Lifecare ASA

Regulatory Filings • Aug 13, 2025

Lifecare advances CE mark preparation for its groundbreaking medical device

Lifecare advances CE mark preparation for its groundbreaking medical device

Bergen, Norway, 13 August 2025 -- Lifecare ASA (LIFE), a MedTech company

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

diabetes management, is pleased to announce that formal preparations towards

CE marking of its CGM as a fully regulated medical device have been underway

for the past six weeks.

Lifecare has started the formal preparations to document regulatory compliance

and achieve CE mark for its CGM system as a fully regulated medical device,

according to our communicated plan, by end of 2026. This phase encompasses the

full CGM system - sensor, implant, reader, manufacturing processes, and

comprehensive ISO 13485-compliant documentation, the international recognised

quality standard for medical devices - firmly placing Lifecare on the

regulatory pathway to market readiness.

"Initiating the full CE preparation phase -- with substantial progress already

achieved - is both a technical milestone and an important public statement of

where we stand," says Joacim Holter, CEO of Lifecare ASA. "It demonstrates our

readiness to deliver a regulated medical device to market and our ability to

build on the strong foundation already established through CE compliance work

on the electronics of our proven implant."

Lifecare has previously announced important compliance achievements for the

electronics within our CGM system, with final CE compliance for the electronic

components expected by end of Q3 2025. This advancement is a partial step

towards full regulatory compliance for Lifecares CGM as a medical device.

Initiating CE mark preparations require more than having a working device --

it demands proof that every device manufactured will meet the same rigorous

standards of safety, performance and quality. This process is comparable to

creating an end-to-end instruction manual and safety log for the entire

lifecycle of the product -- covering every design decision, supplier,

material, and manufacturing step -- and ensuring each one can be repeated

exactly, without compromise. This proof comes from a formalised Quality

Management System, supported by an extensive framework of interlinked,

traceable and auditable documents, including detailed design records, risk

analyses, supplier quality agreements, manufacturing instructions, inspection

reports, and test protocols.

Such documentation is the foundation for regulatory approval, ensuring

consistent, reproductible and safe manufacturing for human use. We are

continuing our strong cooperation with TTP as a highly valued development

partner, ensuring that we meet all the stringent regulatory standards required

to deliver a device ready for market introduction.

As Lifecare advances through this complex and highly structured regulatory

process, each completed step further solidifies our position as a company on

the verge of market introduction -- not only showcasing our technical

capability but also sending a clear signal to stakeholders, partners, and the

market that Lifecare is ready to deliver.

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