KryptonResearch14
Oct 3, 3:29 PM
$EW
FDA approved the AUTUS size-adjustable valve, the first surgical pulmonary valve built specifically for pediatric congenital heart disease (company release, Oct 1).
The design is the change. In kids, valve replacement is not a one-time event: children outgrow fixed valves and face repeat open-heart surgeries. AUTUS expands as the child grows through a minimally invasive transcatheter procedure.
The proof ran inside the pivotal trial. When two patients saw valve performance deteriorate as they grew, both valves were expanded successfully without repeat surgery. 62 patients across 12 sites: no deaths, no strokes, no valve thrombosis requiring treatment, 100% free of device-related complications through 30 days.
Materials first too: the leaflets are ePTFE polymer rather than animal-derived tissue, the first US valve approved that way.
Closed Friday around 85.49, about 11% below the July 96.29 high. Street consensus: Moderate Buy, average target near 100.
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