Dignitana is committed to helping patients preserve privacy and maintain control with technology to diminish the emotional burden of hair loss from chemotherapy.

FREQUENTLY ASKED QUESTIONS – SCALP COOLING

What is scalp cooling?

Some chemotherapy drugs can damage your hair cells. Cooling of the scalp is a proven approach to reduce chemotherapy-induced hair loss that has been used successfully by thousands of patients worldwide. The reduced temperature results in a reduced blood flow to the scalp area so that less chemotherapy reaches the hair cells. Hair cells are therefore not exposed to the full dose of chemotherapy and may be able to survive the chemotherapy treatment. In addition, cellular metabolism within the hair cells is slowed down. As a result, hair is less likely to fall out.


How does scalp cooling work?

When a patient’s scalp is cooled, the blood vessels in the localized scalp area constrict (vasoconstriction). The narrowed blood vessels limit the amount of chemotherapy agents delivered to scalp area. Scalp cooling also causes normal cellular activity in the localized scalp area to slow dramatically. This means that much fewer chemotherapy agents become absorbed by the hair cells and damage is significantly reduced.


Why does chemotherapy cause hair loss?

Chemotherapy affects cells that are in the phase of division or growth. All the cells in the body may be affected by chemotherapy, not just the cancer cells. This means that even healthy cells, especially cells with a high growth rate, such as your hair, are likely to be affected by the chemotherapy.


How large is the market for scalp cooling?

There are over 800,000 total incidences of solid tumor cancers in the United States each year alone. Included in that number are 255,000 new incidences of breast cancer, 60% of who’s patients are on a regimen that would be compatible with DigniCap.The U.S. market for scalp cooling is worth approximately $275 million per year for breast cancer, and an additional $435 million for solid tumors.


What is the demand for scalp cooling?

Hair loss, experienced by most patients during chemotherapy, is consistently ranked as a very distressing side effect. A 2014 study found that 8% of patients refuse chemotherapy due to hair loss as a side effect.Reducing hair loss from chemotherapy contributes significantly to the increased well-being and quality of life for patients. After a short introduction to scalp cooling, 96% of surveyed women showed interest in scalp cooling and 81% said the availability of scalp cooling was an important factor in selecting a medical center.

FREQUENTLY ASKED QUESTIONS – THE DIGNICAP SCALP COOLING SYSTEM

What is The DigniCap Scalp Cooling System?

DigniCap consists of a snug-fitting silicone cooling cap connected to a cooling and control unit, which circulates coolant through channels in the cap. To make this process more comfortable, the cooling cap is at room temperature when placed on the head and the treatment temperature is achieved over a short period of time. To ensure optimal treatment temperature, and outer insulating neoprene cap is applied over the silicone cap. By lowering the temperature of the scalp, constricting the blood vessels and reducing blood flow and cell metabolism, DigniCap helps protect the hair follicles from the damaging effects of chemotherapy.


Who can use DigniCap?

For over a decade, DigniCap has successfully helped thousands of cancer patients outside of the U.S. DigniCap is currently FDA cleared in the U.S. for treatment of men and women with solid tumor cancers. Scalp cooling if effective with many chemotherapy drugs, but not all. Your clinician can tell you if scalp cooling is compatible with your treatment.


When would a patient use DigniCap?

DigniCap is used during each cycle of chemotherapy administration. It is recommended that scalp cooling be used starting at the very first chemotherapy infusion.


How long does a scalp cooling treatment take?

The scalp cooling device is operated by trained clinical staff and will be used during each chemotherapy session. Scalp cooling begins approximately 30 minutes before chemotherapy starts (while pre-meds are administered), continues during the infusion of hair loss causing chemo agents, and then continues for a set period of time after depending on the chemotherapy drug and dose. Patients will need to maintain a reduced scalp temperature for 30-150 minutes following the completion of their chemotherapy infusion. Typically, it ranges from 90-150 minutes. After completion of the post-infusion cooling time, the cooling cap remains on your scalp for another 5-10 minutes to allow temperature to slowly increase and diminish any discomfort.


Why choose DigniCap?

