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Redsense Medical (Swedish public company listed on Nasdaq First North)

Redsense Medical AB (publ) is a Swedish medical technology company that develop and sell the Redsense alarm system. It is used to monitor hemodialysis patients and sound an alarm, or even stop the blood flow, if a blood leakage is detected. The company’s website can be found at [null www.redsensemedical.com]

Why minimizing blood leakage during hemodialysis is important

Blood leakage due to the needle slipping out of the arm (venous needle dislodgement) is a severe patient risk during hemodialysis treatment. As such it is a prohibiting factor slowing down the transition to home dialysis, which often is more simple and cheaper for both the patient and the treatment center, while the quality of life is higher for the patient.

Company group/share information

Redsense Medical was founded in 2006 and has its headquarters in Halmstad, Sweden. The Redsense group is represented in the United States through its subsidiary Redsense Medical Inc. The company’s share is listed on Nasdaq First North in Stockholm, Sweden.

The Redsense Alarm system

The Redsense Alarm system is based on patented optical technology and consists of an optical fiber that is secured to the patient’s arm or neck (depending on where the blood flow from the dialysis machine is connected) with a sensor patch, and an alarm unit. The optical fiber is very sensitive and immediately detects any blood leakage due to so called venous needle dislodgement.

Today, the Redsense system has two levels of functionality. The main functionality, setting of the alarm to notify the patient and any medical personnel if a blood leakage is detected, works regardless of the dialysis machine being used.

If the dialysis machine is equipped with an IEC PAS 63023 contact (international standard for the connection between an external alarm system and a dialysis machine), it can be connected directly to the Redsense alarm system. This enables the dialysis machine to instantly and automatically turn off the blood flow if a blood leakage is detected. According to the company, this enables substantially improved patient safety, including in connection with home dialysis where access to emergency care and blood reserves is limited.

In 2016, this extended functionality was implemented in the dialysis machine Nikkiso DBB-EXA that is available on the market today.

Present use of the Redsense alarm system

In 2017, the Redsense alarm system had been used in over 300 clinics, mostly in the United States and in Europe, according to the company.

The company’s main markets are North America and Europe, but thanks to a large and growing network of distributors the Redsense system is also available in other regions such as Asia and the Middle East.

In September 2017, Redsense Medical, its Italian distributor Spindial and dialysis machine developer Nikkiso was presented as one of three winners in a public procurement process in Italy that is expected to cover over 3 million dialysis treatments. This was the company’s first win in a large public procurement process.

Collaboration partners

Some of Redsense Medical’s most important collaboration partners, according to the company, are the following:

- NxtStage Medical (acquired by Fresenius Medical Care)

NxtStage Medical is an American dialysis machine developer. The company has received two FDA approvals that are relevant for Redsense Medical: one for home nocturnal dialysis, and one for home dialysis by the patient without the assistance by another trained individual. These approvals require that the patient is using the NxtStage System One dialysis machine together with the Redsense alarm system.

Fresenius Medical, the world’s largest dialysis care company, acquired NxtStage Medical in August 2017.

- Nikkiso

Nikkiso is a Japanese company that develops dialysis machines as a part of its medical division. The company’s DBB-EXA model is the first to offer a direct connection to the Redsense alarm system. This enables the machine to automatically turn off the blood flow when a blood leakage is detected.

- Metro Medical

According to Redsense Medical, the United States based medical equipment distributor Metro Medical has a distribution agreement with one of the largest dialysis service providers in the United States with approximately 180 000 patients, including around 40 percent of all home dialysis patients in the country.

- Henry Schein

Henry Schein is the world's largest provider of health care products and services to office-based dental, animal health and medical practitioners.

Competitors

According to the company, and the fact that its optical technology is patented, the Redsense alarm system is the only product that use optical detection of blood leakage during hemodialysis on the market today.

There is however competing solutions and products using different technologies. The most important are:

a) Using medical personnel to monitor the dialysis patient during the whole treatment.

b) Alarm system based on venous pressure monitoring, that can be built into the dialysis machine. This type of system can also use changes in the sound characteristics from the patient’s heart as a way of monitoring the venous needle. An example of this is dialysis machines from Fresenius Medical Care with has this type of alarm system as a built-in feature. According to Redsense Medical, this technology is not as exact as optical blood detection as the venous pressure is sensitive to the patient’s movements, coughing, etc. Blood leakage can also occur when the venous needle is still partly attached, and these cases can be hard to detect with this technology, according to Redsense Medical.

c) External alarm systems that use an electrical current to detect blood leakage. This technology is based on the fact that blood conducts electricity. The product HEMOdialert by the company Anzacare, based in New Zeeland, is based on this technology. In November 2017, the HEMOdialert website was not functional which indicate that the HEMOdialert product has been discontinued.

Clinical trials

Redsense Medical has conducted clinical trials with the help of a number of European hospitals and their personnel to form the basis of the CE approval in Europe and the FDA approval in the United States. The study results showed 100 percent product functionality, that the product was easy to use and very few false alarms. Additionally, both medical personnel and patients felt an increased sense of safety.

Intellectual property

Redsense Medical has been granted several patents for its optical detection technology that covers the United States, Canada, Europe and the Asia-Pacific region. The company also own registered trademarks and other additional intellectual property related to the Redsense brand and product line.

Regulatory demands regarding patient safety

The EU directive on medical equipment stipulates that manufacturers of medical equipment, including dialysis equipment, must use publicly known state of the art products that increases patient safety.

According to the company, the Redsense alarm system is the only system for monitoring and detecting blood leakage during hemodialysis that fulfills these criteria. Furthermore, if this high standard of safety is not met, a dialysis clinic could be held responsible for maltreatment if a patient is injured or dies during the treatment.

The relevant regulations are the above-mentioned EU directive 93/42/EEC, the Code of Federal Regulations e-CFR 60c4 §494.60 Condition: Physical environment (United States) and the international standard IEC 60601-2-16.