INVO Bioscience Inc., a medical device company focused on treatment options for patients diagnosed with infertility, today announced it has started a 40 patient clinical trial in Rio de Janeiro, Brazil, to establish the safety, efficacy and comparative in-vitro fertilization (IVF) measures of the INVOcell device.
The design for the trial is awaiting approval by the Federal Ethics Committee in Brazil, at which time, the results from the completed clinical study will be submitted to the National Health Surveillance Agency (ANVISA), allowing for the registration and approval for the sale of the INVOcell device in Brazil.
“INVO Bioscience continues to look to expand the markets where we can offer the INVOcell solution,” Kathleen Karloff, CEO of INVO Bioscience stated in the press release. “In Brazil, the commencement of this 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. We greatly appreciate the efforts of Dr. Coelho and his team at the Center of Infertility and Fetal Medicine of North Rio de Janeiro, Brazil in proactively spearheading this effort to obtain approval. 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. We look forward to working with Dr. Coelho’s group on this very important trial and submission.”
The trial is sponsored and conducted by Dr. Francisco Augusto Colucci Coelho of the Center of Infertility and Fetal Medicine of North Rio de Janeiro.
The first trial patient has been treated utilizing the INVOcell device and procedure, and a clinical pregnancy has been confirmed. Enrollment for the remainder of the trial population is expected to be completed within four months.
There are more than 125 fertility centers in Brazil that are licensed to perform assisted reproductive procedures; according to the Brazilian Ministry of Health there are more than 15 million infertile couples in Brazil.
“The treatment of couples with INVO is making the original purpose of the Human Reproductive Service of the Hospital School possible again by allowing universal access for infertile couples at a very reasonable cost. Furthermore, the INVO treatment is less invasive, it dramatically lowers the incidence of multiple births and, in my professional opinion, produces a more desirable outcome for couples struggling with the frustrations of infertility. I am very excited to be at the leading edge in advancing the development of this breakthrough in reproductive medicine for the people of Brazil,” Dr. Francisco Augusto Colucci Coelho stated.
For more information visit www.invobioscience.com