Guided Therapeutics Receives Institutional Review Board Approval to Start Clinical Study for FDA Approval of the LuViva® Advanced Cervical Scan
PEACHTREE CORNERS, Ga.
The study protocol has been approved by WCG IRB, a leader in quality ethical review with over 50 years of experience and their approval is accepted by multiple clinical sites including the two key centers that have agreed to participate in the LuViva study. Both of these centers have enough patient volume to provide the number of patients required by FDA, projected to be up to approximately 400 women. The study is expected to start enrolling patients in about 30 to 60 days.
LuViva is already approved for sale in the
“Multiple COVID-19 surges have had a significant impact on the start of our study, as it has for most non-COVID related products,” said
The Guided Therapeutics LuViva® Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use in the
Forward-Looking Statements Disclaimer: A number of the matters and subject areas discussed in this news release that are not historical or current facts deal with potential future circumstances and developments. The discussion of such matters and subject areas is qualified by the inherent risks and uncertainties surrounding future expectations generally and also may materially differ from Guided Therapeutics’ actual future experience involving any of or more of such matters and subject areas. Such risks and uncertainties include those related to the early stage of commercialization of products, the uncertainty of market acceptance of products, the uncertainty of development or effectiveness of distribution channels, the intense competition in the medical device industry, the sufficiency of capital raised in prior financings and the ability to realize their expected benefits, the uncertainty of future capital to develop products or continue as a going concern, the uncertainty of regulatory approval of products, and the dependence on licensed intellectual property, as well as those that are more fully described from time to time under the heading “Risk Factors” in Guided Therapeutics’ reports filed with the