Dignitana announces that the DigniCap scalp cooling system, which was cleared in December 2015 by the FDA to reduce the likelihood of chemotherapy-induced hair loss in women with breast cancer, will soon be available in nine additional medical centers across the United States including the four locations of University of Miami Health System that were contracted in November 2016.
The DigniCap system is the first scalp cooling device to complete rigorous FDA clinical trials in America, where seven out of ten patients with early-stage breast cancer kept at least 50% of their hair. Dignitana continues to rapidly expand its reach across the U.S. as demand for the medical device accelerates, securing contracts with 57 medical centers across 18 states.
“Demand for DigniCap in the U.S. continues to build—especially after the recent publication of such positive study results in the Journal of the American Medical Association,” said William Cronin, Chief Executive Officer of Dignitana Inc, the U.S. subsidiary of Dignitana. “We are pleased and honored to be able to work with so many patient-focused medical centers and have the opportunity to help them provide their breast cancer patients with the only FDA-cleared medical device to reduce hair loss while undergoing chemotherapy.”
The DigniCap scalp cooling system features a patented tight-fitting silicone cooling cap that is placed directly on the head, and an outer neoprene cap that insulates and secures the silicone cap. The cooling cap is connected to a cooling and control unit with touch screen prompts. A liquid coolant circulates throughout the silicone cap, delivering consistent and controlled cooling to all areas of the scalp. The cap is fitted to the head, and the temperature of the scalp is lowered, resulting in vasoconstriction with reduced delivery of chemotherapy to the scalp, as well as reduced cellular uptake of drugs due to decreased intra follicular metabolic rate. These factors together reduce the risk of chemotherapy-induced hair loss.