FONAR Ships World's First
Room-Size MR Scanner to the Nuffield Orthopaedic Centre
in Oxford, England
MELVILLE,
NEW YORK, November 10, 2005 - FONAR Corporation (NASDAQ-FONR),
The Inventor of MR Scanning, announced today that installation
is underway in Oxford, England for the first of its room-size
MR imaging units, the FONAR 360™, where it will commence
clinical trials to develop image guided surgical procedures known
as intraoperative MR imaging. The room-size MR imaging unit will
be housed in the Nuffield Orthopaedic Centre (NOC) in a recently
completed facility specially built for this project.
The
FONAR 360™ will be the centerpiece of what will be the world's
first room-size MR scanner in which surgeons and radiologists
will have full and unimpeded 360 degree physical access to the
patient for performing MR image guided surgical procedures.
Raymond
Damadian, MD, president and founder of FONAR Corporation said,
"The installation of the FONAR 360™ is a major milestone
for FONAR. We are very excited about it, particularly because
of the benefits we believe it holds for patients in need."
"Most
significantly, Dr. Damadian said, "the FONAR 360™,
unlike any other MR imaging system, is a magnet the doctors can
walk inside of. The patient is positioned on a customary surgical
table but the table itself is positioned immediately on top of
one of the two magnet poles of the MR unit. Because of this design,
the entire surgical team consisting of surgeons, anesthesiologists,
OR nurses and their surgical support systems, including, as needed,
respirometers, heart pumps, cardiopulmonary bypass units, lithotriptors,
surgical navigation systems, endoscopy systems, anesthesia carts,
arthroscopy units, defibrillators, thermal regulation systems,
fiberoptic lighting systems, and electrophysiology platforms such
as EEG, EKG and EMG systems, have full 360(degree) access to the
patient(*).
"Thus,
the surgical team may proceed with their intraoperative procedures
under direct MR image guidance throughout, and direct their instruments
through the body and within the body's organs with continuous
MR image monitoring of their position within the body as the procedure
progresses.
"Full
360 degree access and the ability of the surgical team to walk
within the MR magnet is unprecedented and not available in any
other MR imaging system. The Nuffield Orthopaedic Centre system
will be pioneering the first of these.
"Most
importantly, the possibility of direct intraoperative monitoring
by MR imaging adds a critical dimension to the intraoperative
procedure. In general, all operative procedures suffer from the
limitation that visibility of the body's organs is limited to
the surface of the organ. They are not transparent and are opaque
to visible light. Diseased tissues WITHIN the organ, such as tumors,
cannot be visualized at surgery without the surgeon cutting into
the organ. For example, a surgeon looking at the liver in the
operating room sees only the liver's surface. He cannot see INTO
the liver. He must cut into the liver, a tissue destroying step,
if he wants to see the tumor directly in order to remove it. Similarly,
within the breast and brain, for example, tumors inside of these
organs cannot be directly visualized by the operator for the purpose
of removing them, without the operator cutting into these organs
and destroying tissue in the process. Optical instruments such
as the endoscope, laparoscope and surgical microscope all have
the same limitation. The interior of the body's organs are opaque
to visualization by these optical devices for the same physical
reasons they are optically opaque to the human eye.
"The
FONAR 360™ overcomes this intraoperative impediment. The
MR image sees the full interior of any organ in 3 dimensions with
submillimeter resolution. It therefore can see the exact position
of the surgeon's needle, trochar or scalpel inside the organ as
the operative process proceeds, very much improving his prospects
when it comes to tumor surgery of "getting it all".
"The
Nuffield Orthopaedic Centre (NOC) will be the first beta test
site for the clinical evaluation and clinical implementation of
the FONAR 360™. Its first applications will be orthopaedic
MR imaging and the development of MR image guided intraoperative
techniques for surgery of the spine and other orthopaedic structures.
"Important
additional benefits for the treatment of tumors are made available
by the introduction of the FONAR 360™. Currently, systemic
(oral) chemotherapy and its success must cope with several impediments.
- When a chemotherapy agent is given by mouth there is no means
to certify that the agent actually reached the target organ.
