SpectraScience, Inc, a San Diego-based medical device company, has engaged Bielderman BVBA, an experienced European contract research organization to manage the clinical process for its Barrett's esophageal cancer application under trial at certain European locations. The trial results will be used in the company's application to the Food and Drug Administration (FDA) for use in the United States.
Jim Hitchin, SpectraScience's CEO, commented, "The addition of esophageal screening to our portfolio is an important milestone for our company and one that we think can create significant additional value for our customers. Our WavSTAT Optical Biopsy platform can be leveraged with additional software applications, and the addition of an esophageal screening function, will allow for a greater return on hardware investment and, more importantly, can extend the level of care that physicians provide to their patients. To accelerate this process, we have engaged Bielderman to manage the data collection from European hospitals that currently have our WavSTAT Optical Biopsy System."
Generally speaking, quality clinical studies are less expensive in Europe. Through its selection of Bielderman, SpectraScience is employing its strategy of obtaining international approval first and marketing its product in Europe while concurrently moving forward with an FDA submission for approval in the United States.
SpectraScience holds approximately 60 patents worldwide that have been issued or are pending for its WavSTAT Optical Biopsy and LUMA Cervical Imaging Systems. These non-invasive optical biopsy devices are used to diagnose tissue quickly to determine if it is normal, pre-cancerous, or cancerous within seconds. The WavSTAT and LUMA Systems are currently approved by the FDA for detecting pre-cancerous and cancerous tissue in the colon and cervix, respectively. As noted above, evaluation of the WavSTAT for detection of pre-cancers in the throat (Barrett's esophagus) is in process.
SpectraScience is a San Diego based medical device company that designs, develops, manufactures and markets spectrometry systems capable of determining whether tissue is normal, pre-cancerous or cancerous without physically removing tissue from the body.