During 2025, we took clear and tangible
steps toward commercialisation. We
presented positive patient data demonstrating that
the Psyros system delivers laboratory-grade
performance even in whole blood, showcased a
fully functional commercial system prototype for the
first time, and achieved assay design freeze for the
cartridge. In addition, our IP position was further
strengthened through granted patents by the
Japanese and European Patent Offices.
At the international ADLM (Association for
Diagnostics & Laboratory Medicine) congress, we
presented a fully functional commercial prototype of
Psyros for the first time. Interest from potential
partners and end users was very strong. The
positive response reflected a combination of the
platform’s ultra-sensitive detection capabilities,
compact form factor, and cost-efficient
consumables.
Following delivery of the commercial prototypes, we
carried out targeted design and manufacturing
improvements during the autumn to optimise
assembly processes and reproducibility. The year
concluded with an important milestone as we
achieved assay design freeze for the cartridge,
confirming that assay chemistry met the
requirements for verification, validation, and
pilot production. This milestone also led to more
structured and forward‑looking discussions with
several potential partners.
In early 2026, we also announced that, together with
FlexMedical Solutions, we have made significant
progress to optimise the production capacity for
the cartridge. The modular production line enables
scalable output of more than one million cartridges
per year as demand increases.
This production setup supports our ambition to
achieve cost-efficient manufacturing without
compromising analytical performance, thereby
enabling broad adoption in point-of-care testing.
In parallel, 30 instrument prototypes underwent
pre-clinical evaluation, confirming technical
performance and identifying a limited number of
targeted hardware improvements to ensure
long-term robustness and scalable manufacturing.
With these improvements the risks associated with
transfer to production have been materially reduced.
As the instrument design is being finalised,
preparations for the pilot manufacturing line are now
underway. To mitigate the risk of potential delays
in the global supply chain, we have already placed
orders for components with long lead times. The first
pilot instruments will be representative of the
commercial product and will be used for internal
verification and validation activities, to support
design freeze, as well as in the forthcoming clinical
performance study planned for 2026.
The technical advances underpinning this year’s
milestones are further validated by our pre-clinical
programmes. Results demonstrate that Psyros is
well positioned for a high-sensitivity troponin test,
while a joint study with a cardiologist at St Thomas’
Hospital has shown that a biomarker such as cMyC
(cardiac myosin-binding protein C) can be rapidly
and efficiently implemented on the platform. This
confirms the system’s broad clinical potential and
strengthens our long-term development and market
opportunity.
From a financial perspective, we strengthened the
company’s liquidity through a fully subscribed rights
issue of SEK 100 million, securing funding for the
completion of Psyros. With assay design freeze
achieved for the cartridge, a strengthened balance
sheet, and clearly defined next steps, we enter 2026
with a focus on final system verification, validation of
manufacturing processes, pilot production of
cartridges and instruments, followed by initiation of the European multicentre clinical performance
study. These activities represent the final and
decisive steps ahead of commercial launch in 2027.
I would like to extend my sincere thanks to our
employees, our development and manufacturing
partners, and our shareholders for your support
during an important year for Prolight. We have
significantly reduced the technical risk,
strengthened our IP position, delivered on our
commitments, and strategically positioned the
company for potential partnerships and future
commercialisation. With a clear and realistic
timeline, we are now advancing Psyros through the
final clinical performance study and onward to
market, creating value for patients, healthcare,
society, and our shareholders.
Lund February 26 2025
Ulf Bladin
CEO Prolight Diagnostics (publ)