FDA DECISION TRIPLES DIGNITANA U.S. MARKET SIZE

FDA's expanded clearance enables Dignitana's scalp cooling technology DigniCap®, to be used when patients undergoing chemotherapy are treated for solid tumor cancers in the United States. The decision gives Dignitana the opportunity to offer DigniCap® to about 800,000 patients in the US market per year.

Lund, Sweden - July 3, 2017 - Dignitana AB, a world leader in medical scalp cooling technology and manufacturer of the DigniCap® Scalp Cooling System, announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to expand use of its medical device to patients in the United States receiving chemotherapy for solid tumor cancers. The decision means that medical facilities may use DigniCap® to reduce hair loss in patients treated for solid tumor cancers such as breast, prostate, ovary, uterus, lungs and other tissues.

The approval from the FDA is an extension of the decision taken by the authority in 2015 when Dignitana was the first scalp cooling company granted permission to use the patented technology for treating women with breast cancer in the United States. Today's decision means that Dignitana once again is first, now to be able to provide the option to use DigniCap® to about 800,000 cancer patients annually diagnosed with different types of solid tumors cancers (cancer.org).

Dignitana estimates that the market for scalp cooling of breast cancer patients in the United States is worth about US $ 50 million a year, based on an average number of chemotherapy treatments. With the expanded clearance, Dignitana expects to gain access to a market worth somewhere in excess of $ 140 million annually.

"The new decision by the FDA means that our potential market in the US is more than tripled," says Johan Ericsson, CEO of Dignitana AB. "It also means a significantly stronger market position for our brand and business. The expanded indication also shows how well developed and carefully tested our scalp cooling technique is. It is with confidence that we now prepare to reach out to an even greater number of cancer clinics and patients in our main market."

In the United States, DigniCap® is available at more than 80 cancer clinics in 21 states, helping thousands of patients each year to minimize chemotherapy-induced hair loss.

Read more on the FDA website: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm565599.htm 

Corporate contact                                                                   Press contact                                                 

Johan Ericsson                                                                          Anja Trägårdh                                             

Chief Executive Officer                                                              Trägårdh Kommunikation                                                             

+46 46 16 30 92                                                                         +46 709 346664

johan.ericsson@dignitana.se                                                     anja@tragardhkommunikation.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. Headquartered in Dallas Texas, Dignitana, Inc. is the U.S. subsidiary of Dignitana AB. For more information visit www.dignitana.se

About The DigniCap® Scalp Cooling System

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. www.dignicap.com

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 21:15 (CET), 3 July, 2017. 


Dignitana tillförs 42 miljoner SEK i en riktad nyemission av units

Dignitana AB (publ) ("Dignitana" eller "Bolaget") meddelade idag att Bolaget har genomfört en framgångsrik riktad nyemission av units bestående av aktier och teckningsoptioner, vilket tillför Dignitana cirka 42 miljoner SEK före emissionskostnader. Likviden från nyemissionen kommer användas för att kraftfullt öka tillväxttakten i Bolaget med fokus på den nya skalpkylningsmaskinen, DigniCap Delta, som både är CE- och FDA-godkänd. Delta systemet medför även en förbättrad global intjäningsmodell bestående av engångs- och flergångsintäkter. Vid fullt utnyttjande av samtliga teckningsoptioner tillförs Bolaget ytterligare 42 miljoner SEK före emissionskostnader.


Dignitana receives SEK 42 million in a directed new issue of units

Dignitana AB (publ) ("Dignitana" or the "Company") today announced that the Company has successfully conducted a directed new issue of units consisting of shares and warrants, which has now raised proceeds to Dignitana of SEK 42 million before deduction of issue costs. These proceeds will be used to aggressively increase the growth rate of the company with a focus on the new scalp cooling device, DigniCap Delta. This new FDA cleared and CE marked system introduces an improved global business model consisting of one-time and recurring revenue. At full exercise of the warrants, Dignitana will be provided with additional SEK 42 million before deduction of issue costs.


