July – September 2024

• Net sales amounted to kSEK 5,030 (5,287).

• Operating loss, EBIT amounted to kSEK -3,273 (-959).

• Result after tax amounted to kSEK -3,271 (-1,008).

• Earnings per share were SEK -1.99 (-0.07).

• Other operating income/loss kSEK -1358 (260).

Significant events during the period

• On July 15, Redsense announced that ShapeQ GmbH after the second directed issue has passed the 25% threshold.

• On Sept 16, Redsense announced that chairman of the board resigns, and a new acting chairman is appointed.

• On Sept 21, Redsense announced that a board member resigns.

• On Sept 24, Redsense announced that a new CEO is appointed.

Significant events after the period

• On October 24, Redsense announced that it will not renew its agreement with OTC Markets Group, resulting in the cessation of trading on the OTCQX platform in the USA. 

Comment from the CEO

Reflecting on progress and embracing growth at Redsense

The past months have been eventful for Redsense Medical. I am proud to have been given the opportunity to lead Redsense Medical as the new CEO and to work with our talented team and valued partners to elevate our company to new heights. We continue to focus on driving the company forward through both operational improvements and strategic initiatives. We are focused on optimizing internal processes and ensuring that we have the right team and structure in place to support both immediate and long-term growth, and we see great potential for the future.

Consistent sales growth and strengthened collaboration with U.S. distribution partners 

During the quarter we saw a continued positive development in our sales figures. While order patterns and volumes to distribution partners have historically been unpredictable, often fluctuating significantly between periods, sales to end customers have demonstrated greater consistency and are on an upward trend.

In response to this variability we have prioritized improving coordination and communication with our U.S. distribution partners. This has led to the development of a quarterly review and ordering process, first put to the test in June and September, to help create a smoother and more consistent order flow. We are working closely with them to align more effectively on sales and inventory levels, with the goal of streamlining production and logistics planning, resulting in optimized operations and cash flow management. 

This initiative has resulted in steady replenishment orders following the first reviews, paving the way for more consistent results moving forward. A portion of the September order, however, was delivered in the first week of October, just after the close of Q3. If this delivery had been included in Q3, we would have seen year-on-year sales growth for the quarter. Including this partial delivery, the net sales for Q4 to date exceed 6M SEK. With another replenishment scheduled for early December, we are confident in achieving a strong Q4 and a solid year-end in 2024.

We are excited to have reached the target number of treatments for the Clamp usability study. Our next steps involve analyzing the final data and applying for regulatory approval, with the first sales of the Redsense Clamp anticipated in Q1 2025. 

Paired with our Redsense alarm, the Clamp operates independently of specific dialysis machine manufacturers or machine age, to stop the blood flow upon an alarm. This makes it more versatile and accessible across a broader range of customer environments. This combination thus provides a compelling solution to enhance patient safety and we believe it presents a substantial growth opportunity by attracting new customers and opening new markets.

Update on U.S. reimbursement efforts

Redsense has been actively advocating for the Home Dialysis Risk Prevention Act which was introduced in the U.S. House of Representatives to address critical safety concerns in home hemodialysis. At this point the bill has not gained the traction we anticipated, despite our efforts including a congressional briefing and engaging with the House Committee on Ways and Means. However, with the election now behind us, there is potential to re-submit this bill in the coming term.

While we continue to support this legislative path, we are also exploring alternative avenues to achieve reimbursement. This includes working with local intermediaries and securing HCPCS (Healthcare Common Procedure Coding System) codes to secure reimbursement by insurance providers. This will greatly enhance the accessibility of Redsense solutions for home hemodialysis patients and support alignment with U.S. healthcare stakeholders in prioritizing patient safety.

A new direction forward

As we look ahead, I am both optimistic and motivated by the growth opportunities. Our focus remains on building a strong foundation to sustain long-term growth, with an emphasis on transparency and providing clearer insights as we move forward. Expanding into new markets and reinforcing our presence in established ones are key goals, and we will continue to invest in our products, our people, and the strategic partnerships that can elevate our business to new heights.

I am looking forward to lead Redsense Medical as we strive to realize these ambitions. Supported by a dedicated, skilled team and an engaged group of shareholders, we are well-positioned to drive the company toward sustained growth and profitability. After eight years with Redsense, it is a personal honor to continue the legacy of my late colleague and friend, Patrik Byhmer, as we pursue our shared vision.

Thank you to all our shareholders, distributors, customers, and not the least the team for your trust and support. Together, we look forward to a bright and successful future for Redsense Medical.

Sebastien Bollue, CEO 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 November 26, 2024, 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 hemodialysistreatment. Redsense Medical solves one of the most serious remaining safety problems within hemodialysis – to quickly detect Venous Needle Dislodgement and catheter leakage 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) and traded on OTCQX (RDSNF) in the US.