Direct Biologics

TX - AustinBiotechnology1 H-1B visas (FY2023)

Focus: Direct Biologics is a biotechnology company headquartered in Austin, TX, specializing in allograft-based therapeutics with a pipeline focused on exosome and stem cell-derived extracellular vesicle programs. The company operates across infectious diseases, immunology, respiratory, and ophthalmology indications.

Infectious Diseases Immunology Respiratory Ophthalmology

Profile data last refreshed 10h ago · AI intelligence enriched 2mo ago

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Should You Work at Direct Biologics?

AI assessment

Direct Biologics presents a high-risk, high-reward opportunity best suited to early-stage biotech operators comfortable with capital-dependent timelines and minimal institutional infrastructure.

Why Work Here

Lead Phase 3 program (ExoFlo for ARDS) provides visibility into potential commercialization and regulatory pathway clarity within next 12–24 months.

Data completeness

4/9 — Basic

Company HealthStrong

Pipeline

Mid-stage

1 Phase 3+

LOE Risk

Protected

No near-term cliffs

Hiring

Stable

Automated analysis based on publicly available data (FDA, SEC, ClinicalTrials.gov). May be incomplete or delayed. This score does not reflect insider knowledge and should not be used as the sole basis for investment or employment decisions.

Pipeline & Clinical Trials

ExoFlo

Solid Organ Transplant Rejection

N/A

Clinical Trials (1)

NCT05215288Expanded Access for Use of ExoFlo in Abdominal Solid Organ Transplant Patients

N/A

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.

Platform approach with ExoFlo deployed across 7 distinct indications (COVID-19, ARDS, Crohn's, ulcerative colitis, transplant rejection, fistula) offers broad therapeutic exposure and mechanistic learning.

Innovative allograft and extracellular vesicle modality is a differentiated entry point into regenerative medicine and cell-derived biologics, an emerging sector.

Watch Out For

Minimal hiring footprint (1 active role, Quality Assurance only) signals either dormant growth or severe financial constraint; career trajectory and advancement opportunities appear limited.
No public financials, disclosed funding, or revenue data available; impossible to assess cash runway, burn rate, or sustainability beyond near-term Phase 3 readout.
Lack of published data (0 publications on record) raises questions about scientific rigor, regulatory transparency, and ability to attract top talent or partnerships.

Generated by Claude from Direct Biologics's SEC filings, pipeline programs, hiring velocity, FDA actions, and WARN data. Inference, not editorial — verify before quoting.

ExoFlo

Covid19

N/A

Clinical Trials (1)

NCT04657458Expanded Access for Use of bmMSC-Derived Extracellular Vesicles in Patients With COVID-19 Associated ARDS

N/A

ExoFlo

Ulcerative Colitis

PHASE_1

Clinical Trials (1)

NCT05176366Study of ExoFlo for the Treatment of Medically Refractory Ulcerative Colitis

Phase 1

ExoFlo

Crohn Disease

PHASE_1

Clinical Trials (1)

NCT05130983Study of ExoFlo for the Treatment of Medically Refractory Crohn's Disease

Phase 1

ExoFlo

Perianal Fistula

PHASE_1_2

Clinical Trials (1)

NCT05836883Study of ExoFlo for the Treatment of Perianal Fistulas

Phase 1/2

Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles

ARDS, Human

PHASE_1_2

Clinical Trials (1)

NCT05127122Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for ARDS

Phase 1/2

Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles

Covid19

PHASE_1_2

Clinical Trials (1)

NCT05116761ExoFlo™ Infusion for Post-Acute COVID-19 and Chronic Post-COVID-19 Syndrome

Phase 1/2

ExoFlo

COVID-19

PHASE_2

Clinical Trials (1)

NCT05125562Extracellular Vesicles Infusion Treatment for Mild-to-Moderate COVID-19

Phase 2

DB-3Q

Perianal Fistula Due to Crohn's Disease

PHASE_2

Clinical Trials (2)

NCT07625293DB-3Q for the Treatment of Medically Refractory Crohn's Disease

Phase 2

NCT06918808DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease

Phase 2

ExoFlo

COVID-19

PHASE_2

Clinical Trials (1)

NCT04493242Extracellular Vesicle Infusion Treatment for COVID-19 Associated ARDS

Phase 2

ExoFlo

Acute Respiratory Distress Syndrome

PHASE_3

Clinical Trials (1)

NCT05354141Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS)

Phase 3

Interview Prep Quick Facts

Portfolio: 12 clinical trials

Top TAs: Immunology, Infectious Diseases, Respiratory

H-1B (2023): 1 approval

Publications: 8 in PubMed

Open Roles: 1 active job

Therapeutic Area Focus

Immunology

5 pipeline

Infectious Diseases

4 pipeline

Respiratory

1 pipeline

Marketed

Pipeline

Hiring Trend

Stable

Open Roles

Added

-0

Filled/Removed

Based on last 4 crawl cycles

Visa Sponsorship

Sponsors Work Visas

H-1B Petitions (FY2023)

Approved

Denied

100%

Rate

Source: USCIS H-1B Employer Data Hub

Research Publications(8)

Recent peer-reviewed publications with author affiliations at this company

Bone Marrow Mesenchymal Stem Cell Extracellular Vesicle Treatment of Respiratory Failure from COVID-19: Endpoint Analysis of Expanded Access Safety Trial.

Stem cell reviews and reports

2026

PMID:42113080

Treatment of severe traumatic brain injury with human bone marrow mesenchymal stem cell extracellular vesicles: a case report.

Brain injury

2025

PMID:39743543