March 17, 2008

Health Watch: MRI Scan: Traditional vs. open

By FRED MCTAGGART/special to the Daily Press:

When Karla had an MRI scan a decade ago, she was warned that she might feel claustrophobic inside the large tunnel-like machine. In fact, she was more bothered by the loud jackhammer noises that bombarded her periodically.

When Karla’s 4-year-old son had an MRI, she had no concern about either claustrophobia or clanging noises. He sat on her lap watching television while the scan was taken.

MRI stands for magnetic resonance imaging, a procedure that has assumed an important role in medical imaging in the past two decades. As the technology evolves, MRI scanners have become increasingly versatile and useful in detecting and diagnosing disease throughout the body while making the experience less stressful to the patient.

Medical imaging, starting with the introduction of the X-ray in 1895, was a major breakthrough, allowing doctors to look inside the body to visualize a broken bone in the leg or a tumor in the lung.

On their own, X-rays are best at detecting problems in bones and joints, but imaging capability was significantly expanded with the introduction of computer tomography or CT scans and the use of radio-dense contrast materials to allow the visualization of less dense anatomical structures. This technology is now able to create a sequence of X-ray images, giving doctors a high-quality, detailed image of tissue anywhere in the body.

For the majority of cases, the X-ray remains the most practical and inexpensive option and new digital techniques are making X-rays sharper, clearer and easier to store, but the MRI has emerged as another major development in medical imaging.

No dangerous radiation

A traditional MRI scanner is a tube surrounded by a giant circular magnet. After removal of jewelry, watches and all other metal objects, the patient is placed on a bed that is inserted into the tube and asked to remain as motionless as possible while the scan is performed, sometimes an hour or longer.

The strong magnetic field of the MRI machine aligns hydrogen atoms in the body, which respond to radio waves that are then processed by a computer into detailed, high-contrast images in any plane, greatly improving a physician’s ability to visualize the brain or any other body part.

Using magnetism rather than potentially dangerous radiation, an MRI scan adds an important measure of safety and medical imaging. An MRI scan has no known adverse effects and can be repeated any number of times with no danger to the patient or staff.

In addition, MRI is very sensitive, capable of picking up lesions and tumors that may not show up, even on a CT scan.

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FONAR Wins The Wall Street Journal Technology Innovation Award For 2007

MELVILLE, NEW YORK, September 26, 2007 - FONAR Corporation (NASDAQ-FONR), The Inventor of MR Scanning™, reported today that The Wall Street Journal announced in Monday's edition (9/24/2007) that out of over 800 contenders FONAR has been named one of two runners-up for The Wall Street Journal Technology Innovation Award for 2007. The award is for the FONAR UPRIGHT™ Multi-Position™ MRI.

A Mother and 2-year old child sit in the FONAR Upright™ Muti-Position MRI

           The news editor of the Journal congratulated FONAR president and founder Raymond V. Damadian, MD, in an email that stated: "We are pleased to inform you that FONAR is a runner-up in the Medical-Devices category of this year's Wall Street Journal Technology Innovation Awards. You should be very proud of this achievement. We received more than 800 entries, with only about 4% receiving an award. Needless to say, the competition was extremely intense. Full coverage of the awards appears in The Wall Street Journal's three global editions on Monday as well as for online subscribers at http://online.wsj.com/page/2_1323.html."

           Dr. Damadian was also invited to an awards ceremony and dinner on October 24 in Redwood City, California, at the Sofitel San Francisco Bay Hotel.
The announcement in The Wall Street Journal for the FONAR award reads: "The UPRIGHT™ MRI, which allows improved medical imaging. A baby can be scanned sitting on the lap of the mother, eliminating sedation." (The first recorded instance of a child being scanned without sedation occurred at the Hospital de Madrid, Spain in 2003. For details visit: www.fonar.com/news/061404.htm)

