ApiFix has developed a minimally invasive deformity correction system for non-fusion treatment of progressive adolescent idiopathic scoliosis.
US bio-science company OrthoPediatrics Corp. (Nasdaq: KIDS) has announced that it has acquired Israeli scoliosis treatment device company ApiFix. Based in Misgav in northern Israel, ApiFix has developed a minimally invasive deformity correction system for non-fusion treatment of progressive adolescent idiopathic scoliosis. ApiFix is part of Israel's Trendlines Group (SGX: 42T), which has an 18.62% stake in the scoliosis treatment company.
OrthoPediatrics will pay 934,768 shares of common stock (worth $35.17 million at close of market yesterday) and $2 million in cash paid at closing, plus milestone payments and an earn-out over a period of four years. Singapore-based "Business Times" reports that these additional payments could be at least $30 million dependent on ApiFix completing 150 clinical procedures each year as well as on OrthoPediatrics' revenues from using ApiFix's system.
ApiFix 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° and acts as an internal brace implanted unilaterally on the concave aspect of the curvature.
OrthoPediatrics president and CEO Mark Throdahl said, "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. With an 8-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."
ApiFix CEO Paul Mraz said, "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."
Trendlines chairman and CEO Todd Dollinger said, "The acquisition of ApiFix by OrthoPediatrics will expand ApiFix's business under the global leader of the pediatric orthopedics community. We are especially pleased to make this announcement in the time of COVID-19 - and worldwide uncertainty, demonstrating our unwavering commitment to growing shareholder value through creating and building companies to improve the human condition."