Headquartered in Halmstad in the south of Sweden, Redsense Medical began as a project in 2000 with the goal of developing the first monitoring system for venous needle dislodgement during HD, and in 2006 it was incorporated into the legal entity Redsense Medical AB. The Company was founded as a spin-off from the Swedish company Innovation Team, which is a well-established design company within the medical device sector, to develop and commercialize its proprietary technology.
In 2000 and after a number of incidents with venous needle dislodgement during HD at the dialysis clinic, Halmstad County Hospital in Sweden, the clinic’s key technician realized that these incidents were far from unique, and that existing alarm systems were widely notorious for malfunctioning. The technician contacted Daniel Engvall, cofounder of RSM, looking for a solution to this problem. Together, and with input from the local university, they developed the first ever product to solve what has been a well-known problem with HD – to efficiently and securely monitor blood access points. The team’s extensive collective experience of medical technical products and systems enabled them to solve the problem.
In late 2003 the development of the first product prototype was finalized and in 2004 a patent protecting its basic technology was filed. During the development process, the team evaluated existing methods and, instead of attempting to measure activities inside the body or the dialysis equipment, designed a device which keeps an eye on the access points and monitors for the first sign of blood loss. An absorbent patch, which contains a blood sensor, is placed directly over the venous needle blood access point to absorb the blood that flows out from the patient in a situation where venous needle dislodgement occurs. The sensor inside the patch is connected to an external alarm unit to allow the sensor patch to be as small and simple as possible. Another important benefit of the solution is that it enables reuse of the alarm unit.
- Production starts of the Next Generation Redsense device.
- Launch of the Next Generation Redsense device starts in April.
- Redsense receives financing from the EuroStars project in September.
- The Next Generation Redsense device was CE marked as a registered medical device and approved for sale in Europe.
- FDA clearance of the Next Generation Redsense device, approved for sale in USA.
|2011 - 2012
- Diaverum announces that they will do a risk assessment on all their patients and recommend their clinics to use Redsense to certain risk patients.
- Redsense is honored by a listing on the “33-list” from the leading business magazine in Sweden as one of the 33 most interesting start-ups in Sweden.
- Cooperation agreement with a several companies within the dialysis business is initiated.
|2000 - 2010
- The work with developing a blood loss detection device was initiated in early 2003; following on from the birth of the idea in 2000.
- The first prototype of the Redsense device was finalized and tested at Halmstad County Hospital.
- Patent covering sensor technology for detection of blood leakage from wounds was filed in Sweden.
- The Redsense project was incorporated into Redsense Medical.
- Development of the second generation of the product prototype was finalized, including fine-tuning of the software and design improvements.
- Clinical trial including were carried out at five hospitals in Sweden.
- In 2007 the Redsense device was CE marked approved for sale in Europe.
- In May the Company received its first initial order, from the clinic of the Royal Western Infirmary Hospital in Glasgow, Scotland in connection with its evaluation of Redsense.
- In September Redsense held its European launch meeting during the EDTNA congress in Florence and gained significant interest for its device.
- In October 2007 Redsense obtained FDA 510k clearance.
- Redsense Medical receive the 2008 European Hemodialysis Emerging Company of the Year Award from the esteemed analyst firm Frost & Sullivan in September.
- Redsense Medical Sweden received ISO 13485 clearance in 2008.
- Redsense and Redsense Medical became registered trade marks in 2008 within the EU.
- Redsense obtained FDA 510k clearance for Home Hemo Dialysis & nocturnal clinic usage (8 hour).
- US government of Veteran Affairs makes in mandatory to use Redsense for risk patients.