KORU Medical Systems Announces 510(k) Submission for Clearance of the FreedomEDGE® System with a Commercialized Oncology Biologic [Yahoo! Finance]
Repro Med Systems, Inc. (KRMD)
Company Research
Source: Yahoo! Finance
company focused on the development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, today announced the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking clearance for the use of KORU Medical's FreedomEDGE® infusion system to subcutaneously administer PHESGO® (pertuzumab/trastuzumab/hyaluronidase-zzxf), a co-formulated therapy for HER2+ breast cancer. The submission represents a key milestone in KORU Medical's strategy to expand the use of the FreedomEDGE® system beyond its current immunoglobulin (Ig) indications and into the broader oncology infusion center market. The increasing shift from intravenous (IV) to subcutaneous (SC) drug delivery for cancer therapies allows for faster drug administration, reduced patient chair time, and aligns with a movement towards a more efficient care model. However, despite these advances, infusion centers continue to face unmet
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KRMD
News
- KORU Medical Systems (NASDAQ:KRMD) had its "buy" rating reaffirmed by analysts at Craig Hallum.MarketBeat
- KORU Medical Systems Reports Preliminary Q4 and Full Year 2025 Results; Achieves Record Revenue and Full Year Positive Operating Cash Flow [Yahoo! Finance]Yahoo! Finance
- KORU Medical Systems Reports Preliminary Q4 and Full Year 2025 Results; Achieves Record Revenue and Full Year Positive Operating Cash FlowBusiness Wire
- KORU Medical Systems (NASDAQ:KRMD) was upgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=KRMD&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall StreMarketBeat
- KORU Medical Systems Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4) [Yahoo! Finance]Yahoo! Finance
KRMD
Earnings
- 11/12/25 - Beat
KRMD
Sec Filings
- 1/15/26 - Form 4
- 1/15/26 - Form 3
- 1/12/26 - Form 8-K
- KRMD's page on the SEC website