Landmark Independent Study
by UCLA School of Medicine
Reports Comparison of Dynamic™ Upright® MRI With Static
in More Than 1,000 Patients (1,302):
Study is the First to Quantify the "Miss Rate" of
Static MRI (18.1%)
NEW YORK, November 15, 2007 - FONAR Corporation (NASDAQ-FONR),
Inventor of MR Scanning, reported today that in the Proceedings
of the 22nd Annual Meeting of the North American Spine Society
(NASS) [The Spine Journal 7(2007) 1S-163S, October 23-27, 2007,
Austin, Texas], the University of California, Los Angeles (UCLA)
School of Medicine presented four scientific papers comparing
the visualization of spine pathology by Dynamic™ MRI to
images obtained by Static MRI. Studies were performed utilizing
the FONAR Upright® Multi-Position™ MRI scanner in conjunction
with the software image analysis program developed by True MRI
that provides comprehensive quantitative measurements
of spinal structures in Static and Dynamic™ positions.
The results are as
follows. The UCLA School of Medicine study reported the overall "missed
spondylolisthesis" rate (Table 1). "In the patients with back pain,
missed spondylolistheses in neutral MRIs, but found in flexion MRIs, was 18.1%
for all the levels, in the condition that spondylolisthesis is considered more
than 3mm translation." L3-4 was the "most commonly missed" at
38.7% when the allowed slip was 3mm and was 35.1% at L4-5. The "miss rate" was
found to be larger in flexion than in extension (e.g. 35.1% at L4-5 flexion vs.
14% L4-5 extension). The flexion angular rotation was 40º rotation. The
extension rotation was 10º. The highest "miss rate" in the study
was observed to occur at L3-4 (Table 1). It was 53.8% when the allowed slip was
The FONAR Upright® MRI
is the only Upright Weight-Bearing Flexion-Extension MRI. It is a Multi-Position™ Dynamic™ MRI
scanner. The Static position in these studies was defined by the UCLA scientists
as the upright neutral sitting position and the Dynamic positions
as the flexion and extension sitting positions. The study is the first to quantify the "miss
rate" of Static MRI.
In "Missed Spondylolisthesis
in Static MRIs but Found in Dynamic MRIs in the Patients with Low Back Pain" (Paper
#145) the authors calculate the spondylo-listhesis "miss rates" in
510 patients of Static MRI as compared to Dynamic™ MRI. The measurements
summarized in Table 1 establish that it is Dynamic™ MRI rather than Static
MRI that is the method of choice for detecting the presence of lumbar spondylolistheses
(i.e. the movement, or slippage, of a vertebrae in the spine) and for establishing
the full extent of vertebral instability.
% Spondylolistheses "
Missed" by Static MRI
Overall "Miss Rate"
Further, it is important to appreciate the spondylolisthesis "miss
rates" for the upright patient with back pain are likely
to represent an underestimate of the number of spondylolistheses "missed." This
study only compared the upright patient in the flexion, extension
and neutral sit positions and did not take into account the "misses" from
Static MRIs obtained with the patient lying down in the traditional
non-weight-bearing position of the conventional recumbent MRI.
The importance of
paying attention to comparisons with recumbent scanning is underscored by a
published study of 58 patients performed at the University of Aberdeen, Scotland,
U.K. using the FONAR Dynamic™ Upright® MRI scanner ["Dynamic MRI
Using the Upright or Positional MRI Scanner" in Spondylolysis, Spondylolisthesis
and Degenerative Spondylolisthesis, Lippincott Williams & Wilkins, R.
M. Szpalski Eds., 2006, pgs. 67-78]. Images of Upright® patients were compared
to images of the same patients supine (lying down). The University of Aberdeen
authors concluded "The ability to image the spine in different postures
adds significantly to the diagnostic accuracy of the MRI examination. For more
than 50% of the patients examined in our study, a
better understanding of the
condition of the spine was obtained."
In the Dynamic™ MRI
study "The Effect of Lumbar Flexion and Extension on
the Central Canal with
Dynamic MRI" (Paper 79) by Wei, et al., the UCLA authors reported
the impact of flexion and extension on spinal canal stenosis. The authors stated
study of the stenotic lumbar spinal canal (achieved by means of the FONAR Upright® Multi-Position™ MRI)
is the first study reported that has been able to measure the changes in size
that the stenotic canal undergoes when subjected to flexion and extension. They
concluded that the Dynamic™ MRI (made possible by the FONAR Dynamic™ Upright® MRI
equipped with the True MRI analyzer) "can show with high precision the
amount of change of the diameter of the spinal canal that occurs with flexion
Central spinal canal
stenosis is a common cause of the back pain known as neurogenic claudication.
