Today
Colorectal Cancer
Our initial targeted applicationisthe diagnosis of colorectal cancer because of the medical need. According to the American Cancer Society, it is the second leading cause of cancer-related deaths and the third most common cancer in the US. About 101,700 new cases of colon cancer and 39,510 new instances of rectal cancer are expected in the US in 2011. Comparable trends are seen in the EU. About 49,380 deaths are expected between colon and rectal cancer combined. A recent study calculated that if all unnecessary physical biopsies in colon cancer screening were eliminated, savings to the US healthcare system would be approximately $675,000 million per year with no significant increase in mortality rates.
WavSTAT Optical Biopsy System helps to facilitate those savings.
The estimated current annual market opportunity in the diagnosis of colorectal cancer for our technology is $827 million in the EU and $616 million in US for a total of approximately $1.4 billion.
SpectraScience has developed the WavSTAT® Optical Biopsy System to instantly determine if tissue is normal, pre-cancer or cancerous, without the need for exploratory biopsy. The system is designed for use as an adjunct to lower gastrointestinal (GI) endoscopy. Furthermore, it is intended to evaluate polyps less than 1 cm in diameter that the physician has not already decided to remove. The device is used in assessing which polyps should be removed and submitted for biopsy. Presently, approximately 65% of the physical biopsies taken to diagnose colon cancer are of normal tissue.
We are increasing diagnostic effectiveness within the current standard of care for cancer. We are not, however, asking physicians to change their procedures or protocols except for eliminating a physical biopsy. Biopsies would be performed only if a suspicious polyp is discovered.
The WavSTAT® Optical Biopsy System developed by SpectraScience is capable of determining whether tissue is normal, pre-cancerous or cancerous without physically removing tissue from the body and without waiting days for a pathology report. The WavSTAT uses a spectrophotometry technique known as Laser Induced Florescence (LIF). During LIF, cool laser light shines onto and excites tissues to emit a returning florescent signal. The emitted florescence is collected, measured and analyzed by a proprietary software algorithm. This software algorithm provides the physician with an immediate analysis of the tissue. SpectraScience has US Food and Drug Administration (FDA) approval to market the WavSTAT system for the diagnosis of colon cancer and the product also carries the CE mark for the diagnosis of all cancers, a prerequisite for sales in the European Union.
Esophageal Cancer
SpectraScience is also developing an additional application for the detection of pre-cancerous and cancerous tissue in the esophagus.
Esophageal cancer is the eighth most common type of cancer and causes 12,000 deaths per year in the U.S. (2% of all cancer deaths). One type of esophageal cancer, adenocarcinoma, accounts for 50% of esophageal cancers.
Gastroesophageal reflux disease (GERD), in which acid refluxes from the stomach into the esophagus (known primarily for causing heartburn), is a condition that afflicts 20% of the populations of the U.S. and Western Europe.It has been hypothesized that GERD is a precursor of adenocarcinoma of the esophagus. Specifically, the hypothesis is that chronic reflux of acid into the esophagus causes changes in the cells lining the lower esophagus--changes that are referred to as Barrett's esophagus--that ultimately lead the cells to become cancerous. It is estimated that ½ to 1% of patients with Barrett's esophagus develop adenocarcinoma each year they are followed. (This means that during 20 years, a patient with Barrett's esophagus has a 10 to 20% risk of developing adenocarcinoma.) Therefore, it has been recommended that patients with Barrett's esophagus undergo regular and frequent endoscopy (every year) and biopsy of the esophagus so that early malignant changes can be detected and treated early before cancer spreads.(Source: Jay W. Marks, M.D., Medicine.Net)
Commercialization Strategy
For both colon and esophageal cancer, SpectraScience is working within the current standard of care. We are not asking physicians to do anything different than they do today. Instead, we provide a tool for them to diagnose faster, more accurately and more cost effectively.
As part of our market strategy, we will introduce the WavSTAT4 at the 19th United European Gastroenterology Week (UEGW) annual meeting in Stockholm, Sweden, October 22-26, 2011. Introducing our product first to the European Union (EU) is a good financial strategy because the EU markets have a single-payer model focused on providing comprehensive healthcare cost-effectively. We believe this will enable us to minimize regulatory risk, maximize design flexibility, and provide a foundation upon which we can build strategic partner relationships.We will subsequently launch the product in the US, targeting managed care organizations such as the Veterans’ Administration (VA) hospitals and Kaiser Permanente.
