About Cartwheel

Cartwheel helps families have more smiles and laughs and less stress, thanks to effective first-aid products made from natural, non-toxic ingredients.

Launching this September, our first product, Nit Happens, is an over-the-counter gel clinically proven to be 95.8% effective at eliminating head lice. With an exclusive license to this science-backed formula, we are offering families a highly effective, pesticide-free, naturally-derived solution that outperforms conventional OTC treatments.

Our pipeline includes a breakthrough medical device that uses warm CO₂ to kill lice and nits across the entire scalp in minutes—no combing required. This proprietary technology represents a major leap forward in safe, fast, and user-friendly lice treatment.

Tagged with

Consumer Packaged Goods (CPG)HealthcareMedical DevicesConsumer Products

Team

Problem statement

We are solving the treatment burden on parents and children who have contracted head lice. Decades of over-reliance on OTC pediculicides have created drug-resistant "super lice" that are difficult to treat, often requiring repeat treatments lasting for weeks with messy creams and hours of tedious combing. Parents who are reluctant to expose their children to powerful pesticides do not have many options. The anxiety, stigma, and lost days of work and school is a heavy treatment burden which disproportionately impacts mothers, girls, and minorities.

Traction information

- Exclusive license to novel OTC gel formula
- Outside reg opinion: Gel is 510(k) exempt, product code PUN
- Clinical trial showed gel has 95.8% efficacy at killing head lice
- Patch test: officially non-irritant
- Positive pre-sub meeting with FDA, 11/24 for device
- PCT published, search report agreed all 81 claims were novel and patentable
- Raised $495k to date, including grant from American Academy of Pediatrics
- Lice data in vitro and with working device on mannequin head showing 100% kill rate of lice

Product images

Milestones

May 2025

Working device prototype enters testing

Device using warm CO2 to kill head lice and nits enters testing on mannequin head with wig using lice collected from the community.

May 2025

in vitro lice testing successful

Additional testing completed on lice in the laboratory when exposed to heat and CO2 showing 100% mortality rates. Sample of one group of the tests below - but there were many more.

March 2025

Licensed new technology for non-pesticide OTC lice treatment

Exclusive license to technology behind patents US10328112B2 & CA3025269C

OTC gel containing only natural ingredients and works using mild abrasives (diatomaceous earth, ultra-fine walnut shell powder) work to mechanically kill lice and nits.
Shown to be 95.8% effective in human clinical trials.
Class I, 510(k)-exempt liquid medical device

November 2024

FDA pre-sub meeting

Very positive pre-sub meeting with the device section of the FDA. They had no objections to our proposed predicate device, clinical trial plan, or regulatory path of Class I, 510(k).

Updates

Profile created.

Added 18 days ago

Funding

Not raising capital right now

Total raised to date:$495,000