Unilife Corporation announced the debut of its new Imperium platform of instant patch pumps for insulin.
Imperium is a prefilled, disposable, multi-day wearable insulin pump that does not require filling or assembly by the patient. Since it is prefilled and pre-assembled like an insulin pen, only three intuitive steps are required to commence continuous subcutaneous insulin infusion, with on-demand bolus delivery available to the user via the push of a button. According to Unilife, Imperium can include wireless connectivity systems, such as Bluetooth LE, to integrate with smartphone apps for patient reminders and status updates.
With data connectivity available, healthcare providers could also have access to real-time or historic data to tailor the insulin therapy for each patient to achieve and maintain glycemic control, according to the company.
"Imperium combines the therapeutic advantages of a pump with the low cost and convenience of a prefilled, disposable pen,” says Alan Shortall, chairman and CEO of Unilife, in a released statement. “By addressing specific unmet market needs and creating value for all diabetes stakeholders, it is set to empower millions of insulin-dependent patients to achieve and maintain glycemic control."
According to Unilife, Imperium is designed for supply to a select insulin partner or partners ready for filling and packaging using standard pharmaceutical processes, materials, and equipment. Insulin partners can then sell the prefilled, fully-assembled device through existing commercial channels, with no sales, marketing, commercial development, reimbursement, and clinical support costs to Unilife.
As a prefilled, high-precision device with a delivery resolution of 0.5µL, Unilife states that Imperium is suitable for use with high concentration insulins up to U-500.
"Unlike with traditional pumps or patch pumps, Imperium is designed to allow a selected insulin partner or partners to supply a complete basal-bolus insulin therapy directly to the patient under a single prescription at a price that is as attractive for reimbursement as prefilled pens,” Shortall says. “As a compact, ready-to-use and fully integrated insulin system requiring minimal steps for convenient, multi-day wear, it is well positioned to help improve patient adherence and generate positive healthcare outcomes."
"In recognition of Imperium's potential to penetrate large, growing markets, including Type 2 diabetes, that remain under-served due to device complexity, reimbursement constraints and high out-of-pocket-cost for patients, we expect to enter into a collaboration agreement with one or more interested parties that will support its long-term commercial supply with specific brands of insulin,” Shortall adds.