DigniCap long-term study demonstrates safety and efficacy of scalp cooling to reduce chemo hair loss
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.
“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.
For More Information Contact
Melissa Bourestom, Chief Communications Officer, melissa.bourestom@dignitana.com +1 469-518-5031
About Dignitana
Dignitana AB is the world leader in clinically superior scalp cooling technology. The company produces The DigniCap® Scalp Cooling System, a patented medical cooling device that offers cancer patients the ability to minimize hair loss during chemotherapy. FDA cleared since 2015, DigniCap provides continuous cooling with high efficacy, safety and patient comfort. Hailed internationally as a life-changing medical advancement for cancer patients, The DigniCap Scalp Cooling System was invented in 1999 by a Swedish Oncology nurse and has been available in Europe since 2001. Dignitana AB is listed on Nasdaq First North Growth Market in Sweden with headquarters in Lund, Sweden and US operations based in Dallas, Texas in the United States. Company subsidiaries are Dignitana, Inc. in the United States and Dignitana S.r.l. in Italy. Certified Adviser is Redeye AB. Learn more at www.dignitana.com or www.dignicap.com.
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