ReShape Lifesciences Inc (NASDAQ:RSLS) shares rose 41% to 36 cents in premarket trading after the micro-cap firm’s latest obesity treatment, Lap-Band 2.0, was approved by the US Food and Drug Administration (FDA).
The FDA provided the company with a PMA supplement approval for the new generation of ReShape’s Lap-Band – described as a “minimally invasive alternative to surgical stapling procedures – which features ‘FLEX’ technology that the company said acts as a ‘relief valve’ allowing larger pieces of food to move more easily through the narrower passage created by the band.
FDA approval is described by chief executive Paul Hickey as “a key growth catalyst for the company’s Lap-Band franchise”.
“The enhanced Lap-Band 2.0 FLEX development effort was physician-led with the goal of improving the patient experience,” Hickey said in a statement.
He added: “We are preparing for our U.S. product launch of the Lap-Band 2.0 FLEX and look forward to providing updates on our progress.”
Meanwhile, Christine Ren-Fielding, head of Bariatric Surgery at NYU Grossman School of Medicine, commented: “Based on my 20-year use of the Lap-Band, over time, some patients have needed adjustments, particularly when related to urgent loosening to relieve food obstruction,” said in ReShape’s statement.
“Lap-Band 2.0® FLEX will potentially remedy this issue because of the ability for self-correction, utilizing an internal reservoir system.
She added: “In addition, multi-modal therapy is becoming a mainstay in the bariatric surgery field. GLP-1 agonists can be used to complement and augment weight loss after surgery to help prevent weight regain.”