March 4, 2008

FONAR Invents Radiation-Free Method to Diagnose and Monitor Scoliosis

 MELVILLE, NEW YORK, November 26, 2007 - FONAR Corporation (NASDAQ-FONR), The Inventor of MR Scanning™, announced today at the 93rd meeting of the Radiological Society of North America (RSNA) in Chicago a groundbreaking invention in the diagnosis and monitoring of scoliosis. The patent-pending breakthrough utilizes new software and a new receiver coil developed for the unique FONAR UPRIGHT® Multi-Position™ MRI. The dramatic result is a single picture of the entire spine in the upright position (SEE PHOTO).

          A National Cancer Institute (NCI) Report shows a 70% higher risk of breast cancer for women with scoliosis (www.cancer.gov/newscenter/scoliosis2000). The NCI report says, "Researchers have found that women with scoliosis, or abnormal curvature of the spine, who were exposed to multiple diagnostic X-rays during childhood and adolescence may be at increased risk of dying of breast cancer…. The 5,466 women in the study, who received an average of 24.7 X-rays, were found to have a 70% higher risk of breast cancer than women in the general population." The report goes on to say that "although radiation exposures to breast tissue are much lower today than during the time period covered by this study, they are not insignificant."

           Current medical practice consists of ordering baseline X-rays for suspicious physical findings in children. (http://jaapa.com/issues/j20030901/articles/scoliosis.html). With X-ray, a scoliosis patient has a PA (posterior-anterior) and lateral radiograph two or three times a year. To reduce exposure to radiation, the patient is usually scanned with her back to the source of the X-ray.

           Scoliosis affects 2-3% of the population or an estimated 6 million people in the United States, according to the National Scoliosis Foundation (www.scoliosis.org)

           Raymond Damadian, M.D., president and founder of FONAR, said, "I'm delighted to announce our invention for the radiation-free evaluation of scoliosis with the FONAR Dynamic™ UPRIGHT® MRI. An accurate evaluation of scoliosis requires the patient to be upright. A conventional recumbent-only static MRI cannot meet this need. Of critical importance, our radiation-free application can be performed in the same amount of time and at the same cost as diagnosis and monitoring by X-ray. I believe it's imperative that every hospital and practice performing scoliosis examinations consider providing their patients with the radiation-free choice that is finally available because of the unique benefits of the FONAR Dynamic™ UPRIGHT® MRI."

           The FONAR images provide coronal, sagittal and axial views of the entire spine - with no radiation. The 3-plane visualizations are achieved by 3-D acquisition with curved multi-planar reconstruction. Both the Cobb angles and the angular rotation of the vertebrae are measured. The FONAR UPRIGHT® MRI has another important advantage over X-ray. It sees, not only the curvature of the vertebrae, but the soft tissue, including the spinal cord, intervertebral discs, nerve roots and spinal ligaments.

           "This application to scoliosis is just the latest of many unique advantages found only on the FONAR UPRIGHT® MRI," continued Dr. Damadian. "Last week we reported on the landmark independent study by the UCLA School of Medicine, which reported the comparison of Dynamic™ UPRIGHT® MRI with static Upright MRI in more than 1,000 patients (1,301). A significant overall 'miss rate' of 18.1% by static MRI was cited. This large study proves the diagnostic advantages of FONAR UPRIGHT® Multi-Position™ weight-bearing MR imaging."

           FONAR plans to advertise its groundbreaking radiation-free scoliosis application in major medical magazines. To see the advertisement visit: http://www.fonar.com/news/pdf/scoliosis_ad.pdf.

           As many as 60,000 people attend the Annual Meeting of The Radiological Society of North America. FONAR can be visited at booth 7753 in the South Hall at McCormick Place, Chicago, Illinois.

