A new medical device being developed by a Lexington company could lead to shorter hospital stays for infants and offer daily domestic medical savings that one day could reach into the billions, company officials say.
CCB Research Group of Lexington was recently offered a U.S. patent for its group of products, known as NFANT Technologies. The devices are designed to quantitatively evaluate an infant’s ability to feed based on tongue strength, a breakthrough that could lessen the time infants are required to stay in Neonatal Intensive Care Units (NICU). Treatment at NICUs can cost insurance companies as much as $6,000 a day, CCB officials said.
Clinical trials will take place over the next year in an effort to earn U.S. FDA approval. Company officials say the devices could hit the market in about a year, barring any regulatory hurdles. The clinical trials will take place at the Kentucky Children’s Hospital.
“This originally started out as something small we were doing right here for the University of Kentucky,” said Tommy Cunningham, chief operating officer and co-founder of CCB Research Group. “I can tell you our goal now is to get this product in the hands of every single clinician in the country.”
The major components of the NFANT brand are small devices that are attached to ordinary pacifiers or baby bottles. These devices have the ability to test and record the tongue strength and transfer the information into a mobile interface, such as an iPad, for analysis.
“We have basically turned baby bottles and pacifiers into smart devices,” Cunningham said.
Currently, the only way for doctors to test tongue strength is by placing their finger inside an infant’s mouth to check for resistance. This method is extremely subjective and is believed to offer inconclusive results 40 to 70 percent of the time, Cunningham said. It is for this reason that doctors often err on the side of caution when making the decision to discharge an infant from a NICU, where they can receive advanced feeding assistance and monitoring.
Medical studies have proven in adults and animals that tongue strength plays a critical role in the ability to swallow and eat, but Cunningham said theory had never been tested or applied to infant subjects. That was until a few years ago, when company co-founder Gilson Capilouto, a professor in the UK Department of Rehabilitation Sciences, approached Cunningham with an idea.
“She was interested in the problem of infant feeding, because obviously there is no way for the infant to communicate any difficulty they might be having and there was also no real way to measure it at the time,” Cunningham said. “She came with the idea of why don’t we look at a way to measure the strength of the tongue and look at that.”
At the time, Cunningham had earned a bachelor’s degree from UK in mechanical engineering and a master’s degree in biomechanics and was completing work on his doctorate in the school of exercise science, specializing in diagnostic and rehabilitation tools. He said when Capilouto first approached him, he didn’t know a thing about infant feeding.
“What I did know about was measuring how things work,” Cunningham said. “At the time, I was the only Ph.D. candidate in the college of health science with an engineering background, so a lot of people would come to me with questions on how to build this or that.”
Cunningham received his doctorate in the summer of 2012 and took a job with a medical device firm in Atlanta while continuing to tinker on his own with what would become the NFANT device. He continued corresponding with Capilouto and others at the UK Medical Center, and as momentum for the idea grew, he eventually decided he needed to quit his job in order to grow the company into a full-fledged medical device company, complete with a board of directors and management team. Capilouto became director of clinical research for the company.
The CCB Research Group was formally incorporated last year and recently the company hired Lou Malice as CEO. Malice is a 25-year veteran of medical device companies and formerly served as chief operating officer of Endochoice, American Breast Care and others. Malice said at this point in his career, he prefers working with smaller companies rather than larger ones, in part because of the ability to break new ground.
“I really liked this company because I thought it was a great new product and they had already made a lot of progress on it,” Malice said. “What we need now is to get through the regulatory hurdles and bring the product to the market, which is desperate for a product like this.”
CCB Research Group has raised $650,000 of the $2.25 million in start-up funds it needs to complete final product development, support clinical research and development testing and fund the company through the FDA’s 510 (K) approval process.
Malice said that as long as no major hurdles are encountered during the regulatory review process, the company is forecasting as much as $100 million in revenues in the first five years.
Cunningham sees that only as the beginning. He believes success with premature infants could expand the technology’s reach to include all newborns as well as animals and adult subjects with feeding and swallowing problems.
Newborns, though, will likely be the technology’s primarily application early on, simply because of the amount of potential savings at stake. Cunningham said if implemented, NFANT technology could produce domestic medical savings of $1.5 billion per day, with similar estimates for the European health market.
“We would like this technology to be the gold standard for newborns,” Cunningham said. “Given this is a time where a lot of emphasis has been placed on keeping health costs down, we think our product makes a lot of sense.”