Redsense Medical - The company

After a number of incidents, cooperation between technicians at a dialysis clinic in Sweden and a company specialising in medical technology led to the creation of Redsense Medical in 2006. The company has offices in Halmstad, Sweden, in Chicago IL, USA and in Senai, Malaysia. The Redsense Medical device for blood loss detection has global patent protection

Redsense Medical was awarded as "The 2008 European Hemodialysis Emerging Company of the Year" by Frost & Sullivan.

Redsense Medical Background

Dialysis equipment must provide a system to protect the patient from blood loss due to dislodgement of the venous needle. Although it is currently permissible that this requirement can be met by venous pressure moitoring, a better solution has long been requested by the medical staff.
Studies of serious incidents have showed that even complete disconnections may remain undetected if the venous pressure alarm limit is not properly set. Even with properly set alarm limits, the venous pressure monitor may not alarm. (ref.10)

Considerable, or even fatal, blood loss can occur when the venous needle becomes dislodged. Annual death figures caused by venous needle dislodgement in the US vary between 5 and 10. (ref.2)

Redsense Medical give peace of mind to patients and to medical staff

Despite the majority of dialysis treatment being conducted under the supervision of medical staff, the venous needle can still become dislodged. The resultant blood loss may not be detected immidiately. It takes only a few minutes before such blood loss can prove terminal.

With Redsense, each patient can rest assured that they can rest or change position without risking an undetected dislodgement of their venous needle. This is for inestimable worth for all patients, but even more so for patients visiting self-dialysis centers or performing dialysis at home, on their own.

Redsense Medical easy to use optical fiber technology

The device has two parts: a sensor and an alarm unit. Connected to the alarm unit by a small wire, the sensor patch employs fiber optic technology to continouslymonitor the venous neddle access point. If bleeding begins, the alarm will be raised by the alarm unit worn on the patients arm.

Redsense Medical The growing market

There are 1.5 million dialiysis patients worldwide who are given 200 million hemo-dialysis treatment every year. The market is increasing due to an ageing population and the rise of diseases such as diabetes type II. At the same time, the survival rate for dialysis patients is garadually improving.
Independent treatment forms like self-and home dialysis currentlymake up a very small part of all dialysis, but many countries strive to offer these alternatives to more patients

With nocturnal hemodialysis 5-6 times per week at home, there are less medical complications and patientslive better and longer lives. The added safty provided by Redsense Medical becomes very valuable for these patients. Besides all the advantages on the individual level, home dialysis is also more economical treatment form.

Improtant:

Indication(s) for Clinic usein the United States The Redsense device is intended to monitor for potential blood loss from the hemodialysis access site in hemodialysis patients undergoing continous hemodialysis treatmentup to 5 hours in the clinical setting. The device includes a blood sensor incorporated into an adhesive sensor patch. The sensor monitors potential blood leakage from the venous needle puncture site via an infrared light and will alarm if blood leakage is detected via absorption onto the device´s sensor patch.

Indication(s) for Home/Self use in the United States The Redsense device is intended to monitor for potential blood loss from the hemodialysis access site in hemodialysis patients undergoing hemodialysis treatment up to 5 hours at home or in the clinical setting. THe device includes a blood sensor incorporated into an adhesive dressing. The sensor monitors potential blood leakage from the needle puncture via a infrared light and will alarm if needle dislodgement or blood leakage is detected.
All use must be administrated under physician´s prescription, and must be observedby a trained and qualified person considered to be competent in the use of this device by the prescribing physicians.

Redsense Medical Production & Sales

Redsense iss approved for European sales and has been granted the CE mark. Redsense is also available in the US after receiving a clearance letter form US authority FDA in October 2007 (a 510k application) for hemodialysis in the clinical setting and in May 2010 for home hemodialysis. "Intended use" differs between Europe and the US and more information can be found in "Downloads & Links".
Production started in December 2007.
For more information, please contact CEO, PAtrik Byhmer.