Bergen, Norway, October 17th, 2023: Today, Lifecare AS (LIFE), a clinical stagemedical sensor company developing the next generation Continuous Glucose Monitor(CGM), can reveal an important announcement about regulatory confirmation fromNorwegian Medicines Agency (Statens Legemiddelverk).
In the process of Lifecare's initial planning and preparations to bring SencellCGM to the veterinary market, Lifecare Veterinary has asked for regulatoryclarifications from the Norwegian Medicines Agency. As a governmentaldecision-making body, the Norwegian Medicines Agency are responsible to evolveand safeguard public and animal health by ensuring efficacy, quality, and safetyof medicines and medical devices, administering and enforcing the NorwegianMedical Devices Regulations.
The Norwegian Medicines Agency has now assessed Lifecare's microchip nanosensor(Sencell CGM) and considers the product itself as non-medicinal product. Thisgovernmental statement confirms, as expected, that Sencell CGM is to beconsidered as a medical device in the veterinary market. They further confirmthat, as of today, no specific regulations exist for medical devices for animalsin Norway. Consequently, the Sencell CGM will not be subject to any specificregulatory requirements for veterinary use, and hence launch in the veterinarymarket in Norway. Assuming that Lifecare Veterinary's product is to be injectedinto animals, the product is intended to be used by veterinarians, the NorwegianMedicines Agency also confirms.
- This important confirmation from the Norwegian authority is relevant to thetimeline and previously communicated milestone to launch the first product inthe veterinary market mid 2024. While the statement from the Norwegian body isin line with our expectations, this also increase our confidence that EU statesin general will conclude accordingly, says Managing Director Jo Oeding Amundstadat Lifecare Veterinary.
- The veterinary business case for Sencell CGM is a spin-off towards atremendously huge market. The experience gained from the veterinary market willalso be very valuable as it will provide a unique source of a large amount ofdata and knowledge about product properties of the Sencell CGM. We expect thisto be extra useful in the development towards Lifecare's ultimate goal