Clinical News
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Spectros Closes Agreement With Caliper Life Sciences
(June 2008)
Spectros closed a technology agreement with Caliper Life Sciences
(NASDAQ:CALP) for undisclosed terms. Under this agreement,
Caliper will have access to certain optical technologies related
to optical imaging in drug discovery and clinical life sciences.
Caliper Life Sciences, Inc. engages in the sale of products,
services, and integrated systems consisting of instruments,
software, and reagents to life sciences biomedical and
pharmaceutical researchers worldwide. Spectros markets and
licenses advanced molecular sensing and imaging devices that
shed light on ischemia and cancer, and out-licenses
technology to biotech concerns outside of our clinical product
line. Spectros anticipates additional service, technology, or
licensing to be closed with other life sciences concerns in the
coming year.
Vascular Surgeons Adopt T-Stat®
Platform
(May 2008)
Use of
T-Stat® in Vascular Surgery has expanded with recent
peer-reviewed articles which demonstrate that T-Stat® can be
used to identify patients who will and will not tolerate coil
embolization of the iliacs during aneurysm surgery, allowing a
two-surgery procedure to be performed in one procedure. T-Stat®
probes now can monitor at somatic sites, as well as cranial
sites for patients at risk for localized low-flow and no-flow
ischemia.
Neonatal ICUs Adopt T-Stat®
Platform
(March 2008)
Use of
T-Stat® in the Neonatal ICU is expanding. This month, Spectros
exceeded 50 placements of the T-Stat® Ischemia Monitoring
System, which provides real-time, noninvasive feedback to Neonatal
ICUs, allowing physicians and nurses to receive rapid,
quantitative feedback on the perfusion of their patients during
supportive critical care. Aiding this expansion is the expanded
range of probes available, including probes that monitor in G.I.
tract, providing a reliable early-warning for systemic ischemia,
as well as nasal probes which measure in the distribution of the
internal carotid artery. In turn, this has allowed for better
management of volume, drips, and ventilator changes in these
small and fragile patients. Multiple clinical centers are
testing and adopting T-Stat® as a new standard of care for their
most fragile patients. T-Stat® probes now can monitor at somatic
sites, as well as cranial sites for patients in whom the
perfusion of the brain at risk, including monitoring of tissues
in either or both of the internal and external carotid
distributions.
T-Stat® ix Measures
Tissue Composition in Breast, Brain, Gut in Real Time
(January 2008)
T-Stat®-ix, which monitors, characterizes, and
classifies tissue based upon metabolic profile and chemical
make-up, has now been validated to monitor chemical composition
such as blood content, metabolism index, fat content, tissue
volume, as well as abnormal hemoglobins such as met-Hb,
carboxy-Hb, bilirubin, and beta-carotene (a marker of fat).
Clinical trials are nearing at several centers, including Stanford, the University of California, and
the University of Pennsylvania. The ix stands for
"index" and has been developed under the FirstScan label, a
consortium of academic centers and Spectros, to provides
real-time, noninvasive tissue component characterization in
various disease states. An overlay of optical and ultrasound
information is also under study. This application is currently for research use only, and
has not yet been reviewed or approved by the FDA.
T-Stat® Measures
Arterial and Venous Difference Noninvasively in Real Time
(November 2007)
T-Stat®, the first device approved by the FDA as sensitive to
ischemia, has now been demonstrated to allow for analysis of
Arterio-Venous differences. Using the standard T-Stat sensor
line, which relies on broadband white and infrared light
spectroscopy,
multiple blood components
can be measured using multispectral pulse oximetry, a technology
developed by Spectros in the 1990's. Combining this with tissue
oximetry, a measure of the oxygenation of blood in tissue after
tissue has extracted oxygen, an estimate of the arterio-venous
difference can be generated in real time. T-Stat® provides real-time,
noninvasive feedback allowing physicians and
nurses to receive rapid, quantitative feedback on the perfusion
of their patients during supportive critical care. These recent
features will
allow for parameters previously obtained only through invasive monitoring
in the ICU, without the delay of blood draws. This
application is currently for research use only, and has not yet
been reviewed or approved by the FDA.
