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Ed. Note: The following is a press
release from Fonar, Inc.
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.
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