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Lifecare ASA

Regulatory Filings Jul 1, 2025

3654_rns_2025-07-01_2c01d99c-b6b8-4076-9cab-539e44dfa0ed.html

Regulatory Filings

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Lifecare advances electromagnetic compatibility compliance testing for CGM implant

Lifecare advances electromagnetic compatibility compliance testing for CGM implant

Bergen, Norway, 1 July 2025 -- Lifecare ASA (LIFE), a medtech company

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

diabetes management, today announces the completion of initial testing of

electronics developed for our Continuous Glucose Monitoring implant.

This initial testing of the electronics for use in our implant with wireless

communication includes electromagnetic compatibility (EMC) and Radio Frequency

(Rf). The first EMC tests of electronics were completed by ShortLink

Compliance AB and reported to Lifecare.

EMC testing checks whether the electronics used in our implant and read-out

unit will function correctly in the real world, where it will be surrounded by

things like mobile phones, Wi-Fi, and other wireless technologies. The results

from our first EMC tests confirm a stable technical foundation for the implant

system, validating the core system performance under standard EMC conditions,

supporting the next phase of refinement and final verification.

The results mark an important milestone in the company's CE-marking process

and broader regulatory strategy.

"We are pleased with the outcome of this testing round, which confirms that

our electronics perform according to expectations at this preclinical stage,"

said Joacim Holter, CEO of Lifecare ASA. "This is a planned and productive

step in our quality assurance process, and we are now moving forward with

optimizations to secure full regulatory compliance."

While final adjustments will be implemented to prepare for the final round of

compliance testing of electronics, Lifecare stays on track to start the

first-in-human clinical trials this year, as previously announced. Lifecare

anticipates completing the regulatory testing phase in time for CE-mark

submission in 2026 and commercial launch in 2027.

The testing was conducted by ShortLink Compliance AB, an independent certified

lab, using internationally recognized standards. The process was supported by

a special high-activity operating mode designed to push the system to its

limits and confirm reliability under demanding conditions. Lifecare

anticipates completing final verification activities within three months.

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, [email protected], +47 40 05 90 40

Renete Kaarvik, CFO, [email protected], +47 94 83 82 42

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