ATX-001
ATX-001 is a non-hormonal Class I medical device with Non-Significant Risk (NSR) that will proceed along the 510(k) regulatory pathway for subsequent registration and marketing. ATX-001 comprises a unique combination of generally recognized as safe (GRAS) ingredients that are formulated specifically to mimic the dynamic surface of the vaginal mucosa and effectively restore the vaginal physiology. ATX-001 is an emulsified cream that has a targeted efficacy duration of 24 hours or more, per application.
The ATX-001 FORMULATION
- Utilizes a novel materials science approach to combine all of the positive attributes of vaginal lubricants and moisturizers into a single product
- Is designed to restore essential biochemistry and physiology largely overlooked by vaginal lubricants and moisturizers
- Is designed to eliminate common complaints of vaginal lubricants and moisturizers (e.g. vaginal leakage)
| Designed to... | Lubricants | Moisturizers | ATX-001 |
|---|---|---|---|
| Provide lubrication | ✔✔✔ | ✔✔✔ | |
| VII Provide moisture | ✔✔✔ | ✔✔✔ | |
| Restore vaginal pH | ✔✔ | ✔✔✔ | |
| Be isotonic | ✔ | ✔✔ | ✔✔✔ |
| Replenish essential biochemistry | ✔ | ✔✔✔ | |
| Manifest no leakage from the vagina | ✔✔✔ | ||
| Symptom relief for at least 24 hours | ✔✔ | ✔✔✔ | |
| Provide a microenvironment conducive to healing | ✔ | ✔✔✔ | |
| ✔✔✔ = All ✔✔ = Some ✔ = Few | |||
