Confirmation from Norwegian Medicines Agency

In the process of Lifecare’s initial planning and preparations to bring Sencell CGM to the veterinary market, Lifecare Veterinary has asked for regulatory clarifications from the Norwegian Medicines Agency. As a governmental decision-making body, the Norwegian Medicines Agency are responsible to evolve and safeguard public and animal health by ensuring efficacy, quality, and safety of medicines and medical devices, administering and enforcing the Norwegian Medical Devices Regulations. The Norwegian Medicines Agency has now assessed Lifecare’s microchip nanosensor (Sencell CGM) and considers the product itself as non-medicinal product. This governmental statement confirms, as expected, that Sencell CGM is to be considered as a medical device in the veterinary market. They further confirm that, as of today, no specific regulations exist for medical devices for animals in Norway. Consequently, the Sencell CGM will not be subject to any specific regulatory requirements for veterinary use, and hence launch in the veterinary market in Norway. Assuming that Lifecare Veterinary’s product is to be injected into animals, the product is intended to be used by veterinarians, the Norwegian Medicines Agency also confirms.   Managing Director Jo Oeding Amundstad at Lifecare Veterinary and CEO Joacim Holter at Lifecare   – This important confirmation from the Norwegian authority is relevant to the timeline and previously communicated milestone to launch the first product in the veterinary market mid 2024. While the statement from the Norwegian body is in line with our expectations, this also increase our confidence that EU states in general will conclude accordingly, says Managing Director Jo Oeding Amundstad at Lifecare Veterinary. – The veterinary business case for Sencell CGM is a spin-off towards a tremendously huge market. The experience gained from the veterinary market will also be very valuable as it will provide a unique source of a large amount of data and knowledge about product properties of the Sencell CGM. We expect this to be extra useful in the development towards Lifecare’s ultimate goal; product CE mark necessary to enter the market with a medical CGM device for humans, says CEO Joacim Holter at Lifecare.