T-Stat® Measures
Carboxy-Hemoglobin and Met-Hemoglobin
(October 2007)
T-Stat®, first demonstrated to allow for analysis of
multiple blood components
with the measurement of bilirubin and methemoglobin (metHb), and
tissue levels of drugs such as anti-cancer
anthracyclines, has now been demonstrated in human subjects
to measure carboxyhemoglobin (COHb). T-Stat® provides real-time,
noninvasive feedback allowing physicians and
nurses to receive rapid, quantitative feedback on the perfusion
of their patients during supportive critical care. These recent
features will
allow for monitoring of met and carboxy blood components in the ER and
other hospital sites, without the delay of blood draws. This
application is currently for research use only, and has not yet
been reviewed or approved by the FDA.
Neonatal ICUs Adopt T-Stat®
Platform
(September 2007)
T-Stat® now provides real-time, noninvasive feedback to Neonatal
ICUs, allowing physicians and nurses to receive rapid,
quantitative feedback on the perfusion of their patients during
supportive critical care. In turn, this has allowed for better
management of volume, drips, and ventilator changes in these
small and fragile patients. Multiple clinical centers are
testing and adopting T-Stat® as a new standard of care for their
most fragile patients. T-Stat® probes now can monitor at somatic
sites, as well as cranial sites for patients in whom the
perfusion of the brain at risk, including monitoring of tissues
in either or both of the internal and external carotid
distributions.
T-Stat®-ix for
Breast Cancer Reaches Limited Production
(August 2007)
T-Stat®-ix, which monitors, characterizes, and
classifies tissue based upon metabolic profile and chemical
make-up, has reached limited production, in anticipation of
clinical trials at Stanford, the University of California, and
the University of Pennsylvania. The ix stands for
"index" and has been developed under the FirstScan label, a
consortium of academic centers and Spectros, to provides
real-time, noninvasive tissue component characterization in
various disease states. First to trial will be testing in Breast
Cancer screening, anticipated to begin clinical trials in
2008. This application is currently for research use only, and
has not yet been reviewed or approved by the FDA.
Cerebral/Cranial Probes Introduced
(June 2007)
Responding to clinical requests for cerebral monitoring,
Spectros has broadened use of the T-Stat® sensors to operate
within the domain of internal carotid blood supply. Now,
clinicians can obtain stable, noninvasive, and real-time
detection of ischemia in the perfusion of tissues supplied by
the internal carotid artery. These T-Stat® sensors were
demonstrated in studies to correlate with cerebral perfusion
measured by other techniques in subjects undergoing heart-lung
bypass with access to jugular venous drainage. These new T-Stat®
probes expand the tissues that can be monitored by T-Stat® to
include the head for procedures which place the perfusion of the
brain at risk, now including monitoring of tissues in either or
both of the internal and external carotid distributions.
Spectros Introduces Next-Generation T-Stat®
(May 2007)
Spectros announced the next-generation T-Stat®, available in
mid-2007. This new monitor is capable of tracking multiple sites
simultaneously, as well as performing (for investigational use)
new, advanced, real-time calculations that will allow ICU and
surgery users to detect and interpret ischemia data more
readily. This improved monitor will assist in the expansion of
T-Stat® into new areas of use, including general surgery,
vascular repair, trauma, and breast cancer.
Spectros Expands Ischemia Sensor Probe Line
(April 2007)
Spectros introduced new probes for T-Stat® this month, including
probes for neonates, esophageal monitoring, and monitoring of
organs such as the gut and kidney. These new probes will become
available over 2007. These new probes will assist physicians to
apply T-Stat in an ever-growing range of applications, ICU care,
including general surgery, vascular repair, trauma, and breast
cancer.
T-Stat®
Allows Detection and Management of Gut / Mesenteric Ischemia
(February 2007)
T-Stat® was again shown to detect ischemia in the gut, an
approach applicable in all age ranges, from neonate to adult.
Spectros is the leader in real-time noninvasive somatic
molecular monitoring, such as the T-Stat® 303 ischemia detection
system.
T-Stat®
is more sensitive than Near-Infrared NIRS for Cortical Cerebral
Ischemia
(December 2006)
T-Stat® was shown to detect large differences between cortex and
deep white matter oxygenation, differences that could be missed
by near-infrared approaches. In a landmark study from the
Stanford University Medical Center, T-Stat® detected cortical
ischemia likely missed by NIRS systems. Spectros is the leader
in real-time noninvasive somatic molecular monitoring, such as
the T-Stat® 303 ischemia detection system.
Noninvasive T-Stat®
Sto2 Correlates with Invasively Measured Svo2
(October 2006)
T-Stat® was shown to correlated well with invasive Svo2,
providing a measure available for patients without invasive
central lines, such as in the ICU, ER, OR, and patients who do
not tolerate large, invasive, indwelling sample lines. Spectros
is the leader in real-time noninvasive somatic molecular
monitoring, such as the T-Stat® 303 ischemia detection system.
