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Dignitana Release - wkr0006.pdf

Lund, Sweden – 19 June 2018 –  Dignitana AB, world leader in clinically superior scalp cooling technology, has responded to the announcement made earlier today by the American Medical Association (AMA), on their decision to reject the company’s application to create a unique CPT® code for FDA-cleared automatic scalp cooling devices. The request, which was made at the May 2018 CPT Editorial Panel Meeting, was part of Dignitana’s efforts to provide a pathway for a more universal and standardized patient coverage method. At present, the service of scalp cooling used in conjunction with patients’ chemotherapy treatments for solid tumor cancers is not reflected in CPT nomenclature.

CPT® Codes, which are designated by the American Medical Association (AMA) and used to report medical, surgical, and diagnostic procedures and services to physicians, health insurance companies and accreditation organizations, are required by insurance companies (Third Party Payers) to correctly and consistently process claims for scalp cooling. Though Third Party Payers determine covered items within a specific patient plan, the creation of a CPT® Code provides a pathway for a more universal and standardized patient coverage method thereby providing greater access to this quality of life cancer care option nationwide.

“While we are disappointed with the outcome of our request to establish a new CPT code for scalp cooling which would have simplified the process for all parties involved, we respect the AMA’s decision and will continue to provide the necessary documentation and data needed to aid in their future assessments,” said William Cronin, CEO of Dignitana AB. “This decision does not change the increasing demand for scalp cooling by patients and we remain committed to working on behalf of all cancer patients to make access to this valuable therapy option easier and more affordable.”

Until recently, hair loss was deemed an inevitable side effect of chemotherapy and continues to serve as an unwelcome reminder of the disease to cancer patients and their caregivers. An estimated 10 percent of patients decline prescribed chemotherapy out of fear of losing their hair, making greater accessibility and coverage of scalp cooling a vital component of cancer care.

Demand for scalp cooling grew exponentially across the U.S. following successful results from extensive, multi-center clinical trials and subsequent FDA clearances of the technology. The DigniCap® Scalp Cooling System was the first of its kind to be cleared by the FDA in 2015 for use by breast cancer patients and in July 2017 it became the first device to receive FDA clearance for use by patients with solid tumor cancers.

Dignitana will continue to work with the AMA on the complex process of creating a pathway to insurance coverage for scalp cooling and remains dedicated to its role as a market leader and advocate for improving comprehensive cancer care on a national scale.

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 contact below, for publication at 1720 (CET) 19 June 2018

For more information contact:

William Cronin, CEO, Dignitana AB  bill.cronin@dignitana.com +1 469 917 5555

Mikael Wahlgren, Deputy Managing Director, Dignitana AB  mikael.wahlgren@dignitana.com    +46 709 33 72 20

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. DigniCap®is a patented scalp cooling system that offers cancer patients the ability to minimize hair loss during chemotherapy. FDA cleared since 2015, DigniCap provides continuous cooling with high efficacy, safety and acceptable patient comfort.

 For more information visit www.dignitana.se  and www.dignicap.com.