Business
KORU Medical Systems Receives FDA 510(k) Clearance for Delivery of EMPAVELI® (pegcetacoplan), Expands European Label for FreedomEdge®
KORU expands label indication for self-administered FreedomEdge infusion system CHESTER, N.Y.--(BUSINESS WIRE)-- Repro Med Systems, Inc. dba KORU Medical
About this update from Koru Medical Systems, Inc.
[{"type":"text","content":"\nKORU expands label indication for self-administered FreedomEdge infusion system\n\n CHESTER, N.Y.--(BUSINESS WIRE)--\nRepro Med Systems, Inc. dba KORU Medical Systems (NASDAQ: KRMD) (\"KORU Medical\" or the \"Company\"), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and easy-to-use specialty infusion solutions that improve quality of life for patients, today announced 510k clearance for use of the KORU Medical FreedomEdge® infusion system to deliver pegcetacoplan 20 mL solution, branded as EMPAVELI® or Aspaveli® and commercialized by Apellis in the United States and by Sobi outside the United States.\n\nEMPAVELI® and Aspaveli® are approved to treat adults with a chronic disease called paroxysmal nocturnal hemoglobinuria (PNH), which affects approximately 15,000 patients with PNH worldwide. PNH is a rare, life-threatening blood disorder caused by an acquired mutation, which leads to the body’s immune system destroying its own red blood cells, causing frequent transfusions and symptoms such as severe fatigue, hemoglobinuria, and difficulty breathing (dyspnea).\n\n\"As the leader in subcutaneous self-administration of high-volume (>10 milliliters) drug delivery in the home, we are pleased to expand our label to another drug therapy class with the addition of EMPAVELI® and Aspaveli®,\" said Linda Tharby, KORU Medical's President and Chief Executive Officer. \"We're confident that our online training capability and our support to healthcare providers, as proven by our work with tens of thousands of subcutaneous immunoglobulin patients, will help enable EMPAVELI® and Aspaveli® infusions. The FreedomEdge was used in EMPAVELI’s PNH pivotal studies and is now commercially available. This FDA clearance is another example of our strategy to expand the use of our self-administered Freedom pump platforms to further drug therapies and optimize the infusion experience.\"\n\nAbout KORU Medical Systems\n\nKORU Medical Systems develops, manufactures, and commercializes innovative and easy-to-use specialty infusion solutions that improve quality of life for patients around the world. The FREEDOM Syringe Infusion System currently includes the FREEDOM60® and FreedomEdge® Syringe Infusion Drivers, Precision Flow Rate Tubing™ and HIgH-Flo Subcutaneous Safety Needle Sets™. These de...