Cooler Heads Care, a San Diego-based medical technology company, created Amma, a cold cap therapy device that aims to help chemotherapy patients preserve their hair. Hair loss is a very common side effect of chemotherapy and poses a major psychological challenge for patients who are already struggling with their diagnosis and treatment.
Simply cooling the scalp during chemotherapy can drastically reduce the amount of drug absorbed by the hair follicles, leading to a reduction in hair loss. However, current technology to achieve this is expensive and can cost the patient up to $ 8,000. This is beyond the reach of many patients, so Cooler Heads Care has developed the cold cover system administered by Amma’s patient that costs much less in rent, at about $ 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 take the device to their chemo sessions and then take it home with them to continue therapy. The company was a finalist in Medtech’s recent global innovator competition.
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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, Cold Head Care: Hair loss due to chemotherapy (chemotherapy) is devastating for both men and women. When a chemotherapy patient loses their hair, it is suddenly a public, and sometimes permanent, reminder to him and the outside world that he is sick. Patients often talk about feeling sorry for themselves and being treated as disabled when they go through chemotherapy.
Cold cap therapy is not about beauty, but about protecting privacy, agency, and identity. Patients with chemotherapy want to be seen as the whole person they are, and not as someone who is sick. Keeping your hair up during chemotherapy allows people to control who knows about their disease and who doesn’t. It also offers patients the ability to choose how they manage their side effects and provides them with stability when their lives feel completely out of control and indebted to treatment. Most importantly, maintaining hair allows patients to continue to recognize themselves in the mirror, which is incredibly powerful for maintaining self-sense.
Medgadget: What inspired you to develop technology to reduce hair loss during chemotherapy?
Kate Dilligan: It’s one of the quintessential stories of the founders: in 2016 I was diagnosed with cancer. When I asked my navigating nurse about cold cap therapy, which my friend had discovered, her response was, “We’ve used patients successfully, but most people pay at least $ 6,000 because they don’t. we talk about it”. I decided to move on with cold cap therapy and was able to keep my hair on for eight cycles of chemotherapy at a cost of $ 8,000.
During my chemo treatment sessions, I would see the same patients. I clearly remember a woman who asked me how I still had my hair. I told him about the cold cap therapy and how much it cost, and he immediately started crying. I will always remember her saying, “I wish it was a choice I could have made.”
What surprised me as I went through chemotherapy, surgery, and radiation was that my medical team usually told me I didn’t look sick. I felt pretty awful, but I still felt like myself and kept working and being social. Keeping my hair during the treatment allowed me to compartmentalize my illness and treatment.
I built our cold-capped therapy device, Amma, because all chemotherapy patients with solid tumors deserve a choice about whether or not they want to endure one of the most notable side effects of cancer treatment.
Medgadget: Give us an overview of the device and how a patient would use it.
Kate Dilligan: Amma, our cold-capped therapy device, consists of three main parts: 1) A cooling wrap that provides cooling to the head; 2) a compression lid that holds the cooling wrapper in place; and 3) a portable refrigeration unit that keeps the fluid circulating through the refrigeration wrapper at the correct temperature.
We send Amma directly to patients and train them at home on how to use the system and take her with them to chemotherapy. They put on the cap system, enter the amount of time it will take for your chemotherapy infusion, and connect it to the portable refrigeration unit when they get to chemotherapy. When their infusion is made, they have an additional two hours of cooling the scalp. During this time, patients disconnect the device and continue treatment while in the car and in the comfort of their home. Once the cooling is complete, the patient simply stores the device and takes it with him for his next infusion. When they finish the chemotherapy, the patients send Amma back to us.
We spent a lot of time working with patients, advocates, and providers to understand the barriers to accessing this treatment. The main problems were the cost, poor adjustment and loading of the infusion centers. While existing solutions cost an average of $ 3,000 to $ 8,000, Amma has a flat rental rate of $ 2,000. In addition, we have built a flexible cooling layer so that patients have uniform coverage over the scalp and avoid uneven baldness. Finally, we built Amma to be truly patient-managed and portable, so that infusion center resources and nurses are downloaded.
Medgadget: How do cooler temperatures help reduce chemotherapy-related hair loss?
Kate Dilligan: Cold cap therapy is a medically induced hypothermia. By bringing the patient’s scalp temperature to 68 degrees Fahrenheit before, during, and after chemotherapy, the hair follicles do not absorb chemotherapy and allow patients to maintain their hair.
Medgadget: At what stage of clinical development is the device? What are the next steps for technology?
Kate Dilligan: We are pleased to announce that Amma was authorized by the FDA last month. We expect the device to be in the hands of patients in the first quarter of 2022. We have already selected our pilot sites where the device will be available for the first time and we also hope to begin post-market studies in early 2022. We also hope to have data available soon to demonstrate that Amma can become the standard of care for cooling the scalp.
Medgadget: Congratulations on being a finalist in this year’s MedTech Innovator Global contest. How do you plan to spend the prize money?
Kate Dilligan: MedTech Innovator was a fantastic experience. We are using the money we have earned as finalists as part of our drive towards marketing the Amma device. We are looking forward to and excited to start helping patients early next year.
Link: Cold Head Care …