Prolight Diagnostics CEO: “We deliver on all goals”
Prolight Diagnostics’ year-end report for 2023 shows that the company met all the goals for the year. The company’s point-of-care analysis system has shown proof-of-performance for measurement of troponin in whole blood. In addition, the company has formed a Clinical Advisory Board and established an R&D manufacturing line for the upcoming pilot production. The goal for 2024 is to complete the development of the system for clinical validation.
Prolight Diagnostics develops Psyros, which is a point-of-care analysis system with the potential to become the first digital and portable system for detecting myocardial infarction through highly sensitive measurement of troponin in just one drop of blood. The system can quantify individual molecules of the protein at low levels, allowing for rapid and early detection of heart attacks. This, in turn, can save lives and reduce the burden on healthcare and healthcare costs.
The company’s point-of-care analysis system also enables multiplexing, i.e. measurement of several biomarker tests at the same time.
Proven performance in 2023
According to the company’s Q4 report, several important advancements were made in the development of the platform in 2023. At the beginning of the summer, the company showed proof-of-performance for its Psyros system for measuring highly sensitivity troponin. The system demonstrated the ability to quantify individual molecules of troponin down to single-digit nanograms per liter (ng/L).
During the autumn, Psyros also showed proof-of-performance in whole blood, which means that the analysis can be performed without cell separation. According to the company, there is no other single molecule counting POC system that can function with whole blood.
Interest from potential partners after US congress
The capabilities of the Psyros platform were presented at the American Association for Clinical Chemistry (AACC) Annual Scientific Meeting & Clinical Lab Expo in California in July. According to Prolight Diagnostics, the company’s proprietary POC technology attracted a lot of interest during the congress.
Following the congress, Prolight initiated an intensified phase of business development, including meetings and non-disclosure agreements (NDAs) regarding collaboration opportunities with leading global diagnostics companies. The strong industrial interest in point-of-care analysis was further demonstrated at the end of 2023 when big pharma Roche acquired LumiraDx‘s POC technology for USD 295 million. Read more about the interest in point-of-care systems here.
Established Clinical Advisory Board and manufacturing line
In the report, CEO Ulf Bladin says that during the year the company also established a Clinical Advisory Board consisting of six prominent internationally recognised experts in cardiology, emergency medicine and clinical pathology; MD Richard Body, MD Paul Collinson, MD Thomas Kaier, MD Michael Marber, MD Nicholas Mills. According to the company, they have already provided valuable insights on the most effective development pathway towards clinical validation and commercialisation of the Psyros system.
In 2023, the company has also established a dedicated R&D manufacturing line to optimise the manufacturing processes required for pilot production. An important step forward in this work is that the company recently obtained ISO 13485:2016 certification for the Quality Management System (QMS), meaning that it meets the international quality requirements, which is a prerequisite for market approval in the US and Europe.
Development milestones in 2024
In 2024, Prolight Diagnostics will continue to develop the system for clinical validation. The design of the alpha prototypes is currently being fine-tuned in close collaboration with Integrated Technologies Limited, ITL. The next step in the product development together with ITL is to produce beta prototypes that are estimated to undergo testing, evaluation and verification of regulatory compliance during the third quarter.
In the year-end report, Ulf Bladin says that they also plan to finalise and freeze the cartridge design during the first quarter, as well as appoint a Contract Manufacturing Organisation (CMO) partner for cartridge manufacturing.
Once these processes are complete, the company will shift towards the pilot production line to produce the first commercial instruments ready for validation and clinical performance studies.
Comments from the CEO
Prolight reports an operating loss of SEK -8.1 million for the full year, as well as a cash flow for operating activities of SEK -25 million. As of December 31, 2023, the company’s cash amounted to SEK 13.3 million.
In the end of 2023, the company strengthened its cash position with a rights issue. This means that the company is financially ready for the continued development of Psyros into a commercial POC system by the end of 2024, ready for clinical validation in early 2025.
BioStock reached out to CEO Ulf Bladin to learn more.
First of all, how would you sum up 2023 in three words?
– Eventful, reliable and proof-of-performance.
What are the key messages in the year-end report?
– That we have delivered on all set goals and have an eventful 2024 ahead of us.
Your POC analysis system, Psyros, garned interest of potential partners in 2023. How do you plan to further raise awareness about the system in 2024?
– Currently, we are closely following up on the initial contacts established in 2023. We anticipate even more in 2024 as our goals are achieved. Additionally, an analysis on Prolight was recently published by Emergers, which can enhance awareness, interest, and showcase the potential for our unique POC system.
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.