The winner of the Medical Device category for 2007 was SeQual Technologies, San Diego, California, for developing portable equipment that provides concentrated oxygen. In 2006, there were nine (9) runners-up in the Medical Device category but only two in 2007, the other going to Kyphon for its X-Stop device, an implant which is used to treat spinal stenosis. It is noteworthy that tests verifying the efficacy of the X-Stop were performed with the FONAR UPRIGHT™ Multi-Position™ MRI at the University of Aberdeen by Professor Francis Smith, M.D. For the peer reviewed paper about the X-Stop and the UPRIGHT™ MRI visit: www.stenosidelcanalelombare.it/00_files/pdf/100SiddiquiMJSpinalDisordTech%5B1%5D.2006Jul_19(5)_328-333..pdf (Due to its length, this URL may need to be copied/pasted into your Internet browser's address field. Remove the extra space if one exists.)

Prior recognition of the UPRIGHT™ MRI was given on June 11, 2007, by the Intellectual Property Owners Education Foundation, which presented Dr. Damadian with the 2007 National Inventor of the Year Award for the FONAR UPRIGHT™ Multi-Position™ MRI. For details visit: www.ipoef.org

Last year FONAR was awarded the North American Medical Imaging Industry Innovation and Advancement of the Year Award. At that time, a Frost and Sullivan spokesman said, "For nearly 30 years, FONAR has led the medical imaging industry in promoting the clinical utility of MR and the multitude of applications that can be performed with this technology. In recognition of the company's longstanding role as a pioneering innovator of MR technology, Frost & Sullivan is proud to bestow upon FONAR the 2006 North American Medical Imaging Industry Innovation and Advancement of the Year Award."

The Frost and Sullivan spokesman also said, "FONAR has also established itself as the only manufacturer that offers an UPRIGHT™ Multi-Position™ MR scanner that allows for the imaging of patients in seated, standing, flexion and extension positions, which permits dynamic visualization of the fully weight-loaded spine, in contrast to the present day pictures of the non weight-loaded spine obtained in conventional static single-position recumbent-only MRIs." For details visit: www.fonar.com/news/112006.htm

Dr. Damadian said, "I am delighted that FONAR has received The Wall Street Journal's recognition for our FONAR UPRIGHT™ Multi-Position™ MRI. It is something that all of our employees and users can also be proud of, since they all participate in creating the impact that the scanner is having on medicine."

           More about The Wall Street Journal Technology Innovation Awards
As part of the 2007 award nomination process, The Wall Street Journal screened more than 800 applications, narrowing the field to about 150 entries. A panel of 13 judges picked category winners and runners-up in 12 different entry categories, including computing systems, energy, environment, materials and other base technologies, media/broadcasting, medical research, medical devices, network/internet technologies, network security, semiconductors, software and transport. Each entrant was required to offer extensive details and explain why the entry merited consideration. Judging criteria included innovativeness, clarity of explanation, whether the innovation was covered by patents and if it had achieved some measure of success.

Factors the panel considered included:
- The innovation should have gone well beyond what already existed and cannot simply represent incremental improvements.

- It needed to address major challenges for which new solutions would have a wide-ranging impact in a particular industry.

- The written application needed to be supported by rigorous data rather than unsubstantiated claims of potential.

About FONAR

FONAR has the most accomplished history of any company in MRI. The company's heritage helps to document the quality of its products and distinguishes it from all other MRI companies. A timeline of its achievements follows. It includes the groundbreaking discovery of the principle that makes MRI imaging possible, the patent for the first MRI, and the sale of the world's first MRI.

1969 - Original Idea for MR Scanner (Grant Application to Health Research Council of the City of New York)*

1969 - Realizes Need for a Compelling Application to Justify Building Human Scanner. Decides on Cancer Detection

1970 - Key Discovery Makes the MRI Possible

Discovery of the marked T1 and T2 signal differences among the normal tissues and also between the normal tissue and cancer tissue. Discovery enables soft-tissue detail previously absent from medical imaging, and early cancer detection; used today to detect cancers worldwide. "NMR developed into a laboratory spectroscopic technique capable of examining the molecular structure of compounds, until Damadian's ground-breaking discovery in 1971." MRI From Picture to Proton, Cambridge University Press, 2003)

March 1971 - First Article Published (Science)

Spring 1971 - First Ever Method Proposed (Downstate Reporter)

March 1972 - First MR Patent Filed (3D Serial Voxel Scanning Method). Patent Issued 1974.

