Interim Report Q1 – January – March, 2023 Redsense Medical AB (publ)

January – March 2023

• Net sales amounted to kSEK 6,824 (3,127), an increase by 118%.
• Operating loss, EBIT amounted to kSEK 104 (2,076).
• Result after tax amounted to kSEK 413 (-1,549).
• Earnings per share was SEK 0.03 (-0.11) before and after dilution.

Significant events during the period

• On January 3, Redsense Medical announced that MSEK 4.75 of the previously disclosed record order had been delivered in December 2022, with the balance of the order planned for delivery in Q1.
• On January 20, Redsense Medical announced that Jennie Kardell will join the company as new Chief Financial Officer as of March 2023.
• On January 26, Redsense Medical announced that ECRI (Emergency Care Research Institute) included Venous Needle Dislodgement as number 4 on its 2023 list of Top Technology Hazards.

Significant events after the reported period

• On April 28, Redsense Medical announced that it held a 510(k) Pre-Submission meeting with the United States Food and Drug Administration (FDA) concerning the 510(k) premarket submission for the Redsense Clamp.
• On May 8, Redsense Medical announced that the Home Dialysis Risk Prevention Act has beenintroduced by the US House of Representatives

Comment from the CEO

Strong start with 118 percent sales growth

We started 2023 with an excellent quarter where net sales increased by 118 percent to kSEK 6,824 (3,127) being the second-best quarter in the history of the company. The increase growth generated profit for the first quarter, which we are pleased with.

The US market is still the driver of our business. During the first quarter we continued to make part deliveries of the record order of MSEK 15.2 from December 2022, from one of our US distributors. In addition, we delivered a new order from our other US distributor.

Moving into the second quarter, we plan for additional deliveries of the large order from December last year, which will cater for another good quarter revenue wise.

The US in focus

The underlying demand for the sales growth in the US is driven by the development of the home hemodialysis market where Redsense has a unique position as the only blood leakage system being FDA cleared. Around 12,000 patients are currently treated in home settings with hemodialysis and this modality is expected to grow faster than other modalities.

Most of our products in the US are used for home hemodialysis, where we have a strong position. In terms of patients and number of treatments, the large market is however hemodialysis in the clinics. Close to 500,000 patients are currently treated by hemodialysis several times a week in clinics. The key to an introduction in a broader scale in the clinics, is legislation and Medicare reimbursement. Therefore, we are continuing our work in this area. During the quarter we meet with stakeholders in Washington D.C. to increase the awareness of VND (Venous Needle Dislodgement) and the opportunities to increase patient safety by using a blood leakage detection system.

Speaking about VND, ECRI (Emergency Care Research Institute), a global independent, non-profit organization devoted to improving safety, quality, and cost-effectiveness of care across all healthcare settings, is also highlighting the risks with VND. Ranking # 4 on the 2023 list of Top 10 Technology Hazards, ECRI’s spotlight brings attention to the gravity VND and Access-Bloodline Separation, a potentially life-threatening but preventable complication of hemodialysis that can happen to any dialysis patient at any time.

For implementation of the Redsense system in home settings, nurses, technicians and other supporting personnel play an important role. In March we exhibited at the DTX40 conference in Las Vegas arranged by the National Association of Nephrology Technicians/Technologists. Participants from the major US dialysis providers showed a large interest in the Redsense solution. Home hemodialysis came into the spotlight in the session “Growth in Home Modalities”, clearly indicating the focus the major dialysis providers have in this area. 

Innovation to increase patient safety

One of our focus areas for 2023 is the launch of our new Redsense Clamp, an accessory to the alarm unit enabling automatic stop of the flow in the blood line in case of an incident, independently of the type of dialysis machine. The final step before launching the Clamp, is a user study to complete the CE-mark and preparations to start the study at the Toronto General hospital in Canada is underway. Key markets for initial launch of the Clamp will be Canada and Australia and selected countries in Europe. The Clamp are also of interest for the US market and preparations for the required regulatory activities is on-going.

Looking ahead

After concluding a strong first quarter, and with an excellent team in place, I look forward with confidence to the rest of the year. Our new CFO, Jennie Kardell, joined in March and I am very pleased to have Jennie onboard. She is a valuable addition to the team and will play an important role in the development of the company.

We will continue our activities to execute on the main strategic goals in 2023; further grow our position in the US home hemodialysis segment as well launch of the Clamp. Furthermore, our efforts to increase awareness about VND as the foundation for legislation and reimbursement in the US, will also be on the agenda.

In the short term, customer focused activities will be important to increase the sales pipeline. The promotional activities will be high going forward, and we will be exhibiting at conferences in the US and Europe. In June we will exhibit at the largest nephrology congress in Europe, the 60th ERA Congress in Milan.

I look forward to getting back to you on our progress and would like to express my appreciation to the team for their dedication and contributions. Our journey to improve patient safety and saving lives continues!

Pontus Nobréus
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 Markets Act. The information was submitted for publication, through the agency of the contact persons set out below, on May 9, 2023, at 08:30 CET.