  • Experienced clinical team provides ongoing training and support
    Led by a nationally respected oncology nurse, the DigniCap clinical support team is available to patients and clinicians by phone, online, app, and in person.
  • Superior results in the pivotal trial
    DigniCap achieved 66.3% success with taxanes in the U.S. clinical trial vs the competitor’s success rate of 59% with taxanes and 50.5% overall.
  • Longer clinical trial treatment evaluation period
    More hair loss will occur with a greater number of treatments. For accuracy, success must be measured at end of treatment. In the clinical trial DigniCap was evaluated one month after the end of all the patient’s chemotherapy cycles, whereas the competitor’s trial was evaluated after just four chemotherapy sessions.
  • Wide range of cap sizes
    DigniCap is available in four sizes to fit a wide range of head shapes and sizes.
  • Extensive experience in the U.S. market
    In 2015, DigniCap became the first scalp cooling device to receive clearance from the US Food and Drug Administration.
  • Expanded clinical indications from the US Food and Drug Administration
    After an extensive review of worldwide studies, in 2017 the FDA expanded the clinical indication for DigniCap to include men and women with solid tumor cancers.
  • In-cap sensors for superior temperature control and safety
    DigniCap is the only scalp cooling system with patented dual sensors in the cooling compartments for consistent cooling and temperature management, plus a built-in safety sensor to ensure scalp temperature always stays above 32°F / 0°C.
  • Marketing services with extensive media attention
    Proactive promotion of your institution, clinicians, and patient stories to consumer and healthcare media.

Where is DigniCap available?

For a list of locations, please visit the Availability page on this site.


How can a medical facility acquire a DigniCap?

Medical facility may contact Dignitana directly at info@dignitana.com.

FREQUENTLY ASKED QUESTIONS – DIGNITANA

Who are Dignitana AB and its related entities?

Dignitana AB is a Swedish medical technology company listed on the NASDAQ OMX First North stock exchange in Stockholm. The company is currently focusing on a widespread market launch of the DigniCap scalp cooling system – a product that counteracts chemotherapy-related hair loss in cancer patients with solid tumors and may significantly contribute to improving patient well being and quality of life. Dignitana develops a patented scalp cooling system, DigniCap, that reduces chemotherapy-induced hair loss. Dignitana’s patented DigniCap system has proven its safety and efficacy in clinical studies.

Dignitana, Inc. is a wholly owned subsidiary of Dignitana AB and is responsible for North American distribution and support for the DigniCap scalp cooling system.

Dignitana S.r.l. is a wholly owned subsidiary of Dignitana AB and registered in Italy.


How is Dignitana an innovator in the scalp cooling field?

Dignitana, a world leader in scalp cooling innovation, has helped patients reduce hair loss from chemotherapy for over a decade. As the first scalp cooling system to receive FDA clearance in the United States, Dignitana paved the way for infusion centers in the U.S. offer cancer patients scalp cooling while they receive their chemotherapy treatments. Dignitana is committed to helping patients preserve privacy and maintain control with technology to diminish the emotional burden of hair loss from chemotherapy.


What protections and patents exist for Dignitana’s products?

TRADEMARKS
Dignitana, DigniCap, DigniCard, DigniCool, DigniStick, DigniTherm and DigniLife are trademarks of Dignitana AB (publ).

REGISTERED TRADEMARKS
Dignitana, DigniCap and DigniLife are registered trademarks owned by Dignitana AB (publ).

The DigniCap Scalp Cooling System is patented in Europe, China, Korea, Japan and the United States. For additional intellectual property information see the Intellectual Property page.

The use or modification of Dignitana trademarks is strictly prohibited except with specific written authorization from Dignitana AB (publ)).

Please note that the content of this website is not intended as professional medical or healthcare advice and should not be construed as a substitute for professional healthcare advice, or services from a qualified professional healthcare provider familiar with your unique situation. This content is intended solely as a general product and corporate information.

OPERATIONS
Dignitana
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Dallas, TX 75238
+1 469-917-5555

HEADQUARTERS
Dignitana AB
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226 60 Lund, Sweden
+46 46 16 30 90