Incept BioSystems, a privately-held biomedical device company, has completed the US human clinical trial of its SMART Start embryo culture system and submitted 510(k) application to the US Food and Drug Administration (FDA).
Incept said that SMART Start embryo culture system enables a continuous, refreshable culture microenvironment while using IVF culture medium, when compared with the current in vitro fertilization (IVF) practice of culturing embryos in a static environment.
The data from the study showed that Incept’s SMART Start embryo culture system met the primary endpoint and was non-inferior to the conventional static dish culture, based on the number of embryos that reached the 8-cell stage at 72 hours of culture.
Incept president and chief executive officer Christopher Bleck said that they are pleased with the trial results, which confirmed the safety of the SMART Start embryo culture system.
“This is the first time that any microfluidic technology has been used successfully to help treat infertility patients and is, therefore, a key milestone for our company, and potentially, for the future of IVF and we anticipate initiating a second study in 2011 to evaluate implantation and pregnancy rates using the system,” Bleck said.