Dignitana Receives U.S. FDA De Novo Clearance for The DigniCap® Scalp Cooling System

Dignitana Receives U.S. FDA De Novo Clearance for The DigniCap® Scalp Cooling
System that Reduces Hair Loss Related to Chemotherapy for Women with Breast
Cancer

Dignitana Brings First and Only U.S. FDA-Cleared Scalp Cooling System to Market

Alternative to one of the most devastating side effects feared by women with
breast cancer will soon be available at leading cancer centers nationwide
DALLAS, TX, DECEMBER 8, 2015—Dignitana, a world leader in medical scalp-cooling
technology, announced today that the U.S. Food and Drug Administration (FDA) has
granted the company’s de novo application to market the DigniCap® scalp cooling
system, designed to reduce the severity of chemotherapy-induced hair loss. After
rigorous clinical studies and wide use overseas the DigniCap® scalp cooling
system is now FDA-cleared for use in the United States. The system, which is the
only such device to have completed an FDA approved multi-center clinical trial,
is used by patients undergoing chemotherapy infusion, and is cleared for use
with treatment regimens associated with breast cancer.

Dignitana is currently finalizing agreements with major cancer centers and
community oncology groups across the country so that they will be able to offer
DigniCap® to patients as soon as possible. Prior to clearance, the DigniCap®
scalp cooling system was clinically studied in women with breast cancer at some
of the most prestigious medical centers in the nation, including:

  · UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco,
California
Principal Investigator Hope S. Rugo, M.D.
  · Wake Forest Baptist Medical Center, Winston Salem, NC
Principal Investigator Susan Melin, M.D.
  · Weill Cornell Breast Center, New York, NY
Principal Investigator Tessa Cigler, M.D.
  · Mount Sinai Beth Israel, Comprehensive Cancer Center, New York, NY
Principal Investigator Paula Klein, M.D.
  · UCLA’s Jonsson Comprehensive Cancer Center, Santa Monica, CA
Principal Investigator Sara Hurvitz, M.D.

“Some of today’s most powerful, life-saving chemotherapy treatments still cause
complete hair loss, a side effect that many women consider to be emotionally
devastating,” said Dr. Hope S. Rugo, Principal Investigator for the study and
Director of Breast Oncology and Clinical Trials Education at the UCSF Helen
Diller Family Comprehensive Cancer Center. “For the past several years, we’ve
worked closely with Dignitana to conduct rigorous clinical trials that
demonstrate the safety and effectiveness of the DigniCap system. This FDA
clearance means that for many cancer patients in the U.S., chemo-induced hair
loss will no longer be a distressing concern.”

In the U.S. clinical trial 7 out of 10 patients with early stage breast cancer
kept at least 50% of their hair. With regards to safety, no severe adverse
events were reported. While most patients had a feeling of chilliness during the
cooling down period only 3 out of 106 trial participants discontinued for this
reason. A patient reported satisfaction score (ranked from 0 to 100, with 100
being “completely satisfied”), showed a mean score of 87.5 satisfaction with the
decision to use scalp cooling, a mean score of 70.9 for hair quantity, and a
mean score of 69.1 for satisfaction with hair quality. In the U.S. trial, scalp
cooling was evaluated mainly on regimens including taxanes (such as paclitaxel
and docetaxel) but outside of the U.S. there is also experience from scalp
cooling with anthracyclines (such as epirubicin and doxorubicin).

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 hair loss.

DigniCap® is the only system to offer gradual cool down and effective scalp
cooling at temperatures above freezing for greater patient comfort. Two built-in
cap sensors continuously monitor scalp temperature and allow the system to
maintain optimal cooling throughout the scalp cooling treatment. A third built
-in safety sensor ensures the cooling temperature as measured on the scalp never
drops below the freezing point of 32° F (O° C).

“We are thrilled to be able to advance the science of hair preservation for
women who must undergo chemotherapy and to find ways to make life saving
treatments more tolerable,” said Laura Esserman, M.D., M.B.A., Professor of
Surgery and Director of the Carol Franc Buck Breast Care Center at the UCSF
Helen Diller Family Comprehensive Cancer Center (http://cancer.ucsf.edu/). “An
FDA approved product that makes scalp cooling available for women across the
country is extremely good news.”

"This FDA clearance means that finally, breast cancer patients in the U.S. will
have access to a convenient, safe and scientifically proven option for reducing
chemotherapy-induced hair loss,” said Jan Richardsson, Chief Executive Officer
for Dignitana. “We are tremendously excited to be able to offer this state-of
-the-art technology to hospitals and infusion centers across the U.S.”

“Working with the professionals at our clinical trial sites has given us a
significant head start in learning how best to provide the DigniCap® scalp
cooling system here in the U.S.,” said Dignitana Inc., COO Bill Cronin.
“Additionally, we are fortunate to have attracted a talented group of
professionals with scalp cooling experience, ready to help our future infusion
center clients offer this valuable therapy option to patients as efficiently and
as smoothly as possible.  We are gratified and excited that after such an
extensive and rigorous development and investigational process we are now moving
forward to market the DigniCap in the U.S.”

“I am extremely excited to finally be able to offer patients scalp cooling
during chemotherapy which allows them to retain normalcy and privacy in their
lives,” said Paula Klein, M.D., Medical Director, Breast Cancer Clinical Trials,
Mount Sinai Health System. “I am proud that Mount Sinai Beth Israel was one of
five cancer centers to participate in the important clinical trial that has led
to this approval. Losing hair is one of the more distressing side effects of
chemotherapy and this is a game changer for many.”

Dignitana will be working actively with the payor community with the hopes of
gaining coverage and payment for its product/service. In addition to working on
this issue with the payor industry, Dignitana is also working to engage
philanthropic organizations foundations and potential corporate donors and
sponsors to help ensure that as many patients as possible are able to consider
scalp cooling technology as part of their care regimen. Some donors are already
working directly with individual medical centers, such as the UCSF Helen Diller
Family Comprehensive Cancer Center, to ensure that patient expenses can be
subsidized.

“I am profoundly grateful to be supporting a system that is able to minimize the
psychological impact of an overwhelming diagnosis,” said Ingrid Tauber Ph.D.,
Clinical Psychologist and President of the Laszlo Tauber Family Foundation. Dr.
Tauber provided funding to UCSF to get the first trial underway and has since
created a fund to help support patients who want to use the DigniCap® scalp
cooling system during their chemotherapy infusions at UCSF. “Scalp Cooling
offers patients a way to maintain their dignity, self-esteem, and sense of
empowerment, offering an alternative to one of the most dreaded side effects of
chemotherapy,” Dr. Tauber adds.

To learn more about the DigniCap® scalp cooling system please visit
www.DigniCap.com (http://www.dignitana.com/).
Media Contact:

Caren
Browning


King
Company


00 1 212 561
-7464


Caren.Browning@kingcompr.com

About Dignitana AB (publ)
Dignitana is a Swedish public company, based in Lund, and manufacturer of the
medical cooling device DigniCap®. Dignitana is continuously researching and
developing new uses for DigniCap®. Dignitana AB is listed on the OMX Nasdaq
First North stock exchange and has appointed Erik Penser Bankaktiebolag as
Certified Advisor. For more information visit www.dignitana.com

About the scalp cooling system DigniCap®
Dignitana’s core product - DigniCap® - is a patented scalp-cooling system that
offers cancer patients the ability to keep their hair during chemotherapy.
DigniCap® is developed to provide continuous cooling with high efficacy, safety
and acceptable patient comfort.