Swiss diabetes management firm PharmaSens has submitted the approval application to the US Food and Drug Administration (FDA) for its niia essential insulin pump system.

The niia vital Insulin Patch Pump System, the debut product from PharmaSens, is a basal-bolus patch pump.

It is said to have a user-friendly streamlined design and provides the benefits of an advanced insulin pump with the simplicity of an insulin pen.

According to the company, the system is one of the most compact patch pumps available due to its 3ml reservoir, which also provides an extended usage period and access to reimbursed patch pump therapy.

Additionally, the automatic needle insertion mechanism of the Niia vital Insulin Patch Pump System protects the 90° steel needle before each use.

Furthermore, the semi-reusable concept aligns with the principles of cost-efficiency and sustainable product design, meeting the requirements for a more environmentally friendly approach.

PharmaSens CEO Marcel Both said: “Our submission to the FDA is a pivotal step towards making advanced diabetes care accessible. We are committed to transforming the experience of diabetes management through our innovative technology.”

“As we anticipate a favourable review from the FDA, PharmaSens is gearing up for the market launch of our ‘niia essential’ insulin pump system. Recognising the importance of a strong partnership for successful market entry, PharmaSens is engaging in trade sale discussions.

“The current interest in PharmaSens suggests a perfect timing. Such a move would enable the new owner to focus on a market entry strategy with our scalable and soon-to-be-approved product.”

Designed with patient-centricity and ease of use at its core, the system is also the first of three patch pumps intended to meet demands in the diabetes management market.

The FDA’s approval application comes after the recent achievement of the ISO 13485 certification, which covers the full process of designing, developing, producing, and distributing insulin infusion pumps and accessories.

PharmaSens is focused on simplifying diabetes management and expanding access to insulin pump therapy.