Fonar Press Releases

For Immediate Release

The Inventor of MR Scanning™

 

An ISO 9001 Company

Contact: Daniel Culver

110 Marcus Drive

Director of Communications

Melville, NY 11747-4292

Web site: www.fonar.com

Phone: (631) 694-2929

Email: invest2007 @ fonar. com

Fax: (631) 390-1709


Landmark Independent Study by UCLA School of Medicine
Reports Comparison of Dynamic™ Upright® MRI With Static Upright MRI
in More Than 1,000 Patients (1,302):

Study is the First to Quantify the "Miss Rate" of Static MRI (18.1%)

          MELVILLE, 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™ 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 4mm.
          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.

 

Table 1
           
% Spondylolistheses " Missed" by Static MRI
40° Flexion
 
Overall "Miss Rate"
40° Flexion
 
L2-3
L3-4
L4-5
L5-S1
 
L1-2 to L5-S1
3mm 30.8% 38.7% 35.1% 4%  
18.1%
4mm 33.3% 53.8% 17.9% 3.5%  
12.3%
   
10° Extension
10° Extension
 
L2-3
L3-4
L4-5
L5-S1
 
L1-2 to L5-S1
3mm 25% 20.8% 14% 3.2%  
8.9%
4mm 33.3% 25% 4.2% 2.4%  
5.0%

          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. 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."
          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 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."
          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."
          "Being 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.
          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."
          By radiation-free quantitative MRI measurement, the UCLA team's assessment of cervical disc bulge 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 to the Evaluation of Permanent Impairment" Fifth Edition, AMA Press, p. 378).
          The 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 and quantified.
          "UCLA's 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."

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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 STAND-UP® are 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.
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