Products
WavSTAT System
WavSTAT® System The WavSTAT Optical Biopsy System console contains a laser, electronic components that collect the emitted fluorescent signals, and a computer that operates the system and analyzes the tissue. The WavSTAT Optical Biopsy Forceps with an integral optical fiber delivers the laser light when in contact with the tissue. The forceps with fiber also returns the emitted fluorescent signal to the console for analysis. The WavSTAT Optical Biopsy Forceps are used through the working channel of a standard endoscope and can also be used to begin immediate treatment of the patient by removing diseased tissue after a tissue's analysis has been made.
Colorectal Cancer
According to the American Cancer Society, approximately 145,000 new cases of colorectal cancer are diagnosed annually in the United States. With an estimated 56,000 deaths in 2005, colorectal cancer is second only to lung cancer as the leading cause of cancer death. More women over the age of 75 will die from colorectal cancer than from breast cancer.
Using current methods and techniques to detect and treat colorectal cancer, the American Cancer Society reports these outcomes:
The five-year survival rate is 92% if detected and treated at an early stage;
The five-year survival rate drops to 64% if the cancer spreads outside the colon to the lymph nodes;
The five-year survival rate for those patients in whom the cancer has spread further to the liver or other organs drops dramatically to 7%.
It is clear from these outcomes that early detection is essential to long-term survival. Unfortunately, it is also reported by the American Cancer Society that only 37% of colorectal cancer is currently found at an early stage. Our goal at SpectraScience is to develop technology and products that demonstrably improve cancer detection. The WavSTAT Optical Biopsy System is another diagnostic tool that makes early detection possible which may mean earlier treatment and improved patient outcomes.
Esophageal Cancer
The Company plans to complete a second application for the WavSTAT System 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 of esophageal cancer results in less invasive, more cost effective treatments with a greater chance for long term patient survival.
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. Physicians typically recommend that persons with chronic heartburn should have an endoscopy to look for Barrett's esophagus. 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 random physical biopsies of the esophageal lining, a significantly invasive procedure.
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. Diagnosis is critical, therefore physical biopsies (as many as 20 at once) are performed either randomly or in a geometric pattern throughout the length of the esophagus in the hope of finding the most appropriate tissue to physically biopsy. Current medical practice typically follows the guidelines described below:
1. Patients with chronic GERD (severe heartburn) receive a screening endoscopy of the esophagus with multiple biopsies to check for Barrett's esophagus;
2. Patients with Barrett's esophagus receive an endoscopy with multiple biopsies every year to check for dysplasia;
3. 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; and
4. 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 14,550 new cases of esophageal cancer were diagnosed in the year 2006, with a greater than 90% mortality rate. The rate of esophageal cancer is growing six times faster than any other form of cancer. The relatively high death rate associated with esophageal cancer typically results from a lack of early diagnosis with the outcome being that 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.
SpectraScience completed an initial pre-clinical study in April 2002 using its WavSTAT System for the detection of pre-cancerous and cancerous tissue in the esophagus. This trial was designed to determine the viability of using spectroscopic techniques to detect esophageal cancer in Barrett's patients, and to develop and demonstrate the feasibility of the WavSTAT System for this type of application. A total of 87 patients with Barrett's esophagus were enrolled into the trial with 326 optical and physical biopsies taken. Additional patients are being recruited to continue the evaluation and finalize the software algorithm as well as to establish the sensitivity and specificity of the application.