FDA-CLEARED DIGNICAP® SCALP COOLING SYSTEM COMES TO THREE MORE U.S. CANCER TREATMENT CENTERS
DigniCap® Scalp Cooling System Helps Cancer Centers Provide Patients with
an Alternative to One of Breast Cancer’s Most Devastating Side Effects
Dignitana Release - wkr0006.pdf
Lund, Sweden—April 18, 2016—Dignitana AB, a world leader in medical scalp-cooling technology, announced today that the DigniCap® scalp cooling system, which was recently cleared by the FDA to effectively reduce the likelihood of chemotherapy-induced hair loss in women with breast cancer, is now also available at cancer treatment centers in Tampa and Palm Beach, Florida and Battle Creek, Michigan. Since FDA clearance in December, thirteen U.S. medical centers have begun the process of introducing the DigniCap® scalp cooling system to their patients. Agreements with dozens more are currently in motion.
The DigniCap® system is the first and only scalp cooling device to complete rigorous FDA clinical trials in the U.S., where seven out of ten patients with early-stage breast cancer kept at least 50% of their hair.
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.
Bronson Battle Creek Cancer Care Center in Battle Creek, Michigan and two leading cancer centers in Tampa and Palm Beach, Florida are now in the process of installing the DigniCap® system and incorporating treatments into their patients’ regimens.
“We are very excited to be moving so quickly to fulfill U.S. medical center requests for the DigniCap® scalp cooling system, and proud that these prestigious cancer centers have signed Dignitana as a partner to help provide their patients with an alternative to the emotionally traumatic side effect of chemotherapy related hair loss,” said Jan Richardsson, Chief Executive Officer of Dignitana. “After years of clinical trials, we are pleased to be able to offer physicians and medical centers in the United States a scientifically proven procedure that infusion centers can readily incorporate into their treatment protocols.”
Media Contact:
Jan Richardsson
CEO, Dignitana AB (publ)
Ph +46 (0)46 16 30 92
E jan.richardsson@dignitana.com
About Dignitana AB (publ)
Dignitana is a Swedish public company, based in Lund, and manufacturer of the medical cooling device DigniCap®. Dignitana is continuously researching and developing new uses for DigniCap®. Dignitana AB is listed on the OMX Nasdaq First North stock exchange and has appointed Erik Penser Bank as Certified Adviser. For more information visit www.dignitana.com
About the scalp cooling system DigniCap®
Dignitana’s core product - DigniCap® - is a patented scalp-cooling system that offers cancer patients the ability to keep their hair during chemotherapy. DigniCap® is developed to provide continuous cooling with high efficacy, safety and acceptable patient comfort.
Dignitana launches new initiatives to support reimbursement and market access