Incept BioSystems Initiates First Human Clinical Trial Of Its SMART Embryo Culture System For In Vitro Fertilization (IVF)

Main Category: Fertility
Also Included In: Medical Devices / Diagnostics;  Clinical Trials / Drug Trials
Article Date: 01 Oct 2009 - 2:00 PDT

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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."

About IVF and Incept BioSystem's SMART Embryo Culture System

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 2007, women in the U.S. underwent approximately 132,700 IVF cycles and it is estimated that there will be more than one million cycles worldwide in 2009.

Unlike the current IVF practice of culturing embryos in a static environment (i.e., a microdrop in a culture dish), Incept's microfluidic system brings embryologists a significant step closer to natural conditions by providing a continuous, refreshable culture microenvironment while using industry-standard IVF culture medium. It is believed that this dynamic environment may provide a beneficial physical stimulus to the embryos in addition to replenishing the embryos with fresh medium while removing metabolized waste products. 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.

About Incept BioSystems

Incept BioSystems, Inc., based in Ann Arbor, Michigan, is a privately-held medical device company leveraging its proprietary microscale SMART technology (System of Microfluidics for Assisted Reproductive Technology) platform to improve the in vitro manipulation, performance, and viability of high-value cells for the treatment of patients undergoing in vitro fertilization. The SMART System assisted reproduction device is a cell culture system that can mimic in vivo conditions and is the first microfluidic system that will address the demanding user requirements of fertility professionals while reproducing physiologic conditions ideal for embryo and oocyte culture in the Assisted Reproduction lab.

Source: Incept BioSystems, Inc

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