Memorial Sloan Kettering to offer Dignicap® scalp cooling device in New York metro area locations

Dignitana AB, a world leader in medical scalp-cooling technology, announced today that the DigniCap® scalp cooling system, which was cleared in December 2015 by the U.S. FDA to effectively reduce the likelihood of chemotherapy-induced hair loss in women with breast cancer, will be available at all Memorial Sloan Kettering Cancer Center (MSK) facilities that treat breast cancer.

The DigniCap® system is the first and only scalp-cooling device to receive FDA clearance. In the rigorous FDA clinical trial, seven out of ten patients with early-stage breast cancer kept at least 50% of their hair. The demand for the FDA-cleared DigniCap® system has been significant this year in the United States.

MSK, a world leader in cancer patient care, research, and educational programs, will now have the 17 units ordered in December of 2016 available for use by female patients undergoing breast cancer treatment in eight of their outpatient facilities in the New York City area. These include MSK Basking Ridge and MSK Monmouth, in New Jersey; MSK Westchester, in Westchester County, New York; and MSK Commack and MSK Rockville Centre, on Long Island, in addition to their Manhattan and Brooklyn locations.

"Scalp cooling is clinically proven and can be an important tool for many women in treatment for breast cancer," says Mario Lacouture, MD, Director of the Oncodermatology Program at MSK. "As a world leader in comprehensive cancer care, we are proud to be able to offer our patients across the New York metro area this new FDA-cleared advancement that addresses one of the most distressing and most visible side effects of chemotherapy."

"Bringing the DigniCap® system to MSK is an important milestone for Dignitana," says William Cronin, Chief Executive Officer of Dignitana, Inc., the U.S. subsidiary of Dignitana AB. "We have just passed the one-year anniversary of clearance by the FDA for DigniCap® in the U.S., and we are proud to add Memorial Sloan Kettering, one of the top comprehensive cancer centers in the U.S., to the growing number of facilities that are providing this treatment option to patients on a large scale."

The DigniCap® clinical team is working directly with the clinical practitioners at each of the eight MSK sites to train and certify staff on the machine.  This is the largest scalp-cooling installation at any medical center to date in the U.S. Nearly 100 nurses and other medical personnel will be trained in preparation for the launch of this service at MSK in the Spring of 2017.

The DigniCap® scalp cooling system features a patented tight-fitting silicone cooling cap that is placed directly on the head, and an outer neoprene cap that insulates and secures the silicone cap. The cooling cap is connected to a cooling and control unit with touch-screen prompts. A liquid coolant circulates throughout the silicone cap, delivering consistent and controlled cooling to all areas of the scalp. The cap is fitted to the head, and the temperature of the scalp is lowered, resulting in vasoconstriction with reduced delivery of chemotherapy to the scalp, as well as reduced cellular uptake of drugs due to decreased intra follicular metabolic rate. These factors together reduce the risk of chemotherapy-induced hair loss.

Lund, Sweden - February 13, 2017

Media Contacts:
Caren Browning
King + Company
+1 212 561-7464
Caren.Browning@kingcompr.com

Semmy Rülf
Chairman of the board
+46 (0)709 312730
semmy.rulf@dignitana.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 the OMX Nasdaq First North stock exchange and has appointed Erik Penser Bank as Certified Advisor. Headquartered in Dallas, Texas, Dignitana, Inc. is the U.S. subsidiary of Dignitana AB. For more information visit www.dignitana.com.

About Memorial Sloan Kettering
We are the world's oldest and largest private cancer center, home to more than 14,000 physicians, scientists, nurses, and staff united by a relentless dedication to conquering cancer. As an independent institution, we combine 130 years of research and clinical leadership with the freedom to provide highly individualized, exceptional care to each patient. And our always-evolving educational programs continue to train new leaders in the field, here and around the world. For more information, go to www.mskcc.org.


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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