WEILL CORNELL Medical College opens FDA Approved Clinical

DigniCap® Scalp Cooling System Now Available at Leading U.S. Medical Centers NEW YORK – AUGUST 23, 2013 — Dignitana, a world leader in medical scalp-cooling technology, announced today that Weill Cornell Medical College in New York will be part of its multi-center pivotal trial of the patented DigniCap® System for the prevention of chemotherapy-related hair loss. The trial, which was recently approved by the FDA, is part of the second and final phase of study in the United States and paves the way for FDA market approval of the scalp-cooling device, which is already widely used overseas. Weill Cornell joins other prestigious medical centers initiating the trial, including University of California San Francisco and Wake Forest Baptist Medical Center. The study will be conducted with 110 patients. Additional sites in New York and California will be announced in the near future. "Our partnership with Weill Cornell is a testament to the eagerness of leading medical professionals to provide their patients with an alternative to potentially devastating hair loss associated with treatment,” said Martin Waleij, Chief Executive Officer for Dignitana “Clinical evaluation by such trusted medical centers is a primary reason that the DigniCap® System is fast becoming the preferred treatment option for cancer patients throughout the world. We are excited to get the study underway at Weill Cornell.” To participate in the trial, patients must be at least 18 years old and have a documented diagnosis of Stage I or Stage II breast cancer, and must plan to complete chemotherapy within six months of using standard chemotherapy regimens stipulated in the trial protocol. “Going through a cancer diagnosis is painful enough without dealing with the emotional trauma and stress of losing your hair to chemotherapy. Some women even avoid recommended therapies because of the risk of losing their hair,” said Dr. Anne Moore, medical director of the Weill Cornell Breast Center and principal investigator for the Center’s trial. “This clinical study could help lead us to remove that barrier and make patients more relaxed and open to the best possible course of cancer treatment.” UCSF and Wake Forest previously conducted a pilot study using the DigniCap® System in 20 women with early stage breast cancer. The treatment was successful in the majority of women and well tolerated, laying the groundwork for this pivotal and larger trial. The state-of-the-art DigniCap® System being tested in this study features a tight-fitting silicone cap that is placed directly on the head, and an outer neoprene cap that insulates and secures the inner one. Both are connected to a cooling and control unit with touch screen controls. A patented coolant circulates throughout the inner silicone layer, and the cap is designed to deliver consistent cooling to all areas of the scalp. DigniCap is the only system to offer scalp-cooling above freezing with patented, built-in temperature sensors and a precision cooling mechanism that allows for gradual and highly tolerable scalp temperature fluctuations. When a cap is applied to the head, the temperature of the scalp is lowered and blood vessels surrounding the hair roots contract, resulting in a significant reduction of cytotoxins to the follicle. Reduced blood flow leaves a smaller amount of chemotherapy available for uptake in the cells and the decreased temperature results in less absorption of and reduced effects from chemotherapy. These factors together reduce the risk of hair loss. Clinical trials done in Europe and Asia show eight out of 10 women who used the DigniCap® System during chemotherapy retained their hair. Additional trials at leading medical centers around the world have proven the system to be a viable alternative for both women and men of diverse ethnicities. “The DigniCap® System has been extremely well received in clinical trials at leading medical centers around the world,” Waleij says. “We are pleased to be able to work now with the U.S. regulatory system and these prestigious medical centers to provide this highly tolerable, safe and effective therapy for cancer patients in the United States.” Historically, cooling systems and cold caps have not been used in the United States because of concerns that the scalp cooling could allow cancer cells to hide in the scalp. Hope S. Rugo, principal investigator for the study in San Francisco and Director of Breast Oncology and Clinical Trials Education at the UCSF Helen Diller Family Comprehensive Cancer Center, reports that “the incidence of scalp metastases in breast cancer is extremely low and in a large review of published data on scalp cooling systems, scalp metastases were not increased. We are carefully following patients using these systems in several clinical trials.” For more information about participating in one of The DigniCap® System clinical trials, please visit www.Dignitana.com. About Weill Cornell Medical College Weill Cornell Medical College, Cornell University's medical school located in New York City, is committed to excellence in research, teaching, patient care and the advancement of the art and science of medicine, locally, nationally and globally. Physicians and scientists of Weill Cornell Medical College are engaged in cutting-edge research from bench to bedside, aimed at unlocking mysteries of the human body in health and sickness and toward developing new treatments and prevention strategies. In its commitment to global health and education, Weill Cornell has a strong presence in places such as Qatar, Tanzania, Haiti, Brazil, Austria and Turkey. Through the historic Weill Cornell Medical College in Qatar, the Medical College is the first in the U.S. to offer its M.D. degree overseas. Weill Cornell is the birthplace of many medical advances — including the development of the Pap test for cervical cancer, the synthesis of penicillin, the first successful embryo-biopsy pregnancy and birth in the U.S., the first clinical trial of gene therapy for Parkinson's disease, and most recently, the world's first successful use of deep brain stimulation to treat a minimally conscious brain-injured patient. Weill Cornell Medical College is affiliated with NewYork-Presbyterian Hospital, where its faculty provides comprehensive patient care at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. The Medical College is also affiliated with the Methodist Hospital in Houston. For more information, visit weill.cornell.edu. About Dignitana Dignitana AB (publ) is a Swedish medical device company listed on the OMX NASDAQ First North Stockholm is a world leader in technologies within the area of medical cooling. For more information about Dignitana and the DigniCap® System, please visit http://www.dignitana.com. ###