 

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FONAR Announces Installation of First Stand-Up MRI In Alabama; Birmingham Center is the Second Medica Facility to Use FONAR Upright MRI Technology

MELVILLE, N.Y. — FONAR Corporation (NASDAQ-FONR), The MRI Specialist(TM), announced the installation of its Upright(TM) MRI, also known as the Stand-Up(TM) MRI, at Medica Stand-Up MRI of Birmingham. The center, a partnership between Dynamic Imaging of Birmingham and Medica Stand-Up MRI of Atlanta, is the second Medica facility to utilize the FONAR technology. Medica Stand-Up MRI of Birmingham is located at 3105 Independence Drive in Homewood, Alabama.

"We decided to open the Homewood, Alabama facility because of the success of our first Stand-Up(TM) MRI in Atlanta and the demand we were seeing from physicians in Birmingham and other areas of Alabama," said Kay Baker, Vice President of Operations for Medica Stand-Up MRI. "The FONAR Stand-Up(TM) MRI offers the community technology that no other MRI possesses. For example, only using FONAR Stand-Up(TM) MRI can a patient be imaged in the position of pain, in weight-bearing positions or in positions of flexion and extension. Its totally open architecture makes it the only truly Open MRI that is able to scan patients as large as 500 lbs. It is ideal for even the most severe claustrophobic patient."

"We have been open just a month and over 35 different physicians in the area have sent patients to the new Medica Stand-Up MRI of Birmingham center," added Ms. Baker. "We have even had calls from other MRI facilities where patients have not been able to complete their exams due to claustrophobia or the inability to lie down flat. Medica Stand-Up MRI of Birmingham has been able to accommodate these patients, and they were thrilled to be able to complete their exams."

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March 3, 2008

Positional Magnetic Resonance Imaging (MRI)

From Regence.com:

Conventional magnetic resonance imaging (MRI) systems acquire images with the patient in the recumbent, neutral position.  Recently, a new fully open MRI system, the upright or positional MRI,  has been developed which allows multiple position as well as recumbent imaging.  This system allows partial or full weight bearing, as well as simultaneous kinetic maneuvers of the patient’s whole body or individual body parts.

It is theorized that imaging the body in positions related to the axial loading of the spine, which occurs when standing upright or sitting or in the specific position  related to the patient’s clinical symptoms, may lead to more accurate diagnosis. This is being evaluated in patients with suspected nerve root compression and in some cases of spondylolisthesis and may be particularly relevant in cases where disease is not visible on a recumbent MRI.

FONAR Corporation has 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for a MRI system that performs positional MRI scans.

Policy/Criteria

Positional or upright MRI for the diagnosis and management of any condition, including, but not limited to cervical, thoracic or lumbosacral back pain, is considered investigational.

Scientific Background

Validation of any new imaging technique involves the following steps:

  1. Demonstration of its technical feasibility, including assessment of its reproducibility and precision. For comparison among studies, a common standardized protocol is necessary.
  2. Establishment of normal and abnormal values as studied in different clinical situations. For accurate interpretation of study results, sensitivities, specificities, and positive and negative predictive values compared to a gold standard must be known.
  3. Assessment of the clinical utility of both positive and negative tests. The clinical utility of an imaging study is related to how the results of that study can be used to benefit patient management. Relevant outcomes of a negative test (i.e., suspected pathology is not present) may be avoidance of more invasive diagnostic tests or avoidance of ineffective therapy. Relevant outcomes of a positive test (i.e., suspected outcome is present) may also include avoidance of a more invasive test plus the institution of specific, effective therapy.

In evaluating this approach to imaging, it is important to first determine if positional MRI results in additional findings.  However, it is also important to determine if treatment of these additional findings results in improved outcomes.  This second step is important given the previously described false positive findings of MR imaging of the spine.  Jarvik and colleagues reported that many MR imaging findings have a high prevalence in subjects without low back pain and that findings such as bulging discs and disc protrusion are of limited diagnostic use.(2)  They also reported that the less common findings of moderate or severe central stenosis, root compression, and disc extrusion were more likely to be clinically relevant.

