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


10/12/2010 7:31:34 AM

ANN ARBOR, Mich., Oct. 12 /PRNewswire/ -- Incept BioSystems, Inc. ("Incept"), a privately-held biomedical device company using patented, microfluidic technology developed at the University of Michigan, announced today the completion of the first U.S. human clinical trial of its proprietary, SMART Start Embryo Culture System, and the recent submission of a 510(k) application to the U.S. Food & Drug Administration ("FDA"). A decision as to market clearance for the device is expected from the FDA sometime in 2011.

As compared with the current in vitro fertilization ("IVF") practice of culturing embryos in a static environment (i.e. a microdrop in a culture dish), Incept's SMART Start Embryo Culture System is a device that enables a continuous, refreshable culture microenvironment while using industry-standard IVF culture medium.

The objective of the clinical trial, for patients undergoing IVF, was to assess the impact on a) morphological embryo development (structural characteristics), and b) embryo survival rates, when embryos are subjected to a refreshable culture microenvironment. A total of 496 embryos from 36 couples who were diagnosed with infertility, and were planning to undergo IVF and embryo transfer, were enrolled in the prospective, randomized performance study, which took place at four investigational sites. Data from the study (P=0.0145) 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.

Commenting on today's news, Christopher Bleck, President and Chief Executive Officer of Incept, noted, "We 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. 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 polystyrene, microfluidic SMART Start cartridge -- a single-use disposable component that attaches to the pump and is configured to contain wells and channels to provide a dynamic, microfluidic culture environment up to the time of embryo transfer.

About Incept BioSystems

Incept BioSystems, Inc., based in Ann Arbor, Michigan, is a privately-held medical device company leveraging its proprietary, microscale SMART Start technology (System of Microfluidics for Assisted Reproductive Technology) platform to provide the in vitro manipulation, performance, and viability of high-value cells for the treatment of patients undergoing in vitro fertilization. The 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 for embryo and oocyte culture in the Assisted Reproduction lab. For additional information about Incept BioSystems, visit the Company's website at: http://www.inceptbio.com.

SOURCE Incept BioSystems, Inc.



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