During the first quarter of 2024, we continued our
set path to quickly and cost-effectively carry out the
development steps required to launch our proprietary digital POC platform Psyros™ on the international market.

Our plan is to develop and finalize our platform all
the way to a commercial POC system that is ready
for clinical validation by the end of 2024. In close
collaboration with Integrated Technologies Limited
(ITL), we fine-tuned the design of our alpha prototypes during the first quarter. The next step in
product development with ITL is to produce beta
prototypes, which are expected to undergo testing,
evaluation, and compliance verification during the
third quarter of 2024.

During the quarter, we appointed the Scottish
contract manufacturer FlexMedical Solutions as
our CMO for the manufacturing of our disposable
cartridge. This collaboration is a significant step
in expanding our capabilities, as FlexMedical is
a specialized medical device manufacturer with
existing, fully validated facilities and extensive IVD
experience.

Our usability studies have provided valuable insights into cartridge design and system workflows,
not only to ensure that the product meets stringent
regulatory requirements but also to satisfy the endusers’ needs in various clinical environments.

The simplicity of the design of our cartridge allows
for a highly competitive cost and the outsourcing
of our manufacturing. After the end of the quarter,
we were pleased to announce the finalization of
the cartridge design to be used on the commercial
platform.

The cartridge has a number of important competitive features with its simple design containing few
parts, designed for large-scale manufacturing to
ensure a competitively low production cost. Another
key competitive advantage is that it contains all the
necessary reagents required to complete the test
without the need for complex and costly liquid reagents and blister packs. Additionally, it is ergonomically designed for ease of use and compatible with
both venous and capillary blood as well as plasma
samples. One more competitive advantage is multiplexing, meaning it can measure multiple analytes
on a single cartridge.

After the end of the quarter, we also appointed MDx
CRO to conduct the clinical validation studies for
hs TnI assays concerning the clinical performance
of the commercial POC system required for regulatory approval. MDx CRO will be responsible for the
preparation and execution of the upcoming clinical
multicenter study, which is scheduled to start in early 2025. The clinical evaluation will form the basis
for a regulatory application ahead of the planned
commercial launch in early 2026.

Our POC system will focus on the rapid and early
rule-in or rule-out of heart attack through quantification of individual molecules of the protein troponin,
down to single-digit nanograms per liter (ng/L). Our
achievements so far have confirmed that our system could become the first digital, ultra-sensitive,
portable platform for high-sensitivity troponin POC
testing. The system’s ease of use and low production costs makes it ideally suited for the stringent
requirement set by the market.

During the quarter, the analysis firm Emergers and
the investment bank Mangold began covering
Prolight, and I recommend that anyone interested
in us to read their analyses, which not only provide
reviews of Prolight but also give a good overview of
the market. 

Today we were able to announce that our wholly
owned subsidiary, Psyros Diagnostics, in
collaboration with King’s College London, Guy’s
and St. Thomas’ NHS Trust and market access
consultancy Lightning Health, has been awarded
a prestigious grant of 17 million SEK from the UK’s
National Institute of Health and Care Research
(NIHR). The grant is an Invention for Innovation (i4i)
Product Development Award (PDA) which will be
invested, among other things, in the final steps of
the development of the Psyros platform, including
pilot manufacturing of the instruments, furthering
our understanding of needs of patients and performing initial clinical studies. The i4i PDA grant is
extremely competitive; it is a strong positive external validation of our proprietary Psyros digital point
of care system.

From Monday, May 20, 2024, through Friday, May
31, 2024, there will be the opportunity to exercise
warrants for series TO6, which grants the right to
subscribe for one new share at a price of 0,10 SEK.
The maximum capital that can be raised through
TO6 is 21,8 MSEK before issue costs. Obviously,
we hope that as many holders of the TO6 warrants
as possible will participate so that we can accelerate our efforts.

We look forward to continuing to finalize the
development of our innovative digital technology
into a commercial POC product to create value for
healthcare providers, patients, and our shareholders. I look forward to updating you again soon.

Lund May 17th 2024
Ulf bladin CEO Prolight Diagnostics (publ)