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FDA approves Invictus Medical’s GELShield product for market
May 4, 2015

Invictus Medical has received FDA approval for a new commercial product to help infants with cranial issues. (Photo courtesy of Invictus Medical)

By James Aldridge, San Antonio Business Journal

Invictus Medical has secured Food and Drug Administration approval to begin marketing its GELShield extracranial pressure relief device to hospital neonatal centers across the United States.

The FDA cleared the GELShield for procedures that call for alleviating extracranial pressure in premature newborns due to prolonged immobility. The device underwent a comprehensive safety validation study at the Baylor University Medical Center in Dallas, which operates a Level III neonatal intensive care unit for small and fragile babies.

Invictus President and CEO Tom Roberts said in a news release that more than 100 hospitals so far have expressed interest in the GELShield.

See Also
Invictus Medical gets big funding and global commercialization rights
Medical device firm Invictus raises $3.8 million
Invictus Medical achieves final step before FDA approval

The company's long-term interest is fighting deformational plagiocephaly, a cranial deformity in infants resulting from repeated external pressure to one side of the head. There have been a significant rise in plagiocephaly since the early 1990s.

To date, the San Antonio-based medical device company has raised $5 million toward commercialization efforts. The company is in the process of securing an additional $4.5 million in Series B funding to support the commercialization of the GELShield.

 

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