Embecta, a notable company in the medical device sector, recently announced receiving 510(k) clearance from the Food and Drug Administration (FDA) for its first insulin patch pump. This device is specifically designed for individuals diagnosed with either Type 1 or Type 2 diabetes and is capable of being worn for up to three days per application. Notably, this patch pump is equipped with a 300-unit insulin reservoir, an adaptation especially beneficial for those requiring higher daily doses of insulin, allowing them to utilize the pump continuously for the entire three days without needing a refill.
Following this clearance, Embecta expressed an intention to further innovate within this product line by developing a closed-loop system for the patch pump, which would automate insulin dosing. The closed-loop system, which is still under development, aims to regulate insulin delivery automatically by monitoring blood glucose levels continuously and adjusting insulin delivery accordingly. The company plans to submit this advanced version to the FDA in the future, marking a significant step towards more self-regulating diabetes management solutions.
Embecta’s development of this patch pump was significantly influenced by feedback from people with Type 2 diabetes. Research sponsored by Embecta revealed that while a 200-unit reservoir is sufficient for 38% of adults over a 72-hour period, a 300-unit reservoir would satisfy the insulin needs of 64% of adults, assuming an average daily insulin usage of 96 units. This insight underscores the considerable demand for higher-capacity insulin delivery systems to reduce the frequency of reservoir changes and streamline diabetes management for patients with higher insulin requirements.
In line with their commitment to enhancing diabetes care, Embecta’s CEO, Dev Kurdikar, emphasized the company’s objective to overcome substantial barriers currently faced by individuals relying on daily insulin. This new patch pump platform is not only set to improve the quality of life for its users but is also foundational for the upcoming automated insulin delivery system.
Earlier on, before achieving the recent FDA clearance for the patch pump, Embecta submitted an open-loop version of the device for review. The open-loop system requires users to manually adjust their insulin doses, whereas the planned closed-loop system will automate this process, using continuous glucose monitoring and the Tidepool Loop algorithm to make necessary adjustments.
Despite these advancements and the potential for significant market impact, Kurdikar refrained from projecting sales figures for the new pump in an earnings call held in August, particularly concerning its status in the market by 2025. Nonetheless, the ongoing development and interest in such technologies indicate a robust engagement from the company in evolving diabetes care technologies.
It’s noteworthy that Embecta is not alone in this arena. Insulet, a pioneer in the patch pump market since 2005, also continues to innovate. Insulet recently expanded its Omnipod 5 pump’s clearance to include individuals with Type 2 diabetes. Other companies like Tandem Diabetes Care and Medtronic are also in the process of designing their versions of the patch pump, reflecting a broader industry trend focusing on Type 2 diabetes as insurance coverage for such technologies improves.
By advancing these innovative devices, companies like Embecta are not just providing new tools for diabetes management but are also shaping the landscape of diabetes care by fostering accessibility and automation in treatment options. These developments offer a glimpse into the future of diabetes therapy, marked by increased patient autonomy and potentially improved outcomes through continuous advancements in technology.
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