BD develops 5.5 mL Neopak XtraFlow prefillable syringe with 8 mm needle for large-volume biologics
BD and Ypsomed are developing a 5.5 mL BD Neopak XtraFlow Glass Prefillable Syringe, featuring an 8 mm needle and thin-wall cannulas for faster injection of high-viscosity biologics. Samples for feasibility studies are expected mid-2026, with full compatibility on Ypsomed’s YpsoMate 5.5 autoinjector platform to accelerate market entry.
1. Strategic Partnership Expansion with Ypsomed
BDX has announced an expanded collaboration with Ypsomed to develop a 5.5 mL version of its Neopak™ XtraFlow™ Glass Prefillable Syringe, fully compatible with Ypsomed’s YpsoMate® 5.5 autoinjector platform. The new syringe features a shortened 8 mm needle and ultra-thin cannula walls, designed to handle higher volume and viscosity biologics. This move responds to an estimated 20% annual growth in large-volume subcutaneous self-injection therapies, positioning BDX to capture a larger share of a market projected to exceed $10 billion by 2028.
2. FDA 510(k) Clearance for EnCor EnCompass System
BDX secured FDA 510(k) clearance for its EnCor EnCompass breast biopsy system, paving the way for a commercial launch in early 2026. The system offers clinicians enhanced rotational biopsy flexibility, a programmable tissue sampling range up to 25 mm and integrated multiplanar imaging compatibility. This approval complements BDX’s existing portfolio and is expected to drive incremental procedure volume growth of 5% to 7% in interventional radiology, where the company already holds a 30% market share.
3. Development Timeline and Feasibility Milestones
The 5.5 mL Neopak™ XtraFlow™ syringe is now entering feasibility studies, with sample deliveries to pharmaceutical partners slated for mid-2026. Concurrently, Ypsomed will integrate the new syringe into its YpsoMate® 5.5 platform by year-end, with joint pilot studies planned in Q3 2026. BDX anticipates that these milestones will accelerate combination-product regulatory submissions and shorten time-to-market by up to six months compared to legacy offerings.
4. Investor Impact and Growth Outlook
These product developments reinforce BDX’s leadership in both drug-delivery and diagnostic systems. The Ypsomed partnership expansion and EnCor EnCompass clearance are projected to contribute an incremental $150 million in annual revenues by 2027. With a broad base of over 70,000 employees and presence in nearly every country, BDX expects these innovations to drive mid-single-digit organic growth, bolster its gross margin through higher-value product mix and augment free cash flow for continued investment in R&D and share repurchases.