Direct Biologics CEO Mark Adams said: "After intensively reviewing our preclinical data, manufacturing processes, and clinical data from our Phase II multicentre, double-blinded, placebo-controlled randomised clinical trial, the FDA has recognised ExoFlo as a lifesaving treatment for patients suffering from acute respiratory distress syndrome (ARDS) due to severe or critical Covid-19. Future Medical Products | 257 LinkedIn Future Medical Products is the national distributor for Direct Biologics ExoFlo, XoFlo, and Amniowrap. Direct Biologics is the For more information, visit www.directbiologics . 2022 2023 Direct Biologics ExoFlo ARDS Direct BiologicsExoFloCOVID . Mapping Which Coronavirus Variants Will Resist Antibody Treatments. Direct Biologics is dedicated to pursuing additional clinical applications of ExoFlo through the FDA's investigational new drug application process. For more information, visit www.directbiologics . Biological: DB-001 . Current commercial biologic products include but are not limited to ExoFlo TM and XoFlo TM products. ExoFlo . The mission of Direct Biologics is to deliver disruptive and innovative products that unlock the healing potential within a patient's own cells with an emphasis on reduced chronic inflammation and promoting regeneration. Direct Biologics, LLC: ClinicalTrials.gov Identifier: NCT05176366 Other Study ID Numbers: DB-EF-ULCERATIVE-0004 : First Posted: This platform is designed to produce a new class of transformative . Direct Biologics notes as intensive care units across the country fill to capacity, hospital beds are in dangerously short supply, and deaths from COVID-19 continue to spike, doctors from medical centers coast to coast are reporting on the remarkable healing properties of ExoFlo, an innovative life-saving therapy that leverages the anti-inflammatory and regenerative effects . 5) 16. 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 . Direct Biologics is a market leading innovator and cGMP manufacturer of regenerative biologic products, including ExoFlo, a COVID-19 therapeutic geared solution, that leverages the regenerative properties of bone marrow mesenchymal stem cell (MSC)-derived extracellular vesicles. Direct Biologics is dedicated to pursuing additional clinical applications of ExoFlo through the FDA's investigational new drug application process. Image: Direct Biologics introduces ExoFlo Exosomes. For more information visit www.directbiologics . By NS Medical Staff Writer 09 Jul 2019. About Direct Biologics. 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 . Direct Biologics is an innovative, cGMP manufacturer of regenerative biologic products. Direct Biologics is also enrolling patients in EXIT COVID-19, its national multi-center, Phase II, placebo controlled, randomized clinical trial investigating the use of ExoFlo for COVID-19 . In this case, it was for COVID-19. The safety data from this study has since set the stage for the FDA approval of ExoFlo for an Investigational New Drug (IND) application for COVID-19. Physicians can learn more and may request information on becoming a study site at clinicaltrials.gov. The mission of Direct Biologics is to deliver disruptive and innovative products that unlock the healing potential within a patient's own cells with an emphasis on reduced chronic inflammation and promoting regeneration. The company's flagship product, ExoFlo , is a therapeutic candidate in late-stage development, created using the company's proprietary EV platform technology. ExoFlo Exosomes are allograft isolated extracellular vesicles . Direct Biologics, a market-leading innovator and cGMP manufacturer of regenerative biologic products, announced today that it has received FDA approval to initiate a Phase I/II trial under an Investigational New Drug (IND) protocol for the use of ExoFlo in the treatment of Post-Acute COVID-19 Syndrome. Direct Biologics Announces the Launch of ExoFlo Exosomes 4 Like . Direct Biologics is dedicated to pursuing additional clinical applications of ExoFlo through the FDA's investigational new drug application process. AUSTIN, Texas, July 8, 2019 (Newswire.com) - Direct Biologics, LLC announces the launch of ExoFloTMExosomes. Raymond James & Associates, Inc. is serving as financial advisor to Direct Biologics. A Phase I study of ExoFlo, an ex vivo culture-expanded adult allogeneic bone marrow mesenchymal stem cell derived extracellular vesicle product, for the treatment of medically refractory ulcerative colitis . | Future Medical Products (FMP) is the national distributor for Direct Biologics ExoFlo, XoFlo, and Amniowrap. Here's a nice explainer video from Direct Biologics #hairloss #medicalfuture #stemcells #stemcelltherapy. AUSTIN, Texas, April 21, 2022 - Direct Biologics, a regenerative biotechnology company with a groundbreaking extracellular vesicle (EV) platform technology, announced that the FDA has approved the company to proceed with its Phase 3 clinical trial using its investigational EV drug, ExoFlo, to treat Acute Respiratory Distress Syndrome (ARDS) due to Covid-19. Direct Biologics is a market leading innovator and cGMP manufacturer of regenerative biologic products, including ExoFlo, a COVID-19 therapeutic geared solution, that leverages the regenerative properties of bone marrow mesenchymal stem cell (MSC)-derived extracellular vesicles. LoginAsk is here to help you access Direct Access Registration quickly and handle each specific case you encounter. Direct Access Registration will sometimes glitch and take you a long time to try different solutions. The company's flagship product, ExoFlo , is a therapeutic candidate in late-stage development, created using the company's proprietary EV platform technology. AUSTIN, Texas, Dec. 30, 2020 /PRNewswire/ -- Direct Biologics, LLC, announced today that the first patient has been treated under its expanded access protocol for ExoFlo Infusion Treatment for . Normal saline 90 mL and ExoFlo 10 mL, which is 800 Billion Extracellular Vesicles. Direct Biologics announces the launch of ExoFlo Exosomes, with a mission to deliver disruptive and innovative products that unlock the healing potential within a patient's own cells with an emphasis on reduced chronic inflammation and promoting regeneration. For more information visit www.directbiologics . All of our products go through an extensive vetting process by our advisor board of physicians to . Oct 13, 2020, 20:03 ET. ExoFlo is manufactured by Direct Biologics, a market-leading cGMP manufacturer of regenerative medical products based in Austin, Texas. Furthermore, you can find the "Troubleshooting Login Issues" section which can answer your unresolved problems and equip you . Headquartered in Austin, TX, Direct Biologics is a market-leading innovator and cGMP manufacturer of regenerative medicine products. ExoFlo is an acellular human bone marrow mesenchymal stem cell (MSC) derived extracellular vesicle (EV) product produced with a proprietary EV platform technology by Direct Biologics, LLC. For more information, visit www.directbiologics . Id. The mission of Direct Biologics is to deliver disruptive and . Direct Biologics, LLC announces the launch of ExoFlo TM Exosomes. The flagship product, ExoFlo, contains thousands of signals in . Law360 (October 13, 2022, 6:10 PM EDT) -- Late-stage biotech company Direct Biologics LLC and special-purpose acquisition company Good Works II Acquisition Corp. said Thursday they signed a . Direct Biologics was created to expand the science of cutting-edge biologic technologies through research and commercialization of medical devices and the naturally occurring products from allograft tissue compliant with FDA standards for 361 HCT/P. AUSTIN, Texas, July 8, 2019 /PRNewswire/ -- Direct Biologics, LLC announces the launch of ExoFlo TM Exosomes. About Direct Biologics Headquartered in Austin, TX, Direct Biologics is a market-leading innovator and cGMP manufacturer of regenerative medicine products. Direct Biologics, LLC announced the launch today of EXIT COVID-19, their Phase II, multi-center clinical trial examining the use of ExoFlo extracellular vesicles to treat COVID-19 associated acute respiratory distress syndrome (ARDS). Direct Biologics is an innovator and cGMP manufacturer of the regenerative biologic product candidate ExoFlo, a therapeutic candidate in late-stage development derived from the company's . Direct Biologics is using its proprietary extracellular vesicle platform technology to harness the power of bone marrow-derived mesenchymal stem cells to develop cell-free therapeutic candidates. Its product candidate, ExoFlo, is in a Phase 3 clinical trial for treating moderate-to-severe acute respiratory distress syndrome ("ARDS") in . AUSTIN, Texas Direct Biologics, LLC, is announcing that it has received approval from FDA that it may proceed with a Phase II trial under an Investigational New Drug (IND) application for the use of ExoFlo, a bone marrow-derived extracellular vesicle and exosome product, in the treatment of COVID-19 associated Acute Respiratory Distress Syndrome (ARDS).

