Invictus Gets FDA OK to Sell Device Protecting Newborns’ Skulls

A San Antonio, TX, biotech company has received FDA clearance allowing it to sell a device designed to relieve extracranial pressure on newborns.

Invictus Medical makes a headband-style device that wraps around a baby’s head. While allowing movement in a hospital bassinet, it prevents pressure from building on the skull, which can cause “flat spots” that sometimes appear on newborns. This is especially a concern for premature babies whose skulls are not fully formed at birth. About 500,000 babies are born premature each year.

“No matter to what position the baby moves, it will always have the pressure release system on its head,” says Tom Roberts, Invictus’s CEO.

The device, called GelShield, is composed of seven layers of Invictus’s core technology, a semi-solid solution that cushions and alleviates the pressure on a baby’s head. Roberts says its thin profile allows the head to rest normally—unlike pillows, which would push the head forward—and the solution is formulated so that if the device somehow got punctured or torn, it does not ooze or leak. “It will never bottom out due to the (weight of the) baby’s head,” he adds.

Right now, healthcare providers in a neonatal intensive care unit (NICU) must manually reposition a newborn’s head every few hours or so to make sure any one side isn’t getting more pressure than the other. Or caregivers could use so-called positioning pillows which babies can move off of and may find uncomfortable.

The pressure from resting a baby’s head too long in one spot could lead to them developing deformational plagiocephaly, which is associated with greater risk for developmental delays in infants and toddlers, the company says, citing a study published two years ago in Pediatrics.

“The deformities can get worse if left untreated … think of a pumpkin in patch over time; it becomes more deformed and out of shape,” Roberts says. “The corrective action today is cranial helmets that are in the marketplace.”

The company worked with Baylor University Medical Center in Dallas for a clinical study to obtain data needed for the FDA clearance, and will now begin marketing the device to the approximately 1,200 NICUs nationwide. The device, which would be sold to hospitals, would cost around a couple of hundred dollars, depending on the quantity of orders placed.

“We have product in the warehouse, sales force hired, and distribution channels in place,” Roberts says.

The device company already has $5 million in venture capital and this week began raising a Series B round of $4.5 million, which it hopes to close by the third quarter of this year, Roberts says. Invictus will use the funds to support sales and marketing efforts.

Roberts came on as CEO in late 2012, after the company was founded. Invictus was originally a student startup out of the University of Texas at San Antonio. The team of engineering and business students needed to come up with a marketable product, and one of the engineering students was married to a NICU nurse. The university paid for the patents, and the entrepreneurs began working with The Texas Technology Development Center, an incubator based in San Antonio.

“I found a great opportunity,” Roberts says. “I’m convinced there’s a big need out there.”

 

Angela Shah is the editor of Xconomy Texas. She can be reached at ashah@xconomy.com or (214) 793-5763. Follow @angelashah

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