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 AB Publishes Q3 Interim Report

Results and financial position

Significant events during the period

  • Sales for the period amounted to 10,293 TSEK, $1,150 KUSD, an increase of 125 percent compared to the same period in 2017 and an increase of 14 percent compared to the second quarter 2018.
  • EBITDA amounted to (3,459) TSEK, ($386 KUSD), a 56 percent improvement compared to the same period in 2017.
  • 6 units were sold to facilities in countries outside the U.S.
  • Contracts for 7 locations in the U.S. were signed.
  • Third quarter treatment revenue in the U.S. increased over second quarter 2018.
  • In July Dignitana AB registered a new wholly-owned subsidiary, Dignitana S.r.l (Società a responsabilità limitata), as a new Italian entity to facilitate contracting with public health facilities in Italy.

Significant events after the period

  • Contracts for 10 locations in the U.S. have been signed since 30 September.
  • 8 units sold outside the U.S. since 1 October 2018.
  • On 8 October Dignitana announced that Mr. Greg Dingizian, via his Adma Förvaltnings AB investment vehicle, has accumulated a 4,200,000 share position in the company. The share purchases of Adma Förvaltnings AB represent 10.4 percent of the outstanding common shares of the company.
  • An agreement has been reached with Konica-Minolta and Beijing University Cancer Hospital to perform a limited usage trial of the DigniCap device to evaluate efficacy when compared to manual gel caps. The trial is scheduled to begin during the fourth quarter 2018.

The company has announced a combination of a directed equity and rights issue to obtain 30 MSEK. This transaction is scheduled to be completed by mid-December.


Dignitana genomför företrädesemission och riktad nyemission

Dignitana AB (publ) genomför nyemissioner om cirka 31,6 MSEK fördelat på en riktad nyemission om ca 5.8 MSEK, en fullt garanterad företrädesemission om 24,3 MSEK samt ytterligare en riktad emission genom kvittning av garantiersättning om cirka 1,4 MSEK


Dignitana Announces Rights Issue and Directed Equity Issue

Dignitana AB to carry out new issues of approximately SEK 31.6M in a directed issue of approximately SEK 5.8M, a fully guaranteed rights issue of SEK 24.3M with preferential right for existing shareholders and another directed rights issue offsetting the guarantee fee of approximately SEK 1.4M.






Dignitana AB publicerar delårsrapport för Q2 2018

Väsentliga händelser under perioden

  •  Försäljningen under perioden uppgick till 9 022 tkr (1 041 USD), en ökning med 54 procent jämfört med samma period 2017 och en ökning med 51 procent jämfört med första kvartalet 2018.  
  •  EBITDA uppgick till -2 701 tkr, -312 KUSD, en förbättring med 69 procent jämfört med samma period 2017.  
  •  Dignitana ingick sitt första leasingavtal utanför USA - avtalet rör DigniCap-enheter till 3 kliniker i Spanien.  
  •  9 DigniCap-enheter såldes till vårdinrättningar i länder utanför USA.  
  •  Avtal har ingåtts för 10 DigniCap-enheter på 6 kliniker i USA.  
  •  Behandlingsintäkterna från klinikerna i USA har ökat med 21 procent, jämfört med det första kvartalet 2018.  
  •  Dignitana tar över ansvaret från Sysmex för alla installerade DigniCap-enheter i Europa. Enheterna finns på totalt 70 kliniker i 11 länder. 
  •  Flytten av verksamheten från Lund i Sverige till Dallas i USA var genomförd i april, två månader tidigare än planerat. Dignitana AB:s huvudkontor fortsätter att ha sitt säte i Lund.  
  •  I juni avslog American Medical Association (USA:s läkarförbund) företagets ansökan att få en unik CPT-kod (Current Procedural Terminology) för skalpkylningsenheter. Koden skulle inneburit en förenkling för patienten att få ersättning från försäkringsbolagen. Avsaknaden av en unik CPT-kod har inte haft någon inverkan på Dignitanas försäljning.  
  • Årets bolagsstämma hölls den 24 april 2018 i Lund. Bolagsstämman beslöt i enlighet med styrelsens förslag på samtliga punkter.
  • Thomas Kelly, William Cronin, Ingrid Atteryd Heiman och Mikael Wahlgren omvaldes som styrelseledamöter vid bolagsstämman den 24 april 2018 med Thomas Kelly som styrelseordförande

Dignitana AB Publishes Interim Report for Q2 2018

Results and financial position

Significant events during the period

  • Sales for the period amounted to 9,022 TSEK, $1,041 KUSD, an increase of 54 percent compared to the same period in 2017 and a 51 percent increase over the first quarter 2018.
  • EBITDA amounted to (2,701) TSEK, ($312 KUSD), a 69 percent improvement compared to the same period in 2017.
  • Dignitana initiated its first direct-to-customer leased unit transaction outside of the U.S. for 3 locations in Spain.
  • 9 units were sold to facilities in countries outside the U.S.
  • Contracts for 6 locations in the U.S. were signed representing 10 machines.
  • Treatment revenue from U.S. sites showed a 21 percent increase over first quarter 2018.
  • Transfer of management of all European installations of DigniCap from Sysmex to Dignitana representing 70 locations in 11 countries.
  • Transition of operations from Lund, Sweden to the U.S. was successfully completed in April, two months ahead of schedule. Dignitana AB headquarters remain in Lund.
  • In June the company's application for a unique Current Procedural Terminology (CPT) Code for scalp cooling devices was not approved by the American Medical Association. This code would have helped U.S. patients process insurance claims more simply but does not have any material effect on sales potential at this time.
  • The Annual General Meeting was held 24 April 2018 in Lund. In all the proposed cases the AGM resolved in accordance with the Board's proposals.
  • Thomas Kelly, William Cronin, Ingrid Atteryd Heiman, and Mikael Wahlgren were re-elected to the Board of Directors at the Annual General Meeting 24 April 2018 with Thomas Kelly as Chairman.

Dignitana AB Publishes Interim Report for Q2 2018

Solid progress and growth


Dignitana växer i Italien och startar dotterbolag

Dignitana AB registrerade idag Dignitana Srl (Società a responsabilità limitata) i Italien. Bolaget är ett helägt dotterbolag till Dignitana AB och kommer att fungera under ledning av Dignitana AB. Registreringen av Dignitana Srl möjliggör för Dignitana att tillhandahålla hårbottenkylning tjänster till sjukvårdsenheter i hela Italien. Härigenom kan Dingitana möta det ökande antalet ansökningar om hårbottenkylning tjänster vid nya medicinska centra. Dignitana kan nu som en konsekvens av registreringen av det italienska dotterbolaget nu också tecknat nya kontrakt avseende tre skalpkylningsmaskiner som nu ska installeras i Italien.   


Dignitana grows business in Italy

New Subsidiary Registered 

Dignitana AB today registered Dignitana S.r.l (Società a responsabilità limitata) as a new entity in Italy. The entity is a wholly-owned subsidiary of Dignitana AB and will function under the leadership of Dignitana AB. The registration of Dignitana S.r.l enables Dignitana to provide scalp cooling services to public health facilities throughout Italy. By doing so, Dignitana can meet the increasing number of requests for scalp cooling at new medical centers. With this registration the company can now finalize contracts for the sale of 3 machines in Italy.


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.


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