KORU Medical Systems Announces EU MDR Certification for the Freedom60® Infusion Pump With Prefilled Syringe Compatibility KORU Medical Systems (NASDAQ: KRMD) announced EU MDR certification for its Freedom60® Infusion Pump, including the 50 mL prefilled syringe adapter, enabling commercialization across the European Union. Freedom60 complements the FreedomEDGE® system (20 mL syringe compatibility) to expand prefilled syringe options for subcutaneous immunoglobulin (SCIg) therapy.The certification aims to simplify home infusion, reduce preparation and handling steps, and broaden patient access to intuitive large-volume subcutaneous delivery across Europe.

#KRMD KORU Medical Systems Announces EU MDR Certification for the Freedom60® Infusion Pump With Prefilled Syringe Compatibility

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KORU Medical Systems Announces CEO Transition KORU Medical Systems, Inc., a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, today announced that following five years of service to the Company, Linda Tharby, President and Chief Executive Officer, will retire effective...

#KRMD KORU Medical Systems Announces CEO Transition

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Infusion device maker KORU lifts sales 22% and targets cash-generating 2026 2026 outlook sees $47.5–$50M revenue and positive EBITDA and cash flow, as KORU gains RYSTIGGO clearance and EU MDR-ready Freedom60 pump.

#KRMD KORU Medical Systems Announces +20% Fourth Quarter and Full Year 2025 Revenue Growth, Positive Adjusted EBITDA and Initiates Full Year 2026 Guidance

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KORU Medical Systems Announces 510(k) Submission for Clearance of the FreedomEDGE® System with a Commercialized Oncology Biologic KORU Medical Systems (NASDAQ: KRMD) announced on December 30, 2025 the submission of a 510(k) premarket notification to the U.S. FDA seeking clearance to use the FreedomEDGE® infusion system to subcutaneously administer PHESGO® (pertuzumab/trastuzumab/hyaluronidase-zzxf) for HER2+ breast cancer.The filing targets expansion of FreedomEDGE beyond immunoglobulin indications into the oncology infusion center market and aims to address administration speed, reduced chair time, and nursing workflow challenges. KORU highlights the Freedom System's commercial track record: 15+ years on market, 45,000+ patients, > 2 million infusions annually, 97% adherence, and 8 on-label subcutaneous drugs across 30+ countries. The company anticipates market entry upon FDA 510(k) clearance.

#KRMD KORU Medical Systems Announces 510(k) Submission for Clearance of the FreedomEDGE® System with a Commercialized Oncology Biologic

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KORU Medical Systems Announces 27% Q3 Revenue Growth and Raises 2025 Revenue Guidance Alvotech (NASDAQ: ALVO) said the European Medicines Agency CHMP issued a positive opinion recommending approval of AVT03, its proposed biosimilar to Prolia® (denosumab 60 mg/mL pre-filled syringe) and Xgeva® (denosumab 70 mg/mL vial), on September 22, 2024. The company said AVT03 remains under EMA review with a final European Commission decision pending. Upon approval, commercial partners STADA and Dr. Reddy’s will market the product in Europe under semi-exclusive rights with assigned tradenames Kefdensis, Zvogra, Acvybra and Xbonzy.This step affects access to denosumab therapies indicated for osteoporosis, fracture risk and oncology bone complications and moves AVT03 closer to potential European commercialization pending the final regulatory decision.

#KRMD KORU Medical Systems Announces 27% Q3 Revenue Growth and Raises 2025 Revenue Guidance

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Leading Indicators, Tuesday November 11, 2025 – Crystal Equity Research

Small-cap stocks with declining money flow, Tue Nov 11th - #THM #ULBI #TASK #SDST #RR #QTTB #OM #NB #KRMD #JACK #III #HUMA #GIC #FOXF #ENGN #CCSI #BIVI #ABAT #KLC #HY #EBF #DHO #CNNE #BNED #AMN - More: crystalequityresearch.com/leading-indi... - #smallcap

#KRMD KORU Medical Systems Announces Development Agreement for Innovation in Subcutaneous Immunoglobulin Infusion Systems

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Revolutionary Joint Infection Treatment: KORU Medical and ForCast Join Forces on FDA Fast-Track Therapy KORU Medical's FreedomEDGE infusion system selected for ForCast's WIIS platform treating periprosthetic joint infection. FDA grants Orphan Drug and QIDP designations. Clinical trials set for 2026.

