LEAWOOD, Kan., Sept. 14, 2026 (GLOBE NEWSWIRE) -- Etienna Bio, Inc. today announced that it completed an INTERACT meeting with the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) on August 28, 2026, for ETB-001, its lead regenerative aesthetics program.
ETB-001 is an investigational injectable product that combines a patient’s own adipose-derived cells with the company’s proprietary extracellular matrix scaffold. It is being developed to restore living soft tissue, with an initial focus on addressing volume loss in the back of the hands and potential future applications in other selected areas of the body.
ETB-001 is being developed as a biologic - a regenerative aesthetics product made with a patient’s own living cells. Upon its first FDA approval, ETB-001 would be eligible to receive 12 years of exclusivity under federal law against approval of biosimilar versions. This protection, together with the company’s intellectual property portfolio, would support the program’s long-term commercial value.
The INTERACT meeting provided early FDA feedback on the preclinical studies, manufacturing processes, and clinical development considerations for ETB-001. Etienna is incorporating this feedback into its development plan as it prepares for further FDA discussions and a future Investigational New Drug (IND) application seeking authorization to begin human clinical studies.
“Completing our INTERACT meeting is an important milestone for Etienna and the advancement of ETB-001,” said Janet DeLeon, Chief Executive Officer and President of Etienna Bio. “FDA’s feedback is helping us refine the next steps in our development program. We are grateful to our scientific founders at UMass Chan Medical School, our team, and our investors for their continued support, and we look forward to sharing our progress.”
About Etienna Bio
Etienna Bio is a biotechnology company focused on developing next-generation regenerative and aesthetic solutions using autologous, cell-enabled biomaterials. https://etiennabio.com/ ETB-001 is an investigational product and has not been approved by FDA. Completion of an INTERACT meeting does not constitute FDA approval or authorization to begin clinical trials. This release contains forward-looking statements regarding product development, potential applications, regulatory approval, and exclusivity. Actual results and timelines may differ materially.
About UMass Chan Medical School
UMass Chan Medical School, one of five campuses of the University of Massachusetts system, comprises the T.H. Chan School of Medicine, the Morningside Graduate School of Biomedical Sciences, the Tan Chingfen Graduate School of Nursing, ForHealth Consulting at UMass Chan Medical School, MassBiologics, and a thriving Nobel-Prize-winning biomedical research enterprise. UMass Chan is advancing together to improve the health and wellness of our diverse communities throughout Massachusetts and across the world by leading and innovating in education, research, health care delivery and public service. It is ranked among the best medical schools in the nation for primary care education and biomedical research by U.S. News & World Report. Learn more at www.umassmed.edu.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the development of ETB-001, the company's regulatory strategy and anticipated interactions with FDA, planned nonclinical and clinical studies, and the potential benefits of ETB-001. These statements are based on current expectations and are subject to risks and uncertainties, including the outcome of nonclinical studies, the timing and results of regulatory submissions, the company's ability to obtain financing, and other risks inherent in the development of biologic products. Actual results may differ materially. FDA feedback provided through the INTERACT program is preliminary and non-binding. ETB-001 is an investigational product and has not been approved by FDA or any other regulatory authority for any use. Etienna Bio undertakes no obligation to update these statements.
Janet K. DeLeon, RAC
CEO and Co-founder
Etienna Bio, Inc.
5251 W. 116th Place, Suite 200
Leawood, KS 66211
Ph: 913-444-5577
