The DigniCap™ is a system which induces scalp hypothermia (scalp cooling) to prevent chemotherapy-induced alopecia (hair loss). The DigniCap™ system consists of a refrigerator unit integrated into a control unit based on a computerized interface. This system forms a compact mobile cabinet which is connected to a soft and tight-fitting silicon cap via a tube. A liquid coolant is pumped from the cooled reservoir in the cabinet to circulate through small canals within the cap. Two separate cooling circuits allow coolant to flow through the front and back of the cap autonomously. Scalp temperature is monitored by three separate sensors in the cap: two temperature sensors and a security sensor. Deviations from the preset temperatures are immediately detected and automatically adjusted by the system (scalp temperature can be controlled with an accuracy of ± 1.0°C). An outer cap made of neoprene is used to secure and isolate the inner silicon cap.

The treatment period typically commences approximately 30 minutes before chemotherapy and must continue for 30 to 150 minutes after the conclusion of treatment (cooling time is dependent on the type of chemotherapy regimen used). Two patients can be treated simultaneously as the DigniCap™ actually has two independently controlled systems in one machine.

Temperature graphs for each treatment are shown on the touch-screen display for visual monitoring. The system maintains a controlled scalp temperature during the entire chemotherapy treatment period. The treatment setting on default can easily be changed through touch-screen via a virtual keypad.

The DigniCap™ system is used in a number of hospitals in Scandinavia and has prevented alopecia in a high percentage of patients treated by several chemotherapy drugs which cause hair loss. A number of published clinical trials convincingly demonstrate the DigniCap™ to have reliable efficacy and to present a favorable safety profile, when used as scalp hypothermia system (Lundgren-Eriksson et al, 1999; Henriksen et al 2003; Ridderheim et al, 2003; Byachov, 2006; Kobayashi et al, 2008).

Certifications: Dignitana AB has ISO 13485:2003 certification.
The DigniCap™ has CE-mark MDD 93/42/EC