MD Anderson adopts use of T-Stat
In September of 2016 the University of Texas MD Anderson Cancer Center in Houston, ranked one of the world's most respected centers focused on cancer patient care, has adopted the use of T-Stat Tissue Oximeters by Spectros as a standard of care for post operative monitoring of free flaps in reconstructive plastic surgery.
Spectros headquarters move to Campbell, CA
In February 2016 Spectros Corporation moved its headquarters to a larger facility that is also closer to manufacturing. The new address is 274 E. Hamilton Ave #H Campbell, CA 95008. Contact information remains 650.851.4040 or [email protected]
Spectros signs exclusive agreement with EU distributor with regional expertise in BeNeLux and France
In 2015 Spectros signed an exclusive agreement with a specialized medical distribution group in BeNeLex to market and sell the T-Stat product line primarily to the GI market with plans to expand into other growing markets, including reconstructive plastic surgery and CICU.
Spectros 2014 sales increase 42%
Spectros sales increase overall in 2014 by 42%. This result is part of great trend where each consecutive year T-Stat adoption has helped boost sales, year over year.
Spectros signs agreement with Distribution group in the SE US territory
The growing reconstructive plastic surgery market that utilizes the T-stat tissue oximeter for the monitoring of free tissue flaps, allowing for accurate and quicker diagnosis, has expanded into SE US regional hospitals.
Stanford publishes advantages of using White Light Spectroscopy for Free Flap Monitoring using T-Stat in Microsurgery Journal Volume 33, Issue 3
The Spectros T-Stat monitoring device, which utilizes white light spectroscopy non-invasively to measure hemoglobin, is used after microvascular surgery to allow for early detection of ischemia and thrombosis. The T-stat system recorded an acute decrease in saturation from ∼50% to less than 30% 50 min prior to identification by clinical exam. Prompt treatment resulted in flap salvage. Stanford recommends T-Stat as a useful treatment for providing continuous, accurate perfusion assessment postoperatively.
Spectros Adds Video Training Support for T-Stat Users
Spectros introduced video training for T-Stat use, where physicians and nurses can learn how to operate and interpret T-Stat monitoring using simple, online videos viewable on any laptop, notepad, or smartphone with internet access. The initial videos consist of an "about T-Stat video" that introduces tissue oximetry, and two "sensor selection" and "monitor use" videos to assist with training on the use and operation of T-Stat.
The "about T-Stat" video is accessible from the Spectros homepage on the Company website.
Spectros Enters Into Production of Injectable Contrast Agent to Guide Surgery
Goodwin Biotechnology, Inc. (GBI) and Spectros Corporation jointly announced a collaboration for the cGMP manufacturing of an antibody:dye conjugate that will be used in Phase I and Phase II clinical trials.
"The leading surgical treatment for prostate cancer is prostatectomy, or removal of the prostate," noted David Benaron, CEO at Spectros Corporation. "Unfortunately, residual tumor remains at the edge of surgery about 30% of the time, leading to a significantly higher risk of local recurrence of the cancer and higher rates of death. By collaborating with GBI on the conjugation of a fluorescent dye and a monoclonal antibody that has a high level of affinity with the prostate-specific membrane antigen, we aim to identify and minimize the residual tumor, thereby reducing the number of people who have to receive additional treatment such as high doses of radiation. This type of cancer detection, called Molecular Imaging, may represent an important advance in cancer by improving the diagnosis, individualized treatment selection and monitoring, and even survival. We look forward to clinical trials with this agent, ProstaFluor®, beginning next year."
Spectros T-Stat Shown to Be Earliest Available Method for Detection of Surgical Skin Flap Compromise After Surgery
In an independent study published in the Journal of Reconstructive Microsurgery, researchers at the University of Texas Health Science Center San Antonio have found that the Spectros T-Stat® oximeter responds earliest to compromised blood flow during reconstructive microsurgery when compared clinically to other available monitors.
This landmark study by Dr. Cornejo and colleagues is important as compromised blood flow to microvascular free flaps causes irreversible damage and/or complete loss of the flap, resulting in longer hospital stays and additional costs to both hospital and patient. While a detailed economic analysis was not an endpoint of this study, earlier detection of tissue compromise results in an improved patient outcome and overall reduced hospital costs.
