Highlights:

• Reproducible implant manufacturing established
• Veterinary product cleared for sales in Europe following CE mark of implant electronics
• Regulatory strategy reassessment initiated, moving toward a simplified clinical strategy centred on one pivotal CE-mark clinical investigation, replacing the previously planned two-step approach
• Longevity study confirms beyond 12 weeks implant stability
• Operational restructuring initiated
• Financing secured to support near-term operations

During the quarter, Lifecare achieved several important product and operational milestones. The company demonstrated system-level in vivo functionality using implants from its first reproducibly manufactured production batch, confirming coherent glucose signal generation from the fully integrated implantable CGM system without calibration or post-processing. In parallel, Lifecare confirmed stable implant performance beyond 12 weeks under real-life veterinary conditions.

Lifecare also achieved CE marking of its implant electronics, enabling clearance of the company’s veterinary product in Europe. The milestone strengthens the company’s regulatory and commercial foundation and supports preparations for veterinary market entry.

Following feedback from NOMA on the company’s first-in-human application, Lifecare has initiated a reassessment of its clinical and regulatory pathway together with LINK Medical and through advisory interactions with a prospective notified body. The company is currently progressing towards a simplified strategy centred around one pivotal CE-mark clinical investigation, replacing the previously planned two-step approach.

“To strengthen execution and prepare Lifecare for the next phase, we have initiated organisational measures, streamlined operations and continued transferring key activities in-house. Together with recent product and regulatory milestones, this provides a stronger platform for clinical progression, industrialisation and future market entry,” says CEO Joacim Holter.

Financially, Lifecare have strengthened its position during the quarter. The successful completion of the rights issue, combined with a solid outcome from the subsequent warrant exercise, provides the company with improved liquidity to execute on the company’s strategic priorities.

Results presentation
CEO Joacim Holter and CFO Petter Nielsen will present the results live on webcast today at 10:00 CET.
To access the webcast Join the meeting here.
A recording of the webcast will be available on our website after the event.