Ortho Kinematics: Revolutionizing Spine Motion Analysis

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Market Opportunity

The market need

The KineGraph VMA™ is intended to address the need for an improved functional diagnostic test for the spine. In the currently-used end-range x-ray method, patients bend as far as they can, x-rays are taken of the bent spine, and then the quantity of intervertebral motion is measured manually (protractor and ruler). This method gives inconclusive results in about 85% of cases^1,2, cannot discern normal* and abnormal motion, and can only identify the grossest of instabilities.

The KineGraph VMA solution

Pilot studies reveal that the KineGraph VMA™ has the potential to address several challenges with the current standard of care.³ Additionally, the KineGraph VMA™ could prove game-changing for device design. There are currently over 70 motion-preserving spine devices, but it is impossible to distinguish among their kinematics in vivo. The rich set of biomechanical data from the KineGraph VMA™ is intended to give a more complete view of device performance and the effects on adjacent levels, which could lead to more biomechanically appropriate designs.

Broad patient population

The KineGraph VMA addresses a broad patient population. The following table lists some patient populations that are the targets of current and future clinical studies.

Patient Population

Instability and spondylolisthesis

Stenosis

Degenerative disc disease

Discography patients

Market size

The aim is for the KineGraph to replace the end-range x-ray method of spine functional testing. In the U.S., end-range x-rays are currently ordered 1.6 million times per year for pre-fusion patient work-ups and follow-up testing. Add to this the clinical trials services market, and this opportunity could generate revenues well in excess of $500 million annually in the U.S. market.

*Normal as used here refers to the statistical norm among a population of asymptomatic subjects.

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1. Murphy D, Hurwitz E. A theoretical model for the development of a diagnosis-based clinical decision rule for the management of patients with spinal pain. Musculoskeletal Disorders 2007; 8:75
2. Waddell G. The Back Pain Revolution. Second Edition. New York: Churchill Livingstone, 2004
3. Breen AC, Muggleton JM, Mellor FE. An Objective Spinal Motion Image Assessment (OSMIA): reliability, accuracy, and exposure data. BMC Musculoskeletal Disorders 2006;
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