OrthoPediatrics Announces Full Commercial Launch of VerteGlide® Spinal Growth Guidance System

(NASDAQ:KIDS) OrthoPediatrics Corp. announced the full commercial launch of its VerteGlide® Spinal Growth Guidance System, designed specifically for the treatment of Early Onset Scoliosis (EOS). VerteGlide is intended to address the clinical challenge of achieving deformity correction while preserving spinal growth in children with EOS. The system utilizes established spinal growth guidance principles to provide three-dimensional deformity correction and allows natural growth to continue through additional vertebral segments. VerteGlide offers surgeons an additional growth-friendly treatment option for children with complex spinal deformities. Dr. Josh Murphy, a pediatric orthopedic spine surgeon at Children's Healthcare of Atlanta, stated that his experience with VerteGlide across multiple patients has been very encouraging and that growth-guidance technology is an important treatment option for selected children with complex spinal deformities. Greg Odle, President of OrthoPediatrics Scoliosis, commented that the full commercial launch of VerteGlide is an important milestone for the company's scoliosis business and highlights the need for continued innovation in EOS treatment. Odle noted strong adoption of VerteGlide across the United States, reflecting increasing interest among pediatric spine surgeons in growth-guidance technologies. He also stated that the company is focused on expanding surgeon education and bringing VerteGlide to more children and families. The VerteGlide Spinal Growth Guidance System incorporates Shilla™ technology licensed from Medtronic. OrthoPediatrics was founded in 2006 and is focused exclusively on pediatric orthopedics. The company currently markets over 95 systems serving trauma and deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics distributes its products in the United States and over 75 countries outside the United States.

OrthoPediatrics Announces FDA 510(k) Clearance of PNP | Femur Retrograde Nail System and Completes First Implantations

(NASDAQ:KIDS) OrthoPediatrics Corp. announced that the U.S. Food and Drug Administration (FDA) has granted clearance for the Pediatric Nailing Platform (PNP) | Femur Retrograde Nail System (“PNP Retrograde”). The company also reported the successful completion of the first procedures using the PNP Retrograde system. The system was developed in collaboration with a team of pediatric orthopedic surgeons and is designed specifically for pediatric anatomy to address an unmet market need. PNP Retrograde includes anatomic nails for trauma and straight nails for deformity. The system builds on OrthoPediatrics’ previous launches of PNP Femur and PNP Tibia and utilizes existing PNP instrumentation. The new system features innovative instruments intended to simplify complex varus/valgus and coronal/sagittal plane correction procedures. Joe Hauser stated that the Pediatric Nailing Platform has supported nearly 15,000 patients worldwide, highlighting the impact of the company’s approach to pediatric orthopedic care. He also noted that FDA clearance of PNP Retrograde expands the company’s portfolio and creates an opportunity to reach more children with implants designed for their needs. The PNP Retrograde system is available in diameters ranging from 7 mm to 11 mm in both nail designs. The system will be available through a limited market release for the remainder of 2026, with broader commercialization planned for 2027. OrthoPediatrics currently markets over 95 systems serving trauma and deformity, scoliosis, and sports medicine/other procedures. The company’s global sales organization distributes products in the United States and over 75 countries outside the United States.

OrthoPediatrics Corp. Reports Third Quarter 2026 Financial Results and Increases 2026 Financial Guidance

(NASDAQ:KIDS) OrthoPediatrics Corp. reported financial results for the third quarter ended September 30, 2026. The company helped nearly 42,000 children in the third quarter of 2026. Total revenue reached a new record high of $72.7 million for the third quarter of 2026, up 19% from $61.2 million in the third quarter of 2025. Domestic revenue increased 19% to $57.9 million, while international revenue increased 18% to $14.8 million. Trauma & Deformity revenue grew 19% to $52.6 million, and Scoliosis revenue grew 18% to $19.2 million. Sports Medicine/Other revenue was $0.9 million, a 2% increase from $0.8 million in the prior year period. The company achieved record adjusted EBITDA of $6.9 million, compared to $6.2 million in the third quarter of 2025. Free cash flow generated in the third quarter of 2026 was $1.6 million, a $5.0 million improvement compared to $3.4 million of usage in the prior year period. Gross profit for the third quarter of 2026 was $54.0 million, a 19% increase from $45.3 million, with a gross profit margin of 74%. Total operating expenses were $58.2 million, up 6% from $54.7 million, driven mainly by increased sales commission expense and additional personnel for clinic expansions and acquisitions. Sales and marketing expenses increased $4.4 million, or 24%, to $23.1 million. Research and development expenses increased $0.1 million, or 6%, to $2.5 million. General and administrative expenses increased $2.9 million, or 10%, to $32.0 million. An intangible asset impairment of $0.6 million was recorded due to the fair value of ApiFix and MedTech trademark assets being below carrying value. Total other expense was $1.8 million, compared to $2.5 million in the prior year, with the change primarily driven by a $0.8 million non-cash fair value adjustment of contingent consideration, additional interest expense, and changes in foreign exchange gains and losses. Net loss for the third quarter of 2026 was $5.9 million, compared to $11.8 million in the prior year. Net loss per share was $0.25 per basic and diluted share, compared to $0.50 per share in the prior year. Weighted average basic and diluted shares outstanding for the quarter were 24,153,621. As of September 30, 2026, cash, cash equivalents, short-term investments, and restricted cash totaled $44.9 million, compared to $62.9 million as of December 31, 2025. The company announced the full market release of the 3P Pediatric Plating Platform Hip System and the PediHip Rigid Brace, as well as FDA clearance and limited launches of several new products. Full year 2026 revenue guidance was increased to $270.0 million to $273.0 million from the prior range of $265.0 million to $269.0 million, representing growth of 14% to 16% over 2025 revenue. The company reiterated expectations for annual set deployment of approximately $10.0 million, adjusted EBITDA of approximately $25.0 million, and breakeven free cash flow in 2026. OrthoPediatrics will host a conference call on October 27, 2026, at 4:30 p.m. ET to discuss the results. David Bailey, President & CEO, stated that the company continued to gain share in Trauma and Deformity and Scoliosis globally, improved profitability, and generated positive free cash flow. He emphasized the importance of the company's innovation pipeline and focus on growing the business, improving operating performance, and achieving breakeven or better free cash flow on an annual basis in 2026 and beyond.

