Sponsor Overview
Explore verified public information about Ondine Biomedical's expanded access programs, compassionate use policies, and patient eligibility pathways. This report aggregates official statements, independent research, and regulatory data to help patients, providers, and sponsors collaborate efficiently.
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ClinicalTrials.gov data sources power this status.
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Expanded Access Intelligence
Official Statements
Score contribution: 100 — 1 supporting sources.
“Consistent with applicable laws and regulations, Ondine may provide patients with access to investigational medicines through Expanded/Early Access Programs (EAP’s) prior to regulatory agency approval of the product, when we believe there is sufficient evidence of the safety and effectiveness of the investigational medicine to support its use in the particular circumstance.”
Reagan-Udall Foundation Insights
Single-Patient EA Policies/Criteria Named Patient Access (Single Patient IND in the U.S.) – where a qualified healthcare professional requests an investigational medicine for use for a single patient because, in their judgement, currently available therapies are not satisfactory. Provision of the investigational medicine by Ondine may or may not require approval by FDA as well as an Institutional Review Board. Available Therapies via Single-Patient EA Non-antibiotic nasal decolonization. See https://www.ondinebio.com/solutions/steriwave/ . This is a light-based therapy that can decolonize the nose of bacteria, viruses and fungi within 4 minutes. Typically used for pre-operative patients as well as for vulnerable populations or immunocompromised patients.
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