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KORU Medical Systems, Inc. (symbol: KRMD) is a prominent developer and manufacturer of innovative medical devices and supplies, headquartered at 24 Carpenter Road, Chester, New York, United States. Specializing in mechanical infusion products, the company is renowned for its cutting-edge FREEDOM Infusion Systems. These systems include the FREEDOM60 and FreedomEdge Syringe Drivers, designed to provide efficient and reliable delivery of life-saving therapies.
KORU Medical Systems primarily focuses on subcutaneous infusion devices, which are essential for administering immunoglobulin therapies to patients suffering from chronic illnesses such as Primary Immunodeficiencies (PIDD) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Their product line features the Precision Flow Rate Tubing and HIgH-Flo Subcutaneous Safety Needle Sets, enhancing the safety and effectiveness of home-based treatments.
The company's commitment to quality and innovation has positioned it as a leader in the medical device industry. Recent achievements include advancements in product technology and expanded partnerships aimed at enhancing patient care and expanding market reach. KORU Medical Systems continues to prioritize patient-centered solutions, ensuring their products meet the highest standards of safety and performance.
KORU Medical Systems (NASDAQ: KRMD) has secured regulatory clearance for its FreedomEdge® Infusion System in Japan. This approval includes the delivery of multiple drugs such as CSL Behring’s Hizentra, Takeda Pharmaceutical’s Cuvitru, and Sobi’s Aspaveli for conditions like Subcutaneous Immunoglobulin therapy (SCIg) and Paroxysmal Nocturnal Hemoglobinuria (PNH).
This clearance marks a significant milestone for KORU Medical, expanding its international market reach and enhancing patient care in Japan. The FreedomEdge® System, known for its reliability and patient-friendly design, allows for convenient at-home or clinical administration of large volume subcutaneous therapies.
CEO Linda Tharby highlighted this regulatory success as a testament to KORU’s commitment to improving global healthcare solutions. The system’s customizable features and portable design offer flexible and effective therapy management for patients and healthcare providers alike.
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.
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