Spectros Expands Use of Cerebral/Cranial Probes.

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, correlated with jugular venous saturation.
 

 

Clinical News    (for investor news, click here)

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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