QualityStocks
would like to highlight INVO Bioscience (OTCBB: IVOB), 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.
In the
company’s news Friday,
INVO
Bioscience 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.
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