Thinly traded nano cap Apollo Endosurgery (APEN -30.7%) slumps on double normal, albeit on turnover of only 84K shares, in response to an FDA alert concerning unexpected deaths in patients with liquid-filled intragastric balloon systems used to treat obesity.
A total of five deaths have been reported, four with Apollo's Orbera Intragastric Balloon System and one with ReShape Medical's Reshape Integrated Dual Balloon System. All deaths occurred within a month or less after receiving the product, three within one-to-three days after placement. The causes are unknown at present.
The FDA has received reports of two additional deaths in the same time period related to potential complications associated with balloon treatment, one gastric perforation with Orbera and one esophageal perforation with ReShape.
In February, the agency issued a letter to healthcare providers recommending close monitoring of patients with liquid-filled intragastric balloon systems for acute pancreatitis and spontaneous over-inflation.
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