DIGNITANA RESPONDS TO AMERICAN MEDICAL ASSOCIATION DECISION REGARDING UNIQUE CPT CODE FOR SCALP COOLING

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.

Dignitana Publishes July Newsletter

Lund, Sweden - 1 June 2018 - Dignitana AB, world leader in clinically superior scalp cooling technology, today publishes the July 2018 edition of the company newsletter.


DIGNITANA KOMMENTERAR AMERICAN MEDICAL ASSOCIATION (DET AMERIKANSKA LÄKARFÖRBUNDET) BESLUT ATT INTE INFÖR EN UNIK CPT® CODE FÖR KYLNING AV HÅRBOTTEN

Dignitana AB har ansökt hos American Medical Association (AMA) (Det amerikanska läkarförbundet) om att skapa en unik CPT ®-kod (Current Procedural Terminology kod) som inkluderar kylning av hårbotten vid cytostatikabehandling. Syftet med ansökan var att förenkla processen för patienten i dennes dialog med försäkringsbolag om ersättning för både cytostatikabehandlingen och kylning av hårbotten. Försäkringsskydd för hårbottenkylning är ännu inte standardiserat i USA. De patienter som använder sig av DigniCap-systemet erhåller idag ersättning från försäkringsbolagen för cancerbehandlingskostnaden inklusive kostnaderna för kylning av hårbotten sedan 2015 då DigniCap erhöll sitt FDA-godkännande. Idag har AMA meddelat att de inte avser att införa en unik CPT ®-kod.


DIGNITANA RESPONDS TO AMERICAN MEDICAL ASSOCIATION DECISION REGARDING UNIQUE CPT CODE FOR SCALP COOLING

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.


Dignitana Publishes June Newsletter

Dignitana AB, world leader in clinically superior scalp cooling technology, today publishes the June 2018 edition of the company newsletter highlighting growth in the Middle East, Asia, Europe, and the United States.


Dignitana publishes Interim Financial Report for Q1 2018

Significant events during the period

  •  The DigniTherm™ Click Cap was introduced to facilities in December 2017 and the roll-out to all U.S. facilities was completed in Q1 2018.
  •  13 machines were installed at 12 sites in the US in Q1.
  •  Transition of operations from Lund, Sweden to the U.S. was announced and initiated in Q4 2017 and continued in Q1. It was successfully completed in April, two months ahead of schedule. Dignitana AB remains in Lund.
  •  The Rights offering which was begun in Q4 2017 was fully subscribed and funding was completed in early January 2018.
  •  At an Extraordinary General Meeting 16 March 2018 Thomas Kelly, Ingrid Atteryd Heiman, and Mikael Wahlgren were appointed to the Board of Directors with Thomas Kelly designated as Chairman of the Board for Dignitana AB.
  •  In March James McKinney was named President and COO of Dignitana, Inc.
  •  In March Dignitana initiated an application with the American Medical Association for a unique CPT Code for scalp cooling to provide a pathway for universal scalp cooling coverage. The decision will be announced by the AMA in June.


Dignitana Launches Survey to Gather Critical Insights on Insurance Coverage and Reimbursement for Cancer Patients Undergoing Chemotherapy

Maker of the World's First FDA-Cleared Therapeutic for Reducing Chemotherapy-Induced Hair Loss Takes the Lead in Advocating for Universal Insurance Coverage of Treatments for Women and Men


Communication from the Dignitana AB Annual General Meeting 2018

Dignitana AB, has today held an annual general meeting at the company's premises in Lund. In all the proposed cases, the AGM resolved in accordance with the Board's proposal. Below is a summary of the decisions taken.


Sysmex Europe GmbH to Transfer Management of All European Installations Of The DigniCap Scalp Cooling System Back to Dignitana AB

Lund, Sweden - 9th April 2018 - Dignitana AB, world leader in clinically superior scalp cooling technology, will assume the complete operation from Sysmex Europe GmbH of their DigniLife® scalp cooling division. The agreement is effective April 2018 and the transition with medical facilities will begin immediately.


Dignitana Publishes Annual Report for 2017

Lund, Sweden - 3 April 2018 - Dignitana AB hereby publishes the annual report for 2017. The annual report is attached to this press release and can be downloaded from the website www.dignitana.se. You can also order a printed version via investorrelations@dignitana.com.Note: This report is published in Swedish.


Notice of Annual General Meeting in Dignitana AB (publ) - correction

The shareholders of Dignitana AB (publ), 556730-5346, ("the Company") are hereby invited to attend the Annual General Meeting on Tuesday 24 April 2018 at 12.00 in the Company's premises, Traktorgränden 3, in Lund, Sweden.

This meeting had previously been scheduled for Thursday 26 April 2018 but will instead occur Tuesday 24 April 2018.


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