AUSTIN, Texas, June 29, 2021 (Newswire.com) Direct Biologics, a market-leading innovator and cGMP manufacturer of regenerative biologic products, announced today that the U.S Food . Direct Biologics, LLC Announces One Year Follow Up of Pilot Safety Study of ExoFlo for Treatment of Osteoarthritis in Combat-Related Injuries Direct Biologics, LLC: ClinicalTrials.gov Identifier: NCT05130983 Other Study ID Numbers: DB-EF-CROHNS-0004 : AUSTIN, Texas, July 20, 2021 /PRNewswire/ -- As intensive care units across the country fill to capacity, hospital beds are in dangerously short supply, and deaths from COVID-19 continue to spike . Time and again, patients . Direct Biologics, an innovative biotechnology company with a groundbreaking extracellular vesicle (EV) platform drug technology, announced that the U.S. Food and Drug Administration (FDA) has awarded their EV drug product ExoFlo with a Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. AUSTIN, Texas, Oct. 13, 2020 /PRNewswire/ -- Direct Biologics, LLC, announced today that the FDA has granted expanded access for ExoFlo in the treatment of patients with . Amplifica announcement by Dr. Rassman on Reddit. Direct Biologics is an innovator and cGMP manufacturer of the regenerative biologic product candidate ExoFlo , a therapeutic candidate in late-stage development derived from the company's . It has put strict sterility and quality controls in place, including cGMP and cGTP. Direct Biologics only launched this treatment in July 2019. ExoFlo, developed by Direct Biologics in Austin, is an investigational new drug in the treatment of patients with severe respiratory distress brought on by COVID-19. Help users access the login page while offering essential notes during the login process.

Direct Biologics, a regenerative biotechnology company with a groundbreaking extracellular vesicle (EV) platform technology, announced today that the FDA has approved the company to proceed with its Phase 3 clinical trial using its investigational EV drug, ExoFlo, to treat Acute Respiratory Distress Syndrome (ARDS) due to Covid-19.Direct Biologics is the first and only EV company to receive .

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