A number of studies have reported that positional MRI can identify abnormalities in patients where conventional (supine) MRI did not identify significant abnormal findings.  Weishaupt and colleagues reported finding 13 instances of nerve root deviation in the seated extension position compared with 10 instances in the supine position in a group of 30 patients with chronic low back pain. (3)  They also reported that positional pain score differences were related to foraminal size.  Vitaz reported changes in spinal cord compression, angulation, and alignment that occurred during physiologic movement in 20 patients with cervical spine disorders.(4)  They reported excellent or good image quality in 90% of cases.  Jinkins concluded that supine MRI underestimated the presence and degree of gravity-dependent spinal pathology and missed pathology of a dynamic nature.(5)  Karadimas and colleagues reported the ability to demonstrate changes in healthy and degenerative discs in the weight-bearing position in 30 patients with chronic low back pain using the upright MRI.(6) Other studies have discussed the potential benefits of upright MRI or indicate it’s technical feasibility.(7-12) However, no studies were found that described clinical outcomes of patients whose treatments were selected on the new findings of positional MRI.  In addition, the incremental benefit of this imaging in clinical practice is not yet known.

While this imaging approach is interesting, published results are in an early phase.  Additional study is needed to first determine the characteristics of patients who might benefit from positional MR studies. The clinical benefit of basing treatment decisions, including surgery, on these additional findings needs to be established.  Studies are also needed to determine if this technique might replace current diagnostic tests, such as myelography.  Given this novel approach, randomized trials may be needed to adequately evaluate this technique.

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Upright MRI Ads

Radiology Magazine Ad-July 2007 "Why So Many Surgeons Are Buying the Fonar Upright™ Multi-Position™ MRI" (PDF) 6MB (JPG) 1MB
Patient Seated in Upright MRI
(JPEG - 3.5 MB)
PI-802 Position Imaging…Only Possible on the FONAR Upright MRI (PDF)
JAMA Ad (PDF) "Discover the Power of Upright Imaging - A New Era of Diagnosis"
Upright MRI Scanner
(JPEG - 4.7 MB)
Sample Upright MRI Referral Sheet (PDF)
Spine Magazine Ad "AMA Indicates Why You Must View Spine Problems in Upright Flexion and Extension" (JPEG) | (PDF) Receiver Coils and Patient Positioning (PDF)
Spine Magazine Ad with Timeline
"AMA Indicates Why You Must View Spine Problems in Upright Flexion and Extension" (JPEG) | (PDF)
   
Mobile Showroom for FONAR Upright MRI Postcard (PDF)

 

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Upright MRI Reports

What's New
Powerpoints
Case Studies (PDF)
UCLA Spine Study - Abstracts from The Spine Journal Vol 7, No.5S (PDF) Upright MRI (ver. 5_2) (12.8 MB) SM-700-Case 1: Dr.Chiles "Upright™ MRI Produces Excellent Clinical Results!"
UCLA Spine Study REVIEW (PDF) RSNA 2007 Live Show (27 MB) SM-701-Case 2: Dr.Rose-Mrs.Morgenstern "Reducing Failed Back Surgery"
Case Examples of UCLA Reported "Missed" by Static MRI. Detected by FONAR Spondylography (PDF) AANS 2007 Live Show (15.6 MB) SM-702-Case 3: Dr.Elsig: Ice Hockey Player "Upright™ MRI Saves Professional Ice Hockey Career!"

UCLA Study Ad (PDF) Landmark Study of More Than 1000 Patients Reveals the Miss Rate of Static MRI.

