DIGNITANA MEDICAL ADVISORS HELP LAUNCH INTERNATIONAL SCALP COOLING COLLABORATION AMONG TOP CANCER CENTERS WORLDWIDE

Innovative “CHILL” Registry and Database Will Track and Record Patient Experiences
Related to Reduction of Chemotherapy-Induced Hair Loss

Lund, Sweden – June 26, 2017 – Dignitana AB, a world leader in medical scalp-cooling technology and manufacturer of the DigniCap® scalp cooling system, is partnering with the organization known as CHILL, Cancer-related Hair Loss, International Leadership and Linkage, which was launched this past weekend at the 2017 Annual Meeting of the Multinational Association of Supportive Care in Cancer (MASCC), held in Washington, D.C.

Led by six globally-recognized experts in cancer care, CHILL is an initiative designed to collect and track evidence-based patient information and provide clinical guidance for health practitioners and patients using scalp cooling medical devices that reduce hair loss for patients receiving chemotherapeutic cancer treatments. Data collected through the initiative will help establish industry-standard best practices and ensure maximum effectiveness of these treatments worldwide.

A new website, scalpcooling.org, will serve as a global hub for patients and care providers seeking information about hair loss and scalp cooling technology, as well as a decision aid with data from the CHILL registry showing chances of hair loss with and without scalp cooling.

With an estimated 14.1 million patients diagnosed with cancer worldwide in 2012 (according to World Cancer Research Fund International), cancer is a significant global health issue affecting every region and socioeconomic group. The CHILL Registry strives to become a platform that allows clinicians to understand cancer-related hair loss during leading edge cancer therapies, improve supportive care by comparing their own data with international estimates, and access the extensive resources of comprehensive cancer treatment teams around the world.

“At Dignitana, we take pride in our ability to be a leader of innovation and remain on the cutting edge of technological developments that help us provide the best possible care and outcomes for our patients,” said Johan Ericsson, Chief Executive Officer of Dignitana AB. “The CHILL Registry is an incredible platform that will allow us to track progress and connect with physicians around the world to ensure that we can continue to deliver the most effective scalp cooling treatments available.”

“Scalp cooling is well-recognized around the globe as a therapeutic solution to one of the most troublesome side effects of chemotherapy,” said CHILL Executive Board Member Dr. Corina van den Hurk, Netherlands Comprehensive Cancer Organisation.  “The launch of the CHILL Registry is a significant step forward as we work together to develop best practices in supportive care.”

CHILL has designed an online registry that makes communication and global research accessible to all health care professionals interested in using scalp cooling with their chemotherapy patients. The registry collects data about severity of hair loss of patients with and without scalp cooling. For patients undergoing treatment with scalp cooling, physicians can also gather information on tolerance and satisfaction with the results of treatment.

As scalp cooling results vary depending on several factors, the CHILL Registry amasses information including:  

• Clinical: type and dose of chemotherapy, infusion time, post-infusion cooling time
• Patient characteristics: age, ethnic background, hair thickness, chemical treatment of hair, smoking, body mass index
• Efficacy: severity and pattern of hair loss, and in case of scalp cooling: tolerance and satisfaction
• Follow up information: dependent on availability and willingness of patient to be contacted six months after treatment to evaluate hair growth and results to determine incidence of persistence hair loss

Launching this unique initiative at the Multinational Association of Supportive Care in Cancer (MASCC) conference June 22-24, 2017 in Washington, DC, the clinicians spearheading the CHILL registry and serving as the CHILL Executive Board include:

• Corina van den Hurk, PhD , Epidemiologist, Netherlands Comprehensive Cancer Organisation (IKNL) – Netherlands
• Annie Young, PhD, Professor of Nursing, University of Warwick and University Hospital Coventry and Warwickshire NHS Trust – Coventry, United Kingdom
• Frances Boyle, AM, MBBS (Hons 1), PhD Pharmacology, FRACP (Medical Oncology), Professor of Medical Oncology and Director of Patricia Richie Center for Cancer Care and Research, Patricia Ritchie Centre for Cancer Care and Research, Mater Hospital and University of Sydney – Sydney, Australia 
• Hope Rugo, MD, Professor of Medicine and Director, Breast Oncology and Clinical Trials Education, UCSF Helen Diller Family Comprehensive Cancer Center – San Francisco, California, United States
• Mario Lacouture, MD, Director, Oncodermatology Program, Memorial Sloan Kettering Cancer Center – New York, New York, United States
• Julie Winstanley, PhD, MSc, CStat, CSci and Associate Professor, Patricia Ritchie Centre for Cancer Care and Research, Mater Hospital and University of Sydney – Sydney, Australia 

 “Hair loss associated with chemotherapy can be devastating for many women,” said oncologist Hope S. Rugo, MD, Professor of Medicine, Director, Breast Oncology and Clinical Trials Education at UC San Francisco and a breast cancer specialist with the UCSF Helen Diller Family Comprehensive Cancer Center. “Working with Dignitana to clinically test and introduce the first FDA-cleared scalp cooling medical device to the U.S. market, our aim has been to care for the emotional wellbeing of our patients as we aggressively treat their cancer. The clinician-led CHILL registry is a forward-looking commitment to providing patients with the best possible practice insights and innovations as scalp-cooling technology continues to advance and evolve.”

Positive results from two separate multi-center clinical trials on scalp cooling were published in February 2017 by The Journal of the American Medical Association (JAMA). Both U. S. studies of breast cancer patients using the DigniCap and Paxman scalp cooling devices found that a majority of patients achieved favorable results from scalp cooling treatments to prevent hair loss.

The scalp cooling medical device features a 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. A liquid coolant circulates throughout the silicone cap, delivering consistent and controlled cooling to all areas of the scalp. Once the cap is fitted to the head, the temperature of the scalp skin is significantly lowered, resulting in vasoconstriction with reduced delivery of chemotherapy to the scalp skin, as well as reduced cellular uptake of drugs due to decreased intra-follicular metabolic rate. These factors together minimize the hair loss that is a side effect of many chemotherapy agents. 

THE CHILL Registry is funded by Dignitana, maker of The DigniCap® Scalp Cooling System and Paxman, maker of the Paxman Scalp Cooling System.

Media Contacts:

Caren Browning                                              Semmy Rülf    

King + Company                                             Chairman of the board, Dignitana AB

00 1 212 561-7464                                          +46 (0)709-312730

Caren.Browning@kingcompr.com                   semmy.rulf@dignitana.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. For more information visit www.dignitana.com

About The DigniCap® Scalp Cooling System

Dignitana’s core product, 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. 

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 8:00 CET, 26 June 2017. 

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