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FDA's expanded clearance enables Dignitana's scalp cooling technology DigniCap®, to be used when patients undergoing chemotherapy are treated for solid tumor cancers in the United States. The decision gives Dignitana the opportunity to offer DigniCap® to about 800,000 patients in the US market per year.

Lund, Sweden - July 3, 2017 - Dignitana AB, a world leader in medical scalp cooling technology and manufacturer of the DigniCap® Scalp Cooling System, announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to expand use of its medical device to patients in the United States receiving chemotherapy for solid tumor cancers. The decision means that medical facilities may use DigniCap® to reduce hair loss in patients treated for solid tumor cancers such as breast, prostate, ovary, uterus, lungs and other tissues.

The approval from the FDA is an extension of the decision taken by the authority in 2015 when Dignitana was the first scalp cooling company granted permission to use the patented technology for treating women with breast cancer in the United States. Today's decision means that Dignitana once again is first, now to be able to provide the option to use DigniCap® to about 800,000 cancer patients annually diagnosed with different types of solid tumors cancers (cancer.org).

Dignitana estimates that the market for scalp cooling of breast cancer patients in the United States is worth about US $ 50 million a year, based on an average number of chemotherapy treatments. With the expanded clearance, Dignitana expects to gain access to a market worth somewhere in excess of $ 140 million annually.

"The new decision by the FDA means that our potential market in the US is more than tripled," says Johan Ericsson, CEO of Dignitana AB. "It also means a significantly stronger market position for our brand and business. The expanded indication also shows how well developed and carefully tested our scalp cooling technique is. It is with confidence that we now prepare to reach out to an even greater number of cancer clinics and patients in our main market."

In the United States, DigniCap® is available at more than 80 cancer clinics in 21 states, helping thousands of patients each year to minimize chemotherapy-induced hair loss.

Read more on the FDA website: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm565599.htm 

Corporate contact                                                                   Press contact                                                 

Johan Ericsson                                                                          Anja Trägårdh                                             

Chief Executive Officer                                                              Trägårdh Kommunikation                                                             

+46 46 16 30 92                                                                         +46 709 346664

johan.ericsson@dignitana.se                                                     anja@tragardhkommunikation.se

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 Nasdaq First North Stockholm 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.se

About The DigniCap® Scalp Cooling System

DigniCap® is a patented scalp cooling system that offers cancer patients the ability to keep their hair during chemotherapy. DigniCap® provides continuous cooling with high efficacy, safety and acceptable patient comfort. www.dignicap.com

This information is information that Dignitana AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, by the above contact, for publication at 21:15 (CET), 3 July, 2017. 



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The new decision by the FDA means that our potential market in the US is more than tripled.
Johan Ericsson