Approximately 15 million babies — about 1 in 10— are born premature every year, and in the U.S., preterm births are actually rising. Though medical advances are allowing doctors to keep more and more of these babies alive, they often must spend an extended period of time in the Neonatal Intensive Care Unit (NICU), a stay that comes with a high price tag — the average cost for an infant to stay in the NICU is around $3,000 per day.
Often, what keeps a baby in the hospital is feeding issues — 70 percent of preemies have trouble feeding. Atlanta-based medical device company nfant, recently named a TAG Top 10 Most Innovative Company in Georgia, is tackling this problem with a high-tech, IoT-connected sensor that attaches to a baby bottle and can measure tongue motion on the nipple.
Developed by Tommy Cunningham, a biomechanical engineer by training, and clinician Dr. Gilson Capitlouto, the smart bottle connects wirelessly through nfant’s mobile app, which aggregates data from feeding and allows the doctor to view and analyze how the baby is progressing in real-time. The company is also developing a robust database of infant feeding stats — kicking off several partnerships with the best hospitals across the country.
This includes a partnership with Boston Children’s Hospital and Harvard Medical School, who are using nfant devices to investigate a link between infant feeding patterns and neurodevelopment — in other words, if how a baby sucks is indicative of brain damage and neurological progress. They also kicked off a new study at the largest NICU in the country, as well as one with the Marcus Autism Center to study the potential of the device for autism diagnosis and intervention.
Cunningham took some time away from white papers and clinical trial results to talk to Hype about how much the health and economic impact nfant can have for every member of the healthcare ecosystem, their major growth over the next year, and how nfant is a pioneer for the Southeast’s medical device industry.
Number of employees?
7 fulltime and 7 interns
Funding or bootstrapped?
We bootstrapped the company at first but have been fortunate to secure two rounds of funding to get us to where we are. We’ve raised $3.5M to date but are going to the Capital Market to raise another $5M to expand sales nationwide.
Feeding is the most complex skill a newborn baby must learn. nfant Lab’s mission is to improve feeding outcomes and expedite safe transition to full breast or bottle feeding by providing objective data and evidence based products to the feeding transition process.
Our Flagship product, nfant Feeding Solution, is the first Internet of Things device cleared by the FDA for the NICU and the first noninvasive diagnostic tool to measure tongue dynamics during feeding. By transforming any bottle into a smart bottle, objective data of a baby’s feeding performance can be streamed at crib side, allowing clinicians to view the immediate impact of therapeutic interventions. Feedings are documented through our cloud-based analytics platform, clinicians can review and compare feedings to iterate clinical care paths and optimize feeding transitions for their patients.
Please describe the market impact.
Before nfant Feeding Solution, there was no objective way to measure and track feeding progress during routine clinical care in the NICU.
Our goal is to become the standard of care in infant feeding. Similar to hearing screening that is mandatory for every infant prior to being discharged when they are born, there is value in screening feeding ability of infants, enabling clinicians to get in front of any problems that may arise and avoid failure to thrive. With nfant Feeding Solution as the standard of care, healthcare teams will screen and provide daily feeding treatments allowing them to effectively detect, mitigate and treat potential problems that result in costly long term outcomes.
How did you come up with this idea?
Dr. Gilson Capilouto and myself teamed up at the University of Kentucky to take an entirely new approach to infant feeding transition. Dr. Capilouto observed many issues with feeding babies in the NICU and hypothesized that it could be related to having a weak and uncoordinated swallow. There was no product available for her to test this hypothesis. With that, I set out to built a smart bottle prototype for her to measure this in a small clinical trial. Low and behold, preterm infants seemed to be lagging in tongue strength despite gaining weight and maturing. After some market research, we decided to build a company around the idea bringing cutting edge smart technology to the NICU and addressing an unmet need.
What is the revenue model?
We bill hospitals a base per patient for equipment that is used for the entire duration of their stay and then have various data services scalable to each individual NICU based accounting for size and their particular priorities. We are currently expanding our data services so hospitals will have the option to purchase various subscription services to track and compare their patient population outcomes within and between other benchmark healthcare providers and payers. All parties from the patient to the hospital to the payer benefit from this relatively small investment.
Talk about the impact you’ve discovered the device can have so far (both health and economic). What have past trials revealed about the success of the device?
We have had a number of clinicians with considerable clinical experience tell us that nfant Feeding Solution has been an education in feeding. It opens a window into the infant’s feeding ability that they did not have before.
We also believe that nfant Feeding Solution will have clinical relevance beyond just feeding. We just published a paper looking at the ability of nfant Feeding Solution to detect subtle changes in feeding metrics and how those changes could relate to detecting neurodevelopmental delays in infants. We are following this up with studies correlating abnormalities in brain imaging with feeding patterns to further improving early detection rates for this fragile population.
How does Atlanta and/or the southeast weave into your story?
Atlanta has all the pieces to make a successful Medtech startup thrive — access to engineering resources, medical research systems, ease of travel, and so forth. It’s a great place to live, put down roots and build something big. It doesn’t, however, have a great track record for Venture backing in the life sciences.
We are the first internet-connected medical device ever cleared by the FDA for the NICU — and it all came from the southeast. There is something to be said for that and the region’s ability to deliver wins on a big scale.
Are you hiring?
We will be hiring after our Series B going from a staff of 7 to just under 30 in the next year.
Are you looking at developing additional products?
We estimate that we can roll out dozens of new and specialized products for the NICU over the next 5 years. We believe our future will consist of continued innovation with medical products, but many additions to our product line will leverage the discoveries we continue to make with our cloud analytics platform and data. We are not short of ideas!