CEO comment

"Psyros® – The Next Generation Point-of-Care Platform"

The first quarter of 2026 was characterized by
continued focus on advancing the Psyros platform
into the final stage ahead of clinical validation and
commercialization. During the period, efforts were
concentrated on finalizing the instrument and
ensuring that the system meets the requirements for
scalable manufacturing and use in clinical settings.

 

Following the end of the quarter, we achieved a key
milestone with the formal design freeze of the
instrument. This marks a major and decisive step
toward industrialization of the platform and enables
pilot production of instruments to be used for
verification, validation, and the regulatory clinical
performance study. The final development work
leading up to the completed instrument design has
resulted in improved robustness and manufacturability.

Following the end of the quarter, we received
approximately SEK 11 million in R&D tax return from
the UK tax authorities (HMRC). This is a significant
amount that strengthens our cash position.

Market interest in the Psyros platform remained
strong during the beginning of 2026. In discussions
with potential industrial partners and clinical users,
as well as at international congresses such as WHX
Labs in Dubai in February, the system was met with
very strong and clear interest, particularly regarding
the combination of ultra-sensitive analytical
performance, rapid turnaround times, and unique
opportunities for cost-efficient manufacturing of
disposable cartridges.

 

These interactions with end users and customers
confirm that the Psyros system meets the market’s
demanding commercial requirements, while also
demonstrating strong demand for the platform
across several prioritized clinical application
areas. A clear example is the collaboration with the
U.S.-based company BRAINBox Solutions, which
has demonstrated how rapidly new biomarkers can
be integrated onto the Psyros platform. We are now
entering the next phase, which is fully funded by
BRAINBox, where 260 clinical samples from their
pivotal HeadSMART II study will be analyzed. The
results will provide important data for the continued
evaluation of the collaboration and the platform’s
potential.

 

A further external validation of the potential of the
proprietary Psyros technology is that Prolight was
recently selected as a semifinalist in the Disruptive
Technology Award Competition 2026, organized by
the international Association for Diagnostics &
Laboratory Medicine congress in the United States.

 

In parallel, work on the Psyros patent portfolio has
continued. Following the end of the quarter, we
received an additional positive patent notification
in the strategically important Japanese market.
This second patent application expands the scope
of protection for Psyros’ core technology and is
particularly relevant for rapid tests based on swab
samples, for example in infectious diseases such as
influenza, RSV, or COVID-19.

 

Overall, we have received highly positive feedback
from many international companies within the
industry, as well as from end users who see Psyros
as a potential next-generation point-of-care platform.
We are frequently told how remarkably fast our small
and cost-efficient organization has succeeded in
advancing this complex and technically demanding
product development program, where many large
global companies have failed.

 

Our upcoming milestones include validating the
manufacturing process for the cartridges, initiating
pilot production of instruments corresponding to the
final commercial product, verifying the POC system,
and commencing the final clinical performance
study in Europe and the UK.

 

Finally, I would like to thank our employees, partners, and shareholders for your continued support.


Lund May 26, 2026


Ulf Bladin
CEO Prolight Diagnostics (publ)