Orthopediatrics Granted Clearance for Expanded Indications of RESPONSE Scoliosis System

OrthoPediatrics Corp. (OrthoPediatrics), a company focused exclusively on advancing the field of pediatric orthopedics, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the indications for its RESPONSE Scoliosis System to include neuromuscular implants.
 
The 510(k) clearance represents a significant milestone in the company’s development toward its next generation RESPONSE Scoliosis System, RESPONSE NeuroMuscular (RESPONSE – NM). This new system will be entirely dedicated to the treatment of neuromuscular scoliosis in pediatrics and builds on existing product offerings focused on treating this unique class of patients. The system is being developed in conjunction with pediatric orthopedic surgeons to address the distinct challenges in treating the neuromuscular scoliosis population.  Building on the base of the Company’s RESPONSE Spine System, RESPONSE – NM will feature a complete set of implants and instruments with unique attributes that simplify insertion and specific options to address extreme hyperlordosis.
 
OrthoPediatrics Executive Vice President David Bailey, stated, “The 510(k) clearance of our revolutionary implants and expanded neuromuscular indications of our RESPONSE System marks substantial progress in developing a scoliosis system dedicated to the treatment of this challenging condition. The anticipated introduction serves as the first of its kind in the industry and represents a further testament to our commitment to advance the development of products that help pediatric orthopedic surgeons and their patients.  While we cannot provide our expected launch timeline given the current environment, we remain undeterred on our cause of improving the lives of children suffering from scoliosis. I’m pleased by the resolve of all our associates who continue to advance our business while working remotely, so that we can emerge from the COVID-19 crisis even stronger together.  We wish for the safety of the healthcare community, including our surgeon customers and their patients, during these challenging times.”
 
The FDA clearance occurred around the same time the company acquired ApiFix Ltd., including its minimally invasive deformity correction (MID-C) system for non-fusion treatment of progressive adolescent idiopathic scoliosis (AIS), for 934,768 shares of OrthoPediatrics common stock and $2 million in cash paid at closing, plus milestone payments and an earnout over a period of four years.
 
ApiFix Ltd. is an Israel and Boston-based medical device company with a less invasive spinal deformity correction system for non-fusion treatment of progressive AIS. Together with vertebral body tethering, it is one of only two non-fusion technologies approved by the FDA under its Humanitarian Device Exemption provision. The MID-C system is approved for use in adolescent patients with Lenke type 1 and Lenke type 5 curves of 40 degrees to 60 degrees and acts as an internal brace implanted unilaterally on the concave aspect of the curvature. It becomes OrthoPediatrics’ 35th surgical system. When compared to both traditional spinal fusion and tethering procedures, the benefits of the MID-C system include measurable reductions in surgery time, blood loss, hospitalization, recovery time, complications, and revision rates. Most significantly, the system avoids permanently limiting range of motion in these young patients with its motion-preserving capabilities and is removable.