Our Story: Two Paths Converge
Manual cold caps have been in very limited use in the US for the past ten years, however, it wasn’t until December 8, 2015 that a scalp cooling device was actually granted Clearance from the United States Food and Drug Administration (FDA).
After receiving a breast cancer diagnosis in 2010, Patsy Graham underwent her first chemotherapy regimen and proceeded to lose almost all of her long dark curly hair. However, by the time she was ready for her second infusion, she had heard about “Cold Caps” that could help protect her hair and enable it to grow back during her remaining chemo treatments. She ordered the caps and by the time she had completed her chemotherapy, her hair was already growing back. Understanding how it felt to be a bald woman and what it meant to be able to regain her hair during chemotherapy was all Patsy needed to inspire her to want to help provide this option to other cancer patients.
Patsy set up a non-profit called Cold Caps Assistance Projects (CCAPS) and began by subsidizing patients in Texas. In early 2014 CCAPS went national and many more patients requested subsidies.
In February of 2010, breast cancer surgeon and researcher Laura Esserman, MD, MBA and Director of the Carol Franc Buck Breast Care Center at UC San Francisco wrote down the words “scalp cooling” on the back of a napkin at a Ferry Building restaurant in San Francisco and handed it to Bethany Hornthal. Dr. Esserman’sinterest was spurred by a patient at the Breast Care Center had heard about a scalp cooling device in Europe that women were using to save their hair during chemotherapy. She asked her doctor, Hope Rugo, MD, if UCSF could make the device available. Intrigued, Dr. Rugo discussed the request with Dr. Esserman. This led to a decision to explore conducting an FDA Trial on scalp cooling, an expensive proposition. Bethany was asked to seek the necessary funds.
An FDA Clinical Trial
Bethany approached Dr. Ingrid Tauber, a psychologist, and president of the Laszlo Tauber Foundation, with a proposal to fund an FDA Trial, code-named HairToStay. Dr. Tauber, understanding all too well how emotionally devastating hair loss can be to patients, generously agreed to fund the necessary research. Bethany stayed involved in the project for the next 5 years, working with UCSF, Dignitana (the Swedish developer of the Dignicap scalp cooling system) and Dr. Tauber.
On December 8th, 2015, the FDA granted the Clearance, and the team from UCSF and Dignitana toasted the wonderful victory they had achieved for patients across the United States.
Insurance Industry is not Cooperative
Receiving FDA Clearance was the initial goal, and might have been the end of the story. However, it became increasingly apparent that scalp cooling would likely not be covered by most insurance carriers for many years, thereby dramatically reducing the number of patients who could afford the treatment.
Bethany was determined to find a way to subsidize scalp cooling for patients with financial need.
The Phone Call
Once FDA Clearance came through,Once FDA Clearance came through, Patsy began having a hard time keeping up with the operational and financial demands of CCAPSThen, in early 2016. Bethany, called Patsy to find out what her vision was for CCAPS.
HairToStay is Born
Bethany and Patsy decided to join forces. They launched HairToStay in April 2016, with a goal of building a national subsidy program that could be supported by partnerships with both philanthropic and commercial organizations.
Changing of the Guard
Patsy had a milestone (70th) birthday in 2017, and decided to focus strictly on being our liaison for patients looking for just a little more personalized support, a role she performs with experience and empathy.
Meeting a Growing Need
Scalp Cooling has taken hold. Demand for treatments and subsidies has grown substantially.
To date, HairToStay has raised over $6M and awarded subsidies to nearly 4,871 recipients who would otherwise have been unable to afford to save their hair. We are deeply grateful for the generosity of our donors and our many sponsors in the haircare industry who have helped ensure that HairToStay can continue to help Cooler Heads Prevail.