Spectros Begins Ischemia-Directed Trial in
Breast Cancer
(September 2006)
Spectros has started enrollment into a large-scale pivotal trial
of the detection of abnormal metabolism detection in patients at
risk for breast disease, including breast cancer. The Spectros
303xi device has been tested in pilot FDA-directed trials in the
colon, skin, and breast, and found to be sensitive to regional
changes in cellular metabolism. Spectros is the leader in
real-time noninvasive somatic molecular monitoring, such as the
T-Stat® 303 ischemia detection system.
T-Stat®
Noninvasive Sto2 Soon Available for Neonates
(August 2006)
T-Stat® Sto2, which has been demonstrated sensitive to the
presence of ischemia in tissues, will soon be available for
neonatal use, with probes specifically designed for rapid
application in small patients available mid-2007. This is ideal
for ill patients who do not tolerate large, invasive, or
indwelling sample lines. Spectros is the leader in real-time
noninvasive somatic molecular monitoring, such as the T-Stat®
303 ischemia detection system.
Limited Human Feasibility Trial with Rita
Medical (RITA) For Breast Tumor Ablation Monitoring
(June 2006)
Spectros performed a human feasibility trial to test
incorporation of the T-Stat® Molecular Detection System to
real-time cancer treatment guidance in the Breast. The study,
run in conjunction with Rita Medical Systems (NASDAQ: RITA), was
intended to duplicate earlier success in the detection and
monitoring of the treatment of liver tumors. Studies such as
ablation monitoring will extend the range of clinical use for
the T-Stat® and FireFly® products. Spectros is the leader in
real-time noninvasive somatic molecular monitoring, such as the
T-Stat® 303 ischemia detection system.
T-Stat® Effective
in Reducing Colon Anastomosis Leak Due to Ischemia.
(May 2006)
T-Stat® was shown effective at reducing post-anastomotic leak in
G.I. surgery, effectively detecting 75% of the patients who
would go on to develop post-operative leak. The T-Stat Ischemia
Detection System is approved for use during procedures in which
a patient it at-risk for local ischemia. Spectros is the leader
in real-time noninvasive somatic molecular monitoring, such as
the T-Stat® 303 ischemia detection system.
Spectros, University of California,
Stanford, University of Pennsylvania, and Others Join Forces for
Molecular Detection of Breast Cancer.
(April 2006)
Spectros has joined with multiple companies and universities to
develop a molecularly-based assay for breast cancer, known as
FirstScan.
Spectros is the leader in noninvasive somatic molecular ischemia
monitoring, such as the T-Stat® 303 ischemia detection system.
Studies such as breast screening will extend the range of
clinical use of the T-Stat®, FireFly®, and FirstScan® products.
Spectros is the leader in real-time noninvasive somatic
molecular monitoring, such as the T-Stat® 303 ischemia detection
system.
Spectros Prepares FDA Filing in the
Monitoring of Drug Delivery
(February 2006)
Spectros initiated studies in the monitoring of drug delivery
with an inhalation therapy company, with plans to submit an FDA
application for T-Stat® in this clinical area. This filing will
complement the current FDA approval in the area of ischemia
granted for the Spectros T-Stat® product. Studies such as the
monitoring of drug delivery will extend the range of clinical
use for the T-Stat® and FireFly® products. Spectros is the
leader in real-time noninvasive somatic molecular monitoring,
such as the T-Stat® 303 ischemia detection system.
Spectros Receives NCI/NIH Funding for the
Detection of Flowing Ovarian Cancer Cells in vivo
(December 2005).
Spectros has received National Cancer Institute funding for the
noninvasive detection of flowing ovarian cancer cells. Ovarian
cancer is typically detected late, and a noninvasive test for
ovarian cancer would be of great benefit to women's health.
Spectros Receives NCI/NIH Funding for
Development of Optical Contrast Agents to Image Prostate Cancer
(November 2005)
Spectros has received National Cancer Institute funding for the
imaging of prostate cancer using targeted fluorescent molecules.
Prostate cancer is often detected early using blood tests, but
finding the prostate cancer can be quite difficult. If
successful, such prostate imaging agents would be of great
benefit to men's health. These proprietary imaging agents will
be detected and imaged using the Spectros real-time room-light
intraoperative FireFly® imaging system.
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