OrthoPediatrics has acquired ApiFix, including its minimally invasive deformity correction (MID-C) system for non-fusion treatment of progressive adolescent idiopathic scoliosis, 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.
A press release reports that 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 adolescent idiopathic scoliosis. It adds that together with vertebral body tethering, the device 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 degress and acts as an internal brace implanted unilaterally on the concave aspect of the curvature.
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. 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 CEO of OrthoPediatrics, comments: “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 USA, 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.”
ApiFix’s technology is supported by strong intellectual property protection, including 46 US and International patents granted and 25 patent applications. The company is led by Paul Mraz, a Boston-based executive with nearly 30 years of spine and orthopaedic medical device experience. Mraz and the entire ApiFix team have joined OrthoPediatrics post-acquisition.