HyperFlex Medical Inc.

HyperFlex Medical Inc. manufactures the HyperFlex® Bunion Correction System, a minimally invasive, non-osteotomy solution for hallux valgus deformity correction. The system uses a small, flexible implant to realign and stabilize the first and second metatarsal bones without cutting or drilling bone, preserving natural foot motion. Designed for mild-to-severe bunion cases, it enables same-day weight-bearing and procedural times of 20–30 minutes through a single small incision. Mechanical testing demonstrates the system is 12× stronger than clinical load requirements and maintains stability through 1 million fatigue cycles. The company positions HyperFlex as a bone-preserving alternative to traditional osteotomy and Lapidus fusion procedures, allowing earlier surgical intervention for approximately 93% of bunion patients. The system features disposable instrumentation, integrates into existing OR workflows without specialized training requirements, and is reimbursable under existing CPT codes. Bilateral treatment capability is supported. The device is designed to reduce surgical time, complications, and recurrence risk compared to predicate devices, while streamlining OR efficiency and reducing sterilization overhead.