BEVERLY, Mass., June 14, 2011 /PRNewswire/ -- INVO Bioscience, Inc. (OTC BB: IVOB), a medical device company focused on treatment options for patients diagnosed with infertility, today announced the completion of a 40 patient clinical trial conducted in Rio de Janeiro, Brazil. Results from this completed clinical study will be submitted to the National Health Surveillance Agency (ANVISA) for the purpose of gaining registration and approval for the sale of the INVOcell device in Brazil. As originally announced on January 25, 2011, the trial was designed as a 40 patient clinical trial to establish safety, efficacy and comparative in-vitro fertilization (IVF) measures of the INVOcell device.
This trial was sponsored and conducted by Dr. Francisco Augusto Colucci Coelho of the Center of Infertility and Fetal Medicine of North Rio de Janeiro, Brazil. Upon computation of the results of Dr. Coelho's Brazilian clinical trial, along with the recently announced clinical trial results from Dr. Elkin Lucena of the Colombian Fertility and Sterility Center (CECOLFES) in Colombia, South America, data will be submitted to ANVISA for registration and approval in the coming weeks.
"We are very excited that Dr. Coelho has completed this 40 patient clinical trial in Brazil," stated Kathleen Karloff, chief executive officer for INVO Bioscience. "While the results are currently being computed and finalized, we are optimistic that the data submitted by Dr. Coelho, in conjunction with the results from Dr. Lucena's clinical trial in Colombia, represent an important step forward in opening the doors to the enormous Brazilian marketplace for INVOcell. We are grateful for the efforts of Dr. Coelho and his team in undertaking this effort to obtain approval, which could offer the more than 15 million infertile couples in Brazil an effective and cost efficient option while eliminating the many risks of multiple births."
Dr. Francisco Augusto Colucci Coelho, commente
|SOURCE INVO Bioscience, Inc.|
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