Patients

Our Commitment

Direct Biologics: Pioneering Healthcare Solutions

At Direct Biologics, we're dedicated to improving the lives of patients by developing innovative therapies. Our mission is rooted in a deep passion for advancing healthcare and a relentless pursuit of excellence.

Extracellular Vesicles (EVs): A Promising Therapeutic

Our unique biological therapies are composed of growth factors and cytokines, which are proteins, and EVs secreted by bone marrow mesenchymal stem/stromal cells (bmMSCs).

EVs play a crucial role in cell-to-cell communication. They contain a vast array of molecules, including chemokines, messenger RNA (mRNA), and noncoding RNA (microRNA or miRNA).

Key Benefits of Direct Biologics’ product EVs

  • Naturally derived from MSCs
  • Potent Anti-inflammatory Effects
  • Acellular and Nonimmunogenic
  • Reduced Risk of Complications
  • Easier Storage and Transport

Our therapies represent a novel approach that leverages the beneficial properties of stem cells by harnessing the power of these natural messengers. EVs may offer a new treatment option for various conditions.

Clinical Trials: Driving Innovation

We're currently conducting clinical trials to evaluate the safety and efficacy of our therapies in different diseases.

Current Ongoing Trials

Acute Respiratory Distress Syndrome (ARDS)


A study of ExoFlo™ for patients with moderate to severe ARDS

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Perianal Fistulizing Crohn’s Disease


A study of DB-3Q for patients with medically refractory perianal fistulizing Crohn’s disease

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Medically Refractory Crohn’s Disease


A study of DB-3Q for patients with medically refractory Crohn’s disease

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Medically Refractory Ulcerative Colitis


A study of DB-3Y for patients with medically refractory ulcerative colitis

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Expanded Access Program

Expanded Access is a pathway that allows patients with serious or life-threatening conditions to gain access to investigational therapies outside of clinical trials. While we believe clinical trials are the most appropriate way to evaluate our therapies, we also support patients in need by making our investigational therapies available in emergency or investigational cases.

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To learn more about the Expanded Access program, please visit the link below

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Direct Biologics

Direct Biologics is a science-based market leading innovator and certified cGMP manufacturer of regenerative biologic products.

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