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news.NeoMend has announced that its ProGEL surgical sealant has received a recommendation for approval from the FDA's anesthesiology and respiratory therapy devices advisory panel.
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The panel’s recommendation will be considered by the FDA during completion of its review of the premarket approval for ProGEL. The panel’s recommendation for FDA approval was conditioned principally on NeoMend conducting a post approval study to gather more safety data.
The panel’s decision was based on the results of a multi-center, prospective, randomized clinical trial, which demonstrated ProGEL’s success in sealing intra-operative air leaks after lung resection surgery.
Jerry Mezger, president and CEO of NeoMend, said: “The panel’s decision brings us one step closer to allowing us to provide ProGEL to surgeons in the US.”