Dignitana receives FDA clearance for DigniCap Delta scalp cooling system

Dignitana AB, world leader in medical scalp cooling technology, announced today that the United States Food and Drug Administration has cleared DigniCap Delta® for use by U.S. 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 tumors. European installations of DigniCap Delta began last month after the device received CE Marking in March 2019.

“DigniCap Delta changes everything about the way scalp cooling is done today,” said William Cronin, CEO of Dignitana.” In the value-based U.S. health care system providers tell us they want to improve the clinical process, reduce nursing intervention and optimize 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 FDA 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 medical centers in the United States and delivery to customers will begin in July. The current DigniCap device is already in use in 30 states in the U.S. and in 37 markets globally. The addition of a disposable cap for single patient use provides a new global revenue stream for the company. Existing revenue comes from leasing fees, treatment fees to patients, service agreements and machine sales outside the United States.

Cronin added, “We are pleased that this approval comes at a time when both awareness of and demand for scalp cooling are rapidly increasing. The clearance of Delta now provides a clear pathway for growth in the important U.S. market and beyond. It is the biggest step yet in the evolution of Dignitana and is the result of a tremendous effort from our staff, partner sites, regulatory team and contract manufacturer.”

This is information that Dignitana AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, by the above contact, for publication at 08:00 (CET) on 27 June 2019.