Bergen, Norway, November 7th, 2023: Today, Lifecare AS (LIFE), a clinical stage medical sensor company developing the next generation Continuous Glucose Monitor (CGM), announces that The Norwegian Food Safety Authority (NFSA) has awarded all necessary approvals to start LFC-SEN-002.
Reference is made to Lifecare’s list of trigger events, as presented at the semi-annual report of August 20th, 2023, and later investor communication. The launch of an automated production line at Lifecare Laboratory by end of Q2 2024 is set as a major milestone, and on this basis the company aim to launch the first product in the veterinary market mid 2024.
The approval means that Lifecare can start working on the second study only six months after finalizing the successful Sencell clinical study: LFC-SEN-001. As previously communicated the LFC-SEN-002 will be carried out in collaboration with The Norwegian University of Life Sciences (NMBU) located at Ås, Norway. Lifecare has received approval from the authority to complete the study on dogs. NFSA considers that the purpose of the experiment and the use of animals are satisfactorily described in the application and that the necessary requirements in the Laboratory Animal Regulations are met.
– We are very pleased to receive this approval. This is another important piece in the development of the Sencell sensor. Earlier this year, we carried out a longevity experiment of up to 6 months and showed through LFC-SEN-001 that the Sencell sensor has the required sensitivity. We are now very much looking forward to soon start testing the technology in dogs for up to 90 days, says CEO Joacim Holter at Lifecare.
It is Managing Director Jo Amundstad in the subsidiary Lifecare Vetarinary who will be responsible for carrying out the study in collaboration with NMBU. – We are incredibly grateful for the collaboration with experts in internal medicine at NMBU and we have already hired PhD candidate Sivert Nerhagen. We have used the time well while waiting for the approval from the NFSA and are well underway with recruiting patients for the study, says Amundstad.