During the quarter, we made significant progress
towards establishing Psyros™ as the next-genera-
tion point-of-care (POC) solution. We delivered the
first commercial prototypes of our POC system to
the preclinical validation study at St Thomas’
Hospital in London. This marks a technical milestone
that shows we are well on our way to initiating the full
clinical performance study later this year. Pre-
clinical data from biobank samples has also
provided strong support: the Psyros platform
demonstrated very high clinical sensitivity and
specificity, with an AUC of 0.97–0.98 (1.00 being
perfect). These results confirm that our small,
portable commercial instrument prototypes perform
on par with large laboratory instruments.
Our pilot production line at FlexMedical Solutions
reached new levels during the quarter. With the
delivery of additional automated equipment, we are
now ready to scale up production for launch – from
hundreds to hundreds of thousands of cartridges
per year. The production cost of our disposable
cartridge remains one of our key competitive
advantages.
It is also encouraging to see how quickly new bio-
markers can be integrated into the Psyros platform.
This was demonstrated in a research collaboration
with cardiologist Dr. Sam McGrath at St Thomas’
Hospital, London, where a new test for the
biomarker cMyC (cardiac myosin-binding protein
C) was transferred to the Psyros system in just a
few weeks. “This clearly demonstrates the power of
single-molecule counting and its potential to
revolutionize POC diagnostics. The transfer of the
test was simple and quick thanks to the user-
friendliness of the Psyros technology,” summarized
Dr. Sam McGrath. This confirms that our strategy —
initially focusing on troponin and then expanding to
other biomarkers — is fully feasible on our Psyros
product platform.
After the end of the quarter, the European Patent Of-
fice (EPO) announced its intention to grant not one,
but two patents related to the Psyros technology,
offering protection in 17 countries until 2040 and
2041, respectively. The first – the core patent EP
3987287 – protects the central measurement system
in our platform, where individual binding events are
detected through the bleaching of fluorescent spots,
enabling extremely sensitive assays. The second,
EP 4264266, builds on this foundation and covers
methods for extending the lifespan of reactive
oxygen species – a technological improvement that
further enhances the system’s precision and
simplifies optical readout. These protections
strengthen our competitiveness and make us an
even more attractive partner in point-of-care testing
and diagnostics.
The granting of these patents is a clear
acknowledgment of the level of innovation and
technical sophistication that Psyros represents. They
reinforce our position in a globally growing market
for advanced point-of-care solutions, where the
need for fast and reliable results has never been
greater. We are particularly proud to have created a
platform capable of counting individual molecules –
something that until now has only been possible in
large laboratories, but which we are now bringing to
the point of care.
Market dynamics also support our strategic focus.
bioMérieux’s acquisition of SpinChip Diagnostics
shows that major players are now actively seeking
next-generation point-of-care solutions. We are
uniquely positioned as the first and only digital,
portable POC system capable of single-molecule
counting with multiplex capabilities and low manu-
facturing costs. We are engaged in discussions with
numerous potential partners who are highly impres-
sed by the rapid development of the POC system,
Psyros – particularly by the fact that we have
already succeeded in delivering strong analytical
and clinical performance using plasma from
biobanks in the pre-clinical validation study.
However, both we and our potential partners are
aware that fresh whole blood samples can
behave significantly differently compared to plasma.
It is therefore critical to demonstrate equivalence
between plasma and whole blood within the target
population. This is the primary objective of the study
being conducted at St Thomas’ Hospital in London.
When equivalence is demonstrated, both we and
future partners can infer that we will achieve the
desired clinical performance in whole blood during
the final clinical performance study – a requirement
for regulatory approval.
The results from the ongoing whole blood study at
St Thomas’ Hospital, expected during the second
quarter of this year, will therefore be pivotal for
potential partners seeking to minimize risk ahead of
a strategic partnership or commercial agreement.
To secure the best possible deal with potential part-
ners, we want to avoid being under financial pres-
sure or in a stressed position. For this reason, the
Board has recommended that we raise capital now.
In the broader perspective, we are confident that
this is the right course of action – a view also
reflected in the strong participation in the share
issue by the board of directors, manage-
ment, employees, and our instrument contract
manufacturing partner ITL.
With our groundbreaking technology, a top-tier team
delivering on ambitious goals, solid preclinical data,
a strengthened IP portfolio, and growing partner
interest, we are now ready to optimize and finalize
the development of the Psyros POC system ahead
of the clinical performance study starting in 2025.
Our goal is clear: we are creating value for our
investors by providing healthcare with rapid,
accurate, and point-of-care testing that enables
faster diagnosis and appropriate treatment – ultimately saving lives.
Lund May 30, 2025
Ulf bladin
CEO Prolight Diagnostics (publ)
