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Dignitana receives FDA clearance

The US Food and Drug Administration (FDA) has granted Dignitana’s de novo application to market the DigniCap scalp cooling system, designed to reduce the severity of chemotherapy-induced hair loss.

After rigorous clinical studies and wide use overseas the DigniCap scalp cooling system is now FDA-cleared for use in the United States. The system, which is the only such device to have completed an FDA approved multi-center clinical trial, is used by patients undergoing chemotherapy infusion, and is cleared for use with treatment regimens associated with breast cancer.

Dignitana is currently finalizing agreements with major cancer centers and community oncology groups across the country so that they will be able to offer DigniCap to patients as soon as possible. Prior to clearance, the DigniCap scalp cooling system was clinically studied in women with breast cancer at some of the most prestigious medical centers in the nation.
“Some of today’s most powerful, life-saving chemotherapy treatments still cause complete hair loss, a side effect that many women consider to be emotionally devastating,” said Dr. Hope S. Rugo, Principal Investigator for the study and Director of Breast Oncology and Clinical Trials Education at the UCSF Helen Diller Family Comprehensive Cancer Center. “For the past several years, we’ve worked closely with Dignitana to conduct rigorous clinical trials that demonstrate the safety and effectiveness of the DigniCap system. This FDA clearance means that for many cancer patients in the U.S., chemo-induced hair loss will no longer be a distressing concern.”

In the U.S. clinical trial 7 out of 10 patients with early stage breast cancer kept at least 50% of their hair. With regards to safety, no severe adverse events were reported. While most patients had a feeling of chilliness during the cooling down period only 3 out of 106 trial participants discontinued for this reason. A patient reported satisfaction score (ranked from 0 to 100, with 100 being “completely satisfied”), showed a mean score of 87.5 satisfaction with the decision to use scalp cooling, a mean score of 70.9 for hair quantity, and a mean score of 69.1 for satisfaction with hair quality. In the U.S. trial, scalp cooling was evaluated mainly on regimens including taxanes (such as paclitaxel and docetaxel) but outside of the U.S. there is also experience from scalp cooling with anthracyclines (such as epirubicin and doxorubicin).


“We are thrilled to be able to advance the science of hair preservation for women who must undergo chemotherapy and to find ways to make life saving treatments more tolerable,” said Laura Esserman, M.D., M.B.A., Professor of Surgery and Director of the Carol Franc Buck Breast Care Center at the UCSF Helen Diller Family Comprehensive Cancer Center. “An FDA approved product that makes scalp cooling available for women across the country is extremely good news.”

“This FDA clearance means that finally, breast cancer patients in the U.S. will have access to a convenient, safe and scientifically proven option for reducing chemotherapy-induced hair loss,” said Jan Richardsson, Chief Executive Officer for Dignitana. “We are tremendously excited to be able to offer this state-of-the-art technology to hospitals and infusion centers across the U.S.”



Source: Dignitana