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.

Delårsrapport Q1 2017

Nyckeltal

Koncernen Q1 2017 Q1 2016 Helår 2016
Nettoomsättning, tkr 6 127 1 134 8 902
Totala Intäkter, tkr 6 177 1 199 9 122
Resultat efter finansiella poster, tkr -8 109 -5 903 -32 269
Kassa och bank, tkr 17 995 11 293 32 864
Resultat per aktie före och efter utspädning, kr -0,40 -0,35 -1,72
Moderbolaget Q1 2017 Q1 2016 Helår 2016
Nettoomsättning, tkr 5 312 1 119 7 767
Totala Intäkter, tkr 5 362 1 174 7 986
Resultat efter finansiella poster, tkr -8 189 -5 927 -32 457
Kassa och bank, tkr 17 762 10 895 31 744

 


Dignitana continues augmented growth across the U.S.

Scalp Cooling Technology for Women with Breast Cancer Available at 71 Medical Centers



Kallelse till årsstämma i Dignitana

Aktieägarna i Dignitana AB (publ), 556730-5346, ("Bolaget") kallas härmed till årsstämma fredagen den 2 juni 2017 kl. 14.00 i Bolagets lokaler, Traktorgränden 3, i Lund.


Se Dignitanas presentation från Stockholm Corporate Finance Life Science Seminarium den 21 mars

Den 21 mars deltog Dignitana på Stockholm Corporate Finance Life Science Seminarium på Operaterassen. Bill Cronin, CEO Dignitana Inc, presenterade den senaste utvecklingen för bolaget och gav sin syn på framtiden.


Dignitana continues exponential growth across the U.S.

Scalp Cooling Technology for Women with Breast Cancer Expands to 67 Medical Centers


Dignitana håller presentation på Stockholm Corporate Finance Life Science Seminarium

Dignitana kommer att delta på Stockholm Corporate Finance Life Science Seminarium på Operaterassen den 21 mars, kl. 10.15 och presenterar senaste utvecklingen och framtid i bolaget.


Bokslutskommuniké - 2016

Väsentliga händelser under året

  • De första leasingavtalen och leveranserna till kunder i USA ägde rum i början av året. Det viktigaste kontraktet hittills är med Memorial Sloan Kettering Cancer Center på flera kliniker i New York-området.
  • Dignitana introducerade framgångsrikt en ny affärsmodell i USA. Modellen består av en fast månatlig leasingavgift för systemet samt en avgift per behandling, pay-per-treatment.
  • Quality of Life data från den kliniska studien presenterades som en poster under det årliga bröstcancersymposiet i San Antonio, SABCS, i december.
  • Dignitana har fortsatt att utveckla sitt dotterbolag i USA, Dignitana Inc. Bill Cronin har tillsatts som VD på Dignitana Inc. och ny personal för försäljning, marknadsföring och klinisk support har tillkommit. Företaget har startat upp sitt kontor i Dallas, Texas.
  • Dignitana AB har tillsatt en ny VD under hösten och har anställt ny personal inom kvalitet och produktutveckling under året.
  • Under året genomförde Dignitana nyemissioner om totalt 52,5 MSEK bestående av två riktade emissioner på totalt 33,1 MSEK och en företrädesemission till befintliga aktieägare på 19,4 MSEK.

Väsentliga händelser efter årets utgång

  • Dignitana AB installerar de 17 system som Memorial Sloan Kettering Cancer Center beställde i slutet av 2016. 
  • Dignitanas studie för att erhålla FDA-godkännande publicerades den 14 februari i Journal of American Medical Association (JAMA).

Dignitana fuels growth with nine new installations in u.s. for Dignicap® scalp cooling medical device

Dignitana, a global leader in medical scalp-cooling technology, announced today that the DigniCap® scalp cooling system, which was cleared in December 2015 by the FDA to effectively reduce the likelihood of chemotherapy-induced hair loss in women with breast cancer, will soon be available in nine additional medical centers across the United States including the four locations of University of Miami Health System that were contracted in November 2016.


Dignitanas kliniska data publiceras i vetenskaplig artikel av prestigefylld medicinsk tidskrift

Klinisk data om säkerhet och effektivitet med Dignitanas skalpkylningsystem DigniCap® publicerades den 14 februari 2017 i The Journal of the American Medical Association (JAMA)


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