FDA's expanded clearance enables Dignitana's scalp cooling technology DigniCap®,
to be used when patients undergoing chemotherapy are treated for solid tumor
cancers in the United States. The decision gives Dignitana the opportunity to
offer DigniCap® to about 800,000 patients in the US market per year.
Lund, Sweden - July 3, 2017 - Dignitana AB, a world leader in medical scalp
cooling technology and manufacturer of the DigniCap® Scalp Cooling System,
announced today that it has received
tm) from the U.S. Food and Drug Administration (FDA) to expand use of its
medical device to patients in the United States receiving chemotherapy for solid
tumor cancers. The decision means that medical facilities may use DigniCap® to
reduce hair loss in patients treated for solid tumor cancers such as breast,
prostate, ovary, uterus, lungs and other tissues.
The approval from the FDA is an extension of the decision taken by the authority
in 2015 when Dignitana was the first scalp cooling company granted permission to
use the patented technology for treating women with breast cancer in the United
States. Today's decision means that Dignitana once again is first, now to be
able to provide the option to use DigniCap® to about 800,000 cancer patients
annually diagnosed with different types of solid tumors cancers (cancer.org).
Dignitana estimates that the market for scalp cooling of breast cancer patients
in the United States is worth about US $ 50 million a year, based on an average
number of chemotherapy treatments. With the expanded clearance, Dignitana
expects to gain access to a market worth somewhere in excess of $ 140 million
"The new decision by the FDA means that our potential market in the US is more
than tripled," says Johan Ericsson, CEO of Dignitana AB. "It also means a
significantly stronger market position for our brand and business. The expanded
indication also shows how well developed and carefully tested our scalp cooling
technique is. It is with confidence that we now prepare to reach out to an even
greater number of cancer clinics and patients in our main market."
In the United States, DigniCap® is
available (https://dignicap.com/availability/) at more than 80 cancer clinics in
21 states, helping thousands of patients each year to minimize chemotherapy
-induced hair loss.
Read more on the FDA website:
Chief Executive Officer
+46 46 16 30 92
+46 709 346664 (http://callto+46709346664)
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 Nasdaq First North
Stockholm and has appointed Erik Penser Bank as Certified Adviser. Headquartered
in Dallas Texas, Dignitana, Inc. is the U.S. subsidiary of Dignitana AB. For
more information visit www.dignitana.se
About The DigniCap® Scalp Cooling System
DigniCap® is a patented scalp cooling system that offers cancer patients the
ability to keep their hair during chemotherapy. DigniCap® provides continuous
cooling with high efficacy, safety and acceptable patient comfort.
This information is information that Dignitana AB 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 21:15 (CET), 3