Dignitana AB announced that a long-term study of The DigniCap Scalp Cooling System was presented by Dr. Hope Rugo at the Multinational Association of Supportive Care in Cancer Annual Meeting in June and has now been published in the journal Supportive Care in Cancer. With a five-year follow-up period, this is the first long term study of scalp cooling to be published. The DigniCap Long Term Safety study followed patients for five years to evaluate risk of metastases and concluded that: Scalp cooling using DigniCap in patients with early-stage breast cancer receiving taxane based neo/adjuvant chemotherapy is safe and effective.

Recurrences occurred in a small number of patients as expected. No scalp metastases were observed. There is no evidence that scalp cooling increases the risk of scalp metastases.

DigniCap is used to minimize chemotherapy induced hair loss in patients with solid tumor cancers. In 2015 the initial phase of this study led to DigniCap becoming the first scalp cooling device to receive FDA clearance, thereby introducing safe and effective scalp cooling to the United States. This pivotal trial achieved clinically superior results, with the majority of patients keeping at least 50% of their hair while undergoing chemotherapy.

The pivotal trial was led by Dr. Hopeugo at UCSF with five pivotal trial sites: University of California San Francisco Comprehensive Cancer Center, San Francisco; Icahn School of Medicine at Mount Sinai, New York; University of California Los Angeles; and Weill Cornell Medical College, New York.