The costs for neonatal intensive care for premature babies can get really expensive when taking into account how many premature children are born each year. It is estimated that nearly 500,000 babies are born prematurely and need to be trained how to eat, at $4,000 a day.

Under normal circumstances, the human infant is pecocial for suck, meaning having a motor behavior that is well established in utero and functional at birth.

However, babies born prematurely exhibit grossly disorganized suck and this leads to medical complications and failure to thrive and develop. There seem to be other ramifications as well concerning the baby's overall sensorimotor development, perceptual capacity, and even delays in higher cognitive function, including speech, language, and other processing skills.

One small startup company is working to bring a device into the market that will help train newborns how to eat and to help improve motorskills.

KC BioMediX (Shawnee, Kansas) reported receiving FDA clearance for its N-Trainer and that it plans to launch the device by the end of this year.

The N-Trainer was developed by Steve Barlow, professor of speech-language-hearing and director of University of Kansas Communication Neuroscience Laboratories (Lawrence), and the company was founded by David Stalling, company CTO, and Michael Litscher, who is president/CEO of KC BioMediX, in 2006.

Barlow has studied premature babies the past 15 years. He found that when premature babies are put on life-support systems in the neonatal unit they lose the ability to suck and feed orally.

During his research, he discovered that some of these children struggle with feeding issues well into their preschool years.

"The application was designed at Kansas University, funded through a grant from the National Institute of Health that was based on finding ways to [feed premature babies]," Stalling told Medical Device Daily. "There are two different phases of the instrument's [use] ... assessment and therapy."

The N-Trainer is an electronic pacifier that measures the babies suck and conditions the baby to develop enough motorskills so it can eat. The suck is measured in waveforms and is displayed on the computer screen.

Traditionally, assessment to see if it is safe for a newborn to begin eating would come from a nurse putting a glove on and in the infant's mouth.

To "train the children" a gentle burst of air that delivers a pattern of vibrations resembling sucking come from the pacifier. The device is essentially a silicone pacifier attached to a computer-controlled special motor.

According to the company, the N-Trainer System uses these neurophysical principles of sensormotor entrainment of the central pattern generator to drive the human suck patterns. To facilitate in this the patients are given entrainment a few times a day.

In essence, the device analyzes NNS (non-nutritive suck) patterns and helps establish the correct sucking patterns for babies, which benefits them by promoting faster weight gain and physical growth. The system trains the baby's brain in a sense, enabling the baby to speed up the ability to eat without a feeding tube.

There are other possible benefits of the device in the future, according to the company. The N-Trainer could be used to help children and adults with brain injuries and patients who recover from a coma or stroke and need to learn how to feed and speak again.

"We're shooting for taking orders by the end of this year," Stalling said. "We want to have the first devices available for the market in 2009."

KC BioMediX intends to offer its medical devices for $125,000 each, focusing first on nearly 1,100 U.S. hospitals with neonatal intensive care units. Eventually, sales can go overseas, as well.

In order to bring the device into fruition, Stalling said that the company has received some strong financial support in the form of grants and financers.

KC BioMediX also has raised $1.5 million in outside investment and expects to close soon on another round of $4 million. That round includes $400,000 from the Kansas Bioscience Authority.

The company, which is private, was founded in 2006 to commercialize devices developed at the University of Kansas that assess the NNS of premature babies. The company said it is possible that that target market for the device could be worth more than $1 billion.