APEN - Apollo Endosurgery shares soar 35% on Breakthrough Device tag for Orbera Balloon

Apollo Endosurgery (APEN) rallies 35% premarket after receiving FDA Breakthrough Device Designation for the Orbera Intragastric Balloon, for use in treating patients with BMI between 30-40 kg/m2 with noncirrhotic nonalcoholic steatohepatitis ((NASH)) with liver fibrosis.he designation, akin to Breakthrough Therapy status for a drug, provides for more intensive guidance on development by the FDA, the involvement of more senior agency personnel, the assignment of a case manager and priority review of the marketing application. Orbera is an incision-less, non-surgical weight loss solution designed for adult patients suffering from obesity, not eligible for surgery, but for whom diet, and exercise or pharmaceutical interventions have not worked.

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Apollo Endosurgery shares soar 35% on Breakthrough Device tag for Orbera Balloon