OrthoPediatrics Corp. Receives FDA 510(k) Clearance and Expanded Neuromuscular Indications for its RESPONSE™ Scoliosis System
WARSAW, Ind., March 31, 2020 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (Nasdaq: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration to expand the indications for its RESPONSE™ Scoliosis System to include neuromuscular implants.
This 510(k) clearance represents a significant milestone in the Company’s development toward its next generation RESPONSE Scoliosis System, RESPONSE™ NeuroMuscular (“RESPONSE – NM”). This new system will be entirely dedicated to the treatment of neuromuscular scoliosis in pediatrics and builds on existing product offerings focused on treating this unique class of patients. The system is being developed in conjunction with pediatric orthopedic surgeons to address the distinct challenges in treating the neuromuscular scoliosis population. Building on the base of the Company’s RESPONSE™ Spine System, RESPONSE – NM will feature a complete set of implants and instruments with unique attributes that simplify insertion and specific options to address extreme hyperlordosis.
OrthoPediatrics’ Executive Vice President, David Bailey, stated, “The 510(k) clearance of our revolutionary implants and expanded neuromuscular indications of our RESPONSE System marks substantial progress in developing a scoliosis system dedicated to the treatment of this challenging condition. The anticipated introduction serves as the first of its kind in the industry and represents a further testament to our commitment to advance the development of products that help pediatric orthopedic surgeons and their patients. While we cannot provide our expected launch timeline given the current environment, we remain undeterred on our cause of improving the lives of children suffering from scoliosis. I’m pleased by the resolve of all our associates who continue to advance our business while working remotely, so that we can emerge from the COVID-19 crisis even stronger together. We wish for the safety of the healthcare community, including our surgeon customers and their patients, during these challenging times.”
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 5, 2020, as updated and supplemented by our other SEC reports filed 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.
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 34 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering span 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 43 countries outside the United States. For more information, please visit www.orthopediatrics.com.
Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
tbui@theruthgroup.com / epoalillo@theruthgroup.com
