BEVERLY, Mass., Jan. 20, 2012 /PRNewswire/ -- INVO Bioscience, Inc. (OTC BB: IVOB), 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. This approval allows the INVOcell to be sold to millions of infertile couples in Brazil and marks a major milestone in the history of the company. The approval opens the door for INVO Bioscience to one of the largest markets and fastest growing economies in the world with over 190 million people.
The approval by ANVISA follows the completion of a 40 patient clinical trial conducted in Rio de Janeiro, Brazil. The 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. The results from Dr. Coelho's trial, along with clinical trial results from Dr. Elkin Lucena of the Colombian Fertility and Sterility Center (CECOLFES) in Colombia, South America were submitted to 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.
"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," stated Kathleen Karloff, chief executive officer for INVO Bioscience. "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."
Ms. Karloff continued, "Ecomed, founded in 1978, has sought to provide the Brazilian medical community with the most current and innovative medical products. We believe that they have the ability to access the segment of the medical professional market that will be providing the INVOcell procedure. If INVOcell is successful in capturing 5% of the identified marketplace, it could equate to more than $10 million in product sales. We look forward to a long and successful relationship."
The many advantages of the INVOcell device and procedure include:
- the processing of significantly 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.
INVOcell is CE Mark approved in Europe and Canada and conforms with all consumer health and safety requirements. Additionally, INVOcell is available in many South American countries, has commenced registration processes in many others, and with this approval is now available for sale in Brazil.
About INVO Bioscience
INVO Bioscience (IVOB) is a medical device company, headquartered in Beverly, Massachusetts, focused on creating simplified, lower cost treatment options for patients diagnosed with infertility. The company's lead product, the INVOcell, is a novel medical device used in infertility treatment that enables egg fertilization and early embryo development in the woman's vaginal cavity. The company was founded by Claude Ranoux, MD, a noted expert in the field of reproductive health, infertility and embryology. For more information, please visit www.invobioscience.com.
Private Securities Litigation Reform Act of 1995
This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The Company invokes the protections of the Private Securities Litigation Reform Act of 1995. All statements regarding our expected future financial position, results of operations, cash flows, financing plans, business strategies, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions are forward-looking statements. All forward-looking statements involve risks, uncertainties and contingencies, many of which are beyond our control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. Factors that may cause actual results to differ materially from those in the forward-looking statements include those set forth in our filings at www.sec.gov. We are under no obligation to (and expressly disclaim any such obligation to) update or alter our forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE INVO Bioscience