Rev (10/2014) VMA: A New Standard in Spine Diagnostic Imaging

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Amberly Payne
6 years ago
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1 Rev (10/2014) VMA: A New Standard in Spine Diagnostic Imaging

Spine Surgeons Lack Reliable Function Tests Critical to Other Surgeons Functional

1940s-era Flex/ex* Non-Specific Chest Pain MULTIPLE advanced technologies Stress EKG

1 million Fusion surgery, decompression surgery Stent, Coronary Artery Bypass Graft

2 Spine Surgeons Lack Reliable Function Tests Critical to Other Surgeons Functional Tests Used to Select Surgery Patients Non-Specific Spine Pain ONE option: the 1940s-era Flex/ex* Non-Specific Chest Pain MULTIPLE advanced technologies Stress EKG Echocardiogram Angiography Related Surgeries Surgery Success Rates 1.1 million 1.1 million Fusion surgery, decompression surgery Stent, Coronary Artery Bypass Graft (CABG) ~75% 95%+ * Standard bending x-rays, or flexion/extension spine x-rays 2 Rev (10/2014)

3 The Flex/ex has Significant Limitations The flex/ex test is prescribed 5 million times per year (US) Higher volume than spine MRI + CT combined The flex/ex test impacts decisions for 1.9 million surgeries per year A positive flex/ex can indicate a patient for fusion surgery (500K/year, US) A negative flex/ex can qualify a patient to potentially receive decompression surgery (600K/year) or spine pain injections (800K/year) Can directly impact decision making for >$50 billion of US healthcare spending However, there are significant issues with the 1940s-era flex/ex Provides directly actionable data for only about 1 in 500 patients Proven in key studies to be of very limited diagnostic value Highly variable and subjective results The continued use of flex/ex demonstrates how important functional testing is in the workup of patients for spine surgery 3 Rev (10/2014)

4 VMA is an Attractive Alternative to the Flex/Ex VMA (Vertebral Motion Analysis) is a spinal radiographic instability test Helps identify more patients with lumbar radiographic instability = More informed decision making & patient selection Device-Assisted Bending During Imaging + Enterprise Software & Big Data Online tools that make a surgeon s job easier See FDA-cleared lumbar and cervical indications for use (last page) Uses standard C-arms (fluoroscopes) to generate images Covered under existing CPT codes * * Ortho Kinematics, Inc. does not provide coding advice, however customers have reported receiving reimbursement for VMA testing under current CPT codes. 4 Rev (10/2014)

5 VMA Provides Compelling Benefits & Strong Science The VMA was validated in the largest Level 1 Evidence study of its kind VMA studies VMA Improvement Relative to Today s Test Detects double the rate of lumbar radiographic instability* Instability rates increased to 11.5% (VMA) vs. 5.5% (flex/ex) Very high specificity (99.5%) Quality of Evidence Level I (best) V (worst) Study Size (# of patients) Level I 1,112 * 68% more repeatable Level III 84 79% more accurate n/a 2 Lower dose of radiation n/a 101 Comparator: Most often-cited study to support the use of the flex/ex (Panjabi & White, 1991) Level III 142 * VMA s key performance benefits were validated in a recently-completed head-to-head study of the VMA vs. the flex/ex in 878 consecutive spine surgery clinic patients and 234 pain-free healthy volunteers. Lumbar radiographic instability was defined as slippage of 5.3 mm (15%) or more between lateral views. 5 Rev (10/2014)

6 Clinical Benefits Doubles the prevalence of lumbar radiographic instability The same high 99.5% diagnostic specificity as the flex/ex More accurate & repeatable data with less radiation Provides access to potential pain-relieving surgery for more patients than the flex/ex A positive VMA test has the same significance as a positive flex/ex test, in that both tests are almost never positive in people without back issues Improved risk-benefit ratio for patient Not only does VMA frequently impact surgical decisions, it also identifies potential surgical candidates that the current test misses. With the VMA, these patients can often be offered potential pain-relieving surgery instead of being either cycled onto the next clinician or continuing with potentially addictive pain killers or expensive pain injections. Dr. Reginald Davis, MD, Spine neurosurgeon 6 Rev (10/2014)

7 Helpful Tools for the Surgeon VMA reports address denials for coverage for surgery, by providing objective 3 rd party evidence of instability. VMA videos allow surgeons to directly visualize spine motion. Prior to VMA testing, surgeons have had to picture motion based on static x-rays. This provides the surgeons a powerful patient consult tool. The VMA gives me instant access to test results and never-before-seen spine views. The views wow the patients and the objective data makes dealing with insurance companies much easier. Dr. James Woodall Jr., MD, Orthopedic surgeon 7 Rev (10/2014)

Personalized Red / Yellow / Green Light Alert System The VMA online system allows surgeons to set personalized thresholds for the detection of radiographic instability.

8 Personalized Red / Yellow / Green Light Alert System The VMA online system allows surgeons to set personalized thresholds for the detection of radiographic instability. Once set, the VMA system will alert the surgeon with a simple red/yellow/green light whenever the specified thresholds are exceeded. These alerts provide the surgeons a tool to improve clinical workflow. The VMA alerts save me time on my busy clinic days by quickly identifying patients with a problem area based on my own criteria. From the VMA portal, I can identify the highest-priority patients before I ever enter the exam room or look at an imaging study. Dr. David Lee, Neurosurgeon 8 Rev (10/2014)

VMA device controls patient bending during imaging, ensuring instability does not go unprovoked. Testing takes 10-20 minutes.

9 2. Proven & Efficient Testing Workflow Standard imaging machines (C-arm fluoroscopes) capture video x-rays of the spine as it bends, which are then uploaded to cloud servers for processing. 1. VMA device controls patient bending during imaging, ensuring instability does not go unprovoked. Testing takes minutes. 3. Special software processes images to generate IVT measurements, which are available via a multi-platform, HIPAAcompliant cloud application in 1-2 hours. 9 Rev (10/2014)

integrate into clinical workflow Backed by strong science Lower radiation

10 Advanced Functional Imaging isn t Just for Cardiologists Anymore VMA Detects instability at higher rates Helps address fusion coverage denials Easy to integrate into clinical workflow Backed by strong science Lower radiation exposure to patient Advanced Functional Imaging for the Spine 10 Rev (10/2014)

11 Indications for Use VMA software is a quantitative imaging software application intended to be used to process digital image files. It is designed for physicians and clinical professionals who are interested in the analysis of motion in medical images, particularly in musculoskeletal images of the spine. VMA software permits users to review static and dynamic digital lumbar and cervical spine images acquired with the assistance of the VMA patient handling and data collection device, which is designed for use by imaging technicians and intended to assist with patient lumbar and cervical bending and data collection during imaging. VMA software also facilitates quantitative assessment of vertebral motion in digital medical images. Information about the motion of selected objects, such as bone structures, can be generated and presented in the form of a motion analysis report containing graphics, charts, and text. 11 Rev (10/2014)

12 12 Rev (10/2014)

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