Dignitana Initiates Action with American Medical Association to Add CPT® Codes for Insurance Coverage of FDA-Cleared Scalp Cooling Medical Devices

Maker of the World’s First FDA-Cleared Therapeutic for Reducing Chemotherapy-Induced Hair Loss Takes the Lead in Making Treatments More Widely Accessible for Women and Men Everywhere

Lund, Sweden16 March 2018Dignitana AB, world leader in clinically superior scalp cooling technology, has begun the process of obtaining a Current Procedural Terminology (CPT®) Code for FDA-cleared scalp cooling systems used in the prevention of chemotherapy-induced hair loss – a move that is critical to wide adoption of the practice in cancer centers across the U.S. and that if approved, will help make treatments more accessible for chemotherapy patients.

CPT® Codes, which are designated by the American Medical Association 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 will still 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.

Recognized internationally as a major quality-of-life medical advancement for cancer patients, 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. In July 2017, it became the only such device to receive FDA clearance for use by patients with solid tumor cancers. As demand for scalp cooling technology grows across the U.S., Dignitana’s decision to initiate the complex process of applying for CPT® coverage demonstrates the company’s leadership in making patient-centered, comprehensive cancer care accessible to a broader community.

“At Dignitana we have led the charge in creating technology that is comfortable, effective, and empowering for those facing an emotionally and physically debilitating time,” said William Cronin, CEO of Dignitana AB. “Now, we are honored to lead this initiative on behalf of our patients. A unique CPT code will streamline the process for receiving insurance coverage for this life-changing technology.”

With approximately 800,000 new cases of solid tumor cancers being diagnosed in the U.S. annually, greater accessibility to scalp cooling is a significant advancement for cancer care.

At present, the service of scalp cooling used simultaneously with patients’ chemotherapy treatments for solid tumor cancers is not reflected in CPT nomenclature. The proposed code defines treatment as a “temperature sensory monitored scalp cooling device using a computer controlled circulating coolant with a cap for the prevention of hair loss during chemotherapy.” The proposed code specifies application of the cooling to “the scalp,” and defines “prevention of hair loss” as the anticipated medical outcome.

Application review for the code is currently underway by delegates to the CPT Advisory Committee and the CPT Editorial Panel. The proposal will be discussed and voted on at the May 2018 CPT Editorial Panel Meeting to be held May 17-19 in San Antonio, Texas. The summary of Panel Actions will be announced on June 19, 2018. If approved, the proposed CPT code would then undergo further review bythe AMA for valuation and ultimately payment by Third Party Payers. It would then be up to each Third Party Payer to determine whether they would add scalp cooling coverage to the insurance coverage that they offer. CPT codes are updated annually and effective for use on January 1 of each year. The AMA prepares each annual update so that the new CPT books are available in the fall of each year preceding their effective date to allow for implementation.

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 and www.dignicap.com 

About The DigniCap® Scalp Cooling System­­

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. www.dignicap.com

Investor Relations                                                       

Melissa Bourestom                                       

Dignitana                                                       

00 1 773 387 8504                                         

investorrelations@dignitana.com                 

Media Contact   

Caren Browning  

King + Company

00 1 212 561 7464

caren.browning@kingcompr.com

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  and www.dignicap.com 

About The DigniCap® Scalp Cooling System­­

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. www.dignicap.com

About Us

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 and www.dignicap.com

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