The DigniCap Scalp Cooling System has been used around the world since 2001. In 2015, after a multi-center clinical trial, DigniCap became the first scalp cooling system to receive FDA clearance in the United States.
THE DIGNITANA ADVANTAGE
Superior results in the pivotal trial for FDA clearance
DigniCap achieved 66.3% success with taxanes in the U.S. clinical trial vs the competitor’s success rate of 59% with taxanes and 50.5% overall.
Longer clinical trial treatment evaluation period
More hair loss will occur with a greater number of treatments. For accuracy, success must be measured at end of treatment. In the clinical trial, DigniCap was evaluated one month after the end of all the patient’s chemotherapy cycles, whereas the competitor’s trial was evaluated after just four chemotherapy sessions.
Innovative cooling technology
DigniCap Delta is the only scalp cooling system that uses thermoelectric cooling for precise temperature control and device reliability.
Flexible cap for precise fit
DigniCap Delta uses a flexible cooling wrap and adjustable thermal cap to achieve uniform contact for optimal results.
In 2015, DigniCap became the first scalp cooling device to receive FDA clearance. After an extensive review of worldwide studies, in 2017 the FDA expanded the clinical indication for DigniCap to include men and women with solid tumors. DigniCap Delta, the next generation of The DigniCap Scalp Cooling System, was FDA cleared in June 2019.
DigniCap is currently available in hundreds of locations worldwide.
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