Reports
Published: 2025-11-19 08:30:00
(Other operating income/loss)
January – September 2025
(Other operating income/loss)
As we mark twelve months since I assumed the role as CEO, I am pleased with our progress we have made. Over the past year, we have strengthened our operations, expanded our market presence, and achieved important milestones that position the company for continued growth. While challenges remain — particularly related to currency effects, U.S. reimbursement and global trade uncertainties — our direction remains focused, and our foundation is solid.
Redsense delivered growth in both the third quarter and the first nine months of the year, despite continued headwinds from a weakening U.S. dollar affecting our reported accounts. The U.S. market remains our primary source of growth, while we have also increased our commercial initiatives in other regions.
Outside the U.S., we are taking consistent steps to build awareness and commercial traction through active market presence, close collaboration with our distributors, and direct engagement with healthcare providers. These efforts are beginning to show results, although establishing engagement and sales outside our core market naturally takes time.
During the quarter, Redsense participated in key industry events across North America and Europe, as well as national congresses together with distributors in markets such as Canada and the UK. The events enable hands-on dialogues with clinicians, care providers and purchasing decision makers. These interactions offer concrete commercial value by strengthening relationships, supporting ongoing evaluations and showcasing how our technology fits into real-world dialysis settings.
We have also announced the initiation of a new pilot study together with a global leading dialysis provider in Germany. The study will start in December 2025 and evaluate our system in a real-world clinical environment and generate updated data on usability, risk reduction of blood leakage and workflow integration. This is yet another important step in strengthening the clinical evidence base for our solution and expanding our footprint in Europe.
Following the launch of the Redsense clamp in selected markets, we are now seeing growing interest from distributors and dialysis providers in UK, Germany, Canada and Australia, although building engagement and sales outside our core market naturally requires time.
The clamp makes our offering more complete and enhances the attractiveness of the Redsense System in new market dialogues, such as in Australia where sales activities were recently initiated. The next step is preparation of the 510(k) submission to the FDA, which will be an important step toward entering the U.S. market with this innovation. We will continue to update the market on the progress of the 510(k) process as it advances in the coming periods.
Internally, the effects of previously implemented efficiency measures are now visible in our operations. We have streamlined administrative processes and strengthened our internal systems, resulting in improved control and reduced overhead. These improvements will continue into Q4 and are expected to further lower administrative costs going forward.
On the development side, work has begun on the next-generation alarm system, integrating the clamp functionality directly into the unit. This next step aims to improve usability, reduce complexity, and enhance margins over time.
The reimbursement dialogue in the U.S. continues, with engagement through our local consultant in ongoing discussions with CMS. Our goal remains to secure a reimbursement pathway that reflects the clinical value our system provides in enhancing patient safety. In parallel, we are reviewing our pricing model to better align with the current reimbursement structure — increasing the share of value in the alarm unit while lowering the cost of the disposable sensor. This adjustment aims to reduce barriers to adoption, as sensor costs currently fall outside the treatment bundle and directly impact provider margins. While the overall process is lengthy and uncertain, our case continues to gain recognition and support within the dialysis community.
Looking ahead, we approach the final quarter of the year with both caution and confidence. While the broader geopolitical and trade environment remains uncertain, demand from our customers has so far remained stable. However, such factors may affect the pace of new market traction.
We are entering a challenging comparative quarter but are better positioned than last year thanks to stronger fundamentals and continued operational improvements. The progress made across the past twelve months gives us a solid foundation for the next stage of Redsense’s journey — with innovation, efficiency, and patient safety at the core of everything we do.
I would like to extend my sincere thanks to our team, partners, and shareholders for your continued trust and commitment. Together, we are building a stronger Redsense, advancing patient safety, and creating long-term value.
Sebastien Bollue
CEO of Redsense Medical
This information is information that Redsense Medical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Market Act. The information was submitted for publication, through the agency of the contact person specified below, on November 19, 2025, at 08:30 CET.
Contact information
For more information, please contact:
Sebastien Bollue, CEO
Telephone: +46 72-171 1264
E-mail: sebastien.bollue (at) redsensemedical.com
Redsense Medical AB (publ), 556646-4862
ABOUT REDSENSE MEDICAL
Redsense Medical is a corporate group with operations mainly in Europe and the United States. The company has developed the Redsense System, an innovation used for monitoring and alarm in the case of blood leakage in connection with a hemodialysis treatment. Redsense Medical solves one of the most serious remaining safety problems within hemodialysis – to quickly detect Venous Needle Dislodgement and catheter eakage to minimize blood leakage. The system consists of a patented fiber optic sensor, designed for either venous needle or central venous catheter, which is connected to an alarm unit. From the very start, the development of the company''s technology has been based on the demands and safety requirements of healthcare providers in the dialysis sector. The Redsense Medical share is listed on Spotlight Stock Market (REDS)
