DigniCap Delta receives TGA approval

Next generation device reduces hair loss for cancer patients

9th September 2019

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

“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 optimises 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.”

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 minimise 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 and delivery to customers will begin in October when the first systems will be placed within Australia with initial orders being placed by a large provider of cancer care services.

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. ”

Please contact Aurora BioScience on 1300 309 994 or info@aurorabioscience.com.au for more information.