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In fact, the existing preclinical research shows the opposite

Notably, BPC157 accelerates burn wound healing after flame exposure [4], and our prior studies in thermal/incisional injury models implicate its proangiogenic activity as a central reparative mechanism [9]

As an example, the applicant cited language from the Uretero1 TM decision in which CMS agreed that the device met the criterion for substantial clinical improvement, which stated that while comparative studies between Uretero1 TM and other disposable devices would be helpful, CMS agreed that the evidence demonstrating improved outcomes and reduced patient risk associated with the disposable device in comparison with reusable devices represented substantial clinical improvement (87 FR 71932)

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