BD Announces First Pharma-Sponsored Clinical Trial Using BD Libertas™ Wearable Injector Technology for Biologic Drugs
Rhea-AI Summary
BD (NYSE: BDX) has announced its first pharma-sponsored combination product clinical trial using the BD Libertas™ Wearable Injector for subcutaneous delivery of complex biologics. The announcement follows successful outcomes from over 50 pre-clinical and clinical studies, with 100% of participants indicating likely future use of the device.
The BD Libertas™ Wearable Injector is designed to enable home-based self-injection of biologics, potentially converting treatments from hospital-based infusions to at-home care. The device supports delivery of high-viscosity biologics up to 50 centipoise and is available in 2-5mL and 5-10mL configurations. This development comes as the biologics market is projected to reach $670 billion by 2030.
Positive
- 100% of study participants indicated likely future use of the BD Libertas Wearable Injector
- Device enables conversion from hospital-based infusions to convenient home self-injection
- Supports high-viscosity biologics delivery up to 50 centipoise, expanding treatment options
- Targeting biologics market projected to reach $670 billion by 2030
- Partnership with multiple CMOs enables commercial-scale production support
Negative
- First pharma-sponsored trial still pending, indicating early stage of commercial validation
News Market Reaction
On the day this news was published, BDX gained 0.72%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
The selection of BD Libertas™ Wearable Injector for this pharma-sponsored trial follows successful outcomes from more than 50 BD-conducted pre-clinical and clinical studies, including a device clinical study demonstrating excellent performance with
The pharma-sponsored combination product clinical trial represents a significant advancement in accelerating innovation in drug-device combination products that provide greater flexibility for patients, including potential conversion from infused medications that require patients to travel to a hospital or clinic to more convenient patient care in various settings, including self-injection at home.
"This trial demonstrates BD's commitment to helping pharma companies by advancing large-volume injection science, ensuring therapies are accessible and patient friendly by offering more efficient and convenient options for biologics," said Patrick Jeukenne, worldwide president of BD Pharmaceutical Systems. "BD's enhanced testing capabilities acquired through ZebraSci and the proven capabilities of the BD Libertas™ Wearable Injector technology further position BD as an innovative leader in drug delivery."
The BD Libertas™ Wearable Injector is an innovative, prefilled, patient ready-to-use drug delivery systemiii designed to enable delivery of complex biologics via subcutaneous injection. The biologics market is expected to grow to more than
- Supports delivery of high-viscosity biologics (up to 50 centipoise), enabling a wide range of subcutaneous therapies
- Is offered in 2 to 5 mL and 5 to 10 mL configurations providing flexibility for diverse therapeutic requirements
- Features a fully mechanical, patient ready-to-use design with a simple "peel, stick and click" mechanism, requiring no end-user filling or assemblyiii
BD's ongoing validations of fill-finish and final assembly processes with multiple Contract Manufacturing Organizations (CMOs) enable the company to support pharmaceutical partners from development through commercial-scale production. For more information about how BD Libertas™ Wearable Injector is enabling biologic therapy delivery, visit www.bd.com/libertas.
About BD Libertas™ Wearable Injector
BD Libertas™ Wearable Injector is a product in development; some statements are forward looking and are subject to a variety of risks and uncertainties. BD Libertas™ Wearable Injector is a device component intended for drug-device combination products and not subject to FDA 510(k) clearance or separate EU CE mark certification.
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its more than 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/, X (formerly Twitter) @BDandCo or Instagram @becton_dickinson.
Contacts:
Media: | Investors: |
Fallon McLoughlin | Adam Reiffe |
BD Corporate Communications | BD Investor Relations |
201.258.0361 | 201.847.6927 |
i Early feasibility clinical study of investigational BD Libertas™ Wearable Injector (WI) evaluated 5ml, non- Newtonian ~8cP subcutaneous placebo injections in 52 healthy adult subjects for functionality, tissue effects, subject tolerability (100mm Visual Analog Scale (VAS)) and acceptability (questionnaires with 5-point Likert or yes /no responses). Tissue effects were measured from WI removal post-injection through 24 hours with calipers (wheals) or graded on a 5-point scale (erythema, bleeding) from 0-none to 4-severe, significant, respectively. Where tissue effects were observed, the majority (>
ii Woodley, W. D. et al. Clinical Evaluation of an Investigational 5ml Wearable Injector in Healthy Human Subjects. Clin Transl Sci. 2021 May;14(3):859-869. doi.org/10.1111/cts.12946.
iii Pharma filled and assembled
iv Mordor Intelligence (2025). Biologics Market Size - Industry Report on Share, Growth Trends & Forecasts Analysis (2025 - 2030). https://www.mordorintelligence.com/industry-reports/biologics-market
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SOURCE BD (Becton, Dickinson and Company)
FAQ
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