Tag: Invictus Medical

Invictus Medical Sells a Device to Help Newborn Babies

Reporter with Silicon Hills News

Tom Roberts, Invictus Medical’s President and CEO

Tom Roberts, Invictus Medical’s President and CEO

Invictus Medical is a homegrown San Antonio biomedical startup focused on improving the lives of newborns.

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

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

The Invictus GELShield eases the care for the baby because the nurses don’t have to fiddle with pillows any longer to make sure they are positioned correctly under the baby’s head, Sturdivant said.

“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_Logo_TagInvictus 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.

BioMed SA Celebrates 10th Anniversary

Reporter with Silicon Hills News

Ann Stevens, president of BioMed SA, courtesy photo.

Ann Stevens, president of BioMed SA, courtesy photo.

Ten years ago, a group of leaders in San Antonio, led by former Mayor Henry Cisneros and the Greater San Antonio Chamber of Commerce, created an advocacy organization for the city’s biomedical industry.

They founded BioMed SA with the core mission to raise the visibility of San Antonio’s sizable biomedical industry locally, statewide, nationally and internationally.

“We’ve gained considerable traction in the last few years,” said Ann Stevens, BioMed SA’s president.

During the last decade, the organization’s mission has evolved to include economic development, Stevens said.

In 2009, Medtronic selected San Antonio for its new Diabetes Therapy Management & Education Center with plans to create 1,400 jobs. San Antonio beat out more than 900 other cities for the project and BioMed SA played an important role in convincing the company to locate here, Stevens said.

“EDF (The San Antonio Economic Development Foundation) had been working on it for more than a year,” Stevens said. “In the final stages, they asked BioMed SA to come into the project and help them land it.”

Since then, BioMed SA has worked closely with the EDF to bring new businesses here and to retain the ones that are here as well as foster new startups.

“We believe we are bringing real value by not only our promotional activities, but we’re beginning to attract outside investments to the city,” Stevens said.

In addition, the local startup scene in the life sciences industry is growing, Stevens said. The entrepreneurial side of the life sciences industry fosters new companies, attracts venture capital, brings seasoned executives to the city and helps the overall ecosystem to grow, she said.

Just recently, Targeted Technology, a locally based venture capital fund, brought Cytocentrics Bioscience, a Rostock, Germany-based biotech company, to San Antonio. The company agreed to relocate its corporate headquarters to San Antonio and create 15 jobs by the end of the year. In June, the City of San Antonio granted Cytocentrics $1 million in economic development funds to attract the company, which has pledged to create 285 additional jobs in the next eight years and invest $15 million. The company will be based initially at 18618 Tuscany Stone. Cytocentrics makes a medical device called a CytoPatch Machine. The company’s patch clamping technology evaluates drug interactions with human cells and analyzes data.

In addition to biomedical startups relocating here, one of the trends locally is to focus on technology transfer by taking academic research out of local institutions like the University of Texas Health Science Center at San Antonio and the University of Texas at San Antonio and spinning that technology out into startups, Stevens said.

On the startup front, Invictus Medical, which makes a cranial support device for the heads of newborn babies, is a prime example of a spin off coming out of the University of Texas at San Antonio, Stevens said. Other startups spinning out of the Health Science Center include Astrocyte Pharmaceuticals, which is developing drugs for brain injuries, and Rapamycin Holdings, a drug development company focused on disease prevention and treatment in pets and humans.

Randy Goldsmith, who heads up Rapamycin, also runs The Texas Technology Development Center, known as T3DC, and hosts a quarterly luncheon to keep everyone informed on what’s going on in the biomedical industry in San Antonio. About 200 people attend the luncheon, which features company presentations.

“By working together and raising visibility we have attracted more economic activity including a lot of activity in entrepreneurial startups and retained our hometown business,” Stevens said.

To continue to move the life sciences industry forward, BioMed SA plans to pursue new revenue sources from foundations, corporate grants and donations from individuals, said BioMed SA Chairman Ken Trevett.

Nobel Laureate, W.E. (William Esco) Moerner, Ph. D., to receive BioMed SA's 10th Annual Julio Palmaz Award. Photo courtesy of BioMed SA

Nobel Laureate, W.E. (William Esco) Moerner, Ph. D., to receive BioMed SA’s 10th Annual Julio Palmaz Award. Photo courtesy of BioMed SA

A few of BioMed SA’s key accomplishments in its first 10 years include the creation of the annual Julio Palmaz Award for Innovation in Healthcare and Biosciences. The next award, now in its 10th year, will go to W.E. Moerner, PhD, a San Antonio native and winner of the 2014 Nobel Prize in Chemistry. He will receive the award at BioMed SA’s annual award dinner in San Antonio on September 10th.

BioMed SA also recently completed a two-year Asset Initiative to identify “five key disease areas in which San Antonio has biomedical assets and expertise of national or world-class caliber.” That information is being used to promote San Antonio to researchers and companies in those areas and helped attract the World Stem Cell Summit to San Antonio last December.

San Antonio’s healthcare and bioscience industry employs nearly one of every six members of the city’s workforce and has an annual economic impact exceeding $30 billion, according to BioMed SA.

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