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),
The 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™
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
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
"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.
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. Gunzburg, 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."
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 that their 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 and extension."
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."
able 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.
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
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 and quantified.
results 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.