MAHWAH, N.J. - KORU Medical Systems, Inc. (NASDAQ: KRMD), a company specializing in large volume subcutaneous infusion solutions, has entered into a clinical supply agreement related to a novel subcutaneous immunoglobulin (SCIg) drug, now proceeding to Phase 3 trials.
The announcement marks a significant step in the development of new treatments for patients with immunological disorders.
The Phase 3 trial will evaluate the drug's safety, efficacy, and performance across a variety of medical conditions, including autoimmune diseases, primary immunodeficiency disorders, and neurological disorders. KORU Medical has developed a custom device for the trial, which is based on the company's existing Freedom System but tailored to the specific requirements of the new drug.
Linda Tharby, President and CEO of KORU Medical, expressed pride in the company's ability to meet the needs of pharmaceutical partners and patients. She highlighted the partnership's role in advancing healthcare through innovation. Tharby also indicated that, contingent upon successful trial results, the company anticipates filing for FDA clearance to commercialize the SCIg drug.
KORU Medical's product portfolio includes the FREEDOM60® and FreedomEdge® Syringe Infusion Drivers, Precision Flow Rate Tubing™, and HIgH-Flo Subcutaneous Safety Needle Sets™, which are utilized for home and alternate care setting infusions.
The information in this article is based on a press release statement from KORU Medical Systems, Inc.
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