Direct Biologics, LLC

Direct Biologics, LLC is a privately held American biotechnology company focused on regenerative medicine and the development of investigational biologic product candidates. The company was founded in 2017 by Mark Adams and Joe Schmidt and is headquartered in Austin, Texas, with operations also based in California and team members collaborating across multiple locations in the United States. Its stated vision is to advance research in cGMP-manufactured, secretome-based investigational products—including extracellular vesicles (EVs)—derived from adult bone marrow mesenchymal stem cells. The scientific premise of Direct Biologics rests on the biology of the secretome: the broad collection of materials that cells naturally release into their surrounding environment, including extracellular vesicles (EVs), proteins, lipids, and other biomolecules. The company describes EVs as individually unique—likening them to snowflakes—and positions its work as exploring the complexity of cellular communication. Its investigational product candidates are secretome-based and derived from adult bone marrow mesenchymal stem cells, and are being evaluated in clinical research rather than marketed as approved therapies. The company emphasizes that these candidate therapies are investigational and have not been approved by the U.S. Food and Drug Administration, and that their safety and efficacy have not been established. Direct Biologics frames its approach under the trademarked concept of "Natural Intelligence®," which it defines as its approach to leveraging naturally derived biological systems and processes in therapeutic development. Manufacturing is central to the company's identity: it operates cGMP manufacturing processes designed to support consistency, scalability, and quality from sourcing through characterization, providing a foundation for advancing clinical research programs. The company states that it combines scientific approaches with a focus on quality, guided by core values of Safety, Innovation, and Quality. Commercially and clinically, the company's journey includes commercializing a cGMP product under the FDA's HCT/P 361 tissue regulations in 2019. In 2020, it initiated multiple clinical programs in response to COVID-19, including a Phase II ARDS trial, an expanded access program, and participation in Operation Warp Speed. It completed a Phase II trial for moderate-to-severe ARDS associated with COVID-19 in 2021, opened a full-time corporate office in Austin in 2022, launched Phase I clinical trials for ulcerative colitis and Crohn's disease, and received a Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for COVID-19-associated ARDS. The company's mission is to advance investigational therapies being studied to better understand their potential effects on immune and inflammatory pathways. As a private company, Direct Biologics does not disclose a public ticker or listed status. Its operations span Texas and California, and it maintains a coordinated operational presence to support its research and manufacturing activities. The company positions itself at the intersection of science, manufacturing, and clinical research, aiming to advance the future of regenerative medicine through rigorously manufactured, secretome-based investigational products.

Direct Biologics, LLC was founded in 2017 by Mark Adams and Joe Schmidt. From its inception, the company oriented itself around regenerative medicine and the biology of the secretome—the collection of materials that cells naturally release into their surrounding environment, including extracellular vesicles (EVs), proteins, lipids, and other biomolecules. Its investigational product candidates are secretome-based and derived from adult bone marrow mesenchymal stem cells, and the company built its identity around cGMP manufacturing designed to support consistency, scalability, and quality from sourcing through characterization. In 2019, the company commercialized a cGMP product under the FDA's HCT/P 361 tissue regulations. This regulatory pathway concerns human cells, tissues, and cellular and tissue-based products, and the milestone marked the company's transition into commercial operations alongside its research activities. In 2020, Direct Biologics initiated multiple clinical programs in response to COVID-19. These included a Phase II ARDS trial, an expanded access program, and participation in Operation Warp Speed, the U.S. government's effort to accelerate the development of COVID-19 countermeasures. The following year, in 2021, the company completed its Phase II trial for moderate-to-severe ARDS associated with COVID-19. In 2022, Direct Biologics opened a full-time corporate office in Austin, Texas, and launched Phase I clinical trials for ulcerative colitis and Crohn's disease. In the same period, the FDA granted a Regenerative Medicine Advanced Therapy (RMAT) designation for COVID-19-associated ARDS. The RMAT designation is a regulatory program intended to expedite the development and review of regenerative medicine therapies for serious conditions. The company's operations are based in Texas and California, with team members collaborating across multiple locations throughout the United States. It maintains a coordinated operational presence to support its research and manufacturing activities. Its stated vision is to advance research in cGMP-manufactured, secretome-based investigational products—including extracellular vesicles—derived from adult bone marrow mesenchymal stem cells, advancing the future of regenerative medicine. Its mission is to advance investigational therapies being studied to better understand their potential effects on immune and inflammatory pathways. The company consistently emphasizes that these approaches are investigational and have not been approved by the U.S. Food and Drug Administration, and that their safety and efficacy have not been established. Direct Biologics frames its scientific approach under the trademarked concept of "Natural Intelligence®," which it defines as its approach to leveraging naturally derived biological systems and processes in therapeutic development. The company describes its work as exploring the complexity of cellular communication and notes that, like snowflakes, each EV is unique. Guided by core values of Safety, Innovation, and Quality, it combines scientific approaches with a focus on quality to support the advancement of clinical research programs.

• 2022

  Opened full-time corporate office in Austin; launched Phase I clinical trials for ulcerative colitis and Crohn's disease; FDA granted a Regenerative Medicine Advanced Therapy (RMAT) designation for COVID-19 associated ARDS.

• 2021

  Completed Phase II trial for Mod-Severe ARDS associated with COVID-19.

• 2020

  Initiated multiple clinical programs in response to COVID-19, a Phase II ARDS trial, an expanded access program as well as participation in Operation Warp Speed.

• 2019

  Commercialized a cGMP product under FDA's HCT/P 361 tissue regulations.

• 2017

  Direct Biologics was founded by Mark Adams and Joe Schmidt.

A regenerative-medicine biotechnology company developing investigational, cGMP-manufactured, secretome-based biologic product candidates, guided by core values of Safety, Innovation, and Quality.

• Secretome-based investigational product candidates derived from adult bone marrow mesenchymal stem cells

  Investigational, secretome-based product candidates including extracellular vesicles (EVs), being evaluated in clinical research; not approved by the FDA.

• cGMP product commercialized under FDA HCT/P 361 tissue regulations

  A cGMP product commercialized in 2019 under the FDA's HCT/P 361 tissue regulations.

• 2020.09.09

  Reported2020.09.09

  Direct Biologics to use Bioclinica IRT in COVID-19 study[4]Direct Biologics将在COVID-19研究中使用Bioclinica的IRT系统prnewswire.com

  Bioclinica announced that Direct Biologics would use Bioclinica's Interactive Response Technology for the EXIT COVID-19 study, a multicenter FDA phase II clinical trial of ExoFlo for COVID-19 acute respiratory distress syndrome.

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1. 1Homedirectbiologics.com
2. 2Company | Direct Biologicsdirectbiologics.com
3. 3Direct Biologics, LLC (United States)wikidata.org
4. 4Direct Biologics将在COVID-19研究中使用Bioclinica的IRT系统prnewswire.com