BD Announces First Pharma-Sponsored Clinical Trial Using BD Libertas™ Wearable Injector Technology for Biologic Drugs
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.
BD (NYSE: BDX) ha annunciato il suo primo trial clinico sponsorizzato da una casa farmaceutica per un prodotto combinato che utilizza il BD Libertas™ Wearable Injector per la somministrazione sottocutanea di biologici complessi. L'annuncio segue risultati positivi ottenuti in oltre 50 studi pre-clinici e clinici, con il 100% dei partecipanti che ha indicato una probabile futura adozione del dispositivo.
Il BD Libertas™ Wearable Injector è progettato per permettere l'autoiniezione domiciliare di biologici, trasformando potenzialmente trattamenti che oggi richiedono infusioni ospedaliere in cure a domicilio. Il dispositivo supporta la somministrazione di biologici ad alta viscosità fino a 50 centipoise ed è disponibile nelle configurazioni da 2-5 mL e 5-10 mL. Questo sviluppo arriva in un momento in cui il mercato dei biologici è previsto raggiungere un valore di 670 miliardi di dollari entro il 2030.
BD (NYSE: BDX) ha anunciado su primer ensayo clínico con producto combinado patrocinado por la industria farmacéutica que utiliza el BD Libertas™ Wearable Injector para la administración subcutánea de biológicos complejos. El anuncio sigue a resultados exitosos de más de 50 estudios preclínicos y clínicos, con el 100% de los participantes indicando un probable uso futuro del dispositivo.
El BD Libertas™ Wearable Injector está diseñado para permitir la autoinyección en casa de biológicos, potencialmente transformando tratamientos que actualmente se realizan mediante infusiones hospitalarias en cuidados domiciliarios. El dispositivo soporta la administración de biológicos de alta viscosidad hasta 50 centipoise y está disponible en configuraciones de 2-5 mL y 5-10 mL. Este desarrollo llega en un momento en que se proyecta que el mercado de biológicos alcance los 670 mil millones de dólares para 2030.
BD (NYSE: BDX)는 복합 생물학적 제제의 피하 투여를 위한 BD Libertas™ 웨어러블 인젝터를 사용한 첫 번째 제약사 후원 복합 제품 임상시험을 발표했습니다. 이 발표는 50건 이상의 전임상 및 임상 연구에서 성공적인 결과를 바탕으로 하며, 참가자의 100%가 향후 기기 사용 의향을 나타냈습니다.
BD Libertas™ 웨어러블 인젝터는 생물학적 제제의 가정 내 자가 주사를 가능하게 하도록 설계되어, 병원 기반 주입 치료를 가정 치료로 전환할 수 있습니다. 이 기기는 최대 50 센티포이즈의 고점도 생물학적 제제 투여를 지원하며, 2-5mL 및 5-10mL 구성으로 제공됩니다. 이 개발은 생물학적 제제 시장이 2030년까지 6700억 달러에 이를 것으로 예상되는 시점에 이루어졌습니다.
BD (NYSE : BDX) a annoncé son premier essai clinique de produit combiné sponsorisé par l'industrie pharmaceutique utilisant le BD Libertas™ Wearable Injector pour l'administration sous-cutanée de biologiques complexes. Cette annonce fait suite à des résultats positifs issus de plus de 50 études précliniques et cliniques, avec 100 % des participants indiquant une probabilité d'utilisation future du dispositif.
Le BD Libertas™ Wearable Injector est conçu pour permettre l'auto-injection à domicile de biologiques, transformant potentiellement des traitements réalisés en milieu hospitalier par perfusion en soins à domicile. Le dispositif supporte l'administration de biologiques à haute viscosité jusqu'à 50 centipoises et est disponible en configurations de 2-5 mL et 5-10 mL. Ce développement intervient alors que le marché des biologiques devrait atteindre 670 milliards de dollars d'ici 2030.
BD (NYSE: BDX) hat seine erste von Pharmaunternehmen unterstützte klinische Studie für ein Kombinationsprodukt mit dem BD Libertas™ Wearable Injector zur subkutanen Verabreichung komplexer Biologika angekündigt. Die Ankündigung folgt auf erfolgreiche Ergebnisse von über 50 präklinischen und klinischen Studien, wobei 100 % der Teilnehmer eine wahrscheinliche zukünftige Nutzung des Geräts angaben.
Der BD Libertas™ Wearable Injector wurde entwickelt, um die selbstständige Injektion von Biologika zu Hause zu ermöglichen und so Behandlungen, die bisher in Krankenhäusern als Infusionen durchgeführt wurden, in die häusliche Pflege zu verlagern. Das Gerät unterstützt die Verabreichung von hochviskosen Biologika bis zu 50 Centipoise und ist in den Größen 2-5 mL und 5-10 mL erhältlich. Diese Entwicklung erfolgt zu einer Zeit, in der der Biologika-Markt voraussichtlich bis 2030 670 Milliarden US-Dollar erreichen wird.
- 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
- First pharma-sponsored trial still pending, indicating early stage of commercial validation
Insights
BD's wearable injector reaching pharma-sponsored clinical trials marks significant commercial validation, potentially expanding their foothold in the growing $670B biologics market.
This announcement represents a pivotal milestone for BD's drug delivery technology. The BD Libertas™ Wearable Injector has progressed from internal testing to pharma-sponsored clinical trials - the critical gateway to eventual commercialization. This validates BD's significant R&D investment in this platform.
The technology addresses several key market needs: allowing conversion of infused medications to self-administered injections, enabling delivery of high-viscosity biologics (up to 50 centipoise), and offering flexible dosing configurations (2-5mL and 5-10mL). These capabilities position BD to capitalize on the biologics market's projected growth to
Particularly promising is the device's patient-centric design with 100% of study participants indicating they would likely use it if prescribed. This high acceptance rate is crucial for adoption and suggests BD has effectively addressed usability concerns that typically challenge such devices.
BD's strategic integration of ZebraSci's testing capabilities strengthens their competitive position, while partnerships with Contract Manufacturing Organizations (CMOs) demonstrate readiness to scale from development through commercial production - essential for pharmaceutical partnerships. This milestone indicates BD is advancing from technology development toward revenue-generating commercialization in the high-value biologics delivery space.
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.
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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)
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