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Lund, Sweden and Dallas, TX – November 7, 2016—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 FDA to effectively reduce the likelihood of chemotherapy-induced hair loss in women with breast cancer, will soon be available in 13 additional medical centers in the United States.

The DigniCap® system is the first and only 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.

Demand for the FDA-cleared DigniCap® system continues to be strong, with orders for 22 additional units coming in this week. The orders represent contracts with three healthcare providers and will be placed in 13 medical centers across four states. This means that DigniCap® is now contracted for 53 medical centers across 17 U.S. states in its first year of production.

“We’re very excited by this growth and expansion in the U.S., which is fueled by patient and physician demand,” says William Cronin, Chief Operating Officer of Dignitana, Inc., the US subsidiary of Dignitana AB. “In line with our goals for 2016, we are pleased to be able to make this quality of life option available for as many patients across the US as possible.”

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.

Media Contacts:

USA                                                                                        Sweden

Caren Browning                                                                   Semmy Rülf

King + Company                                                                   Chairman of the board, Dignitana AB

00 1 212 561-7464                                                               0046 (0)709 312730

Caren.Browning@kingcompr.com                                 semmy.rulf@gmail.com



The information in this press release is such that Dignitana AB must disclose it in accordance with the EU market abuse regulation. The information was submitted, by the above contact, for publication at 17.00 (CET), November 7, 2016.


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