InvoCell won FDA de novo approval in November 2015 and was launched in the U.S. in April 2016. Currently, it is distributed throughout the U.S. under an $8 million agreement with Ferring Pharmaceuticals, into which the companies entered in January of this year.
The device previously held CE Mark approval from 2008 to 2012, but the company shifted commercial focus from Europe to the U.S. for several years.
InvoCell is designed to enable egg fertilization and early embryo development to take place in a woman’s body. The company said it is approximately half the cost of traditional IVF treatment and has shown comparable pregnancy rates while it can be administered without the need to for overhead of IVF centers.
In November 2018, the company announced that a child had been born to a same-sex couple in which both partners were able to carry the baby in separate phases of the pregnancy.
“We are extremely pleased to receive this very important product certification, the CE Mark, which permits us to commercially distribute the world’s only in vivo fertilization treatment to the millions of patients throughout the countries of the EU,” CEO Steve Shum said in prepared remarks. “The European countries represent a large potential market for InvoCell, with an estimated $3 to $4 billion currently spent on IVF treatments. Importantly, InvoCell is a simple and more natural solution with the potential to expand the overall addressable market for treatment due to its ability to lower costs compared to IVF while also demonstrating comparable rates of effectiveness. … We are currently in the middle of active discussions with several distribution partners around the world, including within the European market, and look forward to providing updates on our international efforts in the near future.”
Shares of IVOB were down 1.7% at 28¢ per share in mid-afternoon trading today.