INVO Bioscience Inc., a medical device company focused on treatment options for patients diagnosed with infertility, today announced that the National Health Surveillance Agency (ANVISA) in Brazil has granted approval of the INVOcell for use as a Class II device, which will allow the sale of INVOcell in the Brazilian market.
The approval marks a significant milestone in INVO’s history, and opens the door for INVO to tap into one of the largest markets and fastest growing economies in the world.
“Approval in Brazil is a very important step in the success of INVOcell due to the strength of support in the country by medical thought leaders such as Dr. Coelho,” Kathleen Karloff, CEO of INVO stated in the press release. “Today’s announcement paves the way for the more than 125 fertility centers in Brazil to begin offering infertile couples a safe and cost effective solution compared to traditional IVF. We look forward to working with EcoMed, our distribution partner in Brazil, as they begin ramping up their sales and marketing efforts.”
The approval by ANVISA was triggered by the completion of a 40-patient clinical trial conducted in Rio de Janeiro, Brazil, to establish safety, efficacy and comparative in-vitro fertilization (IVF) measures of the INVOcell device.
The trial results, paired with clinical trial results from the Colombian Fertility and Sterility Center (CECOLFES) in Colombia, were submitted to ANVISA for the purpose of gaining registration and approval for the sale of the INVOcell device in Brazil.
INVOcell is CE Mark approved in Europe and Canada and is also available in many South American countries. Karloff noted that if INVOcell can capture 5 percent of the marketplace in Brazil, it could equate to more than $10 million in product sales.
The company also listed several advantages of the INVOcell device, including a reduced occurrence of multiple pregnancies and subsequent costs and complications; relative cost advantages of the INVOcell procedure as compared to traditional IVF treatments; and pregnancy rates comparable to traditional IVF treatments.
For more information visit www.invobioscience.com
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