OrthoPediatrics Corp. Commences Initial U.S. Launch of ApiFix’s FDA-Approved Spinal Deformity Correction System

ApiFix, the only posterior motion-preserving scoliosis correction technology available in the U.S., provides unique advantages for treating progressive adolescent idiopathic scoliosis

WARSAW, Ind., June 10, 2020 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (“OrthoPediatrics” or the “Company”) (Nasdaq:KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, is pleased to announce the initial U.S. launch of the ApiFix Minimally Invasive Deformity Correction (“ApiFix”) system. Additionally, the Company anticipates approximately 20 leading clinical centers in the United States to enter data related to the use of the ApiFix system into a post-approval study registry hosted by the Pediatric Spine Study Group in order to continue monitoring the safety and probable benefit of the device for the treatment of progressive adolescent idiopathic scoliosis (“AIS”).

The ApiFix technology is a posterior dynamic deformity correction system approved for use in AIS patients with Lenke type 1 and Lenke type 5 curves of 40° to 60° and acts as an internal brace implanted unilaterally on the concave aspect of the curvature. It enables surgeons to perform a unique treatment and provide permanent curve correction while retaining spine flexibility, all via a less invasive surgical procedure compared to spinal fusion. Patient recovery is relatively pain-free and is measured in days, not months. The ApiFix system offers a patented unidirectional, self-adjusting rod mechanism and motion-preserving polyaxial joints, allowing additional post-operative correction over time.

Paul Mraz, Senior Vice President of OrthoPediatrics and former President and CEO of ApiFix Ltd. commented, “ApiFix’s novel approach to correcting spinal deformity is a welcome medical advancement that has the ability to disrupt the continuum of care for scoliosis treatment in certain pediatric patients. Its elegant design and biomechanical considerations combined with the simplistic posterior approach is unmatched and provides a superior technology for treating AIS. Now that the pause of elective surgeries due to COVID-19 is lifting, we look forward to initiating the commercial availability of the procedure in the United States and anticipate the first procedures to be performed in the coming weeks.”