On October 5, 2010, Invo Bioscience (IVOB) announced that it has signed an agreement with Canadian-based Invaron Pharmaceuticals for the exclusive distribution of INVOcell in Canada. We believe this could represent a meaningful near-term revenue driver for INVO Bio, given the growing infertility rates in Canada and recently implemented reimbursement policy that dramatically improves patient access to assisted reproductive procedures.
INVO Bio received Health Canada Regulatory Approval in 2009. The device is CE Mark approved in Europe and Canada and conforms to all consumer health and safety requirements. INVOcell is currently marketed and sold in Austria, Cameroon, Columbia, the Dominican Republic, Guatemala, Nicaragua, Pakistan, Panama, Peru, Spain, Togo, Turkey and Venezuela. Regulatory procedure is underway in additional areas including China, Russia, and India.
There are approximately 27 fertility centers in Canada licensed to perform assisted reproductive procedures. INVO Bio’s more natural alternative to in vitro fertilization (IVF) is an attractive option for the estimated 1 million infertile couples in Canada. Plus, with approval and now distribution in place, the door is open to the estimated 8 million infertile couples in the U.S. and 10 million in Europe to travel to Canada should they chose to seek INVOcell.
Recently, the provincial government of Quebec has initiated the funding of up to three assisted reproductive cycles for residents of the province. Fertility centers in Quebec are currently administering approximately 1,850 cycles annually. By 2014, provincial officials predict that the annual number of embryo-implant cycles administered will grow to between 7,000 and 10,000 in the Quebec province alone due to the new reimbursement policy. INVO Bio’s INVOcell device represents an excellent low start-up-cost alternative to help these centers meet the potential surge in demand for assisted reproductive procedures.
In June 2010, we initiated coverage of INVO Biosciences with an ‘Outperform’ rating and price target of $0.25 per share. We are maintaining our positive rating following the announcement this morning on distribution in Canada. We remind investors that the company signed a similar agreement for distribution in China in August 2010 with the Progressive Group.
We believe that the company has built a superior device for the treatment of infertility. The INVOcell device has been elegantly designed to provide several advantages when compared to interuterine insemination (IUI) or in vitro fertilization (IVF). These advantages include lower risk of ovarian hyperstimulation syndrome, lower risk of anesthesia complications and wider applicability and availability for infertile couples.
Additionally, the INVO procedure provides a far more personalized and natural approach to conception than IVF. Recent trial results demonstrate the INVO procedure has a clinical pregnancy rate similar to that of IVF and about half the cost.