FDA Clears Invictus Medical’s GELShield for Market Launch

Invictus Medical has received U.S. Food and Drug Administration (FDA) clearance to begin marketing its GELShield extracranial pressure relief device.

The FDA cleared the GELShield with an indication to alleviate extracranial pressure due to prolonged immobility. The device has undergone a comprehensive safety validation study at Baylor University Medical Center in Dallas, Texas. The center oversees approximately 4,200 births annually and operates an 83-bed, level III neonatal intensive care unit (NICU) providing the highest level of care for small and fragile newborn babies.

“FDA clearance of the GELShield is a major strategic milestone in that effort and we expect to begin seeing this  product in use in neonatal intensive care units in the very near future,” Invictus Medical President/CEO Tom Roberts said. “More than 100 hospitals so far have expressed significant interest in the GELShield. The company has built a sales and distribution network of highly accomplished medical device industry experts across the U.S.”

Long-term, Invictus Medical’s technology interest focuses on combating deformational plagiocephaly (DP), a cranial deformity exhibited in infants resulting from repeated external pressure to one area of the head. Studies have found a significant rise in the incidence of plagiocephaly since the early 1990s. In addition to being a cosmetic issue, DP has been associated with heightened risk for developmental delays in infants and toddlers, according to a study published in Pediatrics in 2013.

“Our mission is to secure healthy early development milestones in newborns by providing innovative products, services and solutions to the healthcare professional and consumer markets,” said Steve Dufilho, Invictus Medical’s board chairman and vice chairman of Ascension Health.

To date, Invictus Medical has successfully raised $5 million. The company is in the process of securing an additional $4.5 million in Series B funding to support the commercialization efforts of the GELShield.

Invictus Medical is a San Antonio, Texas-based medical device company that develops cranial support technology. The company is privately held.