INVO Bioscience Announces Commencement of Clinical Trial in Brazil to Obtain ANVISA Approval
Published: Jan 25, 2011
BEVERLY, Mass., Jan. 25, 2011 /PRNewswire/ -- INVO Bioscience, Inc. (OTC Bulletin Board: IVOB), a medical device company focused on treatment options for patients diagnosed with infertility, today announced the commencement of a 40 patient clinical trial in Rio de Janeiro, Brazil to establish safety, efficacy and comparative in-vitro fertilization (IVF) measures of the INVOcell device. The design for the 40 patient clinical trial has been submitted for approval to the Federal Ethics Committee in Brazil. Upon approval of the trial design, results from the 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. The INVOcell is a Class II device in Brazil, which requires clinical data obtained in Brazil for submission, registration and approval of the device by ANVISA.
This trial is being sponsored and conducted by Dr. Francisco Augusto Colucci Coelho of the Center of Infertility and Fetal Medicine of North Rio de Janeiro, Brazil. The first trial patient has been treated utilizing the INVOcell device and procedure. An ultrasound exam performed eight weeks after the INVO procedure detected a fetal heart beat confirming a clinical pregnancy. Enrollment for the remainder of the trial population is expected to be completed within four months. Final results of the 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, will be submitted to ANVISA for registration and approval.
"INVO Bioscience continues to look to expand the markets where we can offer the INVOcell solution," stated Kathleen Karloff, chief executive officer for INVO Bioscience. "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."
Dr. Francisco Augusto Colucci Coelho, commented, "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."
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, and Venezuela. 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 China, 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, Brazil
The Center of 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.
INVO Bioscience, Inc.
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