"These are very strong results supporting the superiority of the T-Stat VLS Oximeter," noted CEO and physician Dr. David Benaron, "This study provides solid evidence that the Spectros broadband light technologies offer the earliest and most sensitive detection of tissue compromise, and suggests that all reconstructive surgery cases can benefit from T-Stat monitoring."
Spectros oximeters are currently the only broadband solid-state tissue oximeters on the market in the U.S. and Europe. T-Stat patented broadband technology provides continuous and real-time absolute measurement of tissue hemoglobin oxygenation using 100s of wavelengths of light, a key advantage over competing oximeter product lines that only use 2 or 4 wavelengths. An expanded array of broadband sensors, including NIRS Continuum® cerebral sensor, is currently in testing, with FDA and EU approval anticipated in 2012.
In reconstructive surgery, T-Stat competes with T.Ox® oximeters marketed by ViOptix and Doppler marketed by Cook Medical. In critical care, the ICU and O.R., T-Stat competes with INVOS® oximeters marketed by Covidien and FORE-SIGHT® oximeters marketed by CAS Medical.
Spectros Corporation Signs Distribution Agreements in Korea, Switzerland, Denmark
Spectros Corporation announced an expansion of its distribution channels in Europe and Asia with the signing of 3 new distributors based in Korea, Switzerland, and Denmark. These groups join other distributors already selling Spectros products outside of the U.S.
Physicians are increasingly recognizing the opportunity offered by the superior performance of the T-Stat® 303 VLS Tissue Oximeter, and this move accelerates Spectros' expansion into new and emerging markets in Europe and Asia.
Spectros T-Stat and Continuum Oximeters are currently the only solid-state broadband tissue oximeters on the market in the U.S. and Europe. T-Stat and Continuüm compete in the ICU and operating rooms with INVOS® oximeters, marketed by Covidien, and FORE-SIGHT® oximeters, marketed by CAS Medical. In reconstructive surgery, T-Stat competes with T.Ox oximeters, marketed by ViOptix, and O2C, marketed in Europe. An expanded array of probes, including broadband NIRS Continuüm® cerebral probes are currently in testing, pending FDA approval and release anticipated over the next year.
Spectros Detects Necrotizing Enterocolitis with Continuum® Broadband Sensor
Clinical application of Continuum sensors incorporating a broadband NIRS illuminator in NIH-sponsored clinical trials suggest the device may have use in detection and monitoring of necrotizing enterocolitis, a debilitating and potentially lethal gut disease of newborns; in contrast, conventional NIRS oximeters suffer from interference from water, stool, and fat when placed over the abdomen.
Continuum is a solid-state illuminator that creates light of many wavelengths, called broadband, which allows for noninvasive analysis of various components in tissue and blood, including different types of hemoglobin, fat content, and water content. The new sensor is protected by a broad family of issued patents, and will be incorporated into the Company's flagship T-Stat Oximeter and Analysis platforms.
Spectros Introduces Continuum® Broadband NIRS Sensor
Spectros Corporation announced Continuum®, a proprietary broadband near infrared illuminator sensor under development for several years and now in testing. This sensor represents the newest generation and state-of-the-art for medical sensor probes. Continuum is a solid-state illuminator that creates light of many wavelengths, called broadband, which allows for noninvasive analysis of various components in tissue and blood, including different types of hemoglobin, fat content, and water content. The new sensor is protected by a broad family of issued patents, and will be incorporated into the Company's flagship T-Stat Oximeter and Analysis platforms.
Clinical application of Continuum sensors incorporating the broadband NIRS illuminator will allow placement on the patient's head to monitor the brain, on the abdomen to monitor the gut, and over muscle to monitor local perfusion. Early clinical studies suggest the device may have use in noninvasive detection of necrotizing enterocolitis, a gut disease of newborns; in contrast, standard NIRS oximeters suffer from interference from water, stool, and fat when placed over the abdomen.
