Evolve BioSystems' Evivo Gains Health Canada Approval, Providing First International Expansion Opportunity
DAVIS, Calif., Oct. 30, 2017 (GLOBE NEWSWIRE) -- Evolve BioSystems, a microbiome company developing novel solutions to resolve infant gut dysbiosis, is pleased to announce that Evivo™ (activated B. infantis EVC001, ActiBif®) has now been granted regulatory approval for sale in Canada. Evivo, recently launched in the United States, is a once daily probiotic powder given to breastfeeding infants. Evivo is clinically proven to restore the infant gut microbiome to its natural state. “Acquiring B. infantis at birth from their mother is critical for establishing a healthy microbiome in a newborn infant. Unfortunately, the majority of mothers in Northern America no longer have these bacteria to pass on to their baby,” said Evolve CEO, Timothy B. Brown. “The approval by Health Canada to market Evivo now allows all Canadian babies to have the same opportunity to acquire a healthy microbiome as do American babies.”
The license, granted by Health Canada, states that Evivo is safe to give once a day to babies under 1 year of age. Evivo is mixed with a small amount of breastmilk and fed directly to babies to establish a B. infantis-rich intestinal microbiome. Studies show that bifidobacteria, including B. infantis, are a critical component of the infant gut early in life, and help reduce the abundance of potentially harmful bacteria that have been linked to asthma, allergies, obesity and Type 1 Diabetes.
“Canada is a world leader in early health and wellness, and approval for use of Evivo in newborns is further validation of the safety and quality of our product, as well as the vision we share for optimal health for all babies worldwide,” says Evolve Chairman and Chief Scientific Officer, Dr. David Kyle. “We are now diligently preparing for the launch of Evivo in Canada in the coming months.”
About Evolve BioSystems
Evolve BioSystems, Inc. is a privately-held microbiome company dedicated to developing the next generation of products to establish, restore, and maintain a healthy gut microbiome. Evolve is a spin-out from the Foods for Health Institute (FFHI) at the University of California, Davis and builds on more than a decade of research into understanding the unique partnership of the infant gut microbiome and breast milk components. Having led to the discovery and development of products to resolve infant gut dysbiosis, Evolve’s discovery platform is now being applied to solving gut dysbiosis throughout the human life cycle as well as in various animal species. Evolve has successfully completed a milestone proof-of-concept study to demonstrate the efficacy of its initial proprietary offerings. In addition, Evolve is undertaking further clinical studies to build out its suite of microbiome-based solutions.
For more information on Evolve BioSystems, please visit: www.evolvebiosystems.com
Tracy Shafizadeh, PhD
Dir. Scientific Communications