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KORU Medical Systems Inc (KRMD) specializes in innovative subcutaneous infusion systems for critical therapies. This hub provides authorized updates about the company's medical device developments, regulatory milestones, and strategic initiatives.
Investors and healthcare professionals will find timely announcements including product launch details, financial disclosures, and manufacturing updates. Our curated collection ensures access to verified information about FREEDOM infusion systems and related technologies.
Key updates cover FDA clearances, partnership announcements, clinical application insights, and operational developments. All content maintains strict compliance with financial disclosure regulations and medical device reporting standards.
Bookmark this page for streamlined access to KRMD's latest advancements in immunoglobulin therapy delivery systems. Check regularly for official updates directly impacting the medical device sector and chronic care treatment landscapes.
SCHOTT Pharma and KORU Medical Systems (NASDAQ: KRMD) announced a collaboration to advance large-volume subcutaneous infusion. KORU Medical, known for its Freedom Infusion System, and SCHOTT Pharma, known for its TOPPAC® prefillable polymer syringes, aim to optimize drug delivery in large-volume subcutaneous infusion markets. The collaboration seeks to simplify and de-risk drug administration for both healthcare professionals and patients. The focus is on therapies requiring large volumes and recurring dosing, such as chronic diseases and cancer. Their joint solution promises improved time-to-market for infusion therapies and a streamlined drug development process. SCHOTT's prefillable syringes, available in 5mL to 50mL formats, are compatible with KORU's Freedom System, enhancing ease of use and reducing administration errors.
KORU Medical Systems (NASDAQ: KRMD) announced a collaboration with a global pharmaceutical company to initiate a feasibility study for their Freedom Infusion System. This system, designed for subcutaneous administration, will be tested with an FDA and EMA approved oncology biologic drug currently administered manually by healthcare professionals. The Freedom System, a mechanical ambulatory drug delivery device, can deliver large volumes of medications from 2mL to over 100mL. If successful, the study could lead to the commercialization of the system within 12 months, addressing a growing trend in oncology for subcutaneous drug administration.
KORU Medical Systems (NASDAQ: KRMD) has signed a Phase III clinical supply agreement for a new enzyme replacement therapy targeting a rare endocrinological disease. This follows the successful validation of the KORU Medical Freedom System for subcutaneous infusion. The trial will evaluate bi-weekly infusions, with potential treatment impact for 10,000 patients globally. The experimental drug has been granted Breakthrough Therapy, Rare Pediatric Disease, Fast Track, and Orphan Drug designations by the FDA and in Europe.
KORU Medical President and CEO, Linda Tharby, expressed pride in their device development for large volume subcutaneous delivery and emphasized the company's expanding role in administering rare disease drugs.
KORU Medical Systems, Inc. (NASDAQ: KRMD) reported Q1 2024 financial results with net revenues of $8.2 million, an 11% increase YoY. Gross profit increased by 23% to $5.1 million. The company reaffirmed its full year 2024 revenue guidance of $31.2-$32.2 million, reflecting growth of 10-13% YoY. KORU Medical continues to expand its Core business and Novel Therapies collaborations, aiming for increased value for customers, patients, and shareholders.