Presurgical Lip Alveolus and Nose Approximation offers a non‑surgical method to align displaced nasolabial structures in infants with cleft lip and palate. The system combines the NoseAlign® device with LipAlign™ medical adhesive tapes and orthodontic elastics, allowing clinicians to approximate tissue in both incomplete and complete unilateral or bilateral clefts under physician supervision. It is designed for easy application and can be used alongside standard over‑the‑counter adhesive products.
Funding
Funding not disclosed
Founders
Product
Problem
Infants born with cleft lip and palate have displaced nasolabial structures that must be realigned before surgery, but existing pre‑surgical methods can be cumbersome, require multiple custom appliances, and depend on extensive clinician time.
Solution
Presurgical Lip, Alveolus, and Nose Approximation (PLANA) provides a streamlined, physician‑prescribed system that combines the NoseAlign® device with LipAlign™ medical adhesive tapes and orthodontic elastics. The device is designed for both incomplete and complete unilateral or bilateral clefts, allowing clinicians to approximate the lip, alveolus, and nose in a single, easy‑to‑apply setup. By using over‑the‑counter adhesive tapes together with the reusable NoseAlign® appliance, the workflow reduces the need for multiple custom devices and simplifies the pre‑surgical orthopaedic (PSIO) process. The system is intended to be applied under professional supervision, ensuring proper placement and consistent force application while maintaining infant comfort.
Target Audience
Primary users are pediatric surgeons, orthodontists, and dentists who manage infants with cleft lip and palate, as well as specialized cleft care centers that provide presurgical orthopaedic therapy.
Features
- NoseAlign® reusable device that gently repositions nasal and alveolar segments in infants with unilateral or bilateral clefts
- LipAlign™ medical adhesive tapes that secure the device and provide consistent traction on the lip and alveolus
- Compatibility with standard orthodontic elastics for adjustable force control
- Simple, single‑step application that can be performed in a clinical setting under physician or dentist supervision
- Designed for both incomplete and complete cleft presentations, reducing the need for multiple specialty appliances