INVO Bioscience has initiated a 40 patient clinical trial in Rio de Janeiro, Brazil to establish safety, efficacy and comparative in-vitro fertilization (IVF) measures of the INVOcell device.
The INVOcell is a Class II device, which requires clinical data obtained in Brazil for submission, registration and approval of the device by National Health Surveillance Agency (ANVISA).
The advantages of the INVOcell device and procedure include the processing of fewer eggs from patients, reducing the occurrence of multiple pregnancies and the attendant costs and complications, the relative cost advantages of the INVOcell procedure compared to traditional IVF treatments, pregnancy rates that are comparable to traditional IVF treatments.
INVO Bioscience CEO Kathleen Karloff said in Brazil, the commencement of the clinical trial is the first step in submitting the appropriate data to the governing body that allows for the marketing of a Class II device such as INVOcell.
"The successful outcome of this effort will make the INVOcell device and procedure available to the many Brazilians that are unable to obtain adequate fertility treatment and we look forward to working with Coelho’s group on this very important trial and submission," Karloff said.
The study enrollment is expected to be completed within four months.