Guided Therapeutics, Inc. (OTCBB: GTHP) announced that it filed its completed premarket approval application (PMA) for the LightTouch™ Cervical Scanner with the U.S. Food and Drug Administration (FDA) for patients at risk for cervical cancer. In a multi-center FDA-approved pivotal trial, the device found cervical disease up to two years earlier than with current standard-of-care screening and diagnostic techniques.
“Completing and submitting the PMA is a significant milestone for the company, our associates and shareholders”
"Completing and submitting the PMA is a significant milestone for the company, our associates and shareholders," said Mark L. Faupel, Ph.D., President and CEO of Guided Therapeutics. "We believe that LightTouch, if approved by the FDA, offers the potential to improve healthcare for women, by finding disease earlier, when it is most effectively treated, and to lower healthcare costs by streamlining the diagnostic process. Beyond the LightTouch, we intend to bring additional non-invasive, point-of-care products to market based on our platform technology."
More than $6 billion is spent each year to diagnose cervical cancer disease in the U.S. alone. The chance for effective treatment is greatly increased by early detection, according to the National Cancer Institute. Each year in the U.S. about 55 million Pap (Papanicolau) tests are performed to detect cervical abnormalities that could lead to cancer. Of these tests, approximately six percent are abnormal, requiring additional medical follow-up, such as a biopsy. However, the majority of biopsies reveal no cervical disease, meaning that a significant number of unnecessary procedures are performed each year.
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