OrthoPediatrics Corp. Receives “Breakthrough Device” Designation from FDA for eLLi™ Growing Rod System for Pediatric Patients with Scoliosis

Rhea-AI Summary

OrthoPediatrics Corp. has received the 'Breakthrough Device' Designation from the FDA for its new eLLi Growing Rod System, designed to treat pediatric patients with scoliosis. The device aims to address severe pathology associated with Early Onset Scoliosis, providing increased force, enhanced reliability, and precision, while improving safety. The Breakthrough Program expedites the development and review of medical devices for life-threatening conditions, allowing for timely access to innovative technologies. OrthoPediatrics' CEO, David Bailey, expressed pride in the team's achievement and commitment to advancing pediatric healthcare.

Positive

• OrthoPediatrics Corp. has received the 'Breakthrough Device' Designation from the FDA for its eLLi Growing Rod System, enhancing the company's product suite for pediatric patients with scoliosis.

• The eLLi surgical device provides increased force, enhanced mechanical reliability, and superior distraction precision, addressing safety concerns associated with current technology.

• The Breakthrough Devices Program expedites the development and review of innovative medical devices for life-threatening conditions, allowing for timely patient access to advanced technologies.

• The expert design team behind eLLi includes surgeons dedicated to treating unique patients with Early Onset Scoliosis, highlighting the device's specialized focus on pediatric orthopedics.

Negative

• None.

Insights

Medical Device Analyst

The granting of the 'Breakthrough Device' Designation by the FDA marks a significant stride for OrthoPededics Corp. in the realm of pediatric orthopedics. This designation accelerates the review process, potentially leading to a more rapid market introduction. Historically, such designations can facilitate increased investor confidence and may enhance the company's reputation within the medical community. Given the targeted treatment for Early Onset Scoliosis—a condition with limited non-invasive treatments—eLLi could emerge as a distinct offering in pediatric orthopedic care. From a financial perspective, this new device might broaden the company's market share and drive revenue growth. In assessing the potential upside, one must consider the company's ability to navigate the subsequent steps: successful clinical trials, market adoption and the execution of an effective commercialization strategy. The company's focus on EOS technologies strengthens their specialty in a niche market, which could be a strategic moat against competition.

Pediatric Healthcare Specialist

The eLLi Growing Rod System addresses a critical gap in pediatric healthcare, offering a non-invasive solution to a complex condition. For children with Early Onset Scoliosis, traditional treatment options have often entailed frequent surgeries to adjust growing rods. eLLi's proposition to provide increased force and mechanical reliability, coupled with superior distraction precision, suggests a treatment that could vastly improve quality of life for patients by reducing surgical interventions. Although clinical efficacy and surgeon acceptance remain to be seen, the premise of eLLi aligns with the broader move towards less invasive pediatric treatments. The design input from pediatric surgeons who specialize in such conditions may enhance the device's clinical relevance and adoption. For long-term investors, the focus should be on post-market studies and real-world data, which will be critical in establishing the device's value proposition and justifying a potential premium pricing structure.

WARSAW, Ind., May 02, 2024 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, today announced it has received the “Breakthrough Device” Designation from the Food and Drug Administration (“FDA”) for its new eLLi surgical device, an implant designed to address severe pathology associated with Early Onset Scoliosis (EOS), which can be associated with thoracic insufficiency, a potentially life-threatening condition. eLLi aims to provide a non-invasive means of extending the growing rods that provides increased force, enhanced mechanical reliability, and superior distraction precision, while also addressing safety concerns associated with current technology. eLLi will allow surgeons a new alternative to address deformity of the growing spine with an advanced technology that will complement our efforts to build a platform of EOS technologies.  We are proud to have an expert design team comprised of surgeons who have dedicated their careers to treating these unique patients. 

According to the FDA, the Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The Breakthrough Program is intended to help patients have more timely access to medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.

David Bailey, OrthoPediatrics’ President & CEO, commented, “Receiving the Breakthrough Device designation from the FDA is a great achievement for our team. This innovative product will be a great addition to our suite of products for pediatric patients with Scoliosis and represents our commitment to continuous innovation and advancing healthcare for children all over the world. I’m incredibly proud of my colleagues for all the work they are doing to deliver novel technologies to our surgeon customers and the KIDS they treat!”   

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 71 products 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 over 70 countries outside the United States. For more information, please visit www.orthopediatrics.com.

Investor Contact
Philip Trip Taylor
Gilmartin Group
philip@gilmartinir.com
415-937-5406

FAQ

What is the 'Breakthrough Device' Designation received by OrthoPediatrics Corp. from the FDA for?

OrthoPediatrics Corp. received the 'Breakthrough Device' Designation from the FDA for its eLLi Growing Rod System, designed to address severe pathology associated with Early Onset Scoliosis in pediatric patients.

What is the purpose of the eLLi surgical device from OrthoPediatrics Corp.?

The eLLi surgical device aims to provide a non-invasive means of extending growing rods with increased force, enhanced mechanical reliability, and superior distraction precision, while addressing safety concerns associated with current technology.

Who is David Bailey in relation to OrthoPediatrics Corp.?

David Bailey is the President & CEO of OrthoPediatrics Corp., expressing pride in the team's achievement of receiving the 'Breakthrough Device' Designation from the FDA for the eLLi Growing Rod System.