Lifecare ASA

Regulatory Filings • Jul 8, 2025

Lifecare achieves full radio frequency compliance for CGM implant clearing the way for CE mark of electronics

Lifecare achieves full radio frequency compliance for CGM implant clearing the way for CE mark of electronics

Bergen, Norway, 8 July 2025 -- Lifecare ASA (LIFE), a MedTech company

developing next-generation Continuous Glucose Monitoring (CGM) technology for

diabetes management, is pleased to announce the successful completion of

official radio frequency compliance testing of wireless system for use in its

implantable CGM system.

The successful completion of radio frequency (Rf) compliance testing follows

Lifecare's recent announcement of electromagnetic compatibility (EMC) testing,

marking yet another important milestone in the company's CE-marking process

and broader regulatory roadmap. Rf testing verifies that wireless medical

devices---such as Lifecare's CGM implant---can operate safely and reliably

within the regulatory guidelines for wavelength and emission strength without

causing interference to other electronic equipment. Meeting these strict

European safety standards confirms that the device is suitable for use around

people and in everyday environments. This achievement is a critical step

toward initiating human clinical trials and ultimately securing market

approval.

The latest results confirm that Lifecare's wireless CGM system---consisting of

a miniaturized injectable implant and a lightweight external readout device

--- complies with stringent European standards for radio performance and

safety. Conducted by accredited lab ShortLink Compliance AB, the testing

evaluated the device's wireless communication, signal stability, and safe

operation under a range of real-world conditions.

"Achieving radio frequency compliance is yet another important milestone for

Lifecare," said Joacim Holter, CEO of Lifecare ASA. "It confirms that our

wireless system for readout from our implant meets the highest safety and

performance standards. Alongside our earlier EMC results, this strengthens the

technical foundation of our solution and supports our next step---initiating

clinical trials and advancing toward CE-marking."

With Rf compliance confirmed, Lifecare's regulatory submission remains on

track as the recent results from EMC tests confirmed a stable technical

foundation for the electronics used in our implant. As previously

communicated, Lifecare expects final EMC verification activities to be

finalized within three months. Pending final approval, the first human

clinical trial is scheduled to begin in Q3 2025 and conclude in Q4

2025---supporting the company's pathway toward CE-marking and a commercial

launch in 2027.

Lifecare's CGM technology is designed to transform diabetes care by providing

continuous glucose data by means of the company's proprietary implant with

wireless readout technology. These technical validations not only advance

clinical readiness - but they also strengthen confidence in the system's

market potential.

About us

Lifecare ASA is a medical sensor company developing technology for sensing and

monitoring of various body analytes. Lifecare's focus is to bring the next

generation of Continuous Glucose Monitoring ("CGM") systems to market.

Lifecare enables osmotic pressure as sensing principle. Lifecare's sensor

technology is suitable for identifying and monitoring the occurrence of a wide

range of analytes and molecules in the human body and in pets.

Contacts

For further information, please contact:

Joacim Holter, CEO, joacim.holter@lifecare.no, +47 40 05 90 40

Renete Kaarvik, CFO, renete.kaarvik@lifecare.no, +47 94 83 82 42