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28 May, 2025

Interim Report Q1 - January - March, 2025 Redsense Medical AB (publ.)

January - March 2025

  • Net sales amounted to kSEK 4,776 (1,711).
  • Operating loss, EBIT amounted to kSEK -3,152 (-2,656).
  • Result after tax amounted to kSEK -3,152 (-2,640).
  • Earnings per share were SEK -0,19 (-0,19).
  • Other operating income/loss kSEK -1,960 (952).

Significant Events during the period

  • On January 21, Redsense announced the completion of the Clamp usability testing phase.
  • On January 24, Redsense announced an indicative strong closing of Q4 2024.
  • On January 31, Redsense announced the passing of Board Member Malin Almgren.
  • On February 10, Redsense announced the company reinforced the team with a new CFO and part-time support functions.

Significant Events after 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.

Message from the CEO

Laying the Groundwork for the Future

The first quarter of 2025 has been a period of refocusing and restructuring for Redsense Medical, as we position the company for its next phase of growth. Following a strong finish to 2024, we've spent the past months taking a closer look at our foundations-deepening our market insight, strengthening our team, and improving the tools and systems that support our operations.

A key focus this quarter has been to better understand our position in the U.S. market. By closely analysing sales data and market penetration, we're building a clearer picture of our actual market share, who our current customers are, and-just as importantly-who we're not yet reaching. This work will allow us to more precisely target sales activities and identify untapped clinics and regions. With this improved clarity, we can tailor our approach to better support sales growth and customer engagement moving forward.

As part of this effort, we also increased our presence at smaller, regional nursing meetings throughout the U.S. These events have allowed us to connect directly with frontline staff in a more personal setting, giving us valuable feedback and insights while strengthening relationships that support long-term adoption of our solutions.

Advocating for reimbursement recognition

Upon initial review, CMS considered the alarm system included in the ESRD bundled payment and did not identify the need to establish a new HCPCS Level II code for the alarm. However, Redsense immediately secured a time for rebuttal during CMS' HCPCS next committee meeting on 2 June 2025, and emphasize Redsense's unique role in enhancing patient safety as stand-alone safety device.

Clamp Progress Nearing the Finish Line

We're also pleased to report that the Redsense Clamp is approaching commercial readiness. All required documentation was submitted to the test house in February. Unfortunately, the review process was delayed due to internal capacity issues at the test house. The review was completed early May and commercialization is being finalized.

This week, the Clamp will be ready for sale for the UK market and a sample order is being discussed. In parallel, the translation of necessary documentation is in process as last finalization step to be able to sell in markets with other primary language requirements

Reinforcing the Team and Streamlining Operations

To support our ambitions, we've taken important steps to reinforce our organization. During Q1, we welcomed a new CFO, along with a part-time student and an intern from the Karolinska Institute. These additions bring new energy and capabilities to the team as we continue building a structure that can scale.

In parallel, we've invested in tools to improve efficiency and oversight. A new electronic Quality Management System (eQMS) will streamline our quality processes, while a

A consolidation tool has been implemented to improve the speed and reliability of our financial reporting.

Product Development and Innovation

Product development has also remained active. We've initiated work to combine the alarm and dongle into a single unit, an important next step in enhancing usability and reducing setup complexity for our customers. Additionally, we've developed a new connector for the optical fiber cable, along with reinforcements to the cable itself-both aimed at improving user experience and long-term reliability. We estimate that optic cable samples can be tested in a clinical setting toward the end of Q2.

Preparing for Future Sustainability Reporting

This quarter, we participated in a sustainability workshop funded through a national grant, which provided valuable guidance on upcoming requirements under the European Financial Reporting Advisory Group (EFRAG). As a result, we now have a clearer overview of what will be expected and have outlined a practical plan to meet these reporting obligations. While sustainability reporting is not yet mandatory for us, we are taking the necessary steps to ensure we are ready once it becomes required.

Currency Impact and Commercial Outlook

While favourable USD exchange rates gave us a tailwind at the close of 2024, the first quarter of this year has seen the reverse, with a currency exchange loss over 2MSEK impacting our financials. However, this is not a realised loss, but rather a reporting effect. Since we purchase and sell the majority of our products in USD, the operational impact is minimal. It is only due to our financial reporting being in SEK that this appears as a loss. We continue to monitor currency fluctuations closely to ensure transparency and stability in our reporting.

Despite the headwind from currency effects, we are pleased with how the quarter has turned out overall. Current order volume stands at 4,7 MSEK, and we are engaged in ongoing discussions with our distribution partners to ensure continued alignment on forecasts and inventory levels. At the same time, we are closely monitoring tariff developments that could impact our cost base going forward.

Looking Ahead

Q1 has been about laying the groundwork-refining our strategy, strengthening our team, and finalizing preparations for the launch of the Redsense Clamp. With these foundations in place, we are entering Q2 with renewed focus and optimism. I want to thank our shareholders, customers, partners, and employees for your continued trust and commitment. Together, we are shaping the future of Redsense Medical with purpose and determination.

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 May 28, 2025, at 08:30 CET.

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