BD Announces First Pharma-Sponsored Clinical Trial Using BD Libertas™ Wearable Injector Technology for Biologic Drugs
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BD Announces First Pharma-Sponsored Clinical Trial Using BD Libertas™ Wearable Injector Technology for Biologic Drugs FRANKLIN LAKES, N.J., July 23, 2025 / Biotech Newswire / -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, announces the first pharma-sponsored combination product clinical trial using the BD Libertas™ Wearable Injector for subcutaneous delivery of complex biologics. 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 100% of study participants stating they would likely use the BD Libertas™ Wearable Injector if prescribed(i),(ii). 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 system(iii) designed to enable delivery of complex biologics via subcutaneous injection. The biologics market is expected to grow to more than $670 billion(iv) by 2030 and for pharmaceutical companies developing these complex drugs, the BD Libertas™ Wearable Injector offers a customizable, patient-centric solution. The BD Libertas™ Wearable Injector:
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. Caption: BD Libertas™ Wearable Injector For high resolution please click the image.
About BD Libertas™ Wearable Injector About BD
Contacts Fallon McLoughlin Investors (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 (>50%) were resolved within 60 minutes and all within 24 hours. Subject pain (100mm VAS) peaked mid-injection (mean 9.1mm, SD 13.4) and rapidly resolved within 30 minutes (mean 0 .4mm, SD 2.6). Subjects found acceptable (Likert agree + strongly agree or yes responses) their peak pain (≥90.2%), injection site appearance (≥92.2% ).
Keywords: Subcutaneous Tissue; Biological Products; Pharmaceutical Preparations; Drug Delivery Systems; Injections; Wearable Devices; BD (Becton, Dickinson and Company); BD Libertas™ Wearable Injector; pharma-sponsored clinical trial; drug-device combination product; subcutaneous delivery; complex biologics; self-injection; large-volume injection; high-viscosity biologics; prefilled injector; “peel, stick and click”; customizable drug delivery; home care; Contract Manufacturing Organizations (CMOs); fill-finish validation; commercial-scale production; wearable injector technology; medical technology Source: Biotech Newswire |
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