Dignitana

"Patient safety is critical in the administration of scalp cooling, and we are pleased that this final phase of our pivotal trial has now been published to clearly demonstrate the safety of this therapy and to reiterate the efficacy of DigniCap shown in the pivotal trial," said Catarina Löwenadler, CEO of Dignitana.  

 "In the pivotal trial 66.3 percent of patients using DigniCap kept the majority of their hair using the Dean scale. We are now seeing even better results with our next generation DigniCap Delta device, with 75 percent of patients reporting a high degree of satisfaction on the same scale. Additionally, 94 percent of DigniCap patients surveyed state they would recommend DigniCap to others, and that level of endorsement is a significant accomplishment for any business," she said.

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.

The study poster may be viewed here: Long-term Safety Follow-Up of Patients with Early Stage Breast Cancer

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 percent of their hair while undergoing chemotherapy.

The pivotal trial was led by Dr. Hope Rugo 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.