SM-703-Case 4: Dr.Elsig: Chiari Malformation "Chiari I Malformation Detectable Only by
the Upright™ MRI Leads to Successful Surgery"

Scoliosis Ad (PDF) "At Last, Radiation-Free Diagnosis and Monitoring of Scoliosis"   SM-704-Case 5: Hidden Disk "FONAR Upright™
Full-Range-of-Motion Multi-Position™ MRI Uncovers “ Hidden Disc”
New Ad: "Leading Radiologist Explains Why He Bought 12 Fonar Upright™ MRI's" (PDF) (JPEG)   SM-705-Case 6: Hidden Disk "FONAR Walk-In™ Full-Range-Of-Motion™ Multi-Position™ Upright™ MRI Uncovers “ Hidden” Disc Herniation and Spinal Instability"

Wall Street Journal Article: "Hospital Building Boom Sparks Worry Cities Will Be Left Behind"

 

Hong Kong Radiological Journal
" Upright, Weight-bearing, Dynamic-kinetic Magnetic Resonance Imaging of the Spine-Review of the First Clinical Results"

 

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March 1, 2008

Upright MRI Boom

Philadelphia Business Journal - by Athena D. Merritt Staff Writer

"We simply don't negotiate in price. The reason being is that once a customer has understood the huge advantage of the upright MRI, they don't really care, and the cost is not an issue," said Fonar Corp. spokesman Daniel Culver.

Since attaining FDA approval in 2000 and rolling the first upright MRI scanner onto the market in spring 2001, Fonar has sold 117 and installed 91 as of June 30. Those sales include one in Delaware, four in New Jersey and four in Pennsylvania.

When it comes to growth, New Jersey, with the state Department of Health reporting 214 centers statewide performing MRI scans, is ahead of the curve, said Dr. James P. Borgstede, chair of the American College of Radiology.

"We really see a lot of this growth occurring in the non-radiology community. The growth is probably somewhere between two and three times what growth is in the radiologist (owned and operated centers)," Borgstede said.

But the centers, which some assert are driven solely by profit, will face future obstacles, he said.

"The [health insurance] carriers have made it very clear to us that they expect [growth] would continue unabated without their putting some limits on it," Borgstede said. "They made it clear they would put some limits on it because they can not sustain this type of growth in their programs."

One such means could be across-the-board cuts in services, in which insurance providers pay less on a per-use basis for services, Borgstede said.

Others, he said, are expected to follow in the footsteps of Pittsburgh-based Highmark Blue Cross Blue Shield.

Last year, Highmark set new quality standards for rendering payment for MRI imaging services. Among the restrictions was requiring physicians to get authorizations prior to ordering tests and requiring the locations in its network, in which it would pay for such services, to make such testing available a minimum of 40 hours a week, including some Saturdays. The restrictions were implemented to weed out those who are unskilled at reading images and driven by profit to order and perform them, Borgstede said. Such concerns could lead to the establishment of other quality controls in the future to make sure only the most skilled and educated, such as radiologists, are reading and performing scans.

"People can make a lot of money off of this, and that is why it's growing at this astronomical rate," Borgstede said.

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Upright MRI Trend

Philadelphia Business Journal - by Athena D. Merritt Staff Writer

Growth of freestanding centers has been strong both locally and across the country, Katz said.

"The reason they are popping up is the frequency in which physicians are ordering MRIs has increased exponentially because it is such a useful diagnostic tool," Katz said.

South Jersey Radiology Associates, whose network includes eight offices and two women's centers, has six MRI machines. Located between two offices, those machines include one of the newest on the market — an open 1.5 Tesla MRI, capable of capturing high-field quality diagnostic images.

Yet few patients will be steered into the larger opening it offers and will instead be slid into one of the traditional closed MRIs; the practice said that equipment still offers better quality images and serves 97 percent of its patient base.

"We think we provide a level of service that is above and beyond," said Dr. Edward J. Petrella, president of South Jersey Radiology Associates, whose locations also provide mammographies, computed tomography (CT scan), nuclear medicine and cardiology and PET and bone density scans, among other services.

"In order to keep current in imaging, in order to attract the talent we attract, you have to have state-of-the-art equipment," Petrella said, noting that MRI scanners can cost hundreds of thousands of dollars to upgrade.

Used MRI systems are available. But for those who want the most current technology, such as the upright MRI, the cost can be non-negotiable.

