Clinical News (older)

Selected Older News

Spectros Prepares First FDA Filing in Abnormal Metabolism Detection in Cancer
(October 2005)
Following on success of recent clinical trials in cancer, Spectros plans to submit an FDA application by the close of 2006. This filing will complement the current FDA approval in the area of ischemia granted for the Spectros T-Stat® product. If successful, approval would be expected in 2007.

T-Stat® Ischemia Detection Assesses of Tumor Radiotherapy
(July 2005)
In an ongoing clinical study at the Department of Radiation Oncology at Stanford University School of Medicine, interim analysis shows that T-Stat® is able to follow and predict the effect of tumor radiotherapy. This study will continue through early 2006.

T-Stat® Ischemia Detection System Allows Management of Endoscopic Laser Vascular Surgery
(July 2005)
In an ongoing clinical study, interim analysis shows that T-Stat® is able to follow vascular laser surgery performed through an endoscope, guide treatment extent and location, and predict outcome. This study will continue through early 2006.

T-Stat® Ischemia Detection System Reduces Death Rate and Hospital Stays in Aortic Vascular Surgery
(June 2005)
In a study of 562 patients undergoing vascular surgery, T-Stat® reduced the death rate from ischemia complications, and significantly reduced length of stay. These results have been accepted for presentation at the American Society of Anesthesiologists in October 2005.

T-Stat® Detects Gastrointestinal Tumors During Endoscopy
(June 2005)
VLS tissue oximetry can distinguish neoplastic tissue from normal tissue with a high specificity (and 80% sensitivity), potentially aiding the endoscopic detection of gastrointestinal tumors. The results were published in the June 2005 issue of Technologies in Cancer Site Map and Treatment (see Publications)

T-Stat® Ischemia Detection System Reduces Death Rate and Hospital Stays in Vascular Surgery
(February 2005)
In a study during vascular surgery, T-Stat® reduced the death rate from ischemia complications, and significantly reduced length of stay. These results will be presented at vascular conferences, and are submitted for peer review (see Publications).

T-Stat® Ischemia Detection System Receives FDA Approval
(November 2004)
The FDA has granted marketing approval to the T-Stat® Ischemia Detection System. T-Stat® has been demonstrated sensitive to local and global ischemia due to reduced-flow and no-flow in peer-reviewed human clinical trials.

FireFly® Detects Tissue Ablation Margins
(October 2004)
FireFly® Tissue Identification System allowed for the real-time detection of tumors margins, and monitoring of when radiofrequency ablation viability endpoints have been achieved. These studies have been submitted for peer-review (see Publications).

T-Stat® Endovascular/Vascular Surgery Trials Expanded to Five Centers
(September 2004)
After successful Phase I/II trials (100 patients for safety and efficacy), human validation trials of the T-Stat® Ischemia Detection System were expanded to vascular surgery patients at 5 centers. The pilot trial showed the T-Stat® to be sensitive to downstream ischemia (a lack of adequate blood flow distal to the vascular repair), as well as to lead to a reduction in mortality, morbidity, and length of stay. These pilot trials have been accepted in a peer-reviewed medical journal for publication. An FDA review of the T-Stat® underway.

T-Stat® General Validation Study Published
(June 2004)
A peer-reviewed study by Surgeons, Anesthesiologists, and Oncologists at Stanford University Medical School in humans concluded that the Spectros T-Stat® is sensitive to conditions in which tissues are not receiving adequate blood flow. The study, published in Anesthesiology, a leading medical journal, concluded that the T-Stat® may become a standard monitor in the operating room (see Publications).

Spectros Receives 2 New US Patent Allowances
(March 2004)
Spectros T-Stat® probe technology received notice of allowance of another patent from the US Patent Office. Human validation trials of the T-Stat® VLS Perfusion-Sensitive Tissue Oximeter are under FDA review. FDA Approval is anticipated in early 2005. Spectros FireFly® II Imaging System also received an additional allowance,

FireFly® ER Extends Range to Interventional Vascular Applications
(January 2004)
Spectros extends the optical range of its FireFly® platform for interventional therapeutic applications into the infrared with the introduction of the FireFly® ER Extended Range system. This system is sensitive from the ultraviolet to the infrared (2.2 microns), allowing for spectral characterization of a new range of compounds in vivo, including components of blood vessel walls, such as cholesterol. FireFly® is currently out-licensed in two market areas to public companies.