|DigniCap Intelligent Scalp Cooling System--Courtesy of Dignitana|
Most traditional chemotherapy is designed to kill errant cancer cells. But, unfortunately, sometimes it can also inadvertently damage healthy tissues as well. The FDA has cleared technology designed specifically to protect the hair follicles of female breast cancer patients as they undergo chemotherapy. A common side effect of chemotherapy treatments for breast cancer is temporary hair loss.
The clearance is the first from the U.S. regulatory agency for a cooling cap to reduce hair loss in female breast cancer patients undergoing chemotherapy. Dubbed the DigniCap Cooling System, it is marketed by publicly listed Swedish company Dignitana. The micro-cap saw its share price rise by more than one-third in early trading on news of the decision; its valuation has more than tripled so far this year but it remains below $50 million.
"We are pleased to see a product for breast cancer patients that can minimize chemotherapy-induced hair loss and contribute to the quality of life of these individuals," said Dr. William Maisel, acting director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, in a statement. "Managing the side effects of chemotherapy is a critical component to overall health and recovery."
The system is based on the circulation of cooled liquid through a head-worn cooling cap during chemotherapy treatment. The idea is to reduce the blood flow that would circulate the toxic chemotherapy to hair follicles on the scalp via constriction of the blood vessels due to the cold.
It also slows the cell division being conducted within the hair follicles, thereby reducing the effects of the chemotherapy. The device may not work with some chemotherapy regimens. It was studied in a U.S. trial of 122 women with Stage I and Stage II breast cancer who were undergoing chemotherapy. The cap was used during chemotherapy treatments. About one month after treatment, more than 66% of these patients reported losing less than half of their hair. These data is thought to be transferable to Stage III and Stage IV breast cancer patients as well.
The trial mainly evaluated women on regimens including taxanes such as paclitaxel and docetaxel; but the company notes that ex-U.S. it's also had positive results with scalp cooling for patients on anthracyclines such as epirubicin and doxorubicin.
"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 Rugo, Principal Investigator for the study and Director of Breast Oncology and Clinical Trials Education at the UCSF Helen Diller Family Comprehensive Cancer Center.
She added, "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."
Dignitana said it's already finalizing sales agreements with major cancer centers and community oncology groups around the country. The company added that it's working with payers in hopes of gaining coverage for use of the cap; it's also working with philanthropic groups and corporate donors to get scalp cooling technology to as many patients as it can as quickly as possible and to help defray patient costs.
DigniCap offers gradual, regulated scalp cooling, unlike manual cold caps that require manual replacement every 30 minutes. The most commonly reported side effect of the system include cold-induced headaches as well as neck and shoulder discomfort, chills, and pain associated with wearing the cooling cap for an extended period of time.
The DigniCap was cleared via FDA's de novo classification process, which is pathway for low to moderate risk devices that are also novel and without substantial equivalents.
- here are the announcements from the FDA and Dignitana