Direct Biologics, LLC Announces One Year Follow Up of Pilot Safety Study of ExoFlo for Treatment of Osteoarthritis in Combat-Related Injuries

Thirty-three Navy SEAL veterans were treated with a bone marrow mesenchymal stem cell (MSC) derived extracellular vesical isolate product (EVIP) for Osteoarthritis (OA) of the knee, shoulder, elbow, hip, ankle, or wrist.

AUSTIN, Texas, November 11, 2021

Direct Biologics, LLC, a market-leading biotech company in the field of regenerative biologics, announced the publication of the one year follow up results from a pilot safety study of a MSC derived EVIP for treatment of OA in combat-related injuries in the Journal of Stem Cell Research.

This publication follows the first report on the safety and clinical efficacy of human MSC-derived EVIP ExoFlo to treat OA (East DO J, Alexander DC T, Dordevic M. (2020) IRB Approved Pilot Safety Study of an Extracellular Vesicle Isolate Product Evaluating the Treatment of Osteoarthritis in Combat-Related Injuries. 1(2):1-10). In an independent, IRB approved, pilot study completed in 2020 by Dr. Johnny East, ExoFlo was used to treat thirty-three Navy SEAL veterans for combat-related OA. Patients received a single injection of 2mL of ExoFlo into each treated joint. Six months after being injected with ExoFlo, the average patient experienced significant improvements in both pain and function.

At the one-year follow-up, the average patient improved 82% in BPI, 77% in ODI, 67% in LEFS, 50% in UEFS, and 77% in QD. All improvements were strongly statistically significant with p value < 0.001. Ninety-five percent of the improvement occurred within the first six weeks following the injection and

continued through the one-year follow-up. No complications or side effects were reported, and no patient was worse after the injection.

Mesenchymal stromal/stem cells (MSCs) are believed by scientists to help healing by generating the release of extracellular vesicles (EVs). EVs are key players in cell-to-cell communication and natural healing with potential long-term benefits. The mainstay treatment for OA, steroids, is effective only for one to two months with many long-term side effects—in searching for healthier alternatives, Dr. East chose to investigate ExoFlo as he thought it could not only be beneficial for patients with musculoskeletal and spine issues, but also for OA.

Osteoarthritis is the most common chronic disease in the US affecting up to 55 million people and current treatment options are limited. Patients with OA experience pain and loss of motion limiting or impairing certain activities of daily living. There is a substantial gap in care for non-operative and operative options for patients suffering pain and impairments from OA.

About ExoFlo

ExoFlo is an investigational new drug that has not been approved or licensed by FDA. It is an extracellular vesicle based biologic product isolated from human bone marrow mesenchymal stem or stromal cells (MSCs). ExoFlo provides signaling proteins that have been shown to modulate inflammation and may stimulate bioactivity and direct cellular communication.

About Direct Biologics

Direct Biologics, LLC, is headquartered in Austin, Texas, with an R&D facility located at the University of California, and an Operations and Order Fulfillment Center located in St. Louis, Missouri. Direct Biologics is a market-leading innovator and cGMP manufacturer of regenerative medical products, including a robust line of extracellular vesicle-based biological products. The Company was created to expand the science of cutting-edge biologic technologies. Direct Biologics’ management team holds extensive collective experience in biologics research, development, and commercialization, making the Company a leader in the evolving, next-generation segment of the biotherapeutics industry. Direct Biologics is dedicated to pursuing additional clinical applications of ExoFlo through the FDA’s investigational new drug application process. For more information, visit https://directbiologics.com.

Phone: 1-800-791-1021
Email: info@directbiologics.com

Direct Biologics, a market-leading innovator and cGMP manufacturer of regenerative biologic products, announced today that the U.S Food and Drug Administration (FDA) has approved the application for a Phase I/II trial under an Investigational New Drug (IND) protocol for the use of ExoFlo™ in the treatment of mild-to-moderate COVID-19. This is Direct Biologics’ third FDA approved IND clinical trial, and it represents the very first IND approved by FDA to investigate the use of extracellular vesicles (EVs) to treat mild-to-moderate COVID-19.