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Upright MRIs latest trend for fast-growing industry

Philadelphia Business Journal - by Athena D. Merritt Staff Writer

Patients climbed into the new upright magnetic resonance imaging machine at University Dynamic MRI at a turnstile-like rate of 150 scans per month between April and June.

Those who are claustrophobic or overweight are drawn to the machine because of its design, which has a larger and less confining "tunnel" than traditional MRIs, said Dr. George Rodriguez, director of Philadelphia-based University Dynamic.

The rehab center paid between $1.5 million and $2 million and waited eight weeks to buy and install what Rodriguez refers to as one of the best MRI machines available. Patients will soon have access to another upright MRI, which allows them to have images done in positions that induce their pain, such as kneeling and standing, at a second location at Grant Avenue and Roosevelt Boulevard.

Those offices are just some of the many freestanding sites that are popping up across the country, fulfilling an increasing demand for MRI scans. The images can detect such problems as cancer, strokes, joint pain and muscle tears.

And in Pennsylvania and New Jersey, patients can choose to have a scan performed at a wide choice of locations outside of hospitals.

"Because we are not a certificate of need state, if you can afford it, you can develop it. In other states, you would need to get state approval, but that is not the case in Pennsylvania," said Gerry Katz, a health-care consultant for The Katz Consulting Group in Plymouth Meeting.

In 2003, an estimated 18.9 million MRI scans were performed, according to the Physician Supplier Procedure Summary Master File. Nationwide, the number grew 116 percent between 1998 and 2003, which amounts to about 65 per 1,000 people in 2003. Use of MRIs grew 100 percent in New Jersey over the same period, with an estimated 610,000 scans performed, or 71 per 1,000 people. Use grew 81 percent in Pennsylvania with an estimated 1.03 million scans performed, or 83 per 1,000 people.

Growth of freestanding centers has been strong both locally and across the country, Katz said.

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FONAR SELLS AND INSTALLS UPRIGHT MRI AT RIVERHEAD, LONG ISLAND

MELVILLE, NEW YORK, June 2, 2005 - FONAR Corporation (NASDAQ-FONR), The MRI Specialist™, announced today that it has sold and installed an Upright™ MRI at StandUp MRI of Riverhead, NY. The facility is operated and managed by Diagnostic Imaging Management Company (DIMC), which is affiliated with Long Island Diagnostic Imaging (LIDI). LIDI has been offering full imaging modality services to the Long Island area for more than 30 years.
          Asif Ally, Financial Officer at DIMC said, “We purchased the FONAR Stand-Up™ MRI (Upright™ MRI) because we recognize the value of this “revolutionary” technology. The Stand-Up™ MRI offers multi-position scanning capability, enabling patients to be scanned while sitting, standing, bending or lying down.”
          “Our new Upright™ MRI is gaining widespread physician acceptance for several reasons,” said Sean Sarjoo, Director of Operations at StandUp MRI of Riverhead. “First and foremost is the excellent image quality, but also because the Upright™ MRI can scan all types of patients. We can and have scanned young children, without having to anesthetize them, many claustrophobic and elderly patients, as well as large and overweight patients.”
          One recent case was quite interesting. Dr Franco Jona of Riverhead, NY remarked, “Upon hearing about the availability of Upright™ imaging services at StandUp MRI of Riverhead, I called one of my patients on his cell phone. He was actually sitting in a waiting room at a traditional MRI center. I instructed him to leave that facility and go directly to Stand-Up MRI of Riverhead. This particular patient had a problem with his spine, and had complained about his recumbent scanning experience in the past.”
          As noted on a patient satisfaction survey, Dr. Jona’s patient was ‘positively surprised’ with his scanning experience, especially his ‘extreme pleasure’ in watching a big-screen TV. StandUp MRI of Riverhead is equipped to handle walk-in patients and was able to accommodate him.
          “The imaging market has become a consumer-driven business for both patients and providers,” said Mr. Ally. “Physicians want superior image quality to help them make appropriate diagnoses, while patients are demanding a higher level of comfort and customer service. Word-of-mouth publicity from satisfied patients and physician testimonials about image quality and reliability are driving the Upright™ imaging revolution.”
          StandUp MRI of Riverhead is located at 205 Osborne Avenue, Riverhead, Long Island, New York. For more information, phone toll free 877- STANDMRI (782-6367) or visit the web site: http://www.dimc-mri.com