1976 - The Struggle Begins. Expert Declares, "Any further discussion of scanning the human body by MR (NMR) is visionary nonsense."

1976 - Construction of First Human MR Scanner Commences

1977 - Construction Completed; First Human Scan Achieved: Thoracic Image at T-8

1980 - FONAR Installs First Commercial MRI; Initiates MRI Industry

1997 - Patent Upheld by High Court on U. S. Patents and the U. S. Supreme Court. (1.1 Million Pages of Documentary Evidence Scrutinized and Argued; No Prior Art)

2001 - Introduction of the FONAR UPRIGHT™ Multi-Position™ MRI

2007 - National Inventor of the Year Award for the UPRIGHT™ Multi-Position™ MRI.

* For documents visit www.fonar.com/fonar_timeline.htm

More about the FONAR UPRIGHT™ Multi-Position™ MRI.

The FONAR UPRIGHT™ Multi-Position™ MRI is a dramatic advance over all other MRI's, which can only scan the patient in a recumbent-only, non-weight-bearing position. The UPRIGHT™ allows the patient to be imaged upright, with the weight of the body on the spine.

Most patients are scanned sitting, while they enjoy watching TV. Patients can also be scanned in flexion, extension, rotation, as well as lying down. This positional imaging allows surgeons and radiologists to see patients in the position of their symptoms. Studies and physician experience show that diagnosis using the FONAR UPRIGHT™ changes surgical protocols and provides better surgical outcomes in approximately 20% of the cases.

The FONAR UPRIGHT™ Multi-Position™ MRI is also unrivaled in patient comfort. It has a near zero claustrophobic rejection rate by patients. It can scan obese patients who cannot fit into a recumbent MRI, and it allows imaging of children while they sit in their mother's lap.

Over a half million patients have been scanned by the FONAR UPRIGHT™ MRI.

To date, 152 UPRIGHT™ MRIs have been sold. The superiority of the technology is achieving wider recognition every day.

Another New FONAR MRI: The FONAR 360™

FONAR has invented another breakthrough MRI, the FONAR 360™. It's a room-size recumbent scanner that optimizes openness while facilitating physician access to the patient during surgery.

FONAR is headquartered on Long Island, New York, and has approximately 400 employees.

#
The Inventor of MR Scanning™, Full Range of Motion™, STAND-UP™, UPRIGHT™, Multi-Position™, pMRI™, True Flow™, Walk-In™ and The Proof is in the Picture™ are 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.
###

FONAR™ Corporation
110 Marcus Drive
Melville, N.Y. 11747
Tel. 631-694-2929
Fax. 631-390-9540
Email sales@FONAR.com
Investor Information

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Landmark Independent Study by UCLA School of Medicine

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.

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."

#
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.
###

FONAR™ Corporation
110 Marcus Drive
Melville, N.Y. 11747
Tel. 631-694-2929
Fax. 631-390-9540
Email sales@FONAR.com
Investor Information

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The Benefits of the Upright MRI

From Fonar:

The revolutionary design of FONAR's Upright® MRI allows patients to simply walk in and be scanned. The Upright™ MRI allows all parts of the body, particulary the spine and joints, to be imaged in the weight bearing state. The system is equipped with our unique MRI-compatible motorized patient handling system that will move the patient into the magnet and place the anatomy of interest into the center of the magnet gap. It also can rotate the vertically-oriented patient into a horizontal position so the patient can be scanned lying down as in conventional MRI scanning.