Dignitana avser att genomföra en riktad nyemission av units

Dignitana AB (publ) ("Dignitana" eller "Bolaget") meddelade idag att Bolaget avser att, med stöd av bemyndigande från årsstämma den 15 maj 2019, genomföra en nyemission av units bestående av aktier och teckningsoptioner med avvikelse från aktieägarnas företrädesrätt som riktas till kvalificerade investerare i Sverige och internationella institutionella investerare (den "Riktade emissionen").


Dignitana intends to make a directed new issue of units

Dignitana AB (publ) ("Dignitana" or the "Company") today announces its intention to execute a directed share issue of units consisting of shares and warrants with deviation from the shareholders' preferential rights, directed to qualified investors in Sweden and international institutional investors, as authorized by the annual general meeting on 15 May 2019 (the" Directed New Issue").


Delårsrapport Q2 2019

Financial highlights

  •  Total revenue for the Group amounted to 12,002 TSEK, 1,275 KUSD which is an increase of 33 percent over the same period 2018.
  •  Year to date revenue for the Group was 22,109 TSEK, 2,350 KUSD, an increase of 47 percent over the same period 2018.

Business highlights  

  •  FDA clearance of the next generation DigniCap Delta June 2019.  
  •  First European installation of DigniCap Delta at Gemelli University Hospital in Rome, Italy, in May 2019.  
  •  Contracts were signed for 19 locations in the United States, bringing the total number of signed U.S. sites to 139 across 30 states at the close of second quarter.  
  •  The Company continued efforts to initiate legislation providing insurance coverage for scalp cooling with a Bill (HB 3984) introduced in Texas and discussions are underway with legislators in three other states.  
  •  Dignitana co-sponsored a scalp cooling session at the Multinational Association for Supportive Care in Cancer Annual meeting in San Francisco, California in June 2019.  

Dignitana AB Publishes Q2 2019 Interim Report

Financial highlights

  •  Total revenue for the Group amounted to 12,002 TSEK, 1,275 KUSD which is an increase of 33 percent over the same period 2018.
  •  Year to date revenue for the Group was 22,109 TSEK, 2,350 KUSD, an increase of 47 percent over the same period 2018.

Business highlights  

  •  FDA clearance of the next generation DigniCap Delta June 2019.  
  •  First European installation of DigniCap Delta at Gemelli University Hospital in Rome, Italy, in May 2019.  
  •  Contracts were signed for 19 locations in the United States, bringing the total number of signed U.S. sites to 139 across 30 states at the close of second quarter.  
  •  The Company continued efforts to initiate legislation providing insurance coverage for scalp cooling with a Bill (HB 3984) introduced in Texas and discussions are underway with legislators in three other states.  
  •  Dignitana co-sponsored a scalp cooling session at the Multinational Association for Supportive Care in Cancer Annual meeting in San Francisco, California in June 2019.  

Dignitana delivers first DigniCap Delta in United States

Next generation scalp cooling device minimizes hair loss from chemotherapy


Dignitana AB Publishes August Newsletter

Dignitana AB today publishes the August 2019 edition of the company newsletter, attached to this release.



Dignitana får FDA-godkännande i USA för DigniCap Delta scalp cooling system

Nästa generations kliniskt överlägsna skalpkylningssystem minskar håravfallet hos cancerpatienter


Dignitana receives FDA clearance for DigniCap Delta scalp cooling system

Clinically superior next generation device reduces hair loss for cancer patients


Dignitana AB Publishes June Newsletter

Dignitana AB today publishes the June 2019 edition of the company newsletter, attached to this release.


Dignitana installs the first DigniCap Delta Scalp Cooling System in Rome

Dignitana ABmanufacturer of The DigniCap® Scalp Cooling System, has announced installation of the first DigniCap Delta at the prestigious Gemelli University Hospital in Rome, Italy last month.


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