Dignitana receives FDA clearance for DigniCap Delta scalp cooling system

Clinically superior next generation device reduces hair loss for cancer patients

Dignitana AB, world leader in medical scalp cooling technology, announced today that the United States Food and Drug Administration has cleared DigniCap Delta® for use by U.S. health care providers. The new device is the fourth generation of The DigniCap® Scalp Cooling System and is indicated to prevent chemotherapy-induced hair loss in patients with solid tumors. European installations of DigniCap Delta began last month after the device received CE Marking in March 2019.

"DigniCap Delta changes everything about the way scalp cooling is done today," said William Cronin, CEO of Dignitana." In the value-based U.S. health care system providers tell us they want to improve the clinical process, reduce nursing intervention and optimize patient outcomes. This new device, developed along with our partner sites, allows them to accomplish all three of these objectives. We are thrilled to offer patients and clinicians this state-of-the-art advancement in cancer care."

DigniCap Delta uses solid state cooling for precise temperature control in an advanced and redesigned model of the 2015 FDA cleared DigniCap Scalp Cooling System. The new device delivers significant improvements over other scalp cooling systems on the market:

  • Single patient use
    New cap system provides each patient with a flexible Cooling Wrap and an adjustable Thermal Cap designed to optimize scalp cooling outcomes and minimize clinic storage needs.
  • Smaller size
    Streamlined profile is 54 percent smaller than the previous unit.
  • Reduced nursing time
    Intuitive interface means up to 80 percent reduction in nursing time per patient infusion versus the existing device.

DigniCap Delta is now available to medical centers in the United States and delivery to customers will begin in July. The current DigniCap device is already in use in 30 states in the U.S. and in 37 markets globally. The addition of a disposable cap for single patient use provides a new global revenue stream for the company. Existing revenue comes from leasing fees, treatment fees to patients, service agreements and machine sales outside the United States.

Cronin added, "We are pleased that this approval comes at a time when both awareness of and demand for scalp cooling are rapidly increasing. The clearance of Delta now provides a clear pathway for growth in the important U.S. market and beyond. It is the biggest step yet in the evolution of Dignitana and is the result of a tremendous effort from our staff, partner sites, regulatory team and contract manufacturer."

This is information that Dignitana AB (publ) 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 08:00 (CET) on 27 June 2019.

For More Information Contact

Caren Browning, King + Company,  caren.browning@kingcompr.com +1 212-561-7464

Anna Westesson, Anna Westesson PR & Consulting AB, anna@awprc.se  +46 708-82 82 09

Melissa Bourestom, Dignitana AB  melissa.bourestom@dignitana.com  +1 469-518-5031

About Dignitana AB (publ)

Dignitana AB is the world leader in clinically superior scalp cooling technology. The company produces The DigniCap® Scalp Cooling System, a patented medical cooling device 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 patient comfort. Hailed internationally as a life-changing medical advancement for cancer patients, The DigniCap Scalp Cooling System was invented in 1999 by a Swedish Oncology nurse and has been available in Europe since 2001.  Dignitana AB is listed on Nasdaq First North Stockholm in Sweden with headquarters in Lund, Sweden and operations based in Dallas, Texas in the United States.  Company subsidiaries are Dignitana, Inc. in the United States and Dignitana S.r.l. in Italy. Learn more at www.dignitana.se and www.dignicap.com.

Erik Penser Bank AB, Certified Adviser, +46 (0) 8 463 83 00 certifiedadviser@penser.se www.penser.se


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.


Följ oss

Om beQuoted

beQuoted publicerar nyheter, analyser och pressmeddelanden för investerare och journalister. Viktiga företagshändelser bevakas av vår egen nyhetsredaktion och vidaredistribueras i ledande finansiella medier.

Vi uppdaterar även nyhetsrum, Investor Relations och IR-webbplatser för företag som vill utveckla sina relationer med finansmarknaden.

Kontakta oss

beQuoted AB
Sturegatan 32
114 36 Stockholm

08-692 21 90
Kontaktformulär