LIFE: Update on production transfer and longevity programme
LIFE: Update on production transfer and longevity programme
As previously communicated, Lifecare has decided to establish manufacturing operations in Bergen, Norway, as part of the Company's operational restructuring and centralisation of manufacturing activities. Lifecare is currently in the operational phase of a production campaign in Cambridge, executed jointly by Lifecare personnel and the partner's manufacturing team. The campaign represents the final planned manufacturing activity before production processes, manufacturing know-how and operational responsibility are transferred to Lifecare's facilities in Bergen.
The production campaign has three principal objectives:
- Complete the transfer of manufacturing processes and know-how from Cambridge to Bergen.
- Produce implants supporting Lifecare's ongoing regulatory documentation and verification activities towards future clinical studies and CE marking. Lifecare intends to provide further regulatory update in connection with the Q2 report in August. Regulatory preparations continue together with external regulatory specialists.
- Manufacture implants for the next cohort in the Company's ongoing longevity programme in dogs following the summer period.
In the longevity study, the second implant in the current six-month implantation cohort was explanted yesterday in accordance with study protocol following six months of continuous implantation under real-life conditions.
Initial post-explantation observations demonstrated continued electronic functionality, no visible mechanical damage to the implant upon microscopic inspection, and an apparently intact sensor membrane following retrieval. Importantly, no clinically significant adverse events, foreign body reactions, or other observable clinical effects beyond the intended monitoring function were observed during the six-month implantation period. As with the first completed six-month implantation, the explanted implant will now undergo comprehensive laboratory evaluation, including independent histological assessment of the surrounding tissue.
Throughout the six-month implantation period, study data together with reference monitoring devices and in-clinic blood glucose assessments provided the veterinary team with a comprehensive dataset supporting long-term diabetes management.
Consistent with observations from the first completed six-month implantation, both the treating veterinarian and the dog's owners reported that continuous glucose information supported more individualized treatment adjustments and improved diabetes management throughout the study period, further strengthening Lifecare's confidence in the potential clinical value of continuous glucose monitoring in veterinary diabetes care.
The third and final animal in the current six-month cohort is scheduled for explantation during August.
The ongoing longevity programme continues to generate important information regarding long-term implant performance, durability, biocompatibility and overall system functionality, providing valuable input for continued product optimisation, manufacturing development and regulatory preparations.
Based on experience from the current cohort, Lifecare is implementing further refinements to the communication architecture of the complete CGM system. These optimisations do not affect the underlying sensing technology but are intended to further strengthen overall system robustness as part of the Company's continuous product development process.
The repeated demonstration of successful six-month implantations from reproducibly manufactured implants, together with the ongoing transfer of manufacturing to Bergen, further strengthens Lifecare's transition towards scalable production and commercialisation, and supports the Company's position towards potential commercial partners within the veterinary market.