Dominion Vi 3D
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Dominion Vi 3D

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FDA Regulations Class Presentation. Picked product and presented to a mock-up FDA panel.

FDA Regulations Class Presentation. Picked product and presented to a mock-up FDA panel.

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    Dominion Vi 3D Dominion Vi 3D Presentation Transcript

    • Dominion Vi 3D Medical Imaging Scanner Dr. Heather Juhan PhD in Biomedical Electronic Engineering Head of Research and Development
    • Imaging3 Inc. Company Information
      • We are the largest remanufacturer of C-arms in the world.
        • A C-arm is an integral component of a fluoroscopic imaging system.
      • We are also the largest distributor of C-arm tables in the United States.
    • Dominion Vi 3D Medical Imaging Scanner
      • 510 k clearance
      • Class 2 device
      • Predicate Devices:
      • 9990 Plus Mobile Fluoroscopy System
      • Lightspeed 7.1 CT Scanner System
        • Many of the same components
        • Change is in the software, not the hardware.
    • Substantially Equivalent Based On…
      • Circular / Half-Circular gantry
      • 3D medical imaging capabilities
        • CT: reconstructive post processing reference images
      • Fulcrum reference points with a rotating X-ray source and image receptors in reference to those points.
      • 360 degree scans
        • C-arm: 150 to 360 degrees with mechanical orientation or manipulation
    • Our Breakthrough Technology
      • We have developed a breakthrough medical technology that will produce 3D medical diagnostic images in real time, giving us enormous potential to contribute to the improvement of healthcare.
      • Healthcare workers will be able to instantly view 3D, high-resolution images of virtually any part of the human body.
      • Our 3D images are instantly constructed using high-resolution fluoroscopy and can be used as real time references for any current or new medical procedures in which multiple frames of reference are required to perform those procedures on or in the human body.
    • Product Description Dominion Vi 3D Medical Imaging Scanner Introducing an “O-device” Similar to a C-arm
    • Product Description O-device can articulate around a patient in any angle or position. 360 degree scan 30-60 frames per second
    • Mechanism of Action
      • The x-ray source and flat panel CCD detectors are located perpendicular to each other in a ring, called a gantry, that rotates around you.
      • The Dominion Vi Scanner scans 360 degrees, one revolution every 0.2 to 0.8 seconds, and acquires several images throughout the scan at many different angles. These images are instantly placed into a 3D construct and updated again every 0.2 to 0.8 seconds.
      • The Dominion’s 3D, real-time imaging capabilities will allow surgeons to complete less invasive and more precise procedures.
    • What is Fluoroscopy?
      • A technique for obtaining “live” X-ray images of a living patient.
      • A switch controls the X-ray beam that is transmitted through the patient.
      • The X-rays strike a fluorescent plate that is coupled to an “image intensifier” which is coupled to a camera.
      • The images are shown “live” on a TV monitor.
    • Product Description Selection of area of interest Rotation of area of interest With our product, a 3D image can be rotated in any orientation desired.
    • Old Technology Anterior/Posterior View (front to back) Lateral View (side) Current technology allows the view of only one angle at a time. Normally a physician would be required to continually shift from AP view to Lateral view.
    • Our Technology With Imaging 3 technology, physicians are able to view depth and direction simultaneously.
    • Cervical Hand Lumbar Skull
    • Our device is mobile, can fit through a standard sized door, and is powered by a standard wall outlet.
    • Multi-Function Device
      • Our device can perform several functions, which will replace or supplement a number of existing devices, resulting in considerable cost savings for hospitals and healthcare centers.
      • OUR FUNCTIONS INCLUDE:
        • Perform real time, 3D medical imaging
        • Perform standard fluoroscopy
        • Emulate a CT scanner (at a fraction of the capital cost)
      • Our Company's management believes that this multi-function capability will be especially attractive in foreign markets, where the cost of a CT scanner is beyond the means of most hospitals and healthcare centers, and we plan to use our base of operations and channels of distribution to achieve this.
    • Trauma Centers Cardiology Pain Management Neuro-vascular Orthopedics
    • The Dominion
      • Our Technology can go from Diagnosis to Repair IMMEDIATELY.
    • Background on Radiation Exposure
      • The scientific unit of measurement for radiation dose, is the millisievert (mSv).
      • Because different tissues and organs have varying sensitivity to radiation exposure, the actual dose to different parts of the body from an x-ray procedure varies.
      • The radiation exposure from one chest x-ray is equivalent to the amount of radiation exposure one experiences from our natural surroundings in 10 days.
    • 8 months 2 mSv Cardiac CT for Calcium Scoring Heart: 2 months 0.6 mSv Computed Tomography (CT)-Sinuses Face and neck: 10 days 0.1 mSv Radiography-Chest 3 years 8 mSv Computed Tomography (CT)-Chest Chest: 3 years 10 mSv Computed Tomography (CT)-Spine 8 months 2 mSv Computed Tomography (CT)-Head Central nervous system: Less than 1 day 0.001 mSv Radiography-Extremity 6 months 1.5 mSv Radiography-Spine Bone: 8 months 2 mSv Radiography-Upper GI Tract 16 months 4 mSv Radiography-Lower GI Tract 20 months 5 mSv Computed Tomography (CT)-Colonography 3 years 10 mSv Computed Tomography (CT)-Body 3 years 10 mSv Computed Tomography (CT)-Abdomen Abdominal region: Comparable to natural background radiation for: Your effective radiation dose is: For this procedure:
    • Radiation Exposure
      • We are up to 52% less radiation when compared to a standard C-Arm.
      • CT scans give us a lot information, but they also deliver as much radiation as getting 300-600 regular x-rays.
      • When compared to a high resolution CT we can be over 1,000 TIMES less radiation.
      • One way that we get less radiation in CT is we’re a 16 slice CT, not a 64, 128 or higher.
      • Our device uses cone beam CT which has been proven to be not only as effective, but does so at much lower exposure levels.
    • Radiation Exposure
      • The way we are able to do so much more with so much less radiation is in the image constructs that we use to make the 3D images.
      • We basically capture a lot more information in one revolution than a c-arm does in multiple positions and imaging times.
      • The 3D software has to be very efficient in order to image as fast as we do – we are taking 30 images in each revolution which takes between 2 tenths to 8 tenths of a second.
      • Our software is able to construct a 3D image in that short time frame.
    • Projected Users of Our Product
      • No age ranges are limited from using our device.
      • Although, the Dominion will be the standard of care for those patients who are at the highest risk from radiation exposure.
      • We do not recommend our device be used on pregnant women, except in worst case scenario.
    • Pricing
      • The initial prices for the Dominion™ are forecast to range from approximately $150,000 to $400,000 dollars.
      • Toshiba’s new 320 multi-slice CT that can be used only for diagnosis (no surgical applications), has a base system starting at $2.3 million dollars.
    • DViS
      • Our system combines the speed advantage of high-speed photo fluoroscopy with the benefits of 3D imaging and the precision of computed tomography.
    • Conclusion Vision: We intend to become the premiere worldwide provider of advanced technology in medical diagnostic imaging devices.
    •