US firm OrthoPediatrics, a company that develops, manufactures, and distributes orthopedic implants and instruments for pediatric orthopedic surgeons, announced it will acquire US-Israeli medical device firm ApiFix, known for its minimally invasive scoliosis correction system to treat progressive adolescent idiopathic scoliosis (“AIS.”)
ApiFix will be acquired 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.
The ApiFix team, led by Boston-based executive Paul Mraz, will join OrthoPediatrics.
Founded in 2011 by Uri Arnin and Yizhar Floman, ApiFix will become
OrthoPediatrics’ 35th surgical system. The company has created a less invasive spinal deformity correction system for non-fusion treatment of progressive AIS.
ApiFix’s technology 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 to 60 degrees and acts as an internal brace implanted unilaterally on the concave aspect of the curvature, the company says.
“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 recognize non-fusion’s benefits,” said Mark Throdahl, president and CEO of OrthoPediatrics.
“We are excited with the opportunity to grow our business with the leader in the global pediatric 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,” said Mraz, ApiFix CEO. “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.”
The benefits of the MID-C system include measurable reductions in surgery time, blood loss, hospitalization, recovery time, complications, and revision rates. The system avoids permanently limiting range of motion in these young patients with its motion-preserving capabilities and is removable. ApiFix’s unique technology is supported by strong intellectual property protection, including 46 US and international patents granted and 25 patent applications.
“The acquisition of this novel technology keeps OrthoPediatrics at the forefront of pediatric orthopedic 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,” said Throdahl.