Redsense Medical AB (publ)
|Founded 📆||2006 in Halmstad, Sweden|
|Headquarters 🏙️||, |
Area served 🗺️
|Worldwide, mainly Europe and the United States|
Number of employees
Redsense Medical is a Swedish publicly traded medical devices company that focuses on supervision of hemodialysis treatment to prevent blood loss from venous needle dislodgement. The company's main market is the United States, but it also maintains active operations throughout Europe. It was established in Halmstad, Sweden, in 2006.
Redsense Medical's main product is the Redsense Alarm. This device is an alarm system for hemodialysis treatment that continuosly monitors a vascular access for blood leakage by optical means. The device is FDA cleared for in-center and at-home use and has in a 2017 review published in the Clinical Journal of the American Society of Nephrology been suggested for use in high-risk patients and patients receiving hemodialysis treatment at home. An evidence review carried out in 2009 by the UK National Health Service concluded that the Redsense blood loss detector may be of value in high risk patients, but discouraged general use on the basis of a cost-benefit analysis.
In addition to the Redsense Alarm, Redsense Medical has initiated development and prototyping of other applications of the proprietary thin sensor layer which forms the basis for the company's technology, such as bandages and plasters for the global wound care market with built-in ability to perform optical measurements of blood and exudate.
Hemodialysis entails that the blood of a patient is first drawn from a vascular access site at a rate of approximately half a liter per minute, then circulated through a dialysis machine outside the body to be purified, and finally returned to the patient's bloodstream through a second vascular access. A rare but potentially fatal complication of hemodialysis treatment is rapid blood loss from venous needle dislodgement, which may occur if the needle is not properly attached to the venous access, if the bloodline is pulled, or if the needle for some other reason becomes disconnected during the process. Due to the high rate of blood flow during hemodialysis, the leakage resulting from VND can cause the onset of hemorrhagic shock within minutes unless the blood flow is stopped by turning off the dialysis machine's pump.
To detect leakage, an absorbent, disposable sensor patch is attached to the immediate vicinity of the access point and connected to the device with a fiber-optic cable, which carries a light signal. If the sensor detects any presence of absorbed blood in the patch, the device triggers an audio-visual alarm to alert patients and carers of the emergency.
Some manufacturers support the connection of the Redsense device to allow blood flow to be stopped automatically. The device can also be connected to the nurse call system of the clinic. As an accessory to the alarm unit, the Redsense Clamp device, currently in prototype testing, is intended to provide functionality for automatic stop of bloodflow regardless of the type of dialysis machine in use during treatment.
U.S. Department of Veterans Affairs
In 2010, the U.S. federal agency Department of Veterans Affairs, which provides healthcare services to 9 million military veterans through a nation-wide network of clinics, issued a patient safety alert making use of the Redsense Alarm mandatory for patients identified as being at risk of venous needle dislodgement. The decision followed an analysis of previous bleeding episodes in the dialysis facilities operated by the agency, where the dialysis machines in many cases had failed to alarm. The review was based on more than 3.5 million instances of treatment.
Redsense Medical has been studied and cited as a case example in the field of international business study in the context of internationalization of enterprises in high-technology industries, held up as a counter-example of the so-called Uppsala model of internationalization. The Uppsala model suggests that firms intensify their activities in foreign markets gradually, by first gaining domestic experience and then expanding to similar, nearby countries first, reaching more distant countries and more complex modes of operation only in later stages. In contrast, Redsense is described as an example of a new emergence of so-called Born Globals or International New Ventures (INV:s), companies that internationalize within a few years of inception without necessarily establishing themselves on the domestic market first.
In Redsense's case, the company was forced to internationalize to aquire sufficient market shares to reasonably break even. The early move to the U.S. market is attributed in part to the stricter regulations there which acted as a driver of demand, in contrast to many other life science companies where the regulations on foreign markets often act as a cultural hurdle. The company's use of international networks has been considered an important component of its internationalization process.
- Co-founder Daniel Engwall is tasked with developing countermeasures against a series of incidents of venous needle dislodgement in Halmstad County Hospital.
- A patent for the monitoring technology was filed in 2004.
- The company was established in 2006 by Patrik Byhmer, the company's current chief executive, and Daniel Engwall, to commercialize the patent and initiate clinical testing of the product in Swedish hospitals.
- The technology obtained FDA approval in 2007 and was used in clinical practice in thirteen countries by 2011.
- U.S. department of Veteran Affairs (VA) makes the use of Redsense for high-risk patients mandatory.
- The company was near bancruptcy in 2012 and underwent reconstruction.
- In 2015, the company was listed on the Swedish stock market for the first time.
- In May 2019, Redsense Medical changed listing from the Nasdaq First North stock exchange to the Swedish multilateral trading facility Spotlight Stock Market.
Redsense has received the Frost & Sullivan best practices award and the 2008 European Hemodialysis emerging company of the year award.
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