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University of California San Francisco enrolls first patients in FDA Approved Clinical Trial
University of California San Francisco enrolls first patients in FDA Approved Clinical Trial to test treatment for chemotherapy-related hair loss
DigniCap® Scalp Cooling System Now Available at Leading U.S. Medical Centers
NEW YORK – AUGUST 23, 2013 — Dignitana, a world leader in medical scalp-cooling technology, announced today that the University of California, San Francisco (UCSF) has only in one week´s time enrolled the first patients of the multi-center pivotal trial of the patented DigniCap® System for the prevention of chemotherapy-related hair loss. The trial, which was recently approved by the FDA, is part of the second and final phase of study in the United States and paves the way for FDA market approval of the scalp-cooling device, which is already widely used overseas.
UCSF joins other prestigious medical centers initiating the trial, including Wake Forest Baptist Medical Center in North Carolina and Weill Cornell Medical Center in New York which is starting enrollment of patients. The study will be conducted with a total of 110 patients across all sites. Additional sites in New York and California have agreed to join the trial and is to be announced when they have local IRB approval and is expected to open in the near future.
"Our partnership with UCSF is a testament to the eagerness of leading medical professionals to provide their patients with an alternative to potentially devastating hair loss associated with treatment,” said Martin Waleij, Chief Executive Officer for Dignitana “Clinical evaluation by such trusted medical centers is a primary reason that the DigniCap® System is fast becoming the preferred treatment option for cancer patients throughout the world. We are excited to get the study underway at UCSF.”
UCSF and Wake Forest previously conducted a pilot study using the DigniCap® System in 20 women with early stage breast cancer. The treatment was successful in the majority of women and well tolerated, laying the groundwork for this pivotal and larger trial.
Clinical trials done in Europe and Asia show eight out of 10 women who used the DigniCap® System during chemotherapy retained their hair. Additional trials at leading medical centers around the world have proven the system to be a viable alternative for both women and men of diverse ethnicities.
“The DigniCap® System has been extremely well received in clinical trials at leading medical centers around the world,” Waleij says. “We are pleased to be able to work now with the U.S. regulatory system and these prestigious medical centers to provide this highly tolerable, safe and effective therapy for cancer patients in the United States.”
For more information about participating in one of The DigniCap® System clinical trials, please visit www.Dignitana.com.
Dignitana AB (publ) is a Swedish medical device company listed on the OMX NASDAQ First North Stockholm is a world leader in technologies within the area of medical cooling. For more information about Dignitana and the DigniCap® System, please visit http://www.dignitana.com.