April - June 2025

• Net sales amounted to kSEK 6,276 (8,749).
• Operating loss, EBIT amounted to kSEK -1,833 (613).
  • Excl. Exchange rate differences kSEK -750 (-39)
• Result after tax amounted to kSEK -1,830 (625).
• Earnings per share were SEK -1,11 (0.04).
• Other operating income/loss kSEK -1,083 (652).

Significant Events during the period

• On April 7, Redsense updates on tariffs and Clamp.
• On April 24, Redsense held an Extraordinary General Meeting and announced that CFO Peter Larsson would enter as a temporary member of the Board of Directors.
• On May 7, Redsense announced that an independent test house has completed their review of the usability report of the clamp.
• On May 28, AGM was held and Mike Griffiths and Johannes Köpple was elected as new Directors for the period until the end of the next AGM, replacing Peter Larsson.

Significant Events after the period

• On July 25, Redsense receives preemptive order ahead of pending tariff increase.
• On august 12, Redsense announced that the clamp is CE marked and has been introduced in the UK, Canadian, and German markets.

Message from the CEO

Building Strength and Expanding Opportunities

This quarter has been one of important progress for Redsense Medical, with developments across operations, quality, governance, and market expansion. We have continued to strengthen our internal capabilities, refine our processes, and position the company for sustainable growth in the coming periods.

Commercial Performance

We are seeing the positive effects of our efforts to create a more balanced and predictable order flow, resulting in more even sales across the quarters. For the half year period HY, our combined sales were higher than in the same period last year, reflecting both steady end-customer demand and improved coordination with our distribution partners. This reported result includes -3,1MSEK in exchange rate losses compared to an exchange rate gain of 1,6MSEK in HY 2024. Operating loss excluding the negative exchange rate impact would be -1,9MSEK instead of -5MSEK.  This is not operational in nature but rather a reporting effect, as we buy and sell primarily in USD but report in SEK. With orders early July, including a pre-emptive tariff increase order to one US distribution partner, we have also already secured growth for the third quarter, in comparison to last year.

Clamp Launch and Market Expansion

The Redsense Clamp has been CE marked and introduced in key markets including the UK, Canada, and Germany, with first sample orders to distribution partners received, the first live demos completed, and discussions for pilot studies with providers started. Our next steps are to work with our distribution partner in Australia and engage with other European distributors and providers. In some of these countries, additional instructions and certificate translations may be needed before sales can begin.

Team Growth and Innovation

Our team continues to grow, with our part-time student now joining full-time following graduation and recruitment underway for a new Quality Assistant. Alongside these additions, we are focused on optimizing how we work with the team and resources we already have, ensuring that Redsense is organized, efficient, and capable of sustaining growth over the long term. We are therefore also taking advantage of a grant-funded initiative to explore the use of AI in our daily operations, with the goal of easing administrative tasks and improving operational efficiency.

Operational Improvements and Quality Achievements

We have taken significant steps in digitizing our Quality Management System, moving into active quality testing of a new tool built us. Alongside this, extensive internal preparation and work with our quality processes ensured we successfully passed an inspection from Health Canada, with only minor points-all of which were resolved during the audit itself.

On the financial side, we have implemented new consolidation and reporting tools that not only improve reporting efficiency but will also save considerable time in future periods, enabling the team to focus more on analysis and decision-making.

Strengthening Leadership and Networks

Our governance has been reinforced with the appointment of a new Board of Directors, bringing in members with deep experience in both our market and the investment community. We also joined AdvaMed and have begun active participation in several of their working groups, including tariffs, payment and reimbursement, and 510(k) processes. This membership gives us access to experts in these fields with extensive experience and networks in these fields.

Reimbursement Advocacy

In our ongoing reimbursement efforts, we presented a rebuttal before the CMS committee, supported by a former CMO of one of the largest US dialysis providers. We made a strong case for the value and necessity of a dedicated HCPCS code and expect a formal response in due course.

Looking Ahead

With stronger internal systems, an expanded leadership network, important regulatory milestones achieved, and a growing team, we are entering the next quarter with momentum and confidence. We remain committed to delivering both innovation and value to our customers while building the long-term strength of Redsense Medical.

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 above, on August 20, 2025, at 08:30 CET.