South Korea’s CG Bio has treated the first U.S. patient with its next-generation bone graft substitute NOVOSIS Putty, marking a key milestone in the company’s clinical program to secure U.S. Food and Drug Administration (FDA) premarket approval (PMA).
The company said Thursday that the first procedure was completed as part of a pivotal clinical trial evaluating NOVOSIS Putty for FDA approval.
The procedure was performed at a U.S. spine specialty center on a patient with degenerative disc disease undergoing transforaminal lumbar interbody fusion (TLIF) surgery. It marks the first clinical use of NOVOSIS Putty in a U.S. patient.
NOVOSIS Putty is a bone graft substitute that uses a controlled-release delivery platform for recombinant human bone morphogenetic protein-2 (rhBMP-2), designed to release the protein gradually in line with the body’s natural bone healing process.
The putty formulation can be molded by hand during surgery, allowing surgeons to shape it as needed and securely position it within the spinal fusion cage.
Through the pivotal trial, CG Bio aims to evaluate the product’s bone fusion efficacy and safety. The company said its controlled-release technology is designed to improve bone regeneration while reducing the risk of adverse events associated with existing rhBMP-2 products.
The U.S. spinal fusion bone graft substitute market is a high-value segment led by global medical device companies including Medtronic. Industry observers view FDA PMA approval as a critical requirement for commercial success in the U.S. market.
The clinical trial is currently recruiting patients across approximately 30 spine specialty centers in South Korea and the United States. CG Bio plans to submit an FDA PMA application based on the clinical data generated from the study.
“The successful treatment of our first U.S. patient represents an important milestone in bringing NOVOSIS Putty to the world’s largest and most demanding medical device market,” CEO Yoo Hyun-seung said. “We will continue advancing the FDA approval process and strive to provide a differentiated bone regeneration solution.”