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Lund, Sweden – February 13, 2017—Dignitana AB, a world leader in medical scalp-cooling technology, announced today that the DigniCap® scalp cooling system, which was cleared in December 2015 by the U.S. FDA to effectively reduce the likelihood of chemotherapy-induced hair loss in women with breast cancer, will be available at all Memorial Sloan Kettering Cancer Center (MSK) facilities that treat breast cancer.
The DigniCap® system is the first and only scalp-cooling device to receive FDA clearance. In the rigorous FDA clinical trial, seven out of ten patients with early-stage breast cancer kept at least 50% of their hair. The demand for the FDA-cleared DigniCap® system has been significant this year in the United States.
MSK, a world leader in cancer patient care, research, and educational programs, will now have the 17 units ordered in December of 2016 available for use by female patients undergoing breast cancer treatment in eight of their outpatient facilities in the New York City area. These include MSK Basking Ridge and MSK Monmouth, in New Jersey; MSK Westchester, in Westchester County, New York; and MSK Commack and MSK Rockville Centre, on Long Island, in addition to their Manhattan and Brooklyn locations.
“Scalp cooling is clinically proven and can be an important tool for many women in treatment for breast cancer,” says Mario Lacouture, MD, Director of the Oncodermatology Program at MSK. “As a world leader in comprehensive cancer care, we are proud to be able to offer our patients across the New York metro area this new FDA-cleared advancement that addresses one of the most distressing and most visible side effects of chemotherapy.”
“Bringing the DigniCap® system to MSK is an important milestone for Dignitana,” says William Cronin, Chief Executive Officer of Dignitana, Inc., the U.S. subsidiary of Dignitana AB. “We have just passed the one-year anniversary of clearance by the FDA for DigniCap® in the U.S., and we are proud to add Memorial Sloan Kettering, one of the top comprehensive cancer centers in the U.S., to the growing number of facilities that are providing this treatment option to patients on a large scale.”
The DigniCap® clinical team is working directly with the clinical practitioners at each of the eight MSK sites to train and certify staff on the machine. This is the largest scalp-cooling installation at any medical center to date in the U.S. Nearly 100 nurses and other medical personnel will be trained in preparation for the launch of this service at MSK in the Spring of 2017.
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.
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About Dignitana AB (publ)
Dignitana is a Swedish public company, based in Lund, and manufacturer of the medical cooling device DigniCap®. Dignitana AB is listed on the OMX Nasdaq First North stock exchange and has appointed Erik Penser Bank as Certified Adviser. Headquartered in Dallas, Texas, Dignitana, Inc. is the U.S. subsidiary of Dignitana AB. For more information visit www.dignitana.com.
About Memorial Sloan Kettering
We are the world’s oldest and largest private cancer center, home to more than 14,000 physicians, scientists, nurses, and staff united by a relentless dedication to conquering cancer. As an independent institution, we combine 130 years of research and clinical leadership with the freedom to provide highly individualized, exceptional care to each patient. And our always-evolving educational programs continue to train new leaders in the field, here and around the world. For more information, go to www.mskcc.org.