Incept BioSystems commences human clinical trial of its SMART Embryo Culture System

Oct 1 2009

Incept BioSystems, Inc. ("Incept" or the "Company"), a privately-held biomedical device company using patented microfluidic technology developed at the University of Michigan, announced today that it has initiated the first U.S. human clinical trial of its proprietary SMART Embryo Culture System. The microscale SMART technology platform is designed to improve the in vitro manipulation, performance, and viability of embryos for the treatment of patients undergoing in vitro fertilization (IVF).

"We are delighted to be taking part in this important clinical trial," noted Dr. Thomas Pool Ph.D., H.C.L.D. of the Fertility Center of San Antonio and a trial investigator. "Infertility continues to be a major healthcare issue, with only about 30% of IVF cycles nationwide resulting in a live birth using today's procedure. Incept's SMART Embryo Culture System is an important technological advance in the industry and may therefore offer couples a much more efficient and reliable procedure for IVF."

The study will assess the SMART system's capacity to safely enhance morphological embryo development and survival rates at day three of development, in comparison to the existing practice of growing embryos in a conventional culture dish. The prospective, multi-center, randomized performance study, which will take place at three investigational sites, is expected to enroll approximately 400 to 600 embryos from up to 40 couples who have been diagnosed with infertility and are planning to undergo IVF and embryo transfer.

"We are very excited about the potential benefits of using the SMART culture system to improve IVF," said Christopher Bleck, President and Chief Executive Officer of Incept. "This is a key milestone for the Company, which we expect will lead to a second study in 2010 that will evaluate implantation and pregnancy rates using the SMART culture system."