Core Insights - Sustained outperformance in MedTech requires structural demand drivers, improving execution, and clear earnings visibility rather than just short-term market rallies [2][6] - A select group of MedTech stocks, including TransMedics (TMDX), KORU Medical Systems (KRMD), and Cardinal Health (CAH), have significantly outperformed the S&P 500, which rose 19.3% over the past year [3][8] TransMedics (TMDX) - TMDX shares increased by 89.8% over the past year, driven by the adoption of its Organ Care System (OCS) and the expansion of its National OCS Program (NOP) [7][10] - The company reported revenues of $143.8 million in Q3 2025, reflecting a 32% year-over-year growth, with service revenues rising 35% [9][10] - The Zacks Consensus Estimate for 2026 sales is $723.8 million, indicating approximately 20.5% growth, with plans for European expansion [10][11] KORU Medical Systems (KRMD) - KRMD achieved a 45.5% stock growth over the past year, with Q3 2025 revenues of $10.4 million, marking a 27% year-over-year increase [13][15] - Core SCIg revenues grew about 30%, supported by international expansion and market share gains, despite a dip in U.S. revenues due to inventory adjustments [14][15] - The Zacks Consensus Estimate for 2026 sales is $49 million, implying 20.2% growth, with ongoing advancements in non-Ig drug collaborations [15][16] Cardinal Health (CAH) - CAH stock surged by 35.3% over the past year, with Q1 fiscal 2026 revenues of $64 billion, up 22% year-over-year, and earnings per share of $2.55, representing 36% growth [18][20] - The Pharmaceutical and Specialty Solutions segment led performance, with 23% revenue growth and 26% profit growth [19][20] - Management raised full-year fiscal 2026 earnings per share guidance to $9.65-$9.85, indicating 17-20% growth, while also returning $500 million to shareholders [20][21]

Core Insights - KORU Medical Systems, Inc. (KRMD) has submitted a 510(k) premarket notification to the FDA for its FreedomEDGE infusion system to deliver PHESGO, a breast cancer treatment, subcutaneously instead of intravenously, marking a significant regulatory and strategic milestone for the company [2][5] Company Developments - The FDA clearance submission for FreedomEDGE aligns with KRMD's long-term growth strategy to transition oncology care from intravenous to subcutaneous drug delivery, potentially improving efficiency for infusion centers and easing the workload for nurses [3][7] - The successful clearance and commercialization of the FreedomEDGE system could expand KRMD's addressable market by establishing a subcutaneous delivery platform for oncology biologics, moving beyond its traditional immunology treatments [5][8] - The FreedomEDGE system aims to simplify the treatment process for infusion centers by addressing challenges such as complicated treatment steps and time constraints, thereby enhancing patient comfort and operational efficiency [9][10] Market Context - The subcutaneous drug delivery devices market is projected to be valued at $33.56 billion by 2025, with a CAGR of 7.62% through 2034, driven by the increasing prevalence of chronic diseases and the adoption of subcutaneous delivery devices [11]