DIGNITANA BRINGS FDA-CLEARED DIGNICAP® SYSTEM TO THREE MORE CITIES IN THE U.S.
More American Cancer Centers Sign On to Provide Patients with an Alternative to Chemotherapy Related Hair Loss—One of the Most Devastating Side Effects of Chemotherapy
Lund, Sweden —April 27, 2016— Dignitana AB, a world leader in medical scalp-cooling technology, announced today that the DigniCap® scalp cooling system, which was recently cleared by the FDA to effectively reduce the likelihood of chemotherapy-induced hair loss in women with breast cancer, is now also available at three more cancer treatment centers across the U.S.
The DigniCap® system is the first and only scalp cooling device to complete rigorous FDA clinical trials in the U.S., where seven out of ten patients with early-stage breast cancer kept at least 50% of their hair.
Since FDA clearance in December 2015, more than fifteen U.S. medical centers have begun the process of introducing the DigniCap® scalp cooling system to their patients. Agreements with several others are currently in discussion and early adopters like The Angeles Clinic and Research Institute, an affiliate of Cedars-Sinai, are ordering additional systems as well.
To date, the DigniCap system has contracts in place at the following U.S. medical centers: Bronson Battle Creek Cancer Care Center , Charleston Hematology Oncology Associates , Chesapeake Oncology and Hematology Associates , Florida Cancer Specialists & Research Institute , Mount Sinai Beth Israel Cancer Center , Mount Sinai Comprehensive Cancer Center , Orange County Blood and Cancer Care , The Angeles Clinic and Research Institute , an affiliate of Cedars-Sinai , The Dubin Breast Center at The Mount Sinai Hospital , Toledo Clinic Cancer Center , UCSF Helen Diller Family Comprehensive Cancer Center , UT Health Science Center San Antonio’s Cancer Therapy & Research Center , and Wake Forest Baptist Medical Center .
The following cancer treatment centers are the most recent sites in the U.S. to provide the DigniCap® scalp cooling system in their breast cancer treatment regimens:
- Menorah Medical Center
Overland Park, Kansas
- Oncology & Hematology Specialists
Denville, New Jersey
- Stamford Health Bennett Cancer Center
Stamford Health Bennett Cancer Center is the first medical center in Connecticut to sign an agreement with Dignitana in order to offer the DigniCap® system to patients undergoing chemotherapy for breast cancer, making the scalp cooling treatment more accessible to patients in the Northeast.
“For patients and families dealing with a cancer diagnosis, it’s important that a center combines a high level of physician expertise, the most advanced treatment options and a personalized approach that looks not only at the disease, but also at the patient and his or her unique physical, emotional and spiritual needs,” said Elizabeth Manfredo , Director of The Stamford Health Bennett Cancer Center. “Introducing the DigniCap system will allow us to offer our patients a way to address chemotherapy–induced alopecia – hair loss that can have a substantial impact on the quality of life for many patients.”
The Angeles Clinic and Research Institute , an affiliate of Cedars-Sinai, was one of the first ten medical centers in the U.S. to offer the DigniCap® scalp cooling system to their patients. After several successful patient treatments, they are among the first round of centers now requesting additional systems.
“We are thrilled that the DigniCap® scalp cooling system is so well-received in the U.S. marketplace and proud to be fulfilling requests at such prestigious cancer centers,” said Jan Richardsson, Chief Executive Officer of Dignitana. “These three additional centers are committed to bringing better quality of life treatment options to their cancer patients, and this alternative to avoid chemotherapy induced hair loss allows them to do just that.”
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.
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Om Dignitana AB (publ)
Dignitanas, med säte i Lund, affärsidé är att utveckla, tillverka och marknadsföra den medicintekniska produkten DigniCap®. Dignitana bedriver en kontinuerlig forskning och utveckling av nya användningsområden för DigniCap®. Dignitanas aktier handlas på NASDAQ OMX First North med Erik Penser Bank som Certified Adviser. För mer information gå in på: www.dignitana.se
Om skalpkylningssystemet DigniCap®
Dignitanas huvudprodukt - skalpkylningssystemet DigniCap® - är ett patenterat system med syfte att eliminera eller kraftigt reducera håravfall för patienter som genomgår cytostatikabehandling. DigniCap® erbjuder skalpkylning med jämn kyla, hög effektivitet, säkerhet och acceptabel komfort.