“The past few months have been marked by a number of key data announcements from our SAVVE pivotal trial for the VenoValve. In addition to reporting a sustained clinically meaningful benefit as indicated by rVCSS for patients with an average 11-month period since receiving the VenoValve, we reported a significant improvement in venous ulcer healing for our most severe patients. That data is especially impressive because all of these patients have failed conventional treatments, including many requiring years of wound care with poor results. Also important is that none of the patients with healed ulcers have experienced ulcer recurrences, putting an end to the vicious cycle often associated with conventional therapies,” commented Robert Berman, CEO of enVVeno Medical. “As we look toward the remainder of this year, we look forward to completing one-year visits for the full cohort of patients, filing our application seeking PMA approval from the FDA, and reporting the definitive data.”
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