Welcome to our dedicated page for Koru Med Sys news (Ticker: KRMD), a resource for investors and traders seeking the latest updates and insights on Koru Med Sys stock.
KORU Medical Systems develops, manufactures, and commercializes large-volume subcutaneous infusion solutions for drug delivery in home and ambulatory care settings. Its Freedom Syringe Infusion System includes Freedom60 and FreedomEDGE syringe infusion drivers, Precision Flow Rate Tubing, and HigH-Flo Subcutaneous Safety Needle Sets.
Company updates commonly cover quarterly results, revenue guidance, cash flow trends, FDA 510(k) clearances, EU MDR certification, and label expansions, including FreedomEDGE use for RYSTIGGO delivery. News also addresses pharma services and clinical-trial collaborations with biopharmaceutical companies, customization of the Freedom System across drug categories, and governance or leadership succession matters.
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.
KORU Medical Systems (NASDAQ: KRMD) appointed Eric Schiller as Chief Technology Officer, effective December 29, 2025. Mr. Schiller brings more than 25 years of device engineering, R&D, drug–device combination, supply chain, and product lifecycle experience. He previously served as Global Head of Device Development Portfolio at Sanofi, where he oversaw more than 80 pipeline assets, and held senior roles at Bristol-Myers Squibb, Celgene, Becton Dickinson, and Saint-Gobain. Mr. Schiller holds an MBA from Seton Hall and a BS in Mechanical Engineering from NJIT, and is an inventor on more than a dozen U.S. patents. He will lead product development, innovation pipeline, and long-term technology strategy to support KORU's platform expansion and commercialization efforts.
KORU Medical (NASDAQ: KRMD) will present data at the ESID/EHA/SIOPE Focused Symposium 2025 in Vienna, November 18-20, on a multicenter nursing survey comparing the FreedomEDGE® Infusion System with manual push for short-duration subcutaneous infusions.
Key results: 91% of nurses found the system easier to use and faster to set up, 81% reported reduced hand strain, 97% reported increased patient interaction time, and 73% of patients noted improved comfort; 97% would recommend the system. KORU expects a 510(k) filing for use with a commercial oncology drug in Q4 2025 or Q1 2026. The Freedom platform cites 15+ years of home use, 45,000+ patients, >2M annual infusions, 97% adherence, 8 on-label drugs, and distribution in 30+ countries.
KORU Medical (NASDAQ: KRMD) will participate in three investor conferences in Nov–Dec 2025. Management will attend the 16th Annual Craig‑Hallum Alpha Select Conference on Nov 18, 2025, the Canaccord Genuity MedTech, Diagnostics and Digital Health & Services Forum on Nov 20, 2025, and will present at Piper Sandler’s 37th Annual Healthcare Conference on Dec 2, 2025 at 9:30 am ET. Interested parties can access live and archived webcasts on the company’s Investors > News/Events page at www.korumedical.com.
KORU Medical Systems (NASDAQ: KRMD) announced a development agreement with a global pharmaceutical company to collaborate on next‑generation subcutaneous immunoglobulin (SCIg) infusion systems.
The work will support qualification of an infusion system that accepts both vials and prefilled syringes (PFS), built on KORU’s Freedom60®/FreedomEDGE® infusion technology and SCHOTT TOPPAC® polymer syringes. KORU highlights its FREEDOM Syringe Infusion System as supporting 5mL–50mL+ volumes and being market proven with 15+ years of home use, 45,000+ patients, 2M+ infusions annually, a 97% adherence rate, 8 on‑label subcutaneous drugs, and distribution in 30+ countries.
KORU Medical Systems (NASDAQ: KRMD) will report its third quarter 2025 financial results on Wednesday, November 12, 2025.
Management will host a conference call and live webcast at 4:30 p.m. ET to discuss results and provide a corporate update. U.S./Canada dial-in is (877) 407-0784; international dial-in is (201) 689-8560. A live and archived webcast will be available via the Investor Relations calendar at www.korumedical.com. The archived webcast will remain accessible for six months.
KORU Medical Systems (NASDAQ: KRMD) has partnered with ForCast Orthopedics to integrate KORU's FreedomEDGE® infusion system into ForCast's Wearable Intra-Articular Infusion System (WIIS) for treating periprosthetic joint infection (PJI).
The collaboration aims to support ForCast's FC001 program, which has received both Orphan Drug Designation and Qualified Infectious Disease Program (QIDP) designation from the FDA. The program targets PJI, a rare but serious complication of joint replacement procedures where bacteria form resistant biofilms on prostheses. Clinical trials are anticipated to begin in 2026.
KORU Medical Systems (NASDAQ: KRMD) reported strong Q2 2025 financial results, achieving a significant milestone with quarterly revenue exceeding $10.2 million, marking a 21% increase year-over-year. The company's core business revenue grew 19% to $9.3 million, while Pharma Services and Clinical Trials revenue surged 42% to $0.9 million.
Key highlights include gross profit of $6.5 million (63.5% margin), improved cash position with quarterly usage of $0.6 million, and the appointment of Adam Kalbermatten as Chief Commercial Officer. The company raised its 2025 revenue guidance to $39.5-$40.5 million, representing 18-20% growth, while maintaining gross margin guidance of 61-63%.
Notable developments include the Freedom Infusion System's expanded indication for Empaveli® in C3G and Primary IC-MPGN treatment, and a new FDA 510(k) submission for use with a rare disease biologic drug.
KORU Medical Systems (NASDAQ: KRMD), a medical technology company specializing in subcutaneous infusion solutions, has granted inducement equity awards to its new Chief Commercial Officer, Adam Kalbermatten. The compensation package includes:
600,000 nonqualified stock options at $3.44 per share granted on August 1, 2025, and 300,000 restricted shares awarded on July 28, 2025. Both awards vest 25% annually over four years, with potential accelerated vesting. The Compensation Committee approved these awards under Nasdaq Listing Rule 5635(c)(4) as part of Kalbermatten's employment agreement dated June 30, 2025.
KORU Medical Systems (NASDAQ: KRMD), a medical technology company specializing in subcutaneous infusion solutions, has announced its participation in the upcoming Canaccord Genuity 45th Annual Growth Conference.
The Company's management will deliver their presentation on August 13, 2025, at 10:30 am ET. Investors and interested parties can access both the live and archived webcast through the News/Events page in the Investors section of KORU Medical's website.