Authorization

Direct Biologics Granted Expanded Access by FDA for ExoFloa?? in the Treatment of COVID-19

AUSTIN, Texas, Oct. 13, 2020 /PRNewswire/ --A Direct Biologics, LLC, announced today that the FDA has granted expanded access for ExoFlo in the treatment of patients with COVID-19 associated acute respiratory distress syndrome (ARDS).While Direct Biologics is already enrolling patients in EXIT COVID-19, its national multi-center, Phase II, placebo controlled, randomized clinical trial, the new expanded access protocol will make ExoFlo available to a broader group of patients with severe COVID-19, many of whom would not meet acceptance criteria for EXIT COVID-19, often under conditions of "compassionate use."Co-Founder and Chief Executive Officer, Mark Adams, states, "The FDA's approval of expanded access for ExoFlo signifies a critical milestone in the development of advanced treatment for COVID-19 associated illnesses including ARDS. We are excited to be able to provide our product to patients with ARDS associated with COVID-19 in critical need of treatment.""Amid a potential surge in new COVID-19 cases moving into the fall and winter seasons, this approval could not have come at a better time," notes Joe Schmidt, Co-Founder and President. "Our team is working hard to advance our Phase II EXIT COVID-19 trial to offer additional treatment options.""Approval of our expanded access protocol offers an option for doctors to administer ExoFlo as a treatment to reverse disease progression, extending hope to COVID-19 patients who are not responding favorably to standard of care," states Chief Medical Officer, Vik Sengupta, MD. "We at Direct Biologics are grateful for every opportunity to help these additional patients in need."
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