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Incept BioSystems Completes First Human Clinical Trial of the SMART Start™ Embryo Culture System and Submits 510(k) Application to the FDA
Date:10/12/2010

a key milestone for our company, and potentially, for the future of IVF.  We anticipate initiating a second study in 2011 to evaluate implantation and pregnancy rates using the system."

Dr. Joseph Conaghan, Ph.D., H.C.L.D. of the Pacific Fertility Center in San Francisco and a trial investigator, stated, "With only a fraction of IVF cycles in the U.S. resulting in a live birth using today's methods, the successful development of Incept's novel, SMART Start Embryo Culture System, could have broad ramifications for the future of IVF and potentially represent a new standard of care. We were honored, therefore, to have been able to take part in this important clinical trial and look forward to working with Incept on the continued development of this product."

About In Vitro Fertilization

IVF is a technique in which eggs are retrieved from a woman's ovary and inseminated, resulting in fertilized eggs which are then cultured in specialized laboratory conditions. It is the primary treatment for infertility today, common when other methods of achieving conception have failed.  According to the Society for Reproductive Technology, in 2008, women underwent approximately 140,800 IVF cycles in the U.S., and over 1,000,000 cycles, worldwide.

About The SMART Start Embryo Culture System

The SMART Start technology platform is designed to provide a continuous, refreshable culture microenvironment while using industry-standard IVF culture medium. Mouse and bovine studies conducted by researchers at the University of Michigan, and at the Company, have demonstrated that the use of this system improves the rate of embryo development so that a greater percentage of embryos achieve advanced stages of development.

The System is comprised of an electro-mechanical device, consisting of the SMART Start pump, power pack, cable hub, and associated cabling and; the polystyr
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SOURCE Incept BioSystems, Inc.
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