Financial Data and Key Metrics Changes - In Q3 2025, worldwide revenue was $61.2 million, a 12% increase compared to Q3 2024, driven by strong performance in Trauma and Deformity, Scoliosis, and OPSB, offset by declines in 7D unit sales and LATSAM stocking and set sales [19][20] - U.S. revenue reached $48.7 million, a 14% increase from the prior year, representing 80% of total revenue [19] - Adjusted EBITDA improved by 56% to $6.2 million compared to $4.0 million in Q3 2024 [24] - Gross profit margin increased to 74% from 73% year-over-year, primarily due to a favorable product sales mix [20][21] Business Line Data and Key Metrics Changes - Trauma and Deformity global revenue grew by 17% to $44.1 million, driven by strong growth in multiple product lines [20] - Scoliosis global revenue increased by 4% to $16.3 million, led by sales of RESPONSE 5560 and Firefly, despite a decline in 7D unit sales [20][14] - OPSB growth was robust, contributing significantly to overall revenue growth [6][12] Market Data and Key Metrics Changes - International revenue totaled $12.5 million, a 6% increase year-over-year, primarily driven by increased procedure volumes in EMEA and APAC, offset by lower sales in LATSAM [19][16] - The company experienced strong demand in EMEA for scoliosis products, while LATSAM faced ongoing headwinds [17][14] Company Strategy and Development Direction - The company aims to address unmet needs in pediatric healthcare, focusing on expanding its core business segments, including Trauma and Deformity and Scoliosis implants [5][12] - The 3P platform is expected to drive future growth, with new product launches planned for the coming years [11][68] - The company is strategically expanding its OPSB clinics, with a focus on high-demand markets and operational efficiency [13][12] Management's Comments on Operating Environment and Future Outlook - Management acknowledged challenges in 7D capital sales and LATSAM but expressed confidence in the core business's strength and profitability [6][9] - The company expects to generate positive free cash flow in Q4 2025 and aims for breakeven in 2026 [9][25] - Management highlighted the exit of competitors from the pediatric space as a potential opportunity for market share growth [27][28] Other Important Information - Total operating expenses increased by 19% to $54.7 million, driven by restructuring and impairment charges, as well as growth in OPSB clinics [21][22] - The company recorded a GAAP net loss per share of $0.50, compared to $0.34 in the prior year [23] Q&A Session Summary Question: Competitors exiting the space - Management noted that major OEMs like Johnson & Johnson and Smith & Nephew are pulling pediatric-specific products, which could benefit the company competitively [27][28] Question: Expansion of OPSB clinics - Management confirmed high demand for clinics and expressed willingness to accelerate openings if feasible, balancing profitability with growth [29][30] Question: Revenue and EBITDA guidance - Management clarified that product mix is the primary driver of changes in EBITDA guidance, with no significant concerns about the revenue range [34] Question: Impact of 7D sales on growth - Management indicated that delays in 7D placements would not significantly impact long-term growth rates for the implant business [51] Question: EU MDR approvals and staffing changes - Management confirmed that upcoming EU MDR approvals would enhance the Scoliosis portfolio in Europe, while staffing reductions are part of cost management efforts [60][62]