LMAO - SeaStar seeks FDA exemption for its medical device to treat acute kidney injury in kids

• SeaStar Medical on Wednesday said it was seeking a U.S. FDA humanitarian device exemption for its Selective Cytopheretic Device (SCD) to treat acute kidney injury in children.
• SeaStar, a privately-held medical technology company, is set to go public in the U.S. via a merger with special purpose acquisition company LMF Acquisition Opportunities ( NASDAQ: LMAO ).
• In Wednesday's statement , SeaStar said the U.S. drug regulator had accepted the company's humanitarian device exemption (HDE) application and will begin its review.
• The FDA's HDE program seeks to expedite the approval of medical devices and products that are intended for diseases that affect small or rare populations.
• SeaStar's SCD is a device situated outside the body designed to be used with continuous renal replacement therapy (CRRT) to treat acute kidney injury in kids.
• SeaStar said around 4K kids in the U.S. each year with acute kidney injury require CRRT.

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