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FORMER NFL GREAT IS KEY TO FONAR UPRIGHT MRI SALE

MELVILLE, NEW YORK, June 6, 2005 - FONAR Corporation (NASDAQ-FONR), The MRI Specialist™, announced that Garo Yepremian, former Miami Dolphins field goal kicker, played a key role in the sale of a FONAR Upright™ MRI scanner in the greater Philadelphia area.
          Mr. Yepremian was a member of the only undefeated team in professional sports history, the 1972 Miami Dolphins of the National Football League. With a 17-0 record it was known as “The Perfect Season”. He played in 3 Super Bowls (VI, VII, and VIII) and scored in all three. He ended the longest game (82 min. 42 sec.) in NFL history with a 37-yard field goal, and was Pro Football Hall of Fame’s choice as “Kicker of the Decade” from 1970-1980. Since retirement Garo has hosted radio talk shows, written three books and is recognized as a foremost motivational speaker.
          Mr. Yepremian said, “I am excited to be working with the FONAR sales team. The Upright™ MRI is truly revolutionary in the field of medical imaging. It is another highlight of my career to be a part of this effort.”
          “As a retired athlete,” continued Mr. Yepremian, “I am very familiar with MRI scanners and never liked being placed into the MRI ‘tube’. Even the so-called ‘Open’ MRI where the magnet is just inches from your face is only a little better. When FONAR invited me to New York to be scanned in their new Upright™ MRI scanner, I was not only surprised but excited. I sat down and watched TV while being scanned. It was quiet and comfortable and the pictures were clear and precise. I am very appreciative of Dr. Raymond Damadian and all at FONAR who designed and developed this amazing MRI scanner. I have been touting it all over ever since!”
          Mr. Yepremian added, “These days I am invited to celebrity/charity events all over the country where people always ask about my football career and I do enjoy reminiscing about the old days. However my conversations always lead to FONAR and the Upright™ MRI.”
          “FONAR’s Sports Program is designed to introduce the sports world to the benefits of the Upright™ MRI,” said David Terry, Sr. Vice President, and coordinator of FONAR’s Sports program. “We have an opportunity to introduce our product to a special group of people, the sports celebrity, and the people who attend these events with the celebrities. Our Upright™ MRI scanner is perfect for the athlete and everyone can learn why.”
          “Football was an obvious area to start since there are a lot of big men in the NFL and 500 pound patients have been scanned in the Upright™ MRI,” continued Mr. Terry. “Athletes from all sports are encouraged to try our scanner when they need an MRI. We take ‘Invincible’, (see http://www.fonar.com/invincible.htm), the showroom in a tractor trailer, to these events. It is the opportunity to actually place athletes into the scanner in order to give them a feel for it. Most say they will definitely use the Upright™ MRI if they ever need another MRI scan. Several players have traveled to Long Island to be scanned at our facilities. We also talk with coaches, owners, trainers, the media and others who attend these events.”
          “It was at an event with ‘Invincible’ that we had the good fortune to meet Garo,” said Mr. Terry. “He is recognized wherever he goes and has become a valuable member of our sales effort. It was Garo’s excitement about the Upright™ MRI that encouraged several entrepreneurial businessmen and a local MD to make this recent sale in the Philadelphia area.”
          Mr. Yepremian concluded, “After my own satisfying experience in the FONAR Upright™ MRI, I think every MRI should be an Upright™ MRI.”
          To Learn more about Garo Yepremian visit www.garoyepremian.com

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