#KRMD ForCast Orthopedics and KORU Medical Systems Announce Agreement for Novel Antibiotic Infusion Therapy

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SmCpStr Technicals – Technical Indicators for Small-cap Stocks

Small-cap stocks with improving money flow, Mon Jul 7th - #ZVRA #ZJK #XHG #VIGL #TRS #MDIA #LNSR #KRMD #BTCS #ALLR #OCFT #MUX #MED #AMPX - More: crystalequityresearch.com/SmCpStr/ - #smallcap

KORU Medical Joins Elite Russell 3000 Index: Growth Strategy Pays Off With Dual Index Inclusion KORU Medical's addition to Russell 3000 and Russell 2000 indexes validates growth strategy. Learn how this milestone impacts $10.6T in benchmarked assets. See details.

#KRMD KORU Medical Systems to Join Russell 3000® and Russell 2000® Indexes

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KORU Medical Systems Announces Record Q1 2025 Financial Results and Raises 2025 Revenue Guidance KORU Medical Systems (NASDAQ: KRMD) reported strong Q1 2025 financial results, with net revenues reaching $9.6 million, an 18% increase year-over-year. The company's core business grew 21% to $9.4 million, driven by domestic and international expansion. Gross profit increased 19% to $6.0 million, with improved margins of 62.8%.Key highlights include plans to submit two FDA 510(k) clearances for commercialized drugs with the Freedom Infusion System™ in 2025. The company raised its 2025 revenue guidance to $38.5-39.5 million from $38.0-39.0 million, maintaining gross margin guidance of 61-63% and expecting positive cash flow from operations for 2025.Despite a quarterly net loss and cash usage of $0.8 million, KORU ended Q1 with $8.7 million in cash. The company's growth was primarily driven by new patient starts, market share gains, and international geographical expansion.

#KRMD KORU Medical Systems Announces Record Q1 2025 Financial Results and Raises 2025 Revenue Guidance

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KORU Medical Delivers 23% Revenue Surge: Record Quarter Sets Stage for Ambitious 2025 KORU Medical achieves 23% Q4 revenue growth to $8.8M, driven by core business expansion and 122% surge in Novel Therapies. Company projects strong 2025 outlook with 16% growth target.

#KRMD KORU Medical Systems Announces Fourth Quarter and Full Year 2024 Financial Results With Record Revenues and Gross Profit; Issues Full Year 2025 Guidance

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Revolutionary SCIg Therapy Innovation: KORU Medical and SCHOTT Join Forces to Transform Home Infusion KORU Medical teams with major pharma company and SCHOTT Pharma to develop groundbreaking subcutaneous immunoglobulin therapy system, advancing home treatment options.

#KRMD KORU Medical Systems Announces Agreement for Next-Generation Subcutaneous Immunoglobulin Infusion System

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Major Breakthrough: KORU Medical Targets 30,000 Patient Market with Revolutionary Kidney Treatment Trial KORU Medical teams with global pharma leader for Phase III trial targeting rare renal disorder, potentially expanding treatment access to 30,000 patients requiring 300,000 annual infusions.

#KRMD KORU Medical Systems Announces Phase III Clinical Trial Collaboration for a New Drug Indication in Nephrology

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#KRMD KORU Medical Systems to Participate in Piper Sandler’s 36th Annual Healthcare Conference

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#KRMD KORU Medical Systems, Inc. Announces 2024 Q3 Financial Results, Third Consecutive Quarter of Double-Digit Growth; Raises Full Year 2024 Guidance

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