Spectros Prepares IND on ProstaFluor® Optical Contrast Agent for Guided Prostatectomy
Spectros is preparing an IND application for clinical Phase I/II trials for its optical contrast agent, ProstaFluor®, a prostate-seeking fluorescent agent that targets residual prostate cancer for detection and excision during prostate surgery.
Spectros has shown the ability of ProstaFluor to detect residual disease in animals as well as to detect metastatic disease. Spectros anticipates issuance of patents that protect this approach of contrast targeted surgery in the US, Europe, and Japan, with early work on this project since the 1990's, giving Spectros strong and early intellectual property in this area. This agent is being developed in collaboration with developmental commercial and university partners.
Other agents in development include OvaFluor™, an ovarian-cancer and inflammation-seeking fluorescent agent, LeukoFluor™, an activated-macrophage-seeking fluorescent agent for mapping inflammation, and HemoFluor™, a PEG-conjugated agent that remains in circulation for blood pool volume labeling.
Spectros White LED Patent Scope Affirmed In U.S. Patent Office Reexamination
In a reexamination of U.S. Patent No. 6,711,426, the Patent Office has affirmed that Spectros' use of White LEDs in medical spectroscopy is unique and protectable, and that certain other applications in biomedical and industrial spectroscopy devices also fall under this Spectros patent.
"This is a broad affirmation of our dominant I.P. in the white LED and broadband spectroscopy area," noted CEO David Benaron. "This will serve as the basis for our expansion into lab-on-chip devices, color sensors, spectrometers, fluorimeters, and white LED pulse and tissue oximeters."
Spectros holds one of the early White LED patents in the U.S., and the first for use in medical and industrial spectroscopy. Spectros founders began performing color analysis, oximetry, and tissue spectroscopy in the 1980s. In the 1990s they developed a series of high-efficiency, low-thermal transfer broadband illuminators, which have been incorporated into the Spectros T-Stat® and Continuum® Tissue Oximeters, the only broadband tissue oximeters on the market in the U.S. and Europe. T-Stat® competes in the marketplace with INVOS® oximeters marketed by Covidien. Multiple continuations of the Spectros white LED patent family are under prosecution in the U.S., Europe, and Japan.
Spectros Corporation presented new clinical results using tissue oxygen saturation with the T-Stat VLS Tissue oximeter at the San Diego Convention Center during Anesthesiology 2010
This newly released data was presented during poster sessions entitled "Experimental Circulation: Ischemia and Reperfusion" and "Clinical Circulation: Pharmacology/Physiology", held at the American Society of Anesthesiologists (ASA) The studies were both conducted at Loma Linda University Medical Center Loma Linda University Medical Center (LLUMC).
Spectros T-Stat Clinical Studies Presented at the American Society of Plastic Surgeons (ASPS) Plastic Surgery 2010 Conference,
Spectros has begun to see great interest in their VLS white light technology in the reconstructive plastic surgery market. The T-Stat can be easily used to monitor free flaps post-operatively. The concept is not new to the market, however T-Stat’s patented VLS white light technology is. T-Stat’s state-of-the-art second-generation technology yields reproducible and reliable results. Previously, this need was unmet in the clinical world. The need is not only for a noninvasive and easy to use device, but to display an absolute, simple-to-understand, and rapid-responding number that surgeons can trust and treat to. Spectros has put great effort into making this happen by collaborating with microsurgeons, vascular surgeons and clinicians.
“This is quickly becoming a forward moving market for Spectros and we plan on continuing to attend these microsurgery conferences to better understand the market and to present the papers currently being worked on throughout the U.S.”
Spectros T-Stat Validated in Neonatology
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 T-Stat Clinical Studies Presented t the California Society of Plastic Surgeons (CSPS)
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
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.
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
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
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
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
T-Stat® 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-Stat® ischemia detection system.
Phase III Compositional Analysis FDA Trials Reach 500 Breasts Scanned
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
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
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
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
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
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
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
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
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
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
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
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®
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
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
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
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
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
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
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
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.
T-Stat® 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-Stat® 303 ischemia detection system.
Spectros, University of California, Stanford, University of Pennsylvania, and Others Join Forces for Molecular Detection of Breast Cancer.
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
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
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
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.