OrthoPediatrics Expands Its Lower Extremity Bracing Portfolio with the Launch of OPSB® Knee 'TractorFIX

(NASDAQ:KIDS) OrthoPediatrics Corp. announced the expansion of its OrthoPediatrics Specialty Bracing (OPSB) portfolio with the launch of the OPSB Knee 'TractorFIX contracture management orthosis. The Knee 'TractorFIX is designed as a first-of-its-kind pediatric bracing solution for treating knee contractures in patients approximately 2 to 21 years old who are undergoing tibial treatment with an external fixator. The brace connects directly to the external fixator to support contracture management during tibial treatment. The system was developed to address clinical challenges such as limited range of motion, complicated rehabilitation, prolonged treatment, and negatively impacted functional outcomes caused by pediatric knee contractures. Joe Hauser, President of OrthoPediatrics Specialty Bracing and Trauma & Deformity, stated that Knee 'TractorFIX provides a standardized, pediatric-focused alternative to historically custom-built solutions. The product is intended to pair with the ORTHEX External Fixation platform to support surgeons, orthotists, patients, and families throughout the treatment journey. The company highlights that this collaboration addresses an unmet clinical need and integrates products across divisions to deliver more comprehensive pediatric orthopedic solutions. Knee 'TractorFIX expands OPSB's lower extremity bracing portfolio and addresses a clinical indication with limited pediatric-specific options. The bracing system adds to OPSB's growing offering of specialty bracing technologies, including DF2, TRAXIO, and PediHip. OrthoPediatrics currently markets over 90 systems serving trauma and deformity, scoliosis, and sports medicine/other procedures. The company distributes its products in the United States and over 75 countries outside the United States.

OrthoPediatrics Announces Distribution Agreement with OSSIO, Inc. to Provide Revolutionary Orthopedic Fixation Technology to U.S. Children’s Hospitals Nationwide

(NASDAQ:KIDS) OrthoPediatrics Corp. announced an exclusive distribution agreement with OSSIO, Inc. to bring a bio-integrative, metal-free fixation technology to U.S. children’s hospitals nationwide. OSSIO fiber implants are gradually replaced by the patient’s newly formed bone during the natural healing process, decreasing the need for hardware removal surgeries. OSSIO fiber implants provide initial fixation strength comparable to traditional metal implants and integrate into the patient’s bone tissue within 18–24 months post-implantation, leaving no hardware behind. OrthoPediatrics currently markets nearly 90 systems that serve three of the largest categories within the pediatric orthopedic market. The company distributes its products in the United States and over 75 countries outside the United States. OrthoPediatrics was founded in 2006 and is focused exclusively on advancing the field of pediatric orthopedics. The company projects that partnering with OSSIO expands its reach and capabilities with a revolutionary technology that complements its current product offering.

OrthoPediatrics Expands Specialty Bracing Portfolio with TRAXIO Halo Gravity Traction System

OrthoPediatrics Corp. (NASDAQ:KIDS) announced the expansion of its OrthoPediatrics Specialty Bracing (OPSB) portfolio with the launch of the TRAXIO Complete - Weight System, developed in collaboration with Synetik Group, Inc. The TRAXIO system is designed to deliver controlled, weight-based axial traction for gradual spinal realignment in pediatric patients. OrthoPediatrics currently markets over 85 products and distributes its products in the United States and over 75 countries outside the United States. Synetik Group, based in Quebec, Canada, is known for its Vertiflex line and distributes products across North America.