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INVO Bioscience Announces Planned Submission To ANVISA For Brazilian Approval Following Completion of Clinical Trial


6/14/2011 7:54:20 AM

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, commented, "Initial indications point to strong comparative results between INVOcell and traditional in-vitro fertilization measures without any safety concerns. We look forward to finalizing the submission of this application to ANVISA with the goal of obtaining registration and approval for the sale the INVOcell device. As I originally stated, the treatment of couples with INVOcell 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. I remain excited to be at the leading edge in advancing the development of this breakthrough in reproductive medicine for the people of Brazil."

In Brazil, there are more than 125 fertility centers licensed to perform assisted reproductive procedures. According to the Brazilian Ministry of Health there are more than 15 million infertile couples in Brazil, with less than 1% of these couples actively seeking treatment. 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. INVOcell is currently marketed and sold in Austria, Bolivia, Cameroon, Columbia, the Dominican Republic, Guatemala, Nicaragua, Pakistan, Panama, Peru, Spain, Togo, Turkey, Poland, Spain, Switzerland, Greece, and Bulgaria. The company continues to market its products in all applicable countries covered by CE Mark or other local accepted criteria. Additionally, the company has commenced registration processes in Ukraine, China, Argentina, Venezuela, Russia and now Brazil, while continuing to explore additional appropriate countries to begin the registration process to market its products.

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.

About The Center of Infertility and Fetal Medicine of North Rio de Janeiro

The Center for Fetal Medicine and Infertility is associated with the Hospital of the Medicine College of Campos in the state of Rio de Janeiro in partnership with local government offering services to couples for the public health system. The Infertility Center was the first laboratory to obtain certification from ANVISA as well as offered the first agreement for public assistance (free) in the state of Rio de Janeiro.

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.

Contact:

Kathleen Karloff


INVO Bioscience, Inc.


978-878-9505 ext 504


www.invobioscience.com



SOURCE INVO Bioscience, Inc.


Read at BioSpace.com

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