By LAURA LOREK
Reporter with Silicon Hills News

Tom Roberts, Invictus Medical’s President and CEO

In 2010, Daniel Mendez, Israel Cruz and Nicholas Flores, all engineering undergraduates at the University of Texas at San Antonio, invented a device, initially called the aqua bonnet, during an engineering senior design class. One of the engineer’s wives worked as a nurse in a Neonatal Intensive Care Unit and explained the problem about babies developing cranial deformities because of all the pressure on their heads.

So the students developed a soft helmet-like medical device to relieve pressure and help prevent flat-head syndrome in newborn babies. They won the UTSA CITE entrepreneurship and technology competition in 2010.

The students decided to assign their invention to UTSA, which filed the initial patent application. In 2011, the students formed a company and the university licensed the technology to the company and provided further funding for the patent process. For providing those services, the university took an undisclosed equity stake in the venture, said Jackie Michel, director of technology transfer and commercialization at UTSA.

“This turned out to be one invention that makes my heart happy because it fulfills the mission of the university which is to disseminate knowledge for the benefit of society,” Michel said. “It’s a remarkable story.”

In May, Invictus Medical received Food and Drug Administration clearance to begin marketing its medical device, now known as the GELShield, which provides extracranial pressure relief for babies. Invictus is now selling the GELShield to hospitals nationwide. The device, which comes in small, medium and large sizes, focuses on relieving pressure on baby’s heads. That pressure can cause plagiocephaly, a cranial deformity exhibited in infants resulting from repeated external pressure to one area of the head. The condition can result in a baby having a misshaped or flat head. In addition to cosmetic issues, studies have linked the condition to development delays in infants and toddlers.

Already, more than 100 hospitals have expressed interest in the GELShield, said Tom Roberts, Invictus Medical’s President and CEO. The market is large for the device, he said. Nationwide, hospitals run about 1,200 Neonatal Intensive Care Units. Invictus is also working on an application to expand international sales to Canada and eventually Europe.

“In the United States every year there are four million babies born and about 20 percent to 30 percent of all babies develop some kind of cranial deformity,” Roberts said. “It can appear along a spectrum from a flat spot to a more pronounced cranial deformation.”

The problem affects one million infants annually, Roberts said. It’s the problem Invictus Medical’s GELShield helps to solve.

The Baylor University Medical Center in Dallas just completed a validation study using the device in its neonatal intensive care unit with 42 babies. The test began in February of 2014 and finished in the fall of 2014.

“We evaluated the product for safety, fit and function,” said Chrysty Sturdivant, advanced clinical specialist and lead of the study at Baylor University Medical Center in Dallas.

“We wanted to make sure it didn’t cause any other problems like skin irritation or temperature changes or something unknown,” she said. And they found it did not cause any problems, she said.

Right now, nurses in Neonatal Intensive Care Units manually rotate the babies in their care every three to four hours. In the past, they’ve used pillows and other aids to prop the baby’s head. With the GELShield, the device provides the cushioning and relieves pressure to the baby’s head to help prevent deformities.

Newborn at Baylor Medical wearing one of Invictus Medical’s GELShield devices, courtesy photo

“Now it’s easy to tell,” she said. “The medical device is either on or off the baby’s head.”

Before the Invictus GELShield, the market did not provide a device like this to help babies with this problem, she said.

“Our product relieves the amount of pressure being applied on the baby’s head by up to 85 percent,” Roberts said.

The GELShield still allows the baby to continue to move his or her head, Roberts said.

To date, Invictus Medical has raised $5 million and is in the process of securing an additional $4.5 million in Series B funding. That money will go to help market and sell the GELShield.

Roberts joined the company early on in 2011. He spent 30 years working for companies in the medical device industry including for Roche Diagnostics and Kinetic Concepts. He wanted to run a startup. Randy Goldsmith, head of the Texas Technology Development Center, known as T3DC, introduced him to Invictus Medical, which is in the T3DC incubator program.

“I was looking for something I could be very passionate about,” Roberts said. “I had an immediate connection with Invictus.”

Invictus, which means unconquerable in Latin, is a tribute to the young engineering students who started the whole thing, Roberts said. The students are no longer involved in the day-to-day operations of the company but remain shareholders in the venture.

Invictus now has 12 employees and it has outgrown its current space at 12500 Network Drive and is planning to move to larger headquarters soon, Roberts said. The company plans to add a few employees this year but expects its workforce to expand to 25 employees by 2018. It contracts with four separate manufacturing plants to make its GELShield devices.

Invictus has five distribution partnerships with 55 sales people nationwide, Roberts said.

But Invictus is not stopping with the GELShield product.

“We’re building a world class medical company,” Roberts said. “We’re not a one product company.”

Invictus recently secured the worldwide commercialization rights from Northern Illinois University in Dekalb, Illinois for a second innovative technology focused on active noise reduction in the neonatal intensive care units. The company received a Phase I grant from the National Science Foundation for $240,000 to research and development the technology. It is also eligible to apply for a Phase II grant worth $750,000. George Hutchinson, Invictus’ Chief Technology Officer, is heading up the research, Roberts said.