| November 09, 2006 |
Announcement of the Completion of Case Registration for the Clinical Study
of the OCT Diagnostic System |
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This is a notification that registration has been completed for the US
clinical trial of the OCT diagnostic system, developed by Goodman's US
subsidiary, LightLab Imaging. The clinical test evaluates safety and efficacy
of the system, and cases were registered with renowned institutions such
as Massachusetts General Hospital, Washington Hospital Center and Columbia
University Hospital. |
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LightLab Imaging entered into an exclusive licensing agreement to utilize
the OCT technology (ultra-high resolution tomographic imaging of vasculature
and tissues through the use of near infrared light) held in basic patents
by the Massachusetts Institute of Technology for application in a commercial
product, and are initially committed to developing a diagnostic device
for the cardiovascular field. |
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When compared to other current examination devices, the OCT diagnostic
system developed by LightLab Imaging yields higher resolution observation
of traditionally undetectable intravascular details, allowing for more
precise lesion diagnosis. |
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Due to the high resolution nature of the OCT diagnostic system's imaging,
two very topical applications of the product are 1) the detection of vulnerable
plaques which are widely thought to cause acute myocardial infarctions
and 2) the diagnosis of late stent thrombosis and the decision of interrupting
medication in DES patients, an issue that has consistently been raised
in recent medical conference presentations. |
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It is anticipated that, after passing the FDA approval investigation, regulatory
approval will be acquired in the summer of 2007. |
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Regulatory approval for the OCT diagnostic system has already been acquired
in Europe and China, and Japan is also currently involved in the regulatory
approval process. With the conclusion of case registration for the US clinical
trial, we have arrived at the final stage for bringing the product to all
of the major markets throughout the world. |
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(FYR) |
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OCT Diagnostic System (optical interferometrical diagnostic system)Taking
"Microscopy" in vivo |
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OCT technology (Optical Coherence Tomography) uses 1300 nanometer (approx.)
near infrared light to acquire a new dimension of ultra-high resolution
tomographic images of blood vessels and tissue. Goodman's US subsidiary,
LightLab Imaging, entered into an exclusive licensing agreement with basic
OCT technology patent holder, Massachusetts Institute of Technology (MIT),
and LightLab Imaging has since worked on the research and development required
to commercialize OCT as a product. |
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Precise Diagnosis Means Precise Treatment |
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| IVUS Image |
OCT Image |
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Among existing devices, IVUS (Intravascular Ultrasound) is similar in purpose,
mechanical structure and image appearance, but when the performance of
the devices are compared, OCT image resolution is shown to be a dramatic
8 to 10 times higher than that of IVUS.
As a result of this, it has become possible
to perform prompt intravascular lesion diagnosis. OCT can be applied for the
diagnosis of late stent thrombosis and the decision of stopping medication in
drug-eluting stent patients that have lately posed problems for the field. |
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Vulnerable Plaque
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| Histology Cross Section |
OCT Diagnostic Image |
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Due to the fragility of vulnerable plaques, they rupture for various internal
and external reasons and can cause acute myocardial infarctions and acute
coronary syndrome. Vulnerable plaques are very serious ailments for a patient.
Previously, even though there was a great deal of attention focused on
the detection of vulnerable plaques, detection was quite difficult with
conventional examination modalities. The lipid or necrotic cores of most
vulnerable plaques are covered by a thin, less than 65ƒÊ fibrous cap, and
this thin fibrous cap was difficult to detect with previous examination
modalities. It can be identified with the OCT diagnostic system. The thin
fibrous cap that was undetectable with existing imaging platforms is clearly
displayed with the ultra-high resolution of OCT. |
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Product Development Status |
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Market |
Development Status |
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China |
Approved and in use for research purposes at
several notable centers |
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Europe |
Approved and in use by major European physicians
and for studies |
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Japan |
Clinical trail completed in 2005/05. Approval
expected in 2007. |
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USA |
Clinical trial completed in 2006/11. Approval
expected in 2007. |
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