Lifecare ASA — Governance Information 2024

Jan 9, 2024

LIFE Successfully ISO 13485 certified

LIFE Successfully ISO 13485 certified

Bergen, Norway, January 9th, 2024: Today, Lifecare AS (LIFE), a clinical stage

medical sensor company developing the next generation Continuous Glucose

Monitor (CGM), can disclose that Lifecare Laboratory (Mainz, Germany) has

received the official documentation for ISO 13485 certification.

Reference is made to Lifecare's stock exchange notification 27th of November

2022 when the ISO 13495 audit was conducted, and finalized, at Lifecare

Laboratory. This progress is in accordance with the current list of

communicated trigger events.

ISO 13485 is a Quality Management System specific to medical devices and

covers the entire life cycle of a device, from design and development to

production, installation, and servicing. Lifecare's ISO 13485 certification

covers "Development services for manufacturers of medical devices such as CGM

devices".

Lifecare's ultimate goal to enter the human market is product CE marking.

Lifecare has now received ISO 9001 and ISO 13485 certification and thus signed

off on two essential steps on the way to product CE mark.

- This was expected, but still incredibly gratifying to receive the

confirmation that we are ISO 13485 certified. This is of course a very

important step for the company and the organization. I can repeat that I am

deeply impressed by how our QMS team in Bergen and Mainz have driven this

process forward and finally received the final documentation of their

dedication and high standards when it comes to quality management. This

confirms a solid fundament for our continued work with regulatory processes,

says CEO Joacim Holter at Lifecare.

- Safety, compliance and top-class quality are our unwavering guidelines in

our market for medical devices. One thing is that there are demands from the

authorities, but ISO certification also means something for the professional

integrity of the employees, but also for the credibility of the company, says

Senior QMS Manager Barbora Tencer.

According to the International Organization for Standardization (ISO)

regulatory requirements are increasingly stringent throughout every step of a

product's life cycle, including service and delivery. Increasingly,

organizations in the industry are expected to demonstrate their quality

management processes and ensure best practice in everything they do. This

internationally agreed standard sets out the requirements for a quality

management system specific to the medical devices industry.

In November CEO Joacim Holter commented on the successful audit. - It is vital

for the integrity of the production of Sencell Continuous Glucose Monitor, and

later commercialization of the product, that our Quality Management System are

certified. We depend on the trust from the market and patient groups, that our

processes meet international quality standards. It is therefore very

motivating to successfully complete the ISO 13485 audit in accordance with the

planned and communicated timeline. This is solid confirmation that Lifecares

operations are compliant with the standards necessary to develop and produce

medical devices. Lifecare will continue to improve our standards and quality

systems to ensure regulatory compliance in our upcoming operations.

About us

Lifecare AS is a clinical stage medical sensor company developing technology

for sensing and monitoring of various body analytes. Lifecare's main focus is

to bring the next generation of Continuous Glucose Monitoring ("CGM") systems

to market. Lifecare enables osmotic pressure as sensing principle, combined

with the ability to manipulate Nano-granular Tunnelling Resistive sensors

("NTR") on the sensor body for read-out of pressure variations. Lifecare's

sensor technology is referred to as "Sencell" and is suitable for identifying

and monitoring the occurrence of a wide range of analytes and molecules in the

human body.

Contacts

For further information, please contact:

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

Asle Wingsternes, Head of Communications & Public Affairs,

asle.wingsternes@lifecare.no, +47 41 61 42 52

This information has been submitted pursuant to the Securities Trading Act §

5-12 and MAR Article 19 no. 3. The information was submitted for publication

at 2024-01-09 08:00 CET.