Interim Report Q3 – January – September, 2023 Redsense Medical AB (publ)

JULY – SEPTEMBER 2023

• Net sales amounted to kSEK 5,287 (1,023), an increase of 417%.
• Operating loss, EBIT amounted to kSEK 959 (5,857). 
• Result after tax amounted to kSEK -1,008 (-2,372). 
• Earnings per share were SEK -0.07 (-0.17).

SIGNIFICANT EVENTS DURING THE PERIOD

• On July 7, Redsense alarm system was featured in KFF Health News
• On August 15, Redsense secured a strong autumn with a mSEK 11.2 order.
• On September 27, Redsense Medical arranged Congressional Briefing to address Venous Needle Dislodgement.
• On September 28, Redsense announced that Redsense Medical AB has a new large shareholder.
• On September 29, Redsense Medical AB has been qualified and approved to enter share trading on the OTCQX trading platform in the US under the symbol “RDSNF”.

SALES GROWTH FOUR QUARTERS IN A ROW

We are pleased to report four quarters in a row with net sales growth. The driver behind the positive development is the US market, and in August we received another large order from one of our US distributors. Part of this mSEK 11.2 order was delivered during the quarter, but most of it is still to be dispatched. Net sales for the third quarter increased by 417 percent to kSEK 5,287 (1,023). The US market remains the foundation and driver of our growth with 98 (98) percent of the net sales. During the quarter the positive development in the UK continued, with an increased interest in our products. The excellent work of our distributor and their promotion of Redsense resulted in orders which were delivered during the quarter.

Increasing awareness in our main market

During the quarter, we have been busy in the US with activities to increase awareness and promote the use of blood loss detection alarms. We exhibited at the California Dialysis Council, which was an excellent opportunity to engage with dialysis providers, nurses, dialysis technicians, and other stakeholders.

Home hemodialysis is in focus among dialysis providers, and this modality is gaining popularity thanks to all the benefits that come with home treatment. A driving force is the improved clinical outcome for the patient, but also cost savings both for patients and providers. Home hemodialysis means increased convenience for the patient, and, in the end, improved quality of life. To realize the full potential of home hemodialysis, it is important to address one of the remaining safety issues during hemodialysis; Venous Needle Dislodgement (VND).

It is encouraging that the American Association of Kidney Patients (AAKP) has patient safety high on the agenda, and endorses the use of technologies that can reduce the risk of fatalities and adverse events during home hemodialysis. In September, Redsense participated in the AAKP Annual Patient Meeting, giving a presentation in the section “Issues and Policies Impacting Patient Consumer Choice and Access to Treatments”.

As previously communicated, we are pleased that monitoring of VND for home hemodialysis patients is also acknowledged by the US House of Representatives. The Home Hemodialysis Risk Prevention Act (H.R. 3118) is a bipartisan legislation introduced in May 2023, which aims to provide for Medicare coverage of monitoring devices. This is an important initiative, both for patients and dialysis providers, as there is currently no Medicare coverage for blood loss monitoring devices. For Redsense, the enactment of this legislation will be important as the Redsense system is the only blood loss monitoring device cleared by the FDA.

In July, VND was also on the agenda at the AAKP Annual Policy Meeting, attended by a member of Congressman Adrian Smith (NE) office, a sponsor of the legislation from the House of Representatives. Furthermore, Redsense was featured in a KFF Health News report in July, which also was distributed through CBS News. KFF Health News highlighted the potentially fatal danger of VND, and emphasized the need for a safety system like the Redsense alarm system.

At end of September, Redsense arranged a Congressional briefing to address VND, in order to share knowledge and experience, as to discuss the risks with VND and how to increase patient safety for home hemodialysis patients. The briefing included presentations from AAKP, the Emergency Care Research Institute (ECRI), and our US Clinical Director, Jane Hurst. This event gave the members of the US Congress an understanding of the real risks with VND, and how the enactment of the Home Dialysis Risk Prevention Act can improve patient safety.

To conclude, it is very promising with all the increased awareness of VND among a number of US stakeholders. Moving forward, this support will be instrumental for our continued growth within the US home hemodialysis segment.

Good progress with the Clamp

As we have previously communicated, the last step in attaining a CE mark for the Clamp, is a usability study. I am pleased to announce that this study has begun and is underway at the Toronto General Hospital in Canada. There is significant interest for the Clamp, and we are looking forward to launching it in 2024 as it will be an important part of our growth plan.

Looking forward

Our strategic priorities remain firm: to capitalize on our strong position in the US home hemodialysis segment to further grow our sales, promote the advancement of Home Dialysis Risk Prevention Act, and secure the CE mark of the Clamp to pave the way for market launch.

On another note, I am very pleased that our application for cross-trading at OTCQX Markets was approved at end of September, and with that we have opened for US investors to trade the Redsense share.

We move into the last quarter of the year with a lot of confidence, and I look forward to keeping you updated on our progress. We remain committed to improving safety for dialysis patients - and saving lives!

Pontus Nobréus
CEO Redsense Medical AB

This information is information that Redsense Medical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out below, on November 9, 2023, at 08:30 CET.