Direct Biologics Treats First Patient in Phase II Expanded Access Program for ExoFlo™ in COVID-19 Treatment
The Expanded Access Program provides a pathway for patients to receive ExoFlo treatment outside the ongoing Phase II clinical trial.
AUSTIN, Texas (FreePR.org) -- Direct Biologics, LLC has announced the successful treatment of the first patient under its expanded access protocol for ExoFlo Infusion Therapy for COVID-19-associated ARDS (EXIT COVID-19).
“Our Phase II clinical trial is actively recruiting patients at multiple sites nationwide and has reached significant milestones. We are close to completing this phase and are excited to share our findings as we prepare for Phase III,” shared Mark Adams, Co-Founder and CEO.
The expanded access protocol functions as an open-label study, focusing on treating patients with advanced disease under a "compassionate use" framework.
Joe Schmidt, Co-Founder and President, explained, “This expanded access allows us to address the urgent needs of critically ill patients who lack viable treatment alternatives. It also broadens our ability to deliver care to additional hospitals and communities across the country.”
Chief Medical Officer Vik Sengupta, MD, emphasized, “We are deeply grateful for the opportunity to assist patients in dire need of treatment.”
This initiative operates under the same IND application as the Phase II clinical trial, utilizing bone marrow-derived extracellular vesicles (EVs) to treat COVID-19-associated ARDS. Preclinical studies have shown that EVs derived from mesenchymal stem cells (bmMSCs) possess remarkable anti-inflammatory and tissue-repair properties.
Physicians interested in learning more can visit clinicaltrials.gov or submit patient access requests via email at msl@directbiologics.com. Requests must be made by licensed U.S. physicians.
About ExoFlo
ExoFlo is an investigational therapy derived from human bone marrow mesenchymal stem or stromal cells (MSCs). The product delivers bioactive signals that regulate inflammation and facilitate cellular communication. ExoFlo has not been approved or licensed by the FDA and remains under investigation.
About Direct Biologics
Headquartered in Austin, Texas, Direct Biologics operates an advanced R&D facility at the University of California and an Operations and Fulfillment Center in St. Louis, Missouri. The company is a leader in regenerative medicine, specializing in extracellular vesicle-based biological products. By leveraging groundbreaking technology, Direct Biologics aims to advance the science of regenerative healing.
Led by a team of seasoned experts in biologics research, development, and commercialization, Direct Biologics is at the forefront of next-generation biotherapeutics. The company is committed to expanding the clinical applications of its extracellular vesicle products through FDA investigational new drug processes.
For more information, visit www.directbiologics.com.
Phone: 1-800-791-1021
Email: info@directbiologics.com
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