It is distinct from the back pain arising from the more lateral direct impingement
of the nerve root within the foraminal canal. In their study of 461 patients
with low back pain, disc degeneration had a measurable impact on the change in
the A-P diameter of the stenotic canal that occurred with flexion and extension.
The authors showed that flexion relief of the stenotic canal increases as disc
degeneration increases. The authors concluded that Dynamic™ (Upright®)
MRI was able to successfully quantify the changes in the A-P diameter of the
stenotic spinal canal that occur with flexion and extension. They further concluded
that the Dynamic™ (Upright®) MRI equipped with the True MRI analyzer
can determine "change in the cross-sectional area (of the spinal canal)
with the highest accuracy."
to readily measure the cross-sectional area of the spinal canal accurately and
quantify its changes on flexion and extension using FONAR's Dynamic™ Upright® MRI
makes available another key dimension important to the surgical analysis of spinal
stenosis", said Raymond V. Damadian, M.D., President of FONAR.
In the study by the
UCLA team of one hundred sixty-three (163) patients with cervical spine symptoms "Positional
MRI: A Valuable Tool in the Assessment of Cervical Disc Bulge" (Paper 80),
the authors concluded that extension MRI views were important in assessing cervical
disc pathology, that "extension MRI views yield a higher detection rate
of missed cervical disc bulges than flexion views" and that "positional
MRI (Dynamic™ MRI) might be especially beneficial in patients with symptomatic
radiculopathy and unimpressive static MRI studies."
radiation-free quantitative MRI measurement, the UCLA team's assessment of cervical
confirms the American Medical Association's findings by X-ray Motion Segment
Analysis that "the dominant motions of both the lower cervical and entire
lumbar spine, where most clinical pathology occurs, are flexion-extension" (Linda
Cocchiarella, M.D. and Gunner B. J. Anderson, M.D., Eds., AMA "Guides
the Evaluation of Permanent Impairment" Fifth Edition, AMA Press, p. 378).
results of multiple independent investigations of the kinetics of the impaired
spine therefore concur (UCLA, U.S., University of Aberdeen, U.K., and the AMA).
Dynamic™ MRI, as opposed to Static recumbent-only MRI, is the key to accurate
assessment of spine pathology, which in turn is the key to optimum surgical outcomes.
When the impact of
disc degeneration on cervical spine mobility in 168 patients was evaluated by
Dynamic™ MRI in the "Kinematic Analysis (study) of the Relationship
Between the Grade of Disc Degeneration and the Motion Unit in Cervical Spine" (Paper
111), Dynamic™ MRI showed that the most severe disc degeneration, Grade
V, resulted in significantly reduced cervical spine mobility when quantified
by the True MRI analyzer, and that the lesser Grade III and Grade IV disc degeneration
resulted in increased cervical instability once cervical mobility was measured
from a very large patient database of 1,302 patients establish beyond question
that MRI 'miss rates' of important pathology by Static MRI technology are substantial
and not inconsequential", said Dr. Damadian. "Even imaging voxels cubic
micron in size, should they ever exist, would be of no value if they could not
visualize the patient's problem", i.e. 'If the surgeon cannot see the problem
because Static only MRI "misses" it and does not visualize it, he cannot
fix it.' Worse yet, there is the ever present risk that he may do the wrong surgery
if he is unable to see the anatomy that causes the problem. The UCLA School of
Medicine study demonstrates convincingly that a spine surgeon intent on top patient
outcomes, as all surgeons are, cannot afford to take a patient to surgery without
first obtaining Dynamic™ Upright® MRI images of the patient for a full
assessment and complete characterization of the patient's spinal pathology. The
Static recumbent-only MRI is clearly falling short of the accuracy depicting
spinal structures that is needed for the surgeon to achieve top results."
The Inventor of MR Scanning, Full
Range of Motion, pMRI, Dynamic, Multi-Position,
True Flow and The Proof is in the Picture are
trademarks and UPRIGHT® and
registered trademarks of FONAR Corporation.
This release may include
forward-looking statements from the company that may or may not
materialize. Additional information on factors that could potentially
affect the company's financial results may be found in the company's
filings with the Securities and Exchange Commission.