"Notwithstanding the statistical conclusions of the clinical trial results, the FDA would like to see more data to confirm the safety and effectiveness of CelluSTAT in surgical procedures in the intestinal and thoracic organ space, where organ movement can impact the postoperative stability of a hemostat and where observation of postoperative rebleeding is more difficult. To address this concern, UHP has proposed to enroll a limited number of human subjects in a multi-site study as an extension of the original pivotal study, with patients undergoing surgical procedures within the organ space. Separately, the FDA confirmed that its earlier stated concern regarding use of CelluSTAT in vascular graft procedures had been adequately addressed."
“While we are pleased to confirm the path to resolving the list of deficiencies in our PMA application, we are disappointed that the strong results of our pivotal study and low incidence of adverse events were not sufficient to address the FDA’s specific concern regarding organ space applications of our device. The company will devote its resources to completing these additional surgical procedures efficiently and is confident that the results will reinforce the results of the existing study.” I am buying more shares!! $5-$10++
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