The Company’s lead platform—the WavSTAT® Optical Biopsy System—is in the final stages of a multicenter, 1,200-patient European study and is poised to commence sales in Europe and potentially Saudi Arabia in 2016. The current WavSTAT4 product is initially targeted to the colorectal cancer screening market where recent colonoscopy guidelines have created opportunities for new, improved diagnostic technologies.
Up to 80% of colorectal biopsies performed are estimated to be identified as normal, non-cancerous tissue. Replacing these invasive physical biopsies with an optical biopsy, as SpectraScience's WavSTAT4 does, reduces risks to patients and may lead to a healthcare cost savings of over $1 billion in the U.S. alone.
WavSTAT4 has been designed for ease of integration into the current standard of care. It entails essentially the same process as how physicians screen for cancer today, and is compatible with existing endoscopes. SpectraScience merely adds a layer of diagnostic interpretation and confidence by notifying physicians that, at a particular tissue location, they do not need to take a physical biopsy that they otherwise might have performed.
Tissue that WavSTAT4 finds to be precancerous or cancerous returns a red “suspect” icon. Unlike the traditional method of visual inspection, there is no ambiguity to the result and no need for physician interpretation.
SpectraScience’s patent portfolio in the field of optical methods to detect cancer, cancer precursors, and tissue abnormalities includes 34 U.S. utility patents, seven U.S. design patents, 25 foreign counterpart patents, and an exclusive license to the Massachusetts General Hospital’s optical forceps patent.
The Company’s leadership has extensive experience in the medical device industry, specifically in the areas of strategic management, engineering, manufacturing, global sales, and marketing.