Koru Medical Systems (Nasdaq:KRMD) announced today that it received regulatory clearance in Japan for its FreedomEdge infusion system. Clearance covers the delivery of multiple drugs, including CSL Behring’s Hizentra subcutaneous immunoglobulin (SCIg), Takeda Pharmaceutical’s Cuvitru SCIg and Sobi’s Aspaveli paroxysmal nocturnal hemoglobinuria (PNH). FreedomEdge offers the convenient and efficient administration of large-volume subcutaneous therapies at […]
Koru Medical Systems
Koru Medical submits infusion system for FDA 510(k) clearance
Koru Medical Systems (Nasdaq:KRMD) announced today that it submitted its Freedom60 infusion system for FDA 510(k) clearance. The submission covers the use of the Freedom60 infusion system with the Hizentra 50 mL prefilled syringe. In January, Koru inked a development agreement with a manufacturer of subcutaneous immunoglobulin therapy (SCIg). The deal sought to garner regulatory […]
Koru Medical Systems inks development deal on Freedom Infusion System with prefilled syringe
Koru Medical Systems (Nasdaq:KRMD) announced that it entered into a development agreement with a manufacturer of subcutaneous immunoglobulin therapy (SCIg). The agreement aims to develop and seek regulatory approval for the Freedom Infusion System with an SCIg prefilled syringe. Koru said the agreement provides it the opportunity to develop an adaptation to the Freedom system. […]
Koru Medical appoints new VP of medical affairs
Koru Medical Systems (Nasdaq:KRMD) announced today that it appointed Brent Rutland as its new VP of medical affairs. Rutland joins the Mahwah, New Jersey-based drug delivery technology developer with 27 years of experience in the space. Most recently, he served as a senior director for health outcomes at La Jolla Pharmaceutical Company. Among his previous […]
Koru Medical names former Fresenius Kabi VP as chief technology officer
Koru Medical Systems (Nasdaq:KRMD) announced that it appointed medtech veteran Brian Case as its new chief technology officer (CTO). With more than 20 years of experience in medtech R&D, Case joins after spending more than 16 years at Fresenius Kabi as VP of R&D. Before Fresenius Kabi, he served as an R&D program manager for […]
Koru Medical Systems rises as Q4 earnings beat Street projections
Koru Medical Systems (NSDQ:KRMD) shares ticked up today on fourth-quarter results that topped the consensus forecast. The Chester, New York-based infusion technology developer posted losses of $1.1 million, or 2¢ per share, on sales of $6.5 million for the three months ended Dec. 31, 2021, for a bottom-line slide further into the red on sales […]
