The device is the DigniCap which is marketed by a Swedish company called Dignitana It is designed to circulate cold liquid through a snug-fitting cooling cap made of silicone while the patient undergoes chemotherapy treatment. The system reduces blood flow to the head by constricting the blood vessels, thereby reducing the circulation of the toxic chemotherapy drugs to the hair follicles on the scalp.
In order to receive FDA approval, Dr Hope Rugo of the University of California, San Francisco conducted a clinical trial of 122 women with Stage I and Stage II breast cancer who were undergoing chemotherapy. She commented “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.” After one month of treatment, two-thirds of the patients reported losing less than half of their hair.
The DigniCap incorporates a separate sensor that ensures the temperature never drops below freezing point. Among the reported side effects are cold-induced headaches, together with neck and shoulder discomfort, as well as mild pain associated with long-term use. The system (seen at left) has two independently controlled cooling systems that enable the simultaneous treatment of two patients. Interestingly, the DigniCap was approved via the FDA’s de novo classification approach, which is a pathway designed for devices with low to moderate risk that are novel and no equivalent device exists.
With the news of FDA approval, Digitana – which has a United States patent and is listed on the NASDAQ stock exchange – saw its stock price increase by more than one-third and its market capitalization approach $50 million. This is good news for the company but also for American women who now have access to a technology that’s been available to patients in Europe for more than a decade.