KORU Medical Systems, a prominent company in the medical technology sector, has entered into a clinical supply agreement for a groundbreaking subcutaneous immunoglobulin (SCIg) drug that is set to undergo Phase 3 trials. This development is a significant step forward in the quest to provide innovative therapies for individuals suffering from various immunological disorders.
The Phase 3 trials are designed to evaluate the safety, efficacy, and overall performance of the SCIg drug in treating a range of medical conditions, including but not limited to
autoimmune diseases,
primary immunodeficiency disorders, and
neurological disorders. The novel drug is expected to offer a new avenue of treatment for patients who have limited options.
KORU Medical's team of experts has developed a custom device that integrates advanced technology with user-friendly interfaces. The device is specifically designed to enhance patient comfort and ensure the precise delivery of therapy. This development aligns with KORU Medical's commitment to improving the quality of life for patients through the provision of innovative and patient-centric solutions.
Linda Tharby, President and CEO of KORU Medical, expressed pride in the company's role in developing devices that cater to the needs of large volume subcutaneous delivery. She highlighted the company's dedication to supporting pharmaceutical partners in their drug development processes and meeting patient needs. The execution of the Phase 3 clinical supply agreement is seen as a critical milestone in KORU Medical's ongoing mission to advance healthcare through innovation.
In the event of successful completion and positive results from the Phase 3 trial, KORU Medical anticipates filing a 510k and commercializing the novel
SCIg drug. The company's flagship product, the FREEDOM Syringe Infusion System, includes a range of devices designed for home and alternate care settings, which are aimed at improving the infusion experience for patients.
KORU Medical Systems is dedicated to developing, manufacturing, and commercializing large volume subcutaneous infusion solutions that are both innovative and centered around patient needs.
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