Ann Arbor-based Incept BioSystems Inc., a privately held biomedical device company using patented, microfluidic technology developed at the University of Michigan, announced completion of the first U.S. human clinical trial of its proprietary, SMART Start Embryo Culture System.
The company also said it had submitted a 510(k) application, a requirement for marketing new medical devices, to the U.S. Food & Drug Administration.
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 practice of culturing embryos in a static environment — essentially, 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 morphological embryo development (structural characteristics) and 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 showed that Incept’s 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.
Said Incept president and CEO Christopher Bleck: “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.”
Added Joseph Conaghan of the Pacific Fertility Center in San Francisco and a trial investigator: “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.”
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.
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.
SMART is an acronym for System of Microfluidics for Assisted Reproductive Technology. 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.
More at www.inceptbio.com.
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