FONAR Ships World`s First Room-Size MR Scanner to the Nuffield Orthopaedic Centre in Oxford, England
Posted on: 11/10/2005
FONAR Ships World's First Room-Size MR Scanner to the Nuffield Orthopaedic Centre in Oxford, England
November 10, 2005 08:20 AM US Eastern Timezone
MELVILLE, N.Y.--(BUSINESS WIRE)--Nov. 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(TM), 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(TM) 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(TM) 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(TM), 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(TM) 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(TM). 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(TM). Currently, systemic (oral) chemotherapy and its success must cope with several impediments.
1. When a chemotherapy agent is given by mouth there is no means to certify that the agent actually reached the target organ.
2. 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.
3. 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(TM) 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(TM) 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.
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 FONAR has installed over 300 MRI scanners worldwide. Their stellar product line includes the Upright(TM) MRI (also known as the Stand-Up(TM) MRI), the only whole-body MRI that performs Position(TM) imaging (pMRI(TM)) 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(TM) 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(TM) 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. FONAR's latest MRI scanner is the FONAR 360(TM), 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.
Additional information may be found on the FONAR Web site at www.fonar.com.
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.
Daniel Culver, 631-694-2929
Darrow Associates, Inc.
Jordan M. Darrow, 631-367-1866
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