Dignitana receives TGA approval for DigniCap Delta scalp cooling system in Australia

First deliveries planned for October

Dignitana AB, world leader in scalp cooling innovation, today announced that the Therapeutic Goods Administration (TGA) has cleared DigniCap Delta® for use by health care providers in Australia. 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.

“DigniCap Delta changes everything about the way scalp cooling is done today,” said William Cronin, CEO of Dignitana. “The Delta system improves the clinical process, reduces nursing intervention and optimizes 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. Australia is a very important market for us and, as scalp cooling has become a standard of care for patients here, the Delta device will enable our partner sites to offer this valuable therapy option to more patients and much more efficiently.”

DigniCap Delta uses solid state cooling for precise temperature control in an advanced and redesigned model of the 2015 TGA 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 hospitals in Australia through Dignitana’s longtime distribution partner, Aurora BioScience, with first deliveries expected in October.

Darren Banks, Managing Director of Aurora BioScience, stated “We are pleased that this approval comes at a time when both awareness of and demand for scalp cooling are rapidly increasing. We are expecting significant interest in the Delta system moving forward as it is a major improvement over existing systems currently on the market.”

For More Information Contact

Investor Relations +1 469 518 5031 investorrelations@dignitana.com

About Dignitana

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 Growth Market 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.  Erik Penser Bank AB, Certified Adviser, +46 (0) 8 463 83 00 certifiedadviser@penser.se www.penser.se  Learn more at www.dignitana.se and www.dignicap.com.

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