Dignitana signs Atrium Health in U.S. for DigniCap Delta scalp cooling system

Dignitana AB, world leader in medical scalp cooling technology, announced today that the company has signed a contract with Atrium Health to provide the DigniCap Delta model of The DigniCap® Scalp Cooling System to Atrium Health's Levine Cancer Institute sites. Dignitana's advanced and redesigned scalp cooling device received FDA clearance for use on 26 June 2019. Atrium Health is a leading healthcare provider in the U.S. and the first new customer with multiple locations to contract with Dignitana for the DigniCap Delta device.

"DigniCap Delta provides state-of-the-art scalp cooling and we are seeing growing demand for this new technology," says William Cronin, Chief Executive Officer of Dignitana AB. "As we work to move modern cancer care forward, we are proud to add Atrium Health to the list of progressive healthcare organizations that offer cancer patients this important therapy option."

Headquartered in Charlotte, North Carolina, Atrium Health has a network of more than 50 hospitals, including more than 25 locations of Levine Cancer Institute across the Carolinas. The first DigniCap Delta will be installed at the flagship Levine Cancer Institute facility in Charlotte in September, after which time Dignitana will work closely with administration to provide scalp cooling at the remaining infusion centers based on market demand.

Following FDA clearance in June, DigniCap Delta is now available to medical centers in the United States. European installations of DigniCap Delta began last month after the device received CE Marking in March 2019. The previous DigniCap device, C3, is already in use in 30 states in the U.S. and in 37 markets globally.

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.

Lund, Sweden 30 July 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 DigniCap Delta 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

ATTACHED MEDIA
Video: DigniCap Delta Introduction https://youtu.be/GiCVZ20ViOU


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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