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 växer i Italien och startar dotterbolag

Dignitana AB registrerade idag Dignitana Srl (Società a responsabilità limitata) i Italien. Bolaget är ett helägt dotterbolag till Dignitana AB och kommer att fungera under ledning av Dignitana AB. Registreringen av Dignitana Srl möjliggör för Dignitana att tillhandahålla hårbottenkylning tjänster till sjukvårdsenheter i hela Italien. Härigenom kan Dingitana möta det ökande antalet ansökningar om hårbottenkylning tjänster vid nya medicinska centra. Dignitana kan nu som en konsekvens av registreringen av det italienska dotterbolaget nu också tecknat nya kontrakt avseende tre skalpkylningsmaskiner som nu ska installeras i Italien.   


Dignitana grows business in Italy

New Subsidiary Registered 

Dignitana AB today registered Dignitana S.r.l (Società a responsabilità limitata) as a new entity in Italy. The entity is a wholly-owned subsidiary of Dignitana AB and will function under the leadership of Dignitana AB. The registration of Dignitana S.r.l enables Dignitana to provide scalp cooling services to public health facilities throughout Italy. By doing so, Dignitana can meet the increasing number of requests for scalp cooling at new medical centers. With this registration the company can now finalize contracts for the sale of 3 machines in Italy.


DIGNITANA KOMMENTERAR AMERICAN MEDICAL ASSOCIATION (DET AMERIKANSKA LÄKARFÖRBUNDET) BESLUT ATT INTE INFÖR EN UNIK CPT® CODE FÖR KYLNING AV HÅRBOTTEN

Dignitana AB har ansökt hos American Medical Association (AMA) (Det amerikanska läkarförbundet) om att skapa en unik CPT ®-kod (Current Procedural Terminology kod) som inkluderar kylning av hårbotten vid cytostatikabehandling. Syftet med ansökan var att förenkla processen för patienten i dennes dialog med försäkringsbolag om ersättning för både cytostatikabehandlingen och kylning av hårbotten. Försäkringsskydd för hårbottenkylning är ännu inte standardiserat i USA. De patienter som använder sig av DigniCap-systemet erhåller idag ersättning från försäkringsbolagen för cancerbehandlingskostnaden inklusive kostnaderna för kylning av hårbotten sedan 2015 då DigniCap erhöll sitt FDA-godkännande. Idag har AMA meddelat att de inte avser att införa en unik CPT ®-kod.


DIGNITANA RESPONDS TO AMERICAN MEDICAL ASSOCIATION DECISION REGARDING UNIQUE CPT CODE FOR SCALP COOLING

Lund, Sweden - 19 June 2018 -  Dignitana AB, world leader in clinically superior scalp cooling technology, has responded to the announcement made earlier today by the American Medical Association (AMA), on their decision to reject the company's application to create a unique CPT® code for FDA-cleared automatic scalp cooling devices. The request, which was made at the May 2018 CPT Editorial Panel Meeting, was part of Dignitana's efforts to provide a pathway for a more universal and standardized patient coverage method. At present, the service of scalp cooling used in conjunction with patients' chemotherapy treatments for solid tumor cancers is not reflected in CPT nomenclature.


Dignitana publishes Interim Financial Report for Q1 2018

Significant events during the period

  •  The DigniTherm™ Click Cap was introduced to facilities in December 2017 and the roll-out to all U.S. facilities was completed in Q1 2018.
  •  13 machines were installed at 12 sites in the US in Q1.
  •  Transition of operations from Lund, Sweden to the U.S. was announced and initiated in Q4 2017 and continued in Q1. It was successfully completed in April, two months ahead of schedule. Dignitana AB remains in Lund.
  •  The Rights offering which was begun in Q4 2017 was fully subscribed and funding was completed in early January 2018.
  •  At an Extraordinary General Meeting 16 March 2018 Thomas Kelly, Ingrid Atteryd Heiman, and Mikael Wahlgren were appointed to the Board of Directors with Thomas Kelly designated as Chairman of the Board for Dignitana AB.
  •  In March James McKinney was named President and COO of Dignitana, Inc.
  •  In March Dignitana initiated an application with the American Medical Association for a unique CPT Code for scalp cooling to provide a pathway for universal scalp cooling coverage. The decision will be announced by the AMA in June.

Dignitana Launches Survey to Gather Critical Insights on Insurance Coverage and Reimbursement for Cancer Patients Undergoing Chemotherapy

Maker of the World's First FDA-Cleared Therapeutic for Reducing Chemotherapy-Induced Hair Loss Takes the Lead in Advocating for Universal Insurance Coverage of Treatments for Women and Men


Communication from the Dignitana AB Annual General Meeting 2018

Dignitana AB, has today held an annual general meeting at the company's premises in Lund. In all the proposed cases, the AGM resolved in accordance with the Board's proposal. Below is a summary of the decisions taken.


Sysmex Europe GmbH to Transfer Management of All European Installations Of The DigniCap Scalp Cooling System Back to Dignitana AB

Lund, Sweden - 9th April 2018 - Dignitana AB, world leader in clinically superior scalp cooling technology, will assume the complete operation from Sysmex Europe GmbH of their DigniLife® scalp cooling division. The agreement is effective April 2018 and the transition with medical facilities will begin immediately.


Dignitana Publishes Annual Report for 2017

Lund, Sweden - 3 April 2018 - Dignitana AB hereby publishes the annual report for 2017. The annual report is attached to this press release and can be downloaded from the website www.dignitana.se. You can also order a printed version via investorrelations@dignitana.com.Note: This report is published in Swedish.

Note: For a similar report in English, view the Dignitana 2017 Year End Report that was released 22 February 2018.


Notice of Annual General Meeting in Dignitana AB (publ) - correction

The shareholders of Dignitana AB (publ), 556730-5346, ("the Company") are hereby invited to attend the Annual General Meeting on Tuesday 24 April 2018 at 12.00 in the Company's premises, Traktorgränden 3, in Lund, Sweden.

This meeting had previously been scheduled for Thursday 26 April 2018 but will instead occur Tuesday 24 April 2018.


Notice of Annual General Meeting in Dignitana AB (publ)

The shareholders of Dignitana AB (publ), 556730-5346, ("the Company") are hereby invited to attend the Annual General Meeting on Tuesday 24 April 2018 at 12.00 in the Company's premises, Traktorgränden 3, in Lund, Sweden.

This meeting had previously been scheduled for Thursday 26 April 2018 but will instead occur Tuesday 24 April 2018.


Report from Extraordinary Shareholders Meeting on 16 March 2018

Dignitana AB, world leader in clinically superior scalp cooling technology, today held an extraordinary shareholders meeting at the company's office in Lund. In all scheduled actions the shareholders acted in accordance with the board's proposals. Below is a summary of the decisions.  


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