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The company’s POSE2.0 incisionless weight loss procedure has treated over 16,000 patients globally. It recently received FDA approval to conduct a pivotal study (“INSPIRO”) evaluating safety and effectiveness of POSE2.0 versus lifestyle intervention alone for primary obesity treatment at up to seven sites in the U.S., enrolling up to 186 participants. The platform enables endoscopic gastroplasty without external incisions; prior studies have shown promising results on weight loss and recovery time but it remains investigational for obesity treatment in the United States.
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