PharmaSens announced today that it submitted an application for FDA approval for its Niia Essential insulin patch pump system.
FDA submission follows the pump’s recent ISO 13485 certification for the Switzerland-based company. This encompassed the entire process of design, development, manufacturing and distribution for insulin infusion pumps and accessories.
Niia Essential, the first of three patch pumps from PharmaSens, features a patient-centric design aimed at enhancing ease of use. The company says it aims to address unmet needs in the diabetes management market. Patch pumps are an intriguing space, currently dominated by Insulet and its automated Omnipod 5 system. Tandem Diabetes Care made its entry into the market with FDA clearance of the Mobi pump earlier this year.
Medtronic sought to enter through a $738 million acquisition of South Korea-based EOFlow. However, that deal fell through this month when Medtronic said EOFlow committed multiple breaches to the acquisition agreement. Embecta also has a patch pump for type 2 diabetes under development.
PharmaSens designed its basal-bolus patch pump to combine the ease of an insulin pen with the advantages of a sophisticated pump. It features a 3 mL reservoir, offering extended usage periods and access to reimbursed patch pump therapy. PharmaSens says the design positions Niia Essential as one of the most compact patch pumps on the market.
Niia Essential also incorporates a distinctive automatic needle insertion mechanism, safeguarding the 90° steel needle before each use. The design also aligns with the principles of cost-efficiency and sustainable product design for an environmentally friendly approach.
PharmaSens CEO Marcel Both expects a favorable review from the FDA, with the company gearing up for a market launch. He also said the company has ongoing trade sale partnership discussions to ensure successful market entry. A sale would also allow the company to advance its product pipeline, which includes a closed-loop system and an integrated CGM sensor and pump.
“Our submission to the FDA is a pivotal step towards making advanced diabetes care accessible,” Both said. “We are committed to transforming the experience of diabetes management through our innovative technology.”