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
clearance (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/u
cm565599.h
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
annually.
"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:
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm565599.ht
m
Corporate
contact
Press contact
Johan Ericsson
Anja Trägårdh
Chief
Executive Officer
Trägårdh Kommunikation
+46 46 16 30 92
+46 709
346664 (http://callto+46709346664)
johan.ericsson@dignitana.se
anja@tragardhko
mmunikation.se (anja@tragardhkommunikation.se)
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.
www.dignicap.com
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
July, 2017.
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