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  • FDA-CLEARED DIGNICAP® SCALP COOLING SYSTEM IS NOW AVAILABLE FOR WOMEN WITH BREAST CANCER AT 10 U.S. CANCER TREATMENT CENTERS
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FDA-CLEARED DIGNICAP® SCALP COOLING SYSTEM IS NOW AVAILABLE FOR WOMEN WITH BREAST CANCER AT 10 U.S. CANCER TREATMENT CENTERS

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First and Only FDA Cleared Scalp Cooling Device To Reduce Chemotherapy Related Hair Loss Provides an Alternative to One of the Most Devastating Side Effects Feared by Patients with Breast Cancer

Lund, Sweden —March 29, 2016—Dignitana Inc., a world leader in medical scalp-cooling technology, announced today that the DigniCap® scalp cooling system, which was cleared by the FDA in December to effectively reduce the likelihood of chemotherapy-induced hair loss in women with breast cancer, is now available at ten cancer treatment centers across the United States. Scalp cooling is administered alongside chemotherapy in medical infusion centers.

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 10 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.

The following cancer treatment centers will be the first 10 sites in the U.S. to provide the DigniCap® scalp cooling system in their breast cancer treatment regimens:

Wake Forest Baptist Medical Center in North Carolina was the first medical center in the United States to sign an agreement with Dignitana in order to offer the DigniCap® system to patients undergoing chemotherapy for breast cancer, while UT Health Science Center’s Cancer Therapy & Research Center in San Antonio was first to actually use the device for treatment. Dr. Hope Rugo at UCSF’s Helen Diller Family Comprehensive Cancer Center, principal investigator for the FDA multi-center clinical trial, and Dr. Susan Melin at Wake Forest Baptist, principal investigator for the trial there, originated early clinical trials and shepherded studies throughout the FDA process.

“We are proud to have helped bring this new treatment option to women in the U.S.,” says Dr. Hope S. Rugo, Principal Investigator for the study and Director of Breast Oncology and Clinical Trials Education at the UCSF Helen Diller Family Comprehensive Cancer Center. “A breast cancer diagnosis is traumatizing enough, there’s no need to add fear of hair loss to the experience.”

"We are very excited to be the first oncology practice in the area to provide the DigniCap system to our breast cancer patients. Losing hair during chemotherapy can be a devastating experience and no woman should have to go through such physical and emotional trauma in this day and age,” comments Dr. Young Lee from Chesapeake Oncology & Hematology COHA. “In the past, we have used different types of scalp cooling caps that were very cumbersome and labor intensive. DigniCap makes the process so much easier and is truly a breakthrough technology that will forever change the lives of breast cancer patients. Cancer will no longer take your hair and your identity away. You are in control. No more stigma!"

“The availability of DigniCap to improve the quality of life and enhance the self-image of patients undergoing chemotherapy provides a tremendous boost to cancer patients and their families,” said Dr. Cathie Chung, a hematology/oncology physician at The Angeles Clinic and Research Institute, an affiliate of Cedars-Sinai. “It’s about time that we have a safe, effective and comfortable way to prevent chemotherapy–induced alopecia, as this can be the most devastating side effect of therapy for many patients.“

“We are very excited about this first group of 10 sites offering the DigniCap scalp cooling system to their patients. They represent an excellent cross section of the oncology industry and range from large research hospitals to specialty community practices,” said Bill Cronin, COO of Dignitana, Inc., which is headquartered in Dallas, Texas. “We are grateful for the opportunity to work with these facilities and all of those we will be bringing on across the country to begin the process of helping women deal with this most unfortunate side effect of chemotherapy.”

To learn more about the DigniCap® scalp cooling system please contact one of the treatment centers or visit www.DigniCap.com.

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 Bankaktiebolag 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.

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