- More importantly, there is no way of ascertaining what dose
level was achieved within the target organ and for how long the
required dose level was maintained within the tissue without being
washed out.
- Additionally, because it is given by mouth (systemically) the
actual dose the patient receives is often limited by the toxic
side affects on the body's healthy tissues.
"The
FONAR 360™ being implemented at the Nuffield Orthopaedic Centre
has the prospect of getting past these impediments.
"With
the availability of MR image guidance, the intraoperative process
made possible by the FONAR 360™ and its 360 degree open access
to the patient by the operative team, needles can now be relatively
easily introduced directly into the tumor or tumors by means of
intraoperative MR image guidance. The dose, readily calculated from
the number of cc's injected into the tumor, assures that the pharmaceutical
agent has reached the tumor at the required dose level. A magnetic
tag such as gadolinium injected with the agent will show the agent
on the MR image and enable the surgeons or post-operative teams
to measure the rate of "washout" of the chemotherapy agent.
Additionally, direct injection and exclusive delivery of the chemotherapeutic
agent to the tumor circumvents the toxic effects of the agent on
the body's other healthy organs and bypasses these toxicities that
limit the dose that can be given to the patient when the chemotherapeutic
agent is given by mouth.
"For
this reason, namely the avoidance by direct injection of the dose
limiting toxicity of systemic treatments, it is likely that much
higher doses of the chemotherapeutic agent may be achievable within
the tumor. Additionally, tumor tissue dose levels can be continually
monitored quantitatively by MR imaging of the gadolinium enhanced
tumor to determine the degree to which effective dose levels are
being maintained within the tumor. Once the needle has been successfully
placed within the tumor, the needle itself can be replaced with
a permanent indwelling catheter for the delivery of follow-up doses
of the chemotherapy agent (or other anti-tumor agents e.g. angiogenesis
inhibitors, immunotherapy agents, etc.) to certify by post-operative
MR imaging that effective dose levels of the anti-tumor agent are
being achieved within the tumor and maintained throughout the course
of therapy.
"It
is a great honor, as well as a great opportunity for FONAR,"
Dr. Damadian said, "to have our new product installed at one
of Oxford University's teaching hospitals, Oxford being arguably
the most prestigious institution in the world. We are eager to work
together with the Oxford Nuffield team to make the full potential
of this wonderful product unfold for the benefit of humanity."
(*) Note: Commercial devices vary in their susceptibility to magnet
fields and depending on their magnet susceptibility may vary in
the distance they have to be positioned from the patient. Regarding
surgical tools, a full complement of MR compatible surgical instruments
is available from commercial vendors.
About the NOC
The NOC is located in Oxford, England and affiliated
with Oxford University which is the oldest English-speaking university
in the world and can lay claim to nine centuries of continuous existence.
About FONAR
FONAR was incorporated in 1978, making it the first, oldest and
most experienced MRI manufacturer in the industry. FONAR introduced
the world's first commercial MRI in 1980, and went public in 1981.
Since its inception, we have installed nearly 300 MRI scanners
worldwide. FONAR's stellar product line includes the Upright™
MRI (also known as the Stand-Up™ MRI), the only whole-body
MRI that performs Position™ imaging (pMRI™) and scans
patients in numerous weight-bearing positions, i.e. standing,
sitting, in flexion and extension, as well as the conventional
lie-down position. The FONAR Upright™ MRI often sees the
patient's problem that other scanners cannot because they are
lie-down only. With over 100,000 patients scanned, the patient-friendly
Upright™ MRI has a near zero claustrophobic rejection rate
by patients. As a FONAR customer states, "If the patient
is claustrophobic in this scanner, they'll be claustrophobic in
my parking lot." Approximately 85% of patients are scanned
sitting while they watch a 42" flat screen TV. Our latest
MRI scanner is the FONAR 360™, a room-size recumbent scanner
that optimizes openness while facilitating physician access to
the patient. FONAR is headquartered on Long Island, New York,
and has approximately 500 employees.
#
MRI Specialist, Stand-Up, Upright, Position,
pMRI and The Proof is in the Picture are trademarks of FONAR.
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
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