We hope this expanded FDA clearance will be welcome news for thousands of Americans diagnosed with solid tumors each year.
The new decision by the FDA means that our potential market in the US is more than tripled.
“The CHILL Registry is an incredible platform that will allow us to track progress and connect with physicians around the world to ensure that we can continue to deliver the most effective scalp cooling treatments available.”
“Dignitana is keen to align with support groups in the area to facilitate awareness and access to DigniCap treatments”
Mario Lacouture, MD, Director of the Oncodermatology Program at Memorial Sloan Kettering
William Cronin, Chief Executive Officer of Dignitana, Inc.
We are pleased with the consistent strong growth we are experiencing in the U.S. since FDA clearance nine months ago. The DigniCap system is being included as an integral part of the treatments offered by national leaders in comprehensive breast health services in the U.S. Up to date, forty-seven DigniCap scalp-cooling systems have been ordered for installation by US customers.
We are very excited that DigniCap® is being so well-received in the U.S., and that we’ve been able to quickly and effectively fulfil product requests. From the New York Metropolitan area to communities throughout the midwest, the south, and California, it is clear that DigniCap is filling an important need in quality of life cancer care and medical centers are eagerly promoting its addition to their cancer services.
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.
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.
The time is right to introduce DigniCap® at SABCS to physicians who are eager to provide their patients with an alternative to one of the most widely feared side effects of chemotherapy.
“We feel honored to be nominated and ranked as one of the fastest growing technology companies by Deloitte. We’ve grown during the ranking’s period, and we have fantastic journey in front of us with United States Food and Drug Administration approval pending.”
To have recruited all patients is a milestone for our company and a major step forward in our PMA process.