During the past quarter, we have continued to make significant progress with our point of care system, Psyros™. With the support of the prestigious UK i4i grant of 17 million SEK, we are now preparing for a comprehensive pre-validation study in collaboration with St. Thomas’ Hospital in London. This study will help with the fine-tuning of our test and platform in preparation for the clinical performance study in 2025. Our ongoing focus is on ensuring a smooth transition to commercial production through partnerships.
The pre-validation study will be conducted with fresh whole blood from approximately 120 cardiac patients at St. Thomas’ Hospital in London, UK.
Additionally, around 800 frozen plasma samples will
be tested and analyzed from a biobank of healthy
patients, as well as approximately 400 frozen
plasma samples from patients with chest pain, of
which approximately 200 have had a confirmed
heart attack. The data generated from these studies
will be used for the final fine-tuning of the
high-sensitivity troponin test and platform. The
results will minimize risks and help ensure an
optimal outcome for the clinical performance study
in 2025, which is expected to increase the already
high interest from potential partners in the Psyros
POC system.
In September, we conducted a business review with
our partner for the disposable cartridge FlexMedical Solutions (FMS), which included an inspection of the pilot line for manufacturing. This line is being
brought online to support regulatory approvals,
including the clinical performance study as well as
commercial volumes. We are very pleased that the
technologies and processes developed by FMS
have the capacity to produce hundreds of thousands of cartridges at a low, competitive cost and are designed to be scalable with a future high level of automation, enabling a swift transition to large-scale commercial production.
The prestigious meeting, the Cardiac Markers Dialogue Meeting, held on September 26–27, 2024, in Glasgow, brought together global experts in cardiology to discuss advancements in cardiac marker diagnostics and their impact on patient care. For Prolight, this was an important forum to showcase Psyros while gaining valuable insights into the progress of biomarker research and its application in the early detection of cardiac events, as well as how new technologies can be integrated into clinical practice. Participation as one of the sponsors raised awareness amongst KOLs and the cardiovascular biomarker community. The Psyros POC system was well received and recognized as fulfilling a significant need in today’s healthcare.
Shortly after the end of the quarter, we took an
important step forward with the granting of a European patent for our innovative solution to separate
plasma from whole blood within a fluidic consumable. This method provides high-quality
plasma quickly, without requiring much space,
which is crucial when designing a point of care system. The separation method, developed in conjunction with the MicroFlex system, could also be utilized in other disposable fluidic systems, meaning
the patent opens new business opportunities for our partner TTP (The Technology Partnership). The patent strengthens the market position of MicroFlex and enhances its value in the commercial discussions TTP has with potential partners.
I would like to take this opportunity to thank both our
existing and new shareholders for the trust placed
in us during the exercise of the warrant program
carried out in October. Warrants of series TO7 were
exercised to approximately 96.4 percent and the
company receives approximately SEK 12.6 million
before issue costs. Both the board and management
fully exercised their options, and I can also confirm
that management and the board have increased
their total shareholding over the year.
The total ownership among the board, management
and employees after subscription of the warrants of
series TO7 amounted to approximately 22,8
percent of the outstanding shares.
Overall, we are following our plan to develop the
Psyros platform all the way to a commercial POC
system.
The interest we are encountering for Psyros is
very flattering. We frequently hear that the system
has developed rapidly and successfully, while the
needs are substantial. Our list of potential partners
is therefore extensive, and they, like us, are eager
to see the results of the pre-validation study. I look
forward to keeping you updated as Prolight reaches
its upcoming milestones.
Lund November 27th 2024
Ulf bladin
CEO Prolight Diagnostics (publ)
