BETA
San Diego medical device company commercializing Amma, a portable scalp-cooling system intended to reduce chemotherapy-induced hair loss in adults with solid tumors.
Cooler Heads Care was founded in 2018 by cancer survivor and technology entrepreneur Kate Dilligan. Headquartered in San Diego, it develops tools to help patients manage cancer-treatment side effects, with Amma scalp cooling as its established commercial product.
Amma received FDA 510(k) clearance in October 2021. Its portable design supports cooling before, during and after chemotherapy, with post-infusion cooling outside the infusion chair within a participating treatment facility. Access requires clinical oversight and is separate from eligibility for insurance coverage.
The company announced a US$11 million Series A in July 2025 to expand manufacturing and rollout. Adoption is documented by providers including St. Clair Health and New York Oncology Hematology. A UCSF-led post-market study remains active but not recruiting according to its April 2026 registry update; no results are posted.
Class II · Product code PMC · K211526, October 21, 2021. Indicated to reduce chemotherapy-induced alopecia in adults with solid tumors; current company information specifies 21+ and clinical contraindications apply. [6][3][14][1][15]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [17][18]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
Portable circulating-liquid cooling system with a fitted scalp wrap/cap. Designed to support scalp cooling before, during and after chemotherapy; post-infusion cooling can continue outside the infusion chair within the treating facility. [6][3][7][8]
FDA-clearedCommercially available through participating infusion centers with a provider prescription; availability and patient charges vary by facility and insurance.
NCT06215469: registry status active not recruiting in the 2026-04-22 update; 40 participants (estimated). Study completion is estimated for 2029-12-31; this is not an FDA decision or commercial launch date. [21]
Palmetto GBA’s local article updates to 97007, 97008 and 97009 effective January 1, 2026. Coverage remains conditional and payer-specific; this is a market-access development rather than a company FDA milestone. [10]
Oversubscribed financing supports manufacturing and rollout. Mutual Capital Partners participated; the announcement describes new board appointments. [22]
Hospital reports introducing two devices through foundation support, with trained staff and funding to assist with cooling caps. [8]
Registry lists an actual start of May 16, 2024 for NCT06215469. As of its April 2026 update it is active, not recruiting, with estimated enrollment of 40 and no posted results. [7]
The company’s NCI investor-showcase disclosure dates first patient use to June 2022. [5]
K211526 cleared the portable system for reducing chemotherapy-induced alopecia in adult patients with solid tumors. [6]
Historical company disclosure in the NCI showcase reports a US$210K Phase I SBIR award for a human-factors study in 2021. [5]
Kate Dilligan founded the company following her experience using manual cold caps during breast-cancer treatment. [2]
Accessed 10/29/2026