Lifecare successfully manufactures first functional implants in-house in Bergen

The implants were manufactured on the temporary production line established in Bergen in August. Two implants successfully passed functional testing in Bergen and were subsequently transferred to Lifecare Chemistry in Bristol, UK, where they have now also successfully completed in-vitro and end-of-line testing. The testing confirmed that the first Lifecare-manufactured implants are functional and generate stable measurable signals. The implants are expected to be transferred to Lifecare’s ongoing veterinary development programme, pending completion of final pre-implantation testing.

This marks the first time functional CGM implants have been manufactured internally by Lifecare rather than by an external contract manufacturer.

From production transfer to controlled manufacturing

While the successful production demonstrates that the core implant manufacturing process has been transferred to Bergen, controlled manufacturing has not yet been established. This requires the process to demonstrate the necessary repeatability, process control, traceability and quality documentation across a larger number of implants.

Subsequently, Lifecare has transferred its temporary production line to the new manufacturing facilities at Ocean TuniCell's premises in Bergen. The facilities provide significantly improved infrastructure for implant manufacturing, including dedicated production and laboratory areas and controlled-environment capabilities.

Production in the new facilities is expected to commence shortly. Lifecare will then increase production volumes and systematically qualify the manufacturing process, maintaining its ambition to establish controlled manufacturing during autumn of 2026.

"This is an important operational milestone for Lifecare. For the first time, functional implants have been manufactured by Lifecare’s own team. Our next task is to demonstrate repeatability and establish the controls required for our regulatory programme," says Joacim Holter, CEO of Lifecare.

Supporting regulatory preparations

The production scale-up will provide additional implants and data to support Lifecare's regulatory preparations, including further work related to sterilisation and biocompatibility.

Lifecare is not currently providing a specific date for filing the application for regulatory approval of the planned CE-mark clinical study. The timing will depend on completion of ongoing manufacturing documentation and verification activities. The company will provide further information when sufficient data is available to establish a more precise filing schedule.

Manufacturing consolidated in Bergen

The milestone also marks an important step in Lifecare's operational consolidation. Following the discontinuation of the company's German operations and the transfer of implant manufacturing previously performed by external partners, Lifecare has now established its core implant manufacturing capability within its own organisation in Bergen.

The co-location of Lifecare and its subsidiary Ocean TuniCell is nearing completion, bringing manufacturing, quality, laboratory infrastructure and technical personnel together at the same site.

Lifecare's chemistry development and related R&D activities remain centred at Lifecare Chemistry in Bristol. The Bristol operation will focus on its core competencies in chemistry and chemistry engineering, both to further optimise Lifecare's glucose sensing technology and to explore applications of the company's sensing platform for additional analytes and use areas.

Lifecare will continue production scale-up and qualification activities during the autumn and communicate further progress as material milestones are achieved.