OrthoPediatrics acquired ApiFix Ltd, including its minimally invasive deformity correction (MID-C) system for non-fusion treatment of progressive adolescent idiopathic scoliosis (AIS).
The transaction has been agreed for 934,768 shares of OrthoPediatrics common stock and US$2 million in cash paid at closing, plus milestone payments and an earnout over a period of four years.
ApiFix is an Israel and Boston, USA 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 US Food and Drug Administration (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 40–60 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, hospitalisation, recovery time, complications, and revision rates, OrthoPediatrics said in a press release. Most significantly, the system avoids permanently limiting range of motion in these young patients with its motion-preserving capabilities and is removable.
Mark Throdahl, president and chief executive officer of OrthoPediatrics, commented, “We believe that ApiFix fills a major treatment gap that could potentially allow patients to avoid fusion surgery. We estimate that non-fusion procedures will grow significantly as patients, their families, and surgeons recognise non-fusion’s benefits. With an eight-year clinical history of more than 370 patients outside the US, the ApiFix system has a number of advantages over vertebral body tethering. It is significantly less complex and risky, does not imply the need for a thoracic or general surgeon, and has fewer complications. The acquisition of this novel technology keeps OrthoPediatrics at the forefront of paediatric orthopaedic care with a viable alternative to failed bracing and spinal fusion for the treatment of progressive scoliosis. We are also pleased to announce a major acquisition at this time which significantly enhances our long-term strategic position.”
Paul Mraz, chief executive officer of ApiFix, added, “We are excited with the opportunity to grow our business with the leader in the global paediatric community. The recent FDA approval of the MID-C system provides notable treatment advancements for young patients who would benefit from an alternative solution that fills the gap between non-operative therapies and irreversible spinal fusion. ApiFix’s MID-C technology is a posterior dynamic deformity correction system that enables surgeons to perform a unique treatment providing permanent curve correction while retaining spine flexibility, all via a less invasive surgical procedure. We look forward to OrthoPediatrics’ ability to increase awareness and utilisation of a system that is poised to disrupt the continuum of care for scoliosis treatment in paediatric patients.”