July 20, 2021 (Newswire.com) –
As intensive care items throughout the nation fill to capability, hospital beds are in dangerously quick provide, and deaths from COVID-19 proceed to spike, docs from medical facilities coast to coast are reporting on the outstanding therapeutic properties of ExoFlo, an progressive life-saving remedy that leverages the anti-inflammatory and regenerative results of bone-marrow derived mesenchymal stem cells, when used on their most significantly sick COVID-19 sufferers. The physicians word that using ExoFlo, administered as a single IV infusion, is secure and efficacious and is saving lives on a constant foundation.
One of many product’s earliest advocates, Dr. Vik Sengupta of New York, credit ExoFlo with saving his personal life. He has since used it on many critically sick sufferers, eagerly shared it with colleagues, and coauthored, together with his spouse, Dr. Sascha Sengupta, a medical security trial performed at Christ Hospital in Jersey Metropolis, N.J. as a part of the remedy’s FDA approval course of. The protection information from this examine has since set the stage for the FDA approval of ExoFlo for an Investigational New Drug (IND) utility for COVID-19.
“The commonest explanation for demise amongst critically sick COVID-19 sufferers is acute respiratory misery symptom, or ARDS, through which the lungs are badly broken, scarred and fill with fluid,” defined Dr. Sengupta. “That is basically a results of the physique reacting to a menace by overproducing cytokines and different mediators of irritation that trigger harm to the lungs and different tissues within the physique in a phenomenon generally often called the ‘cytokine storm.’
“ExoFlo does two vital issues: it remediates the irritation nearly instantly by delivering miRNA that cease the inflammatory cascade, and it delivers progress components that promote the regeneration of wholesome lung tissue for a a lot speedier restoration.”
ExoFlo is manufactured by Direct Biologics, a market-leading cGMP producer of regenerative medical merchandise based mostly in Austin, Texas. ExoFlo has amazed docs with its capability to fill an unmet however pressing medical want, saving the lives of sufferers experiencing COVID-19- related Acute Respiratory Misery Syndrome. Repeatedly, sufferers had been capable of be discharged and returned to their households slightly than deteriorating to an irreversible state.
“This product couldn’t have come at a greater time,” famous Dr. Angel Lazo Jr. of New Jersey. “This product additionally opens the door to medical options for post-pandemic considerations, when there can be an pressing want to deal with COVID-19 survivors affected by Publish-Acute COVID Syndrome (PACS), sometimes called long-hauler COVID, and to remediate compromised immune techniques and certain lasting pulmonary scarring.”
Dr. Sengupta recollects his first expertise with ExoFlo: “We had been all exhausted, working a number of shifts in the course of the worst of the early days of the epidemic when the New York space was hit so onerous. A buddy requested me if I may assist her aged mother and father, each of their 80s and each very sick with COVID-19. The spouse had been admitted to the hospital, and sadly, regardless of our greatest efforts, the hospital administration refused us permission to deal with her with ExoFlo. The husband, who had been declining shortly and suffered from a fever, hypoxia, delirium, diarrhea, no sense of style, and lack of urge for food, grew to become the primary documented affected person in medical historical past to be administered an exosome-based remedy for important respiratory sickness. He acquired ExoFlo at residence with none adversarial reactions and was away from bed and singing arias inside two days. Sadly, and unbeknownst to him, his spouse had died within the hospital.”
This was a dramatic and eye-opening expertise. “Once I myself fell sufferer to COVID, I grew to become significantly sick very quick,” famous Dr. Sengupta. “I awoke in the course of the night time, struggling to breath and sinking into delirium, and checked my O2sat, instantly realizing I used to be going into respiratory failure. I referred to as my spouse. She left her shift on the hospital, rushed residence, and administered ExoFlo. Inside 24 hours my supplemental oxygenation requirement, fever, and respiratory signs considerably improved. And inside 5 days of that single dose, I used to be nearly totally recovered from the acute an infection. I firmly consider that ExoFlo saved my life.”
As phrase spreads throughout the medical neighborhood, growing numbers of docs have been astounded by the efficacy and security of ExoFlo. Amongst those that have gone on report singing its praises are Dr. Iman Bar of Newport Seaside, Calif., and Dr. Jack Mann of Flushing, N.Y.
“The COVID-19 pandemic has introduced docs with a heartbreaking studying curve,” stated Dr. Sengupta, who has since develop into Direct Biologic’s chief medical officer. “For months we had no selection however to face by whereas sufferers died regardless of our greatest efforts to avoid wasting them. It is an unimaginable reduction now to have ExoFlo in our arsenal of remedies.”
ExoFlo is a biopharmaceutical grade regenerative medication product that represents a significant remedy within the struggle towards the lethal lung irritation attributable to the COVID-19 virus. The brand new investigational drug makes use of extracellular vesicles and progress issue proteins remoted from human bone marrow mesenchymal stem cells (MSCs) to scale back irritation and direct mobile communication able to strengthening the physique’s defenses and advancing its therapeutic processes.
ExoFlo is at the moment in a Part II medical trial that expands information gleaned from a potential, open-label examine through which 17 out of 24 sufferers demonstrated decision of their ARDS, exhibiting biomarker and oxygenation enhancements inside 48-72 hours following remedy with a single 15mL intravenous dose of ExoFlo. Since receiving FDA approval of an expanded entry protocol in October 2020, ExoFlo can be being utilized by physicians across the nation as a part of single affected person emergency or compassionate use protocol, generally known as eIND.
About Direct Biologics
Direct Biologics, LLC, is headquartered in Austin, Texas, with a lately expanded R&D facility positioned on the College of California, and an Operations and Order Success Heart positioned in St. Louis, Missouri. Direct Biologics is a market-leading innovator and cGMP producer of regenerative medical merchandise, together with a strong line of extracellular vesicle-based organic merchandise. The corporate was created to increase the science of regenerative therapeutic by delivering cutting-edge biologic applied sciences. Direct Biologics’ administration crew holds in depth collective expertise in biologics analysis, improvement, and commercialization, making the corporate a pacesetter within the evolving, subsequent technology phase of the biotherapeutics business. Direct Biologics is devoted to pursuing extra medical functions of its extracellular vesicle biologic merchandise by way of the FDA’s investigational new drug utility course of.
For extra info go to http://www.directbiologics.com.
Supply: Direct Biologics