UHP FDA PMA update: supplemental study needed for organ space, 6-7 month delay

United Health Products, Inc.

FDA requires additional clinical data for CelluSTAT (HemoStyp) use in intestinal/thoracic procedures.
Pivotal study (232 patients, 118 treated) showed non-inferiority and superiority for time to hemostasis.
Company will enroll limited number of human subjects in multi-site supplemental study, taking ~6-7 months.
FDA review period remains paused until all deficiencies addressed; ~90 of 180 days elapsed.
Additional biocompatibility and sterility testing agreed with FDA; BIMO site inspections completed.

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