An Ann Arbor biomedical device company believes its emerging technology offers hope to women who are struggling to conceive through the in-vitro fertilization process.

Incept BioSystems hopes to secure approval next year from the U.S. Food and Drug Administration to market technology that would help improve the success rate of the costly IVF process.

Incept just  launched its first clinical trial for the technology - which is important to establishing the safety of its system. The technology aims to replace petri dishes in the lab, a step that can disrupt the traditional IVF process.

Incept’s cell culture system aims to improve the rate of successful in-vitro fertilization cycles. About 39.6 percent of IVF attempts among women younger than 35 years old result in pregnancies, according to a study by the Centers for Disease Control and Prevention. For ages 35 to 37, it drops to 30.5 percent; and for ages 38 to 40, it plummets to 20.9 percent.

Insurance typically doesn’t cover the elective procedure, and the average cost of a single cycle is $12,400, according to the American Society of Reproductive Medicine.

The "microfluidic" technology, which tries to replicate the natural biological environment for conception, aims to offer an alternative to traditional petri dishes, where embryos are cultivated in the laboratory. The first clinical trial will examine whether the technology successfully nurtures the embryos at day three of development.

“The (petri dish) technology hasn’t changed since the late 1800s when petri dishes were first employed,” Incept CEO Chris Bleck said.

The company is leveraging $8 million in funding compiled from a variety of sources, including Venture Investors, a $200 million venture capital firm with offices in Ann Arbor and Madison, Wisc. About $1.35 million of its capital came from two separate rounds of funding from the Michigan Economic Development Corp.’s 10-year, $2 billion 21st Century Jobs Fund.

“That has made accessing capital easier for a startup company like Incept,” Bleck said. “It’s been a favorable relationship.”

Incept estimates that the potential market for its technology tops $100 million.

Clinicians complete about a million in-vitro fertilization cycles annually, including about 150,000 at some 425 fertility clinics in the U.S., Bleck said.

Bleck hopes to secure FDA approval to start marketing the device in the first half of 2010. The company also wants to raise $10 million to $12 million to support a second clinical trial in 2010, which would study whether the cultivated embryos result in better pregnancy rates in women. That study is not needed to market the device, but it would make it easier to sell the device successfully.

“Infertility continues to be a major healthcare issue, with only about 30 percent of IVF cycles nationwide resulting in a live birth using today’s procedure," Thomas Pool of the Fertility Center of San Antonio, which will participate in the trial, said in a news release. "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.”

If approved, the device could lead to sales jobs for the Ann Arbor region, Bleck suggested.

The company’s progress comes after a period of relative stagnation prompted by early executive turnover. Venture Investors partner Jim Adox of Ann Arbor temporarily served as CEO of Incept in 2008 until Boston native Bleck joined the company in January 2009.

Incept houses its bioengineering and product development work at labs in the Michigan Research Institute, a life sciences incubator on South State Street in Pittsfield Township.

Contact AnnArbor.com’s Nathan Bomey at (734) 623-2587 or nathanbomey@annarbor.com. You can follow him on Twitter.