Lifecare files for human clinical trial, paving the way for CE-mark
Prenumeration
Beskrivning
| Land | Norge |
|---|---|
| Lista | Oslo Bors |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
Bergen, Norway, 20 May 2025 – Lifecare ASA (LIFE), a medtech company developing next-generation Continuous Glucose Monitoring (CGM) solutions for diabetes management, today announces that it has filed for regulatory approval to initiate the first human clinical trial of its wireless CGM implant.
The filing for regulatory approval is based on a design freeze deemed sufficient to support preparations for clinical trials and continued advancement in manufacturing development.
This filing aligns with previous communication and marks a key milestone in Lifecare’s broader clinical and commercial development strategy. Regulatory approval is expected in Q3 2025. Subject to timely approval, Lifecare anticipates completing the trial by early Q4 2025. This progress is in accordance with both budget and operational plans.
The submission is an essential milestone for the company, laying the groundwork for initiating a pivotal CE-mark trial later this year. The pivotal trial is expected to conclude in 2026, with a commercial launch of Lifecare’s glucose monitoring implant for human use planned in 2027.
“Our regulatory filing reflects solid execution of our development roadmap and continued momentum in line with our strategic goals. This trial is a vital step toward bringing our glucose monitoring implant to market,” says CEO Joacim Holter.