HyperFlex Medical Announces First Case in Clinical Evaluation of the HyperFlex® Bunion Correction System

ORLANDO, Fla., Sept. 16, 2025 /PRNewswire/ -- HyperFlex Medical Inc., a medical technology company rethinking bunion care with a minimally invasive, bone-preserving approach, today announced the successful completion of the first case in its clinical evaluation of the HyperFlex^® Bunion Correction System.

The case was performed by Dr. Josef Geldwert at Surgicare of Westside in New York City and marks a key milestone in validating the safety, effectiveness, and clinical utility of this novel technology. The study will track workflow, alignment, and recovery in real-world settings, supporting the company's upcoming commercial launch.

"This system represents a meaningful advancement in how we treat bunions," said Dr. Geldwert. "With a single small incision and no bone cutting, we can achieve effective correction while preserving natural anatomy. Our early results are very encouraging."

Each year, millions of patients with early-stage bunions are told to "wait until it gets worse" because traditional surgical options—osteotomies and joint fusions—involve bone cutting, long recoveries, and delayed weight-bearing. HyperFlex changes that equation. Its flexible, suture-based implant realigns the metatarsals through a small incision, preserving motion, minimizing trauma, and allowing same-day weight-bearing.

"This first case underscores the need for a more patient-friendly approach," said Bob Peterhans, CEO of HyperFlex Medical. "HyperFlex offers a less invasive option earlier in the disease process—without compromising alignment or outcomes. We're excited to see the system in action and grateful to our clinical partners."

HyperFlex received FDA 510(k) clearance in November 2024 and holds issued patents in the U.S. and Europe. Backed by Easton Capital, the company is preparing for broader release following completion of its clinical evaluation.

About HyperFlex Medical
HyperFlex Medical Inc. (formerly FootBridge Medical LLC) develops innovative solutions for foot and ankle surgery. The HyperFlex^® Bunion Correction System is designed for early intervention, aiming to reduce pain, accelerate recovery, and lower complication risk. To learn more visit https://hyperflexmedical.com/

SOURCE HyperFlex Medical Inc.