Distinctive Benefits Include:

  • The only true Open MRI
  • Proven 0.6 Tesla performance
  • Scan patients lying down
  • Scan patients in flexion, extension, rotation and lateral bending
  • Scan patients in a sitting position
  • Position MRI™ (pMRI™)
  • Scan patients in their position of pain
  • Scan cardiovascular patients upright in their position of symptoms
  • Scan patients with cerebrovascular insufficiency in the upright position of symptoms
  • Patient convenience: walk in, sit or stand during the scan and walk out
  • An unprecedented degree of patient comfort due to the unobstructed view of the scanner room from inside the magnet. There is nothing in front of the patient's face

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What Is The Upright MRI?

From UprightImagingMRI.com:

What is MRI?
What is the difference between T1 and T2?
Are MRI scanners dangerous?
What does the term "field strength" mean?
Why are some MRI's "open" and some are not?
Why are MRIs so noisy?
Why do MRI scans take so long?
How do I prepare for an MRI?
What does the MR scanning center staff need to know about me to perform the scan?
What will happen when I get scanned?
Isn't an MRI scan basically the same as a CAT scan?
Do you need a prescription for an MRI?
If I have an MRI scan, how will I find out the results?
Can I choose the kind of MRI scanner I want?
Do I have to lie still when I have an MRI?
When is an MRI called for?

Q: What is MRI?
A: Magnetic resonance scanning or imaging (MRI) is a method of looking inside the body without using surgery, harmful dyes or x-rays. The MR scanner uses magnetism and radio waves to produce remarkably clear pictures of the human anatomy. When you are referred by your physician for an MRI, he or she is utilizing the most advanced method of diagnostic imaging available in the world today. An MRI provides your physician with a great deal of information about your condition. If you are fortunate enough to be referred for a scan in a FONAR MRI machine, it will be a quick, comfortable and safe experience.Although MRI is used for medical diagnosis, it utilizes a physics phenomenon discovered in the 1930s called nuclear magnetic resonance in which magnetic fields and radio waves, both harmless, cause atoms to give off tiny radio signals. In the 1940s, research physicists found that the length of time these response signals are emitted after an atom is stimulated by radio waves varies widely depending upon the substance being examined. This amazing phenomenon also holds true for biological tissue. It wasn't until 1970, however, that Raymond Damadian, a medical doctor and research scientist, discovered the basis for using magnetic resonance as a tool for medical diagnosis when he found that different kinds of animal tissue emit response signals that vary in length and, furthermore, that cancerous tissue emit response signals that last much longer than non-cancerous tissue. He would subsequently find that the response times of other kinds of diseased tissue, normally called "relaxation times," also vary dramatically. There are two kinds of relaxation times that can be detected and they are known as T1 and T2. When a patient is being scanned with magnetic resonance, the response signals emitted by the atoms in the patient's body are picked up by a very sensitive antenna and forwarded to a computer for processing. When the processing of these signals is complete, a two-dimensional, cross-sectional pattern is created on a monochrome monitor that looks very much like what you would expect if you took a black-and-white TV picture of that particular cross-section. In other words, this "image" shows much more detail than any images generated by X-rays-CAT scans also use X-rays, by the way-but the beauty of MRI is that it doesn't use harmful X-rays. Although this picture looks like a photo, it is not a photo. In fact, in the hands of a trained radiologist, the information it provides is much more useful than what would be revealed in a photo. A typical image is typically made up of 65,000 tiny rectangles that are either white, black or one of a wide range of gray tone values that fall somewhere between black and white. To a trained MRI radiologist, these gray tones speak volumes.

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Q: What is the difference between T1 and T2?
A:

Every tissue in the human body has its own T1 and T2 value. For example, white matter in the brain will exhibit different T1 and T2 values than that of blood. Both are different measures of different kinds of magnetic resonance "relaxation" that occurs after an atom has been stimulated by a radio signal in the presence of a strong magnetic field. In magnetic resonance imaging, the emitted radio signal from a particular tissue depends on a combination of that tissue's T1 and T2 values. In constructing an image, to help the radiologist make an accurate diagnosis, the MRI machine can use the tissue T1 to control the brightness of the image pixels (a T1 image) or it can use the tissue T2 to control the brightness of the image pixels (a T2 image). Usually, a radiologist will request both T1 controlled and T2 controlled images.

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