 9, 2018 / CVR Medical Corp. (TSX.V:CVM.V) (FRANKFURT: B3BN) (OTCQB: CRRVF) (“CVR Medical“) is pleased to announce IRB approval of clinical trials for its “Carotid Stenotic Scan (CSS)” device at Michigan’s prestigious Henry Ford Hospital. The trials will be overseen by Judith Lin, MD, MBA, RVT, RPVI, Senior Staff Vascular Surgeon and Medical Director of Henry Ford’s Clinical Vascular Laboratory.
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* CVR Medical, Canon Sign Manufacturing Agreement for Breakthrough Device
January 2, 2018 / CVR Medical Corp. (TSX.V:CVM.V) (FRANKFURT: B3BN) (OTCQB: CRRVF) (“CVR Medical“) announces the signing of a manufacturing agreement with Canon Virginia, Inc., a manufacturing, engineering and technical operation for Canon and a wholly owned subsidiary of Canon U.S.A. The agreement finalizes Canon Virginia’s status as primary manufacturer, assembler, and logistical authority for CVR’s “Carotid Stenotic Scan (CSS)” device.
Note: All infomation obtained from CVR Medical Corp. website
