cleftalign Inc.

CleftAlign, Inc. is a medical device manufacturer specializing in Presurgical Infant Orthopedics (PSIO) therapy for neonates with cleft lip and palate. The company develops and markets innovative presurgical approximation devices and tapes designed to reduce surgical complexity and improve patient outcomes. NoseAlign® is a patent-pending presurgical cleft nose approximation device that simplifies PSIO therapy through a user-friendly, non-invasive approach requiring no dental impressions or laboratory fabrication. The upcoming LipAlign™ product line extends the company's offerings with presurgical cleft lip approximation tapes. CleftAlign's PLANA (Presurgical Lip, Alveolus, and Nose Approximation) therapy protocol addresses limitations of conventional PSIO methods by reducing office visits (4-5 vs. traditional 8+ visits), shortening therapy duration to 11-12 weeks, eliminating intraoral complications, and avoiding the mega nostril risk associated with older techniques. The devices support early soft tissue remodeling by leveraging neonatal plasticity within the first two weeks post-birth, enabling universal application across unilateral and bilateral cleft presentations (complete and incomplete). NoseAlign® operates through simple, caregiver-friendly application with standard medical adhesive tapes and orthodontic elastics, supervised by qualified cleft teams.