Product Research and Development
...The core LIF technology of the WavSTAT™ Optical Biopsy System serves as a platform from which tissue evaluation applications for cancer detection can be created. SpectraSCIENCE is currently developing a second application to evaluate patients with Barrett's esophagus for pre-cancerous tissue changes that may lead to esophageal cancer. SpectraSCIENCE also sees significant opportunities to develop applications for distinguishing tissue changes that lead to other cancers including skin, oral, prostate, breast, and cervical cancer.

Esophageal Cancer
...The second application chosen for the WavSTAT™ Optical Biopsy System is for the detection of pre-cancerous and cancerous tissue in the esophagus. The progression toward esophageal cancer begins with several pre-cancerous stages. It is critical for the physician to be able to identify these various stages of the disease in order to deliver the most appropriate treatment. As with colorectal cancer, early and accurate detection results in less invasive, more cost effective treatments with a greater chance for long term patient survival.  Esophageal Cancer is growing five times faster than other cancers.

...Barrett's esophagus is a condition of the lining of the lower esophagus thought to be caused primarily by Gastro Esophageal Reflux Disease (GERD), more commonly known as chronic heartburn. Barrett's esophagus is considered to be a pre-malignant stage and a precursor to esophageal cancer. Some Barrett's patients will advance further to a stage where additional abnormal tissue called dysplasia is present. Dysplasia is known to be the next progressive step toward esophageal cancer and is categorized in stages of low grade and high grade. Barrett's esophagus, dysplasia and esophageal cancer patients are currently diagnosed by an endoscopy of the esophagus with multiple physical biopsies of the inner lining.

...High-grade dysplasia is a very critical stage to correctly diagnose because physicians frequently recommend surgical resection or removal of the esophagus if Barrett's esophagus with high grade dysplasia is diagnosed. Unfortunately for the patient, dysplasia is difficult to find and/or diagnose because it is not reliably visible to the physician during standard endoscopy. Because pre-cancerous stages such as dysplasia are not reliably visible during endoscopy, but are such a critical diagnosis, physical biopsies (as many as 25 during one procedure) are performed either randomly or in a geometric pattern throughout the length of the esophagus in hopes of finding the most appropriate tissue to biopsy.

...Current medical practice follows the guidelines described below:

•	Patients with chronic GERD receive a screening endoscopy of the esophagus with multiple biopsies to check for Barrett's esophagus;
•	Patients with Barrett's esophagus receive an endoscopy with multiple biopsies every two years to check for dysplasia;
•	Patients with Barrett's esophagus that has progressed to include low grade dysplasia receive an endoscopy with multiple biopsies every 6 months to check for high grade dysplasia;
•	Patients with Barrett's esophagus that has progressed to include high grade dysplasia receive an endoscopy with multiple biopsies every 3 months to check for cancer and/or may be referred for esophageal surgical resection, photodynamic therapy or electrical ablation.

 

...The American Cancer Society estimated that 14,250 new cases of esophageal cancer were diagnosed in 2004 with a greater than 90% mortality rate. The deplorable death rate associated with esophageal cancer is attributed to a lack of early diagnosis until the cancer has grown to an advanced stage. As previously described, the frequency of endoscopic surveillance for these patients increases as the pre-cancerous stages advance in hopes of providing the earliest possible diagnosis. Using the current medical guidelines for esophageal cancer surveillance, the US market for actual WavSTAT™ use is estimated at 2 million procedures annually.

...SpectraScience has successfully completed a Phase I clinical study using its WavSTAT™ Optical Biopsy System for the detection of pre-cancerous and cancerous tissue in the esophagus. Clinical studies comprising 100 patients were performed at the Mayo Clinic (Rochester, MN) and the University of California San Francisco (San Francisco, CA). Results of the Phase I study demonstrated the capabilities of the WavSTAT™ Optical Biopsy System to be greater than 95% accurate in distinguishing between Barrett's esophagus with no dysplasia and Barrett's esophagus with low grade dysplasia, high grade dysplasia or cancer. Derived from the Phase I study data, a proprietary tissue recognition algorithm software program was developed and currently being studied in a Phase II trial.

...Results of the Phase I clinical study suggest that the clinical utility of the WavSTAT™ Optical Biopsy System is to improve the physician's accuracy to detect and/or distinguish between the various stages of esophageal cancer and pre-cancer, dramatically reduce the number of physical biopsies taken, analyze tissue in real time vs. waiting for a pathology report and significantly improve the random chance approach currently used to find esophageal pre-cancers or cancers.