DIGNITANA CELEBRATES FIRST ANNIVERSARY OF FDA CLEARANCE FOR DIGNICAP® SYSTEM AT SAN ANTONIO BREAST CANCER SYMPOSIUM

Technological Advances Are Making Hair Loss from Chemotherapy a Thing of the Past

Lund, Sweden and Dallas, TX – December 8, 2016—One year to the date of receiving FDA Clearance for the DigniCap® scalp cooling system to prevent hair loss in women with breast cancer, Dignitana AB and Dignitana, Inc., are proud to announce that the device will soon be available in 53 medical centers across 17 U.S. states, with demand continuing to grow.

The DigniCap® system is the first and only scalp cooling device to receive clearance after completing rigorous U.S. FDA clinical trials, where seven out of ten patients with early-stage breast cancer kept at least 50% of their hair.

As 2017 approaches, clinical interest in DigniCap® continues to accelerate, and Dignitana will demonstrate new technological advances at its booth at the San Antonio Breast Cancer Symposium (SABCS), where it will also offer a scalp cooling poster presentation on December 9th. Product enhancements developed in this first year include comfort and temperature modifications and an exclusive partnership with Denver based Boa® Technology to customize and create a more precise outer cap fit using the award-winning Boa® Closure System. Visit Dignitana at SABCS in booth 435.

“This is an incredibly exciting period of growth for us here in the U.S.,” said William Cronin, Chief Executive Officer of Dignitana, Inc., “Oncologists and clinicians in medical centers across the country recognize the benefits that scalp cooling can provide their patients. We are proud to be able to offer the only FDA cleared option for reducing chemo-induced hair loss, and we are especially pleased to be partnering with innovators like Boa who can bring their exciting technology to improve our product as we continue to learn and grow.”

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. 

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.  

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