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clinical news
T-Stat validation in neonatology
(March 2010)
Spectros has been working closely with Duke University, (Durham, NC,) Georgetown University Hospital, (Washington, DC) and Children's Hospital at OU Medical Center, (Oklahoma City, OK) on issues that face today's NICU's. Final reports will cover subjects including Transfusions and Mesenteric Perfusion, Hemodynamic Indices during Transition and Validation of VLS (Visible Light Spectroscopy) in Neonates. All data will be presented at the upcoming PAS (Pediatric Academic Societies) Conference, May 1-4, 2010 in Vancouver.
Spectros to present at CSPS
(March 2010)
Spectros prepares to present preliminary data with Stanford University Medical Center, Palo Alto, CA. The presentation will take place at the California Society of Plastic Surgeons Conference. We have been very fortunate to work with such an amazing group of leading Plastic Surgeons. With the Stanford team we look forward to establishing a better standard for patient care and outcome, commented Elizabeth van Thillo, manager of clinical studies for Plastic Surgery applications using the T-Stat.
Spectros enrolls 500 subjects for Earlier Detection of Breast Cancer Trial
(February 2010)
Clinical trials for the earlier Detection of Breast Cancer study have successfully reached 500 subjects. The trials have been a collaboration between clinical teams at Palo Alto Medical Foundation, FirstScan in Portola Valley and Stanford University. "It seems that not only medical professionals want to participate in the fight against breast cancer. We thank the many women in the Bay Area who have participated eagerly and have shown great support for the development of new technology in this specific area of concern."
Spectros recognized for holding on in tough economic times.
(October 11, 2009) San Jose Mercury News (CA)
A SINK-OR-SWIM YEAR : The start-up company. With a national recession well under way, Spectros, a Portola Valley biotech startup, made sure that it had enough support to weather the storm. "We had three years of funding in place had sales fallen to zero," said David Benaron, chief executive officer. "We've actually done quite well."
"The recession will be a temporary thing, and we want to make sure we are not laying off people who helped build the company," Benaron said. "We try to make sure everyone survives."
Spectros took advantage of falling real estate prices and moved to its own building in Portola Valley. "For those who have cash, a depression or recession is a great opportunity," Benaron said.
Spectros enters reconstructive plastic surgery market with a new application for monitoring skin flaps.
(October 2009)
Spectros exhibits the T-Stat VLS Tissue Oximeter as a new means to monitor free flaps during the ASPS Annual Meeting, Seattle WA. The T-Stat has proven its Visible White Light Technology and has rapidly been adopted by surgeons across the US, providing a reliable and responsive actual value of localized tissue saturation during post operative monitoring. The system comes with an option of two different probe sizes, based on the size and location of each unique flap. Aside from the dependability of the information provided by the T-Stat, one of the great benefits surgeons claim most is the ease of use for the bedside nursing staff.
Spectros T-Stat Neonatal Studies Presented at Pediatric Academic Societies' (PAS) Conference
(May 2009)
The T-Stat monitor was featured in two studies at the Pediatric Academic Society Conference annual conference held in Baltimore, Maryland, May 2-5, 2009. The studies focused on clinical applications of the T-Stat in the neonatal intensive care unit (NICU).
The first study was entitled Visual Light Spectroscopy (VLS) for Detecting Alterations in Tissue Oxygenation with PRBC Transfusion in Very Low Birth Weight (VLBW) Neonates. The authors concluded VLS is easy to use and non-invasive method of assessment of tissue saturation in VLBW neonates with various severity of illness. Another study was entitled Noninvasive Measurements of Plasma Bilirubin Levels Using Real-Time Visible Light Spectroscopy. The authors concluded visible light spectroscopy can be used as a method to measure real-time plasma bilirubin levels noninvasively. This compliments prior studies showing T-Stat can measure tissue or plasma met-hemoglobin and carboxy-hemoglobin.
Spectros Sales Expand to Europe, Australia
(April 2009)
Spectros' T-Stat sales have expanded this year to Europe and Australia, reflecting growing acceptance of ischemia monitoring in a broadening array of applications and clinical research areas. "The approval and availability of T-Stat in areas around the world will make the clinical advantages of T-Stat available to a wider array of clinicians," comments David Benaron, CEO.
Skin flap monitoring with T-Stat
(February 2009)
Spectros introduces a new sensor to be used in plastic surgery. The surface sensor is a noninvasive sensor that is placed on the surface of the skin and is approved for up to 30 days per patient. Feedback from practicing plastic surgeons led to the current design. The sensor is successful because of its sensitivity and ease of use while placing and monitoring. The clear plastic sensor base provides stable placement and prevents incoherent and unreliable readings.
With early detection of compromised saturation, measures to save these sensitive flaps can be taken earlier, increasing overall success rates and ultimately saving time and money and improved patient care.
Phase I/II Surgical Anastomosis Trial Interim Analysis
(December 2008)
T-StatŪ was again shown in interim analysis to detect staple line and suture site anastomotic ischemia in the gut, an approach applicable in all age ranges for open and endoscopic surgeries. Spectros is the leader in real-time noninvasive somatic molecular monitoring, such as the flagship T-StatŪ ischemia detection system.
Phase III Compositional Analysis FDA Trials Reach 500 Breasts Scanned
(November 2008)
Spectros' compositional and metabolic screening for breast and Abdominal lesions has reached a milestone of completed 500 real-time breast scans. It is anticipated that 1,000-2,000 patients will be studied over the next 18 months. If successful, the FirstScan Lori will be prepared for FDA approval of compositional analysis in tissue.
ProstaFluor Targeted Agent Specific for Detecting Residual Prostate Cancer
(September 2008)
Spectros' targeted contrast agent, ProstaFluor, was demonstrated to allow real-time detection of prostate cancer, both at the surgical margin and in metastatic lesions. This agent is being prepared for human trials.
FirstScan Lori Metabolic and Composition Screening Device Enters Phase III Trial
(August 2008)
Spectros' compositional and metabolic screening for breast lesions, including cysts, inflammation, and cancer entered Phase III trials. It is anticipated that 1,000-2,000 patients will be studied over the next 18 months. Support for this study is from internal funding, as well as support from the National Cancer Institute. If successful, the FirstScan Lori will be prepared for FDA approval of compositional analysis in tissue.
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-StatŪ Platform
(May 2008)
Use of T-StatŪ in Vascular Surgery has expanded with recent peer-reviewed articles which demonstrate that T-StatŪ 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-StatŪ 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-StatŪ Platform
(March 2008)
Use of T-StatŪ in the Neonatal ICU is expanding. This month, Spectros exceeded 50 placements of the T-StatŪ 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-StatŪ as a new standard of care for their most fragile patients. T-StatŪ 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-StatŪ ix Measures Tissue Composition in Breast, Brain, Gut in Real Time
(January 2008)
T-StatŪ-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-StatŪ Measures Arterial and Venous Difference Noninvasively in Real Time
(November 2007)
T-StatŪ, 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-StatŪ 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-StatŪ Measures Carboxy-Hemoglobin and Met-Hemoglobin
(October 2007)
T-StatŪ, 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-StatŪ 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-StatŪ Platform
(September 2007)
T-StatŪ 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-StatŪ as a new standard of care for their most fragile patients. T-StatŪ 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-StatŪ-ix for Breast Cancer Reaches Limited Production
(August 2007)
T-StatŪ-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-StatŪ 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-StatŪ 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-StatŪ probes expand the tissues that can be monitored by T-StatŪ 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-StatŪ
(May 2007)
Spectros announced the next-generation T-StatŪ, 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-StatŪ 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-StatŪ 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-StatŪ Allows Detection and Management of Gut / Mesenteric Ischemia
(February 2007)
T-StatŪ 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-StatŪ 303 ischemia detection system.
T-StatŪ is more sensitive than Near-Infrared NIRS for Cortical Cerebral Ischemia
(December 2006)
T-StatŪ 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-StatŪ detected cortical ischemia likely missed by NIRS systems. Spectros is the leader in real-time noninvasive somatic molecular monitoring, such as the T-StatŪ 303 ischemia detection system.
Noninvasive T-StatŪ Sto2 Correlates with Invasively Measured Svo2
(October 2006)
T-StatŪ 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-StatŪ 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-StatŪ 303 ischemia detection system.
T-StatŪ Noninvasive Sto2 Soon Available for Neonates
(August 2006)
T-StatŪ 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-StatŪ 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-StatŪ 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-StatŪ and FireFlyŪ products. Spectros is the leader in real-time noninvasive somatic molecular monitoring, such as the T-StatŪ 303 ischemia detection system.
T-StatŪ Effective in Reducing Colon Anastomosis Leak Due to Ischemia.
(May 2006)
T-StatŪ was shown effective at reducing post-anastomotic leakage after 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-StatŪ 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-StatŪ 303 ischemia detection system. Studies such as breast screening will extend the range of clinical use of the T-StatŪ, FireFlyŪ, and FirstScanŪ products. Spectros is the leader in real-time noninvasive somatic molecular monitoring, such as the T-StatŪ 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-StatŪ in this clinical area. This filing will complement the current FDA approval in the area of ischemia granted for the Spectros T-StatŪ product. Studies such as the monitoring of drug delivery will extend the range of clinical use for the T-StatŪ and FireFlyŪ products. Spectros is the leader in real-time noninvasive somatic molecular monitoring, such as the T-StatŪ 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 FireFlyŪ imaging system.
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