OrthoPediatrics Surpasses Milestones of 500 Scoliosis Correction Cases Worldwide and Nine-Years of Clinical Experience with the ApiFix Procedure
The Internal Brace Option™ is a viable alternative for treating progressive moderate scoliosis in adolescents and a game-changing treatment option for medical providers and patients to consider
WARSAW, Ind., March 23, 2021 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics” or the “Company”) (Nasdaq:KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, today announced that it has surpassed two significant procedure milestones for its ApiFix® technology – an exciting alternative for the treatment of progressive adolescent idiopathic scoliosis (AIS). Over 500 ApiFix procedures have now been performed treating young AIS patients at centers in the USA, Canada, Europe, Israel, and Asia with long-term clinical follow-up now exceeding nine years.
“These are significant milestones for this revolutionary technology and the patients it has benefited all over the world,” said David Bailey, President of OrthoPediatrics. “OrthoPediatrics remains committed to providing innovative and game-changing solutions to pediatric caregivers, therapists and surgeons that better enable them to treat their patients.”
The ApiFix procedure offers select AIS patients a less invasive, motion-preserving option for achieving curve correction – without the permanence of fusion. The ApiFix system’s novel approach to correcting spinal deformity is a welcome medical advancement that has the ability to disrupt the continuum of care for scoliosis treatment in certain pediatric patients. Its elegant design and biomechanical considerations combined with the simplistic posterior approach is unmatched.
“Our continued review of the extensive clinical experience with the ApiFix system and our ongoing collection of new data continue to underscore ApiFix’s positive and encouraging results realized in patients with progressive spinal deformity,” commented Daphna Zaroor Regev, PhD, Director of Clinical Affairs at ApiFix Ltd. “We are committed to establishing a new standard of care for spinal deformity treatment and generating peer-reviewed clinical evidence to support its use.”
The Company has recruited 20 leading clinical centers in the United States to enter data related to the use of the ApiFix system into a post-approval study registry hosted by the Pediatric Spine Study Group. The registry will continue to monitor the safety and probable benefit of the procedure for the treatment of progressive AIS. A typical ApiFix surgical procedure is completed in less than two hours with minimal blood loss (<50cc) and requires a hospital stay of only one or two days. Patient recovery is relatively pain-free and is measured in days, not months, with children able to return to school in just several weeks. The ApiFix MID-C System has FDA and CE Mark approvals.
ApiFix‘s unique technology is supported by strong intellectual property protection, including 46 issued patents and 30 additional patent applications worldwide. ApiFix, a leader in motion-preserving scoliosis correction, was acquired by OrthoPediatrics in April 2020 and operates as a wholly-owned subsidiary based in Israel.
About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on advancing the field of pediatric orthopedics. As such it has developed the most comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 35 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This product offering spans trauma and deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 44 countries outside the United States. OrthoPediatrics acquired ApiFix Ltd. in April 2020. The ApiFix system has FDA and CE Mark approvals and is now available in the USA, Canada, Europe, Israel, Australia and countries throughout Asia and the Americas. For more information, please visit www.apifix.com and www.orthopediatrics.com.
Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of U.S. federal securities laws. You can identify forward-looking statements by the use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “believe,” “estimate,” “project,” “target,” “predict,” “intend,” “future,” “goals,” “potential,” “objective,” “would” and other similar expressions. Forward-looking statements involve risks and uncertainties, many of which are beyond OrthoPediatrics’ control. Important factors could cause actual results to differ materially from those in the forward-looking statements, including, among others: the risks related to COVID-19, the impact such pandemic may have on the demand for our products, and our ability to respond to the related challenges; and the risks, uncertainties and factors set forth under “Risk Factors” in OrthoPediatrics’ Annual Report on Form 10-K filed with the SEC on March 11, 2021, as updated and supplemented by our other SEC reports filed from time to time. Forward-looking statements speak only as of the date they are made. OrthoPediatrics assumes no obligation to update forward-looking statements to reflect actual results, subsequent events, or circumstances or other changes affecting such statements except to the extent required by applicable securities laws.
Investor Contacts
The Ruth Group
James Salierno
(646) 536-7028
jsalierno@theruthgroup.com
