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, Inc. (NASDAQ: KRMD) is a medical technology company in the surgical and medical instrument manufacturing industry, focused on large-volume subcutaneous infusion solutions. News about KORU Medical frequently centers on its Freedom Syringe Infusion System, financial performance, regulatory milestones, and collaborations with biopharmaceutical partners.
Investors following KRMD news can expect regular updates on quarterly and annual financial results, including net revenue trends, core business performance, and contributions from Pharma Services and Clinical Trials. The company often provides revenue guidance and discusses metrics such as gross margin and cash position in its earnings-related press releases, which are also referenced in Form 8-K filings.
KORU Medical’s news flow also highlights regulatory and clinical developments. This includes FDA 510(k) submissions for the Freedom System to be used with specific biologic drugs, such as rare disease therapies and oncology biologics like PHESGO for HER2+ breast cancer. The company reports clinical and real-world evidence, including multicenter evaluations comparing the FreedomEdge Infusion System with manual push techniques in oncology and immunology settings, focusing on nurse satisfaction, patient comfort, and workflow efficiency.
Another key news category involves strategic collaborations and development agreements with pharmaceutical and medical technology partners. Examples include agreements to develop next-generation subcutaneous immunoglobulin infusion systems and to integrate the FreedomEdge pump into wearable infusion platforms for targeted antibiotic delivery in periprosthetic joint infection.
In addition, KORU Medical issues announcements about leadership appointments, equity awards, and participation in investor conferences, providing insight into its management priorities and engagement with the investment community. For ongoing coverage of KRMD, this news page aggregates company press releases and related updates so readers can monitor financial disclosures, regulatory progress, and partnership activity over time.
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.
KORU Medical (NASDAQ: KRMD) announced a planned CEO transition: Linda Tharby will retire effective June 30, 2026, and Adam Kalbermatten, currently Chief Commercial Officer, will assume the CEO role effective July 1, 2026 (appointed President effective March 15, 2026).
Under Tharby, the company doubled its recurring patient base to over 55,000, expanded internationally, broadened the Freedom infusion platform beyond immunoglobulin, delivered consistent revenue growth, and achieved profitability. Tharby will remain on the board and advise through the end of 2026.
KORU Medical (NASDAQ: KRMD) reported strong 2025 results with full-year net revenues of $41.1M (up 22%) and fourth-quarter revenues of $10.9M (up 23%). Gross profit rose to $25.6M with 62.3% margin. Net loss improved to $2.6M and adjusted EBITDA turned positive at $0.6M. Ending cash was $8.9M. The company received a 510(k) clearance, announced EU MDR certification, expanded pharma collaborations, and initiated 2026 guidance of $47.5–$50.0M revenue with positive adjusted EBITDA and cash flow.
KORU Medical Systems (NASDAQ: KRMD) will report fourth quarter and full year 2025 financial results on Thursday, March 12, 2026.
Management will host a conference call and live webcast at 4:30 p.m. ET. Dial-in numbers and a live/archived webcast are available via the company's investor relations calendar at www.korumedical.com. The archived webcast will be available for six months.
KORU Medical (NASDAQ: KRMD) received FDA 510(k) clearance to use the FreedomEDGE® infusion system to deliver RYSTIGGO® (rozanolixizumab-noli), expanding the FreedomEDGE label to include administration by a healthcare professional and broadening access for patients with generalized myasthenia gravis (gMG).
The clearance covers weekly 3–6 mL subcutaneous infusions over 15–30 minutes for six weeks with subsequent cycles per clinical evaluation. Freedom System metrics: 15+ years home use history, 45,000+ patients, 2M+ infusions annually, 97% adherence, and 9 on-label subcutaneous drugs across 30+ countries.
KORU Medical (NASDAQ: KRMD) reported preliminary unaudited results for Q4 and full year ended December 31, 2025. Preliminary Q4 net revenues are expected to be $10.9 million (+23% YoY) and preliminary full-year net revenues are expected to be $41.1 million (+22% YoY). The company reported an ending cash balance of $8.9 million and stated it achieved positive cash flow in Q4 and positive operating cash flow for the full year 2025. Management highlighted continued strength in the immunoglobulin business, growth in the recurring patient base, ongoing international expansion, and a recent 510(k) submission for the Freedom Infusion System for use with Phesgo® intended to expand into oncology. Final audited results and 2026 guidance are planned for early March 2026.
KORU Medical (NASDAQ: KRMD) awarded inducement equity to its new Chief Technology Officer under his employment agreement dated December 11, 2025. On January 2, 2026, the company granted nonqualified stock options to purchase 232,297 shares at an exercise price of $5.70 and 76,426 restricted shares.
Each award vests 25% on each anniversary of the grant date, subject to the award agreements and possible accelerated vesting. The Compensation Committee approved the awards as an inducement material to employment under Nasdaq Listing Rule 5635(c)(4).
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.