Cooler Heads Care, a medtech company based in San Diego, created Amma, a cold cap therapy device that aims to help chemotherapy patients to preserve their hair. Hair loss is a very common side-effect of chemo, and poses a significant psychological challenge for patients who are already struggling with their diagnosis and treatment.
Simply cooling the scalp during chemotherapy can dramatically reduce the amount of drug absorbed by the hair follicles, leading to reduced hair loss. However, current technology to achieve this comes with a hefty price tag, and may cost the patient as much as $8,000. This is out of reach for many patients, and so Cooler Heads Care has developed the Amma patient-administered cold cap system that costs significantly less under a rental scheme, at approximately $2,000 per patient.
The device is sent to the patient’s home, and the company provides training on how to use it. Patients can bring the device to their chemo sessions and then take it back home with them to continue the therapy. The company was a finalist in the recent Medtech Innovator Global Competition.
See a video about the technology:
Medgadget had the opportunity to speak with Kate Dilligan, CEO of Cooler Heads Care, about the technology.
Conn Hastings, Medgadget: What is the impact of hair loss for patients receiving chemotherapy?
Kate Dilligan, Cooler Heads Care: Hair loss from chemotherapy (chemo) is devastating to both men and women. When a chemo patient loses their hair, suddenly it’s a public, and sometimes permanent, reminder to them and the outside world that they are sick. Patients often talk about feeling pitied and being treated as an invalid when they are going through chemo.
Cold cap therapy is not about beauty, but instead it’s about protecting privacy, agency and identity. Chemotherapy patients want to be seen as the whole person they are, and not as someone who is sick. Keeping their hair during chemotherapy allows people to control who knows about their disease and who doesn’t. It also gives patients a choice as to how they manage their side effects and provides them with stability when their lives feel completely out of control and beholden to treatment. Most importantly, keeping their hair enables patients to continue to recognize themselves in the mirror, which is an incredibly powerful thing for maintaining their sense of self.
Medgadget: What inspired you to develop technology to reduce hair loss during chemotherapy?
Kate Dilligan: It’s one of the quintessential founder stories – in 2016 I was diagnosed with cancer. When I asked my nurse navigator about cold cap therapy, which my friend had discovered, her response was, “we have had patients use them with good success, but most people pay at least $6,000 so we don’t talk about it.” I decided to move forward with cold cap therapy and was able to keep my hair through eight cycles of chemo at a cost of $8,000.
During my chemo treatment sessions, I would see the same patients. I remember clearly one woman asking me how I still had my hair. I explained cold cap therapy to her and how much it cost, and she instantly started tearing up. I will always remember her saying, “I wish that was a choice I could have made.”
The thing that struck me as I went through chemotherapy, surgery and radiation was that my medical team would routinely tell me that I didn’t look sick. I felt pretty awful, but I still felt like myself and continued to work and be social. Keeping my hair during treatment allowed me to compartmentalize my disease and treatment.
I built our cold cap therapy device, Amma, because all chemotherapy patients with solid tumors deserve a choice as to whether or not they want to endure one of the most noticeable side effects of cancer treatment.
Medgadget: Please give us an overview of the device, and how a patient would use it.
Kate Dilligan: Amma, our cold cap therapy device, is made up of three main parts: 1) A cooling wrap which delivers the cooling to the head; 2) a compression cap that keeps the cooling wrap in place; and 3) a portable cooling unit that keeps the fluid circulating through the cooling wrap at the correct temperature.
We ship Amma directly to patients and train them at home on how to use the system and bring it with them to chemotherapy. They put on the cap system, input the amount of time their chemotherapy infusion will take and connect it to the portable cooling unit when they get to chemotherapy. When their infusion is done, they have an additional two hours of scalp cooling. During this time patients then unplug the device and continue their treatment while in the car and in the comfort of their own home. Once the cooling is complete, the patient simply stores the device away and brings it with them for their next infusion. When they are done with chemo, the patients ship Amma back to us.
We spent a lot of time working with patients, advocates and providers to understand the barriers of accessing this treatment. The main problems were cost, poor fit and burden on infusion centers. While the existing solutions cost on average between $3,000 and $8,000, Amma has a flat rental fee of $2,000. Additionally, we have built a flexible cooling layer so patients get even coverage over their scalp and avoid patchy bald spots. Lastly, we built Amma so that it is truly patient administered and portable so infusion center resources and nurses are offloaded.
Medgadget: How do cooler temperatures help to reduce chemotherapy-related hair loss?
Kate Dilligan: Cold cap therapy is medically induced hypothermia. By bringing the patient’s scalp temperature to 68 degrees Fahrenheit before, during and after chemotherapy, the hair follicles don’t absorb the chemo allowing patients to keep their hair.
Medgadget: What stage of clinical development is the device at? What are the next steps for the technology?
Kate Dilligan: We are excited to announce that Amma was just cleared by the FDA last month. We expect to get the device into the hands of patients by the first quarter of 2022. We have already selected our pilot sites where the device will first be made available and expect to kick off post market studies in early 2022 as well. We also look forward to soon having data available to demonstrate that Amma can become the standard of care for scalp cooling.
Medgadget: Congrats on being a finalist at this year’s MedTech Innovator Global competition. How do you intend to spend the prize money?
Kate Dilligan: MedTech Innovator was a fantastic experience. We are using the money we won as a finalist as part of our push towards commercialization for the Amma device. We are eager and excited to begin helping patients early next